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Business and Scientific Leadership
Our leaders apply their business, therapeutic, and scientific experience to
provide a range of services and expertise to our pharmaceutical and medical
device clients around the world.
Below are lists of some of our key business and project staff. Click on the plus signs to expand and view more details.
Business Management
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| Allen Mangel |
Allen Mangel, PhD, MD
Executive Vice President, RTI Health Solutions
MD
Georgetown University School of Medicine, Washington, DC PhD, Physiology
MS, Physiology
BS, Physiology
University Of Illinois, Urbana, IL Allen Mangel, MD, PhD, is a gastroenterologist and Executive Vice President of RTI-HS. Following completion of his medical training, Dr. Mangel did his internship and residency in internal medicine at Duke University Medical Center and then completed his gastroenterology fellowship also at Duke. Following completion of his formal training, he remained on the faculty in the Department of Medicine, Division of Gastroenterology, at Duke for 3 years. Dr. Mangel also has a PhD from the University of Illinois, where his research focused on control of electrical and mechanical activity in gastrointestinal smooth muscle. After Dr. Mangel left Duke, he joined the gastroenterology clinical research department at Glaxo Wellcome, where he conducted numerous clinical trials and directed product development teams. After departing Glaxo Wellcome, he became Vice-President of Research and Development at Salix Pharmaceuticals. Dr. Mangel has led or participated in numerous FDA interactions, Advisory Committee Presentations, label negotiations, and NDA submissions, and he has authored more than 80 publications.
Email Allen Mangel
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| Larry N Bell |
Larry N Bell, PhD
Vice President, Business Affairs
PhD, Organic Chemistry
Massachusetts Institute of Technology, Cambridge, MA BS, Organic Chemistry
University of Delaware, Newark, DE Lawrence Bell, PhD, is the Vice President of Business Affairs for RTI-HS. He has extensive management and hands-on experience consulting for and within the pharmaceutical industry to develop people, processes, and systems related to outcomes research, drug development, and health policy. At RTI-HS he has guided a number of business and technical functions, including Business Development, Office of Quality Assurance, Health Outcomes Strategy, and Health Economics. In addition, he has been extensively involved in the pre-IND (nonclinical) development of two novel chemical entities. He has broad experience with development strategy, including bench and scale-up chemistry, drug and dosage formulation and stability, and clinical trials. For more than 25 years, he served as a management team member for various divisions and departments of a major pharmaceutical company, establishing and shaping the direction of a number of groups, including Project Planning (tasks and their dependencies, timelines, and costs/budgets to submit INDs and NDAs), Health Economics, Health Policy Research, Clinical Data Processing and Management, and Quality Assurance. He has published in journals, including PharmacoEconomics, Journal of Medicinal Chemistry, International Journal of Technology Assessment in Health Care, Pharmacotherapy, Epilepsia, Journal of the American Chemical Society, and Journal of Organic Chemistry. Additionally, Dr. Bell was coauthor, coordinator, and editor for Chapter 3, “Estimating Drug Development Costs,” in the report “The Economics of TB Drug Development,” available at http://66.216.124.114/7_1_1GenericNewsArticles.asp?itemId=286 _Report.pdf.
Email Larry N Bell
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| Josephine A Mauskopf |
Josephine A Mauskopf, PhD
Vice President, Health Economics
PhD, Economics
MHA, Health Administration
MA, Physiology/Pharmacology
Duke University Josephine Mauskopf, PhD, MHA, is Vice President of Health Economics at RTI-HS. She has extensive experience both as a consultant and within the pharmaceutical industry designing and implementing pharmacoeconomic research strategies. She has designed pharmacoeconomic research programs for drugs for bacterial infections, viral infections, psychiatric illness, and neurologic diseases. Dr. Mauskopf has estimated budget impacts for new products for schizophrenia, bipolar disease, breast cancer, and HIV infection. She has estimated the cost-effectiveness of antiretroviral drugs, as well as drugs for treating herpes zoster, epilepsy, neonatal respiratory distress syndrome, digoxin toxicity, community acquired pneumonia, intra-abdominal infections, and primary pulmonary hypertension. Dr. Mauskopf also has estimated the impact of an antidepressant on work and social disability. Additionally, she has managed projects to develop or culturally adapt psychometrically valid quality of life measures for migraine, genital herpes, and epilepsy. Dr.Mauskopf has developed Markov models of disease progression for lung cancer and HIV infection and has developed a simulation model of time spent in the operating and recovery rooms. Dr. Mauskopf was previously Vice President at MEDTAP International, Department Head of Economics Research at Burroughs Wellcome Co., and Director of Pharmacoeconomics Research for Anti-Virals and Anti-Infectives at Glaxo Wellcome Inc. Dr. Mauskopf is Editor-in-Chief of the journal Value in Health. She served for 4 years as a reviewer on the Health Care Technology and Decision Sciences Study Section at the Agency for Healthcare Research and Quality. She has presented her research at numerous national and international symposia. She has also published extensively in journals, including the Journal of the American Medical Association, Journal of Pediatrics, PharmacoEconomics, Medical Care, American Journal of Public Health, Health Services Research, and the American Journal of Cardiology.
Email Josephine A Mauskopf
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| Dave Obringer |
Dave Obringer, JD
Senior Director, Contracting & Strategic Alliances
Dave Obringer, JD, is a member of RTI-HS’s Business Management Team (BMT). He also directs the contracting group supporting RTI-HS and leads review and implementation of strategic alliances and acquisitions. In these roles, he has led or overseen resolution of numerous contract issues in collaboration and/or negotiation with clients and third-party vendors, led or participated in the development and implementation of contracting and procurement processes, and served key roles in the opening of two new RTI-HS offices, one in the United States and one in Spain. He has also served key roles in due diligence activities in two acquisitions in which RTI-HS expanded its service offerings, one in the United States and one in Canada. Prior to joining RTI-HS, Mr. Obringer served as the lead transactional attorney and counsel for three of the four research divisions at RTI International (RTI-HS, Social & Statistical Sciences, Science & Engineering). In that role, he managed a large legal/administrative team including attorneys, contract professionals, and support staff. Mr. Obringer provided support, advice and counsel to the research business units on corporate-wide legal and regulatory matters including both governmental and commercial transactions, and created, reviewed, and approved contractual and legal documentsin support of their businesses. He also provided counsel to RTI’s administrative units andconsulted with and managed outside counsel as needed. Mr. Obringer has developed and presented training to contract and research staff on various topics, and served on the corporate steering committee overseeing the procurement and implementation of corporate-wide strategic financial systems.
Email Dave Obringer
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| Derek Ross |
Derek Ross, PhD
Vice President, Operations
PhD, Biochemistry
BSc, Biochemistry
Aberdeen University, Aberdeen, Scotland DMS, Management
Napier University, Edinburgh, Scotland PMP, Project Management
PMI (Project Management Institute) Derek Ross, PhD, is Vice President of Operations at RTI-HS and responsible for Project and Proposal Operations and Editorial Services. He has extensive international experience at a senior level in the pharmaceutical industry, leading technical scientific management, project management, and process improvement organizations. Previously, Dr. Ross was Vice President of Worldwide Project Planning, Strategy, and Business Re-Design at Glaxo Wellcome, and Vice President of Information Technology Portfolio and Project Management at GlaxoSmithKline. He has also founded his own management consulting business, which focuses on building high-performance organizations with emphasis on business strategy and the management of major organizational change.
Email Derek Ross
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| Christopher R Simmons |
Christopher R Simmons, CPA
Vice President, Finance
BA, Accounting
North Carolina State University, Raleigh, NC Biotechology for Business Executive Education Course
Duke University, Durham, NC CPA (Certified Public Accountant) Chris Simmons, CPA, is Vice President of Finance at RTI-HS, heading both the finance and business development groups. He has spent more than 20 years in financial, operational, and business development roles. Mr. Simmons began his career in public accounting for 7 years, and since has worked for several technology and biotech businesses, with a particular focus on early stage companies. He has led groups spanning the support functions, including finance, IT, HR, business development, marketing, facilities, and communications.
Email Christopher R Simmons
Senior Scientific Leadership
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| Allen Mangel |
Allen Mangel, PhD, MD
Executive Vice President, RTI Health Solutions
MD
Georgetown University School of Medicine, Washington, DC PhD, Physiology
MS, Physiology
BS, Physiology
University Of Illinois, Urbana, IL Allen Mangel, MD, PhD, is a gastroenterologist and Executive Vice President of RTI-HS. Following completion of his medical training, Dr. Mangel did his internship and residency in internal medicine at Duke University Medical Center and then completed his gastroenterology fellowship also at Duke. Following completion of his formal training, he remained on the faculty in the Department of Medicine, Division of Gastroenterology, at Duke for 3 years. Dr. Mangel also has a PhD from the University of Illinois, where his research focused on control of electrical and mechanical activity in gastrointestinal smooth muscle. After Dr. Mangel left Duke, he joined the gastroenterology clinical research department at Glaxo Wellcome, where he conducted numerous clinical trials and directed product development teams. After departing Glaxo Wellcome, he became Vice-President of Research and Development at Salix Pharmaceuticals. Dr. Mangel has led or participated in numerous FDA interactions, Advisory Committee Presentations, label negotiations, and NDA submissions, and he has authored more than 80 publications.
Email Allen Mangel
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| Elizabeth B Andrews |
Elizabeth B Andrews, PhD
Vice President, Pharmacoepidemiology and Risk Management
PhD, Epidemiology
MPH, Health Policy and Administration, North Carolina School of Public Health
BA
University of North Carolina, Chapel Hill, NC Elizabeth Andrews, PhD, is the Vice President of Pharmacoepidemiology and Risk Management at RTI-HS. She provides consultation for pharmaceutical companies and the US Food and Drug Administration (FDA) on therapeutic risk management and pharmacoepidemiology, and she directs research programs that evaluate drug safety and compliance with prescribing and treatment guidelines. She oversees the conduct of large, prospective patient registries, Web-based surveys, and studies using large existing databases. Dr. Andrews currently serves as principal investigator on several large risk management studies, and serves on various study advisory boards and data safety monitoring boards. Her experience has spanned most therapeutic areas, although she has worked extensively in the areas of HIV and sexually transmitted diseases; birth defects and neonatal health; asthma and COPD; and irritable bowel syndrome. Dr. Andrews is involved in the design of observational research programs within RTI-HS to assure that the methods chosen provide a robust and cost-effective approach to address the study questions and to assure appropriate linkages are forged with academic and governmental partners. Previously, Dr. Andrews was Vice President, Worldwide Epidemiology, at GlaxoSmithKline and conducted epidemiologic research in a variety of therapeutic areas, including rheumatoid arthritis, genital herpes, HIV, asthma, migraine, and irritable bowel syndrome. She initiated the first pharmaceutical pregnancy registry, the Acyclovir Pregnancy Registry, and multiple registries for other medications. She began her career in the pharmaceutical industry at Burroughs Wellcome in 1982 and subsequently built a strong international epidemiology program at Glaxo Wellcome. Prior to joining Burroughs Wellcome, she managed the Statewide Regionalized Perinatal Care Program and directed the non-Medicaid health care reimbursement programs for the State Health Department of North Carolina. She is a Fellow and Past President of the International Society for Pharmacoepidemiology, a member of the editorial board of the Journal of Pharmacoepidemiology and Drug Safety, and coeditor of Pharmacovigilance. She is an Adjunct Associate Professor of the University of North Carolina School of Public Health and School of Pharmacy, a member of the Scientific Advisory Board Observational Medical Outcomes Partnership, senior consultant and investigator with the UNC Center for Education and Research on Therapeutics, and a consultant to the FDA in epidemiology and risk management. .
Email Elizabeth B Andrews
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| Stephen M Beard |
Stephen M Beard, MSc
Global Head of Health Economics, Europe
MSc, Operational Research
University of Birmingham, UK BSc, Mathematics
University of London, UK Stephen Beard, MSc, is Global Head of Heath Economics Europe and is based in RTI HS’s UK office in Manchester. He has more than 20 years of experience in the application of mathematical modeling, optimization, and decision analysis techniques to business problems gained in academic, government, and industrial organizations. He has worked specifically within the health research sector for the past 11 years, having previously held a senior project management and research position within the University of Sheffield, UK, where he headed a team producing rapid review health technology appraisal reports for the National Institute for Health and Clinical Excellence (NICE) in the UK. His work has involved the management of projects using health economics, Markov modeling, and statistical modeling techniques to explore disease progression and the impact of treatment across a range of areas, including colorectal cancer, ovarian cancer, breast cancer, schizophrenia, depression, and infectious diseases. He is a member of the International Society of Pharmacoeconomics Outcomes Research and the Institute for Operations Research and the Management Sciences. He has presented his work at professional conferences and has published in several peer-reviewed journals, including European Journal of Health Economics, British Journal of Cancer, and Pharmacoeconomics.
Email Stephen M Beard
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| Kati Copley-Merriman |
Kati Copley-Merriman, MS, MBA
Vice President, Regulatory and Health Outcomes Strategy and Market Access
MBA, Marketing
Indiana University, Indianapolis, IN MS, Organic Chemistry
Purdue University, Indianapolis, IN BA, Chemistry and German
Smith College, Northampton, MA Kati Copley-Merriman, MS, MBA, is Vice President of Regulatory and Health Outcomes Strategy/Market Access at RTI-HS. Ms. Copley-Merriman has more than 25 years of industry experience, including leadership roles in Global Outcomes Research at Eli Lilly, Parke-Davis, and Pfizer. She has experience in all aspects of Outcomes Research (OR), including clinical trial design with PRO endpoints, economic evaluations, OR strategic plans, and regulatory strategy. In her outcomes research and regulatory role, she leads a team of scientists responsible for developing OR strategic plans for phase 2/3 compounds, developing PRO dossiers for the FDA for Label Claims, and designing clinical trials with OR endpoints. Ms. Copley-Merriman has experience in many therapeutic areas, including oncology, pain and inflammation, dermatology, respiratory, urology, and CNS.
Email Kati Copley-Merriman
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| Dana B DiBenedetti |
Dana B DiBenedetti, PhD
Head, Patient-Reported Outcomes
PhD, Clinical Psychology MS, Clinical Psychology Oklahoma State University, Stillwater, OK BA, Psychology Millsaps College, Jackson, MS Dana Britt DiBenedetti, PhD, Head of Patient-Reported Outcomes at RTI-HS, is a licensed clinical health psychologist with extensive experience in psychosocial assessment of adults and children in numerous therapeutic areas. Her broad clinical and assessment experience includes expertise in psychiatry, women’s health (e.g., menopause, vaginal atrophy, endometriosis), sexual medicine (e.g., erectile dysfunction, female sexual dysfunction, Peyronie’s disease), nicotine dependence, obesity, chronic pain, virology, oncology, and neurology/neuropsychology. Currently, Dr. DiBenedetti specializes in the development of questionnaires designed to measure quality of life, patient satisfaction, and other PROs. As part of the questionnaire-development process, Dr. DiBenedetti has facilitated numerous patient, caregiver, and physician focus groups and conducted cognitive interviews with a wide variety of patient and professional populations. Dr. DiBenedetti has considerable experience in both academic and pharmaceutical settings with instrument development and validation; coordination of instrument translations; and protocol design, functional status and quality of life assessment, and study implementation in phase 2 through phase 4 clinical studies. Dr. DiBenedetti has authored or coauthored numerous manuscripts and scientific presentations on quality of life, treatment satisfaction, and other outcomes in various patient populations, and she has served as a reviewer for several journals, including Journal of Consulting and Clinical Psychology, Health Psychology, Annals of Behavioral Medicine, International Journal of Behavioral Medicine, Addictive Behaviors, and Medical Care.
Email Dana B DiBenedetti
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| Stephanie R Earnshaw |
Stephanie R Earnshaw, PhD
Vice President, US Health Economics
PhD, Industrial Engineering, concentrating in the areas of Operations Research and Management, Dissertation: Determining an Allocation of Trainers and Field Representatives to Training Sites and Start Times
MS, Industrial Engineering concentrating in Operations Research
North Carolina State University, Raleigh, NC BS, Mathematical Science concentrating in Operations Research
University of North Carolina, Chapel Hill, NC Stephanie Earnshaw, PhD, is Vice President of US Health Economics at RTI-HS. Dr. Earnshaw applies mathematical modeling, optimization, and decision-analysis techniques to industry-related issues and health care problems. Her areas of specialization include systems optimization and solving resource allocation problems. She has developed innovative mathematical models to determine pricing strategy, budget impact, and cost-effectiveness of new products. Dr. Earnshaw has developed a variety of mathematical models, including Markov models, Monte Carlo simulation models, and other state transition models, to analyze the effect of new medical drugs and devices. She has developed innovative mathematical models to determine allocations of HIV prevention interventions and trainers and field representatives to training sites. To solve these models, she has used various heuristic, linear programming, and integer programming techniques. In addition to her modeling background, Dr. Earnshaw has extensive programming experience. She has programmed cost-effectiveness, budget-impact, and allocation models along with operations research algorithms such as genetic algorithms, simulated annealing algorithms, linear and integer programming algorithms, and network algorithms. She also has led programmers in developing user interfaces for health surveys and for pharmacoeconomic models. More recently, Ms. Earnshaw provided expert guidance on the creation of an economic model predicting AIDS survival by adherence level, which was highlighted in the December 2006 issue of AIDS Alert. Dr. Earnshaw has experience in quality management, machine scheduling, linear and integer programming, network optimization, stochastic modeling, and personnel-assignment models. She is a member of the International Society of Pharmacoeconomics Outcomes Research and the Institute for Operations Research and the Management Sciences. She has presented her work at professional conferences and has published in several peer-reviewed journals, including Annuals of Internal Medicine, Medical Decision Making, Journal of American Society of Nephrology, Stroke, and Pharmacoeconomics.
Email Stephanie R Earnshaw
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| Sheri Fehnel |
Sheri Fehnel, PhD
Vice President, Patient-Reported Outcomes
PhD, Quantitative Psychology
MA, Clinical Psychology
University of North Carolina, Chapel Hill, NC BS, Mathematics and Psychology
Duke University, Durham, NC Sheri Fehnel, PhD, is Vice President of Patient-Reported Outcomes in RTI-HS. Since joining the RTI staff in 1988, she has combined the study of clinical psychology and psychometrics with practical research and clinical experience. She specializes in the development and evaluation of questionnaires designed to measure health-related quality of life, functional status, patient satisfaction, resource utilization, and other patient-reported outcomes. This work has involved a wide range of therapeutic areas, including depression, attention-deficit disorder, bipolar disorder, schizophrenia, insomnia, incontinence, irritable bowel syndrome, oncology, cardiovascular disease, women’s health, diabetes, asthma, COPD, sexual dysfunction, obesity, cystic fibrosis, chronic pain, and sexually transmitted diseases such as herpes, HPV, and HIV/AIDS. As part of the questionnaire-development process, Dr. Fehnel has moderated countless focus groups, conducted cognitive interviews with a wide variety of patient and professional populations, and assessed potential sources of measurement error through cognitive forms appraisal. She has also evaluated the psychometric properties of many survey and clinical instruments using techniques such as factor analysis, structural equations modeling, and item response theory. Dr. Fehnel is a frequent presenter at annual conferences held by organizations such as the International Society for Quality of Life Research (ISOQOL) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), as well as at various Drug Information Association (DIA) symposia. She also has published a number of articles related to questionnaire development and psychometric evaluation in Quality of Life Research, Medical Care, and Pharmacoeconomics.
Email Sheri Fehnel
Irma Grossi, PhD
Senior Director, Preclinical Pharmaceutical Sciences
MBA Cert
Ohio State University, Fischer School of Business, Columbus, OH PhD, Cancer Biology
Wayne State University, School of Medicine, Department of Radiation Oncology, Detroit, MI Graduate Studies, Biochemistry/Molecular Biology
University of Nebraska, Lincoln, NE BS, Biological Sciences
Central Michigan University, Mt. Pleasant, MI Dr. Irma M. Grossi is Senior Director of Preclinical Pharmaceutical Sciences at RTI-HS, where she is responsible for managing professional and support staff in the planning and implementation of preclinical development programs for new lead candidates. She develops project plans and budgets and monitors technical and financial performance of LST projects, establishing and monitoring corrective action when required. Dr. Grossi has 12 years of experience in preclinical drug development toward investigational new drug (IND) application filings with responsibilities in Good Laboratory Practices (GLP) toxicology ranging from appointments as Study Director/Senior Study Director/Team Leader (IRDC/MPI Research and Battelle Memorial Institute), Laboratory Director (Liberty Research), and Program Manager/Toxicology Manager (Battelle Memorial Institute) to establishing and operating a GLP Toxicology Department for an animal health production and supply company (Liberty Research). Her experience includes conducting, supervising, and coordinating of individual acute, repeat dose, subchronic and chronic toxicology studies for the commercial industry and for the National Cancer Institute (NCI). Dr. Grossi has managed various preclinical toxicology programs and staff who provide drug development support for IND and new drug application (NDA) submissions to the US Food and Drug Administration (FDA), as well as support for the US Environmental Protection Agency (EPA) and European registrations for industrial and government clients. She has extensive experience with leading multidisciplinary teams in performing various programs for NCI, biotechnologies, and multinational pharmaceutical companies. Dr. Grossi has served as the Principal Investigator (PI) on multiyear contracts for anti-AIDS therapies and antineoplastic drugs for the NCI Toxicology and Pharmacology Branch, the Developmental Therapeutics Program, and the Division of Cancer Treatment and Diagnosis. She was the focal point of all program communications and was responsible for the technical and fiscal components for studies associated with each contract. Her work in toxicology and pharmacokinetics has appeared in many publications, including numerous peer-reviewed journal articles and abstracts, and she has authored or coauthored eight book chapters.
Email Irma Grossi
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| Lynne Hamm |
Lynne Hamm, BS
Senior Director of Clinical and Medical Services
BSN, Family Nurse Practitioner
Purdue University Calumet, Hammond, IN Associate of Applied Science
Purdue University North Central, Westville, IN Lynne Hamm is Senior Director of Clinical and Medical Services at RTI-HS. She has extensive experience in the pharmaceutical industry designing, implementing, and managing Phase II-IV clinical studies. Ms. Hamm has developed specifications for interactive voice response systems (IVRS) to facilitate the electronic capture of subject diary data and has experience using IVRS in large international studies. Ms. Hamm has been involved with multiple clinical studies in the United States, Canada, Mexico, and Europe. She has experience with national call centers and script development to assist in subject referral to study sites in response to nationwide study recruitment advertising. While working in the pharmaceutical industry, Ms. Hamm has been involved in protocol design, study report writing, preparations for FDA Advisory Committees, and NDA submissions.
Email Lynne Hamm
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| A Brett Hauber IV |
A Brett Hauber IV, PhD
Global Head of Health Preference Assessment and Market Access
PhD, Economics
MA, Economics
University of Delaware, Newark, DE Bachelor of Business Administration (summa cum laude)
Temple University, Philadelphia, PA A. Brett Hauber, PhD, is Senior Economist and Global Head of Health Preference Assessment at RTI-HS. He has more than 10 years of academic, research, and government experience in health and environmental economics. His primary area of specialization is discrete choice analysis of revealed- and stated-preference data. He also has extensive experience in conducting benefit-risk analysis of patients and other health care decision makers and in estimating health-state utilities. His most recent applied work has included discrete-choice experiments of patient and physician benefit-risk preferences for treatments for conditions, including Alzheimer’s disease, HIV, vasomotor symptoms, Crohn’s disease, idiopathic thrombocytopenia purpura, type 2 diabetes, and irritable bowel syndrome. He has also studied the theoretical and empirical relationships among various health utility measures. Dr. Hauber regularly teaches courses on conjoint analysis and health-state utility estimation. Dr. Hauber’s research has been published in numerous health and medical journals, including Value in Health, Pharmacoeconomics, Quality of Life Research, Journal of Women’s Health, Medical Care, Clinical Therapeutics, ISPOR Connections, The Patient, Supportive Care in Cancer, AIDS Patient Care and STDs, and Alzheimer Disease and Associated Disorders
Email A Brett Hauber IV
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| F Reed Johnson |
F Reed Johnson, PhD
Distinguished Fellow and Principal Economist
PhD, Economics
MA, Economics
State University of New York, Stony Brook, NY BA, Economics
Occidental College, Los Angeles, CA F. Reed Johnson, PhD, has more than 35 years of academic and research experience in health and environmental economics. He has served on the faculty of several universities in the United States, Canada, and Sweden. As a staff member in the US Environmental Protection Agency’s environmental economics research program during the 1980s, Dr. Johnson helped pioneer development of basic nonmarket valuation techniques. These techniques are now widely used for cost-benefit analysis in health and environmental economics. He has designed and analyzed numerous surveys for measuring willingness to pay for health-risk reduction and improved environmental quality. He also has developed and researched various value elicitation methods, including direct questions, discrete choice, graded pairs, and other approaches. Dr. Johnson has extensive experience in using advanced statistical techniques to analyze censored, truncated, and discrete survey data. Dr. Johnson has more than 85 publications in books and peer-reviewed journals. His research has been published in various clinical journals, the Review of Economics and Statistics, Journal of Health Economics, Medical Decision Making, Health Economics, Value in Health, Journal of Environmental Economics and Management, Journal of Policy Analysis and Management, Land Economics, and other journals. He has coauthored a recent book on various techniques for using existing environmental and health value estimates for policy analysis. His current research involves estimating general time equivalences among health states and patients’ willingness to accept side-effect risks in return for therapeutic benefits.
Email F Reed Johnson
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| Josephine A Mauskopf |
Josephine A Mauskopf, PhD
Vice President, Health Economics
PhD, Economics
MHA, Health Administration
MA, Physiology/Pharmacology
Duke University Josephine Mauskopf, PhD, MHA, is Vice President of Health Economics at RTI-HS. She has extensive experience both as a consultant and within the pharmaceutical industry designing and implementing pharmacoeconomic research strategies. She has designed pharmacoeconomic research programs for drugs for bacterial infections, viral infections, psychiatric illness, and neurologic diseases. Dr. Mauskopf has estimated budget impacts for new products for schizophrenia, bipolar disease, breast cancer, and HIV infection. She has estimated the cost-effectiveness of antiretroviral drugs, as well as drugs for treating herpes zoster, epilepsy, neonatal respiratory distress syndrome, digoxin toxicity, community acquired pneumonia, intra-abdominal infections, and primary pulmonary hypertension. Dr. Mauskopf also has estimated the impact of an antidepressant on work and social disability. Additionally, she has managed projects to develop or culturally adapt psychometrically valid quality of life measures for migraine, genital herpes, and epilepsy. Dr.Mauskopf has developed Markov models of disease progression for lung cancer and HIV infection and has developed a simulation model of time spent in the operating and recovery rooms. Dr. Mauskopf was previously Vice President at MEDTAP International, Department Head of Economics Research at Burroughs Wellcome Co., and Director of Pharmacoeconomics Research for Anti-Virals and Anti-Infectives at Glaxo Wellcome Inc. Dr. Mauskopf is Editor-in-Chief of the journal Value in Health. She served for 4 years as a reviewer on the Health Care Technology and Decision Sciences Study Section at the Agency for Healthcare Research and Quality. She has presented her research at numerous national and international symposia. She has also published extensively in journals, including the Journal of the American Medical Association, Journal of Pediatrics, PharmacoEconomics, Medical Care, American Journal of Public Health, Health Services Research, and the American Journal of Cardiology.
Email Josephine A Mauskopf
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| Lori D McLeod |
Lori D McLeod, PhD
Head, Psychometrics
PhD, Quantitative Psychology
MA, Quantitative Psychology
University of North Carolina, Chapel Hill, NC BS, Statistics, Mathematics Education (graduated Summa Cum Laude)
North Carolina State University, Raleigh, NC Lori McLeod, PhD, is Head of Psychometrics at RTI-HS. Dr. McLeod is a psychometrician with more than 10 years of experience in instrument development and validation, as well as experience conducting systematic assessments of clinical and economic literature and developing appropriate health outcome strategies. In her Psychometrics role, she has conducted many psychometric evaluations of both paper-and-pencil and computer-administered instruments. These investigations have included the assessment of scale reliability, validity, responsiveness, and work to identify PRO responders. Dr. McLeod has published numerous related manuscripts in Applied Psychological Measurement, Pharmacoeconomics, Journal of Educational Measurement, and Psychometrika. She has experience in a wide variety of therapeutic areas, including chronic pain, dermatology, oncology, psychiatry, respiratory, sleep disorders, urology, and sexual dysfunction
Email Lori D McLeod
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| Margaret Mordin |
Margaret Mordin, MS
Senior Director, Regulatory and Health Outcomes Strategy
MS, Public Policy
BA, Political Science
University of Rochester, Rochester, NY Margaret Mordin, MS, is a Senior Director of Regulatory and Health Outcomes Strategy at RTI HS. Ms. Mordin has nearly 20 years of experience in conducting and managing outcomes research, including designing and implementing outcomes assessments in prospective trials for regulatory submission and as postmarketing studies. Her areas of expertise include study design, including designing observational postmarketing studies, designing patient-reported outcomes for use in clinical development programs, patient health-related quality of life and satisfaction surveys, analyses of outcomes data, publication development, and outcomes-related regulatory submission strategies. Her experience also includes directing health economic evaluations (prospective economic trials and billing studies). In addition, Ms. Mordin has conducted outcomes research for multiple medical devices, including drug/device combination products, transdermal delivery systems, blood glucose monitoring systems, intravenous patient-controlled analgesia, multiple medication inhalation devices, photodynamic therapy, and digital mammography. Ms. Mordin regularly presents at conferences and has numerous publications in peer-reviewed journals, including the Journal of Managed Care Pharmacy, American Journal of Clinical Dermatology, Clinical Cardiology, Quality of Life Research, Transplantation, Oncology, and New England Journal of Medicine. Ms. Mordin’s therapeutic expertise includes age-related macular degeneration, asthma, cardiology, chronic pain, diabetes, Gaucher disease, HIV/AIDS, kidney transplantation, oncology, ophthalmology, orthopedics, Parkinson’s disease, psoriasis, and schizophrenia.
Email Margaret Mordin
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| Susana Perez-Gutthann |
Susana Perez-Gutthann, MD, PhD
Vice President, Global Head of Epidemiology
MD, PhD Universitat de Barcelona, Barcelona, Spain MPH, Postdoctoral Fellowship Johns Hopkins University, Baltimore, MD, USA Susana Perez-Gutthann, MD, MPH, PhD, FISPE, FRCP, is Vice President and Global Head of Epidemiology at RTI HS. Dr. Perez-Gutthann holds medical and doctoral degrees from the University of Barcelona, and a Master of Public Health with a concentration in epidemiology from Johns Hopkins University. Her prior positions include Global Head of epidemiology at Pharmacia, Novartis, and Ciba-Geigy; European Head of epidemiology at Pfizer; and a postdoctoral fellow in the Division of Clinical Epidemiology at Johns Hopkins. Dr. Perez-Gutthann has 19 years of experience in the research-driven international pharmaceutical environment, developing and leading teams of epidemiologists and driving strategy and research programs for safety, pharmacovigilance, risk management, development, and regulatory activities applying public health and epidemiologic methods. Dr. Perez-Gutthann is an active leader and Past President of the International Society of Pharmacoepidemiology (ISPE). She is a Fellow of ISPE and of the Royal College of Physicians, Edinburgh. She is invited to teach in several programs, to speak and chair conferences and symposia, which have included DIA, TOPRA, Australian National Prescribing Service Symposium, Asian Pacific Regulatory Safety Sciences Meeting, International Conference of Pharmacoepidemiology & Risk Management, and World Congress of Pharmacology and Clinical Therapeutics. Dr. Perez-Gutthann’s roles as an advisor and in international working groups have included WHO TRD Product Development and Evaluation, International Scientific Advisory Board to MHRA General Practice Research Database, ISPE Working Groups on Risk Management Guidances (FDA, EMEA), Good Pharmacoepidemiology Practice, and confidentiality of patient databases in Europe; working groups on gastrointestinal complications associated with NSAIDs, IMBRF on drug-induced disease, and HRT and breast cancer risk. Currently, Dr. Perez-Gutthann serves as a member and chair of several scientific advisory boards for studies, research programs, strategic, and regulatory risk management topics.
Email Susana Perez-Gutthann
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| Kenneth Rothman |
Kenneth Rothman, DrPH
Distinguished Fellow, Vice President of Epidemiology Research
DrPH
MPH
Harvard School of Public Health, Boston, MA DMD
Harvard School of Dental Medicine, Boston, MA AB
Colgate University, Hamilton, NY Kenneth J. Rothman, DrPH, is a Distinguished Fellow and Vice President for Epidemiology Research at RTI-HS. He is also Professor of Epidemiology and Medicine at Boston University. His main career interest has been the development and teaching of the concepts and methods of epidemiologic research. He has authored or coauthored more than 250scholarly publications, most of which are original epidemiologic research studies. His research has spanned a wide range of health problems, including cancer, cardiovascular disease, neurologic disease, birth defects, injuries, environmental exposures, and adverse effects of pharmaceutical agents. In addition to publishing original research, he has devoted time to several other efforts related to the conduct of research. He has written extensively on ethical issues relating to the conduct of science. He regularly teaches intensive courses on epidemiologic research principles in the US and abroad. He has also dedicated a large proportion of his professional effort to editorial activities and publishing. He was the founding editor of the journal Epidemiology, and has served as Assistant Editor of the American Journal of Public Health, Editor of the American Journal of Epidemiology, a member of the Editorial Board of the New England Journal of Medicine and the International Advisory Board of the Lancet. He is a Past President of the Society for Epidemiologic Research, an Honorary Fellow of the American College of Epidemiology, Fellow and member of the Board of Directors and Fellow of the International Society for Pharmacoepidemiology. He has written two widely read epidemiologic textbooks: Modern Epidemiology, first published in 1986 by Little, Brown and Co., which is a comprehensive advanced text of epidemiologic methods, and Epidemiology: An Introduction, published in 2002 by Oxford University Press.
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| Beth H Sherrill |
Beth H Sherrill, MS
Global Head, Biometrics
MS, Statistics
North Carolina State University, Raleigh, NC NC Science Teacher Certification
University of North Carolina, Chapel Hill, NC BS, Biology
Davidson College, Davidson, NC Beth Sherrill, MS, is Global Head of Biometrics at RTI-HS. She has more than 15 years of professional experience analyzing pharmaceutical and health-related data. Ms. Sherrill brings insight and expertise to statistical issues in drug development and outcomes research to multiple clients in the pharmaceutical industry. Ms. Sherrill started her career as an industry biostatistician designing and analyzing phase 2/3 clinical trials for international submissions and is familiar with regulatory requirements for drug approval. In the past 10 years, she has broadened her experience in postmarketing studies such as epidemiologic analyses from disease registries, econometric work with claims databases, and large patient surveys. She has extensive experience with the use of propensity scoring and proportional hazards modeling with time-dependent covariates, working in such complex disease areas as oncology and HIV. She has training from the Cochrane Collaboration for performing meta-analyses that may include indirect comparisons and network analysis. Ms. Sherrill continues to publish and represent her clients at Advisory Board meetings. She provides senior leadership to a team of statisticians in the US and the UK, applying advanced biostatistical techniques to issues in pharmaceutical development, epidemiology, health care utilization, and outcomes research.
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| Pat Tennis |
Pat Tennis, PhD
Senior Director, Epidemiology
MPH, Epidemiology
University of North Carolina, School of Public Health, Chapel Hill, NC PhD, Biology
MS, Biology
Case Western Reserve University, Cleveland, OH BS, Zoology
University of Wisconsin, Madison, WI Patricia Tennis, PhD, MPH, is Senior Director of Epidemiology at RTI-HS and was previously Senior Director of Safety Epidemiology at a large international pharmaceutical company, where she designed and implemented safety studies and risk management activities to evaluate medications within the therapeutic areas of neurology, psychiatry, respiratory, and metabolic diseases. Dr. Tennis was the lead epidemiologist on international pregnancy exposure registries. At RTI-HS and elsewhere, she has overseen the conduct of numerous epidemiology studies and participated in discussions of drug safety issues with regulatory agencies in the US, Canada, and Europe. She is a fellow of the International Society of Pharmacoepidemiology and has numerous publications. Dr.Tennis’s graduate education involved a minor in population genetics, and while within the pharmaceutical industry, she provided epidemiologic consultation for genetic studies. She brings to RTI-HS her decades of experience and expertise to clients facing issues of drug safety and risk management.
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| Maria Vazquez-Gragg |
Maria Vazquez-Gragg, MD, MPM
Global Head, Safety and Pharmacovigilance
MD, Universidad de Buenos Aires
Buenos Aires, Argentina MPM, UADE University
Buenos Aires, Argentina Maria (Ale) Vazquez-Gragg, MD, MPM, is Global Head of Safety and Pharmacovigilance at RTI-HS. Following her completion of her medical training, Dr. Vazquez-Gragg worked as a pediatric surgeon in the Pediatric Hospital of San Isidro. After Dr. Vazquez-Gragg left clinical practice, she joined the regulatory affairs department at Merck, where she was responsible for safety and regulatory activities. Following this, she held positions in the areas of drug safety and pharmacovigilance throughout her career, including at Wyeth, Johnson & Johnson, and PAREXEL. Over her 10 years of experience, Dr. Vazquez-Gragg has authored numerous articles on a wide array of topics, including pharmacovigilance, and has given several presentations at biopharmaceutical industry conferences, as well as at meetings held by health authorities
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Business Development
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| Tony Bloise Jr |
Tony Bloise Jr, MS
Director, Business Development
MS, Pharmaceutical Administration and Marketing
University of North Carolina, Chapel Hill, NC BS, Pharmacy
Albany College of Pharmacy, Albany, NY Tony Bloise, RPH, MS, is Director, Business Development at RTI-HS. In this role, he assists clients with their pricing and reimbursement optimization strategies for their pharmaceutical, biological, and medical device brands. Prior to joining RTI-HS, Mr. Bloise spent more than 18 years at GlaxoSmithKline, where he held a number of positions with increasing responsibility in the commercial organization. His experience includes sales, sales management, sales training, marketing, and global commercial strategy in a wide variety of therapeutic areas, including adult and pediatric vaccines, antiherpetic, HIV, migraine, gastrointestinal, oncology, anti-infective, depression, anxiety, bipolar, schizophrenia, epilepsy, respiratory, cardiovascular, smoking cessation, obesity, and diabetes.
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| Paul Borron |
Paul Borron, PhD
Business Development Specialist
PhD, Biochemistry
BS (with honors), Microbiology/Immunology
University of Western Ontario, London, ON, Canada MSc, Immunology
University of Toronto, Toronto, ON, Canada Paul Borron, PhD, MSc, is a world-class medical researcher with extensive experience in the areas of immunology, inflammation, cell biology, cardiovascular and pulmonary research, and assay development. He successfully obtained more than $700,000 in grant funding for anti-inflammatory and pulmonary research. These grants were awarded from National Institutes of Health, Bayer, The Ontario Thoracic Society, Canadian Lung Association, and the Parker B. Francis Foundation. Dr. Borron was the first to discover the anti-inflammatory properties of two lung proteins: surfactant protein-A (SP-A) and surfactant protein-D (SP-D). Dr. Borron has pharmaceutical industry experience in research and development, discovery, business development, and sales, including the following: § Developing drugs and diagnostics for clinical use § Working knowledge of prerequisites for obtaining government approval for drug commercialization § Preclinical toxicology proposal writing, business development, and in vivo pharmacology § Holds patent for vaccine development method § Establishing and maintaining productive collaborations with world-renowned scientists § Published in top research journals § Outstanding communicator with passion for fact finding and medical research
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| Graham Dyck |
Graham Dyck, MBA
Senior Director, Marketing and Business Development
MBA, Business Administration
University of North Carolina, Chapel Hill, NC BSc, Bachelor of Science
University of British Columbia, Vancouver, BC BA, Business Administration
Fresno Pacific College, Fresno, CA Graham Dyck, MBA, is a Senior Director of Marketing and Business Development at RTI-HS. He is a creative manager with 16 years of experience in product management, business development, marketing, and domestic and international sales. He is an innovative, bottom line–oriented manager with excellent strategic marketing and financial analysis skills and strong interpersonal skills. Mr. Dyck’s experience includes business plan development, profit and loss management, strategic market analysis, forecasting and budgeting, marketing communications, business to business sales, negotiating licensing agreements, and product launch planning.
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| Nancy Faith |
Nancy Faith, BS
Senior Marketing Specialist
BS, Business Administration and Marketing
Meredith College, Raleigh, NC Nancy Faith is a Senior Marketing Specialist at RTI-HS. She supports the business development team with the development of marketing collateral, the external Web site, trade shows, conferences, advertising, and other marketing communications. She has 15 years of experience in pharmaceutical marketing and communications and has worked on several product launches, assisted in direct-to-consumer advertising campaigns, and executed business development programs to support and optimize the marketing brands across most therapeutic classes. Before joining RTI-HS, Ms. Faith worked in the CRO industry and produced communications to support the sales efforts worldwide.
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| Jennifer Hart |
Jennifer Hart
Manager, Business Development
Jennifer Hart
BS, Microbiology
BA, Chemistry
North Carolina State University, Raleigh, NC Jennifer Hart is a Manager of Business Development/Client Services at RTI-HS. She manages $8.5M sales for a 140-member unit that consists of a full spectrum of preclinical services (DMPK, toxicology, chemistry). Her primary responsibility is over 108 accounts (bioanalytical/analytical chemistry [cGMP release testing], and developmental and reproductive toxicology). Ms. Hart supervises a Business Development unit of three members that markets DMPK/general toxicology services and provides sales support (budgeting and quote preparation) across the unit. She creates detailed training plans and quarterly goals for employees, and has experience in constructing a detailed business plan for the unit, including revenue forecasts for all research groups and schedule of prospective targets, events, and the creation of new marketing material and services offered. She budgets creation and monitoring for travel, sales, and marketing activities for entire fiscal year. Ms. Hart participates in decisions for new equipment/hires/capabilities of analytical and bioanalytical chemistry labs. She leads onsite visits with potential clients, organizing quality assurance, lab staff, and accommodations for the client. Other duties include development of marketing materials, managing incoming requests for bids, growing new opportunities through detailed market research, and arranging meetings with target companies. Her major accomplishments include determining and marketing niche offerings of each group, serving as project manager for the Chemistry group’s largest client ($1M in the last year), facilitating communications between technical staff and clients, establishing solid relationships with a diverse client base from small biotech to large pharma companies in all roles from study director to CEO, and training staff to effectively market and maintain client relations.
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| Peter Wirth |
Peter Wirth, BS
Senior Director, Business Development
Peter Wirth, RPH, Senior Director of Business Development at RTI-HS, provides support of the business development activities for the entire portfolio of RTI-HS services. He applies various skills based on his 22 years of pharmaceutical industry experience. He has a wide range of experience in customer relationships, people management, sales, medical and drug information, marketing support, clinical trials, and product safety. He is involved in developing strategic alliances that support the needs and goals of RTI-HS’s clients. Mr. Wirth is a pharmacist who began his career in 1988 working with GSK as a pharmaceutical representative in Monterey, CA. In 1992 he relocated to North Carolina and joined Ask the Pharmacist, a nationally known leader in the provision of medical and drug information services. He served as the VP of Sales and Client Operations and became responsible for operations, training, QA, HR, IT, and sales and marketing. During this time, Mr. Wirth was involved in the launch of more than 35 products, as well as several drug recall/withdrawal projects. In 1999, PPD acquired Ask the Pharmacist and Mr. Wirth was appointed as Senior Business Development Executive for PPD Market Development. He focused on selling their late-phase suite of services, which included product safety, medical writing, marketing-support programs, patient registries, postmarket studies (phase 3b/4), and medical and drug information. He also sold their risk management, health outcomes, and Rx-to-OTC switch studies. In 2004, Mr. Wirth joined Ninaza, Inc. as Director of Business Development and marketed their electronic data collection (EDC) services
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Practice Areas
Health Economics
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| Josephine A Mauskopf |
Josephine A Mauskopf, PhD
Vice President, Health Economics
PhD, Economics
MHA, Health Administration
MA, Physiology/Pharmacology
Duke University Josephine Mauskopf, PhD, MHA, is Vice President of Health Economics at RTI-HS. She has extensive experience both as a consultant and within the pharmaceutical industry designing and implementing pharmacoeconomic research strategies. She has designed pharmacoeconomic research programs for drugs for bacterial infections, viral infections, psychiatric illness, and neurologic diseases. Dr. Mauskopf has estimated budget impacts for new products for schizophrenia, bipolar disease, breast cancer, and HIV infection. She has estimated the cost-effectiveness of antiretroviral drugs, as well as drugs for treating herpes zoster, epilepsy, neonatal respiratory distress syndrome, digoxin toxicity, community acquired pneumonia, intra-abdominal infections, and primary pulmonary hypertension. Dr. Mauskopf also has estimated the impact of an antidepressant on work and social disability. Additionally, she has managed projects to develop or culturally adapt psychometrically valid quality of life measures for migraine, genital herpes, and epilepsy. Dr.Mauskopf has developed Markov models of disease progression for lung cancer and HIV infection and has developed a simulation model of time spent in the operating and recovery rooms. Dr. Mauskopf was previously Vice President at MEDTAP International, Department Head of Economics Research at Burroughs Wellcome Co., and Director of Pharmacoeconomics Research for Anti-Virals and Anti-Infectives at Glaxo Wellcome Inc. Dr. Mauskopf is Editor-in-Chief of the journal Value in Health. She served for 4 years as a reviewer on the Health Care Technology and Decision Sciences Study Section at the Agency for Healthcare Research and Quality. She has presented her research at numerous national and international symposia. She has also published extensively in journals, including the Journal of the American Medical Association, Journal of Pediatrics, PharmacoEconomics, Medical Care, American Journal of Public Health, Health Services Research, and the American Journal of Cardiology.
Email Josephine A Mauskopf
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| Stephen M Beard |
Stephen M Beard, MSc
Global Head of Health Economics, Europe
MSc, Operational Research
University of Birmingham, UK BSc, Mathematics
University of London, UK Stephen Beard, MSc, is Global Head of Heath Economics Europe and is based in RTI HS’s UK office in Manchester. He has more than 20 years of experience in the application of mathematical modeling, optimization, and decision analysis techniques to business problems gained in academic, government, and industrial organizations. He has worked specifically within the health research sector for the past 11 years, having previously held a senior project management and research position within the University of Sheffield, UK, where he headed a team producing rapid review health technology appraisal reports for the National Institute for Health and Clinical Excellence (NICE) in the UK. His work has involved the management of projects using health economics, Markov modeling, and statistical modeling techniques to explore disease progression and the impact of treatment across a range of areas, including colorectal cancer, ovarian cancer, breast cancer, schizophrenia, depression, and infectious diseases. He is a member of the International Society of Pharmacoeconomics Outcomes Research and the Institute for Operations Research and the Management Sciences. He has presented his work at professional conferences and has published in several peer-reviewed journals, including European Journal of Health Economics, British Journal of Cancer, and Pharmacoeconomics.
Email Stephen M Beard
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| Stephanie R Earnshaw |
Stephanie R Earnshaw, PhD
Vice President, US Health Economics
PhD, Industrial Engineering, concentrating in the areas of Operations Research and Management, Dissertation: Determining an Allocation of Trainers and Field Representatives to Training Sites and Start Times
MS, Industrial Engineering concentrating in Operations Research
North Carolina State University, Raleigh, NC BS, Mathematical Science concentrating in Operations Research
University of North Carolina, Chapel Hill, NC Stephanie Earnshaw, PhD, is Vice President of US Health Economics at RTI-HS. Dr. Earnshaw applies mathematical modeling, optimization, and decision-analysis techniques to industry-related issues and health care problems. Her areas of specialization include systems optimization and solving resource allocation problems. She has developed innovative mathematical models to determine pricing strategy, budget impact, and cost-effectiveness of new products. Dr. Earnshaw has developed a variety of mathematical models, including Markov models, Monte Carlo simulation models, and other state transition models, to analyze the effect of new medical drugs and devices. She has developed innovative mathematical models to determine allocations of HIV prevention interventions and trainers and field representatives to training sites. To solve these models, she has used various heuristic, linear programming, and integer programming techniques. In addition to her modeling background, Dr. Earnshaw has extensive programming experience. She has programmed cost-effectiveness, budget-impact, and allocation models along with operations research algorithms such as genetic algorithms, simulated annealing algorithms, linear and integer programming algorithms, and network algorithms. She also has led programmers in developing user interfaces for health surveys and for pharmacoeconomic models. More recently, Ms. Earnshaw provided expert guidance on the creation of an economic model predicting AIDS survival by adherence level, which was highlighted in the December 2006 issue of AIDS Alert. Dr. Earnshaw has experience in quality management, machine scheduling, linear and integer programming, network optimization, stochastic modeling, and personnel-assignment models. She is a member of the International Society of Pharmacoeconomics Outcomes Research and the Institute for Operations Research and the Management Sciences. She has presented her work at professional conferences and has published in several peer-reviewed journals, including Annuals of Internal Medicine, Medical Decision Making, Journal of American Society of Nephrology, Stroke, and Pharmacoeconomics.
Email Stephanie R Earnshaw
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| Naoko Akashi |
Naoko Akashi, PhD
Associate Director, Health Economics
PhD, Economics
MA, Economics
University of Virginia, Charlottesville, VA BA, Business and Commerce
Keio University, Tokyo, Japan Naoko Akashi-Ronquest, PhD, is an Associate Director of Health Economics at RTI-HS. Her experience at RTI-HS includes developing cost-effectiveness, cost-utility, cost-benefit, and budget-impact models using Microsoft Excel and Visual Basic for Applications. She has experience in the therapeutic areas of HIV, schizophrenia, systemic lupus erythematosus, and rheumatoid arthritis. Prior to joining RTI-HS, Dr. Akashi-Ronquest taught microeconomic theory, econometrics, and applied econometrics at California State University, Fullerton. She has conducted numerous empirical health economics studies, including her doctoral thesis on the effects of managed care organizations’ restrictions on patients’ well-being. She has developed various advanced economic models, including discrete choice models with simulations, and is proficient with various programming languages and statistical software packages such as FORTRAN, MATLAB, SAS, STATA, and SPSS. .
Email Naoko Akashi
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| Bela Bapat |
Bela Bapat, MA
Research Health Economist
MA, Applied Economics
University of North Carolina, Greensboro, NC MA, Economics
PGDFT, Post Graduate Diploma in Foreign Trade
BA, Economics
University of Pune, Pune, India Bela Bapat, MA, is a research health economist at RTI-HS. Prior to joining RTI-HS, Ms.Bapat worked in the field of health services and health economic research in RTI’s Public Health Economics Program. She has extensive experience in database analysis, specifically retrospective health care claims database analysis, state cancer registry data analysis, and cross-sectional and longitudinal survey analyses. Ms. Bapat has conducted research to estimate the prevalence and economic burden of contrast-induced nephropathy and chronic kidney disease. She has also worked on several high-profile cost-effectiveness evaluations for the Centers for Disease Control and Prevention (CDC) such as evaluation of the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) and Colorectal Cancer Screening Demonstration Project (CRCSDP). She also has extensive knowledge and experience in data collection methodologies, including development of data collection tools, chart abstraction, and surveys. Ms. Bapat has conducted research to estimate the prevalence and economic burden of various medical conditions, including meningococcal disease, abdominal adhesiolysis, Dupuytren’s contracture, adhesive capsulitis, Peyronie's disease, chronic hepatitis C, colorectal cancer, breast cancer, cervical cancer, oral cancer, chronic kidney disease, and contrast-induced nephropathy. Ms. Bapat has coauthored research published in the Journal of Medical Economics, Cancer, Preventing Chronic Disease, and Bulletin of the World Health Organization. Her research has also been accepted for presentation at numerous professional conferences and workshops, including the North American Congress of the International Society for Pharmacoeconomics and Outcomes Research, International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 9th Annual European Congress, Scientific Forum on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke, the CDC’s Cancer Conference and the Academy of Health’s annual meetings.
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Melissa J Bell, BSc
Health Economist
BSc (Hons), Mathematics
University of Manchester, Manchester, UK Melissa Bell is a Trainee Health Economist with RTI-HS in the Manchester, UK, office. She recently graduated from The University of Manchester after obtaining a mathematics degree. During her degree, she primarily studied statistics modules, including reliability and survival analysis and medical statistics. Ms. Bell also has more than 5 years of experience in customer service in the retail sector.
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| Victoria Brennan |
Victoria Brennan, MSc
Health Economist
Currently undertaking PhD in evaluation of ePAQ: an online assessment tool for women’s health MSc, Health Economics and Management
Sheffield University, Sheffield, United Kingdom BSc, Physiotherapy
Coventry University, Coventry, United Kingdom Victoria Brennan, MSc, is a Health Economist at RTI-HS. Ms. Brennan has a broad spectrum of experience in both the clinical and academic settings. Clinically, she has 8 years of experience working as a physiotherapist specializing in elderly care, and also worked as a Senior Lecturer in physiotherapy at Sheffield Hallam University. Ms. Brennan undertook an MSc in Health Economics and Management and is currently undertaking a PhD at Sheffield University in Health Economics. She has an Honorary Research Contract with Sheffield Teaching Hospitals in the UK. She has also worked with The University of Sheffield and UK Department of Health on the evaluation of modernization programs for elderly care in the NHS. Her work has been presented at the European Respiratory Society’s annual meeting and at the ISPOR 13th Annual International Meeting in Toronto in 2008. In addition to this, Ms Brennan has traveled to Mbarara Hospital in Uganda to work as a voluntary physiotherapist and lecturer. Since working at RTI-HS, MS. Brennan has acted as project manager for several cost-effectiveness studies; undertaken targeted literature reviews and systematic reviews of economic evaluations; supported the writing, development, and presentation of manuscripts and posters for publication; and developed cost-effectiveness, cost-utility, and budget-impact models in Microsoft Excel. Therapeutic areas include rheumatoid arthritis, breast cancer, NSCLC, malignant melanoma, and VTE.
Email Victoria Brennan
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| Anita Brogan |
Anita Brogan, PhD
Head, Decision Analytic Modeling, US Health Economics
PhD, Operations Research
MSc, Operations Research
University of North Carolina, Chapel Hill, NC BS, Mathematics
Harvey Mudd College, Claremont, CA Anita Brogan, PhD, is Head of Decision Analytic Modeling, US Health Economics at RTI-HS. Dr. Brogan uses analytical techniques to assess and present the clinical and economic value of emerging pharmaceutical and biotechnology products. She has developed cost-effectiveness, budget-impact, and population models; cost-consequence analyses; and product value dossiers. She has experience with all types of modeling procedures, including Markov and other stochastic models, simulation, regression, linear and nonlinear programming, and various types of sensitivity analysis. Dr. Brogan has extensive experience with programming models, user-friendly interfaces, and other software applications using the Visual Basic for Applications language in Excel. She is proficient with various other programming languages and mathematical and statistical software packages. Dr. Brogan has developed models and analyses in the areas of HIV, influenza, diabetic nephropathy, colorectal cancer, breast cancer, non-Hodgkin’s lymphoma, osteoporosis, chronic pain, age-related macular degeneration, schizophrenia, bipolar disorder, epilepsy, bone healing, hospital-acquired infection, financial portfolio optimization, and vehicle routing. Her research has been presented at various professional conferences and published in several peer-reviewed journals, including Value in Health, American Journal of Preventative Medicine, European Journal of Operational Research, American Journal of Health-System Pharmacy, and Journal of Parenteral and Enteral Nutrition.
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| Sean D Candrilli |
Sean D Candrilli, PhD
Head, Data Analytics, US Health Economics
PhD, Pharmacy Administration
The Ohio State University, Columbus, OH MS, Economics
BS, Economics
BS, Biological Science
Florida State University, Tallahassee, FL Sean Candrilli, PhD, is Head of Data Analytics, US Health Economics, at RTI-HS. During his tenure at RTI-HS, he has worked extensively in the area of data management and analyses of clinical trial and commercially available and public use databases. His academic experience is heavily grounded in applied economics and econometrics, particularly as related to public health topics, and he has extensive experience in all aspects of retrospective health care claims database analyses, cross-sectional and longitudinal survey analyses, econometric modeling, and data management using a variety of statistical packages, including SAS, SUDAAN, and Stata. Dr. Candrilli has conducted research to estimate the economic burden of various diseases and conditions, including diabetic microvascular complications, constipation, and traumatic injury. He has also conducted research to characterize patterns of medication utilization, including adherence and persistence, in patients with epilepsy. Additionally, Dr. Candrilli has analyzed numerous survey databases (including the National Health and Nutrition Examination Survey, the Medical Expenditure Panel Survey, and the Healthcare Cost and Utilization Project family of databases) to estimate the prevalence of various medical conditions and their associated economic burden. Dr. Candrilli has coauthored research published in Managed Care Interface, Journal of Trauma, Journal of Diabetes and its Complications, Epilepsia, Clinical Lymphoma and Myeloma, Epilepsy and Behaviour, Ethnicity and Disease, Pediatric Critical Care Medicine, and Journal of Pain & Palliative Care Pharmacotherapy. Dr. Candrilli’s research has also been presented at numerous professional conferences, including the Academy of Managed Care Pharmacy, the European Organisation for Research and Treatment of Cancer, the International Society for Pharmacoeconomics and Outcomes Research, the American Heart Association, the American College of Cardiology, the American Society of Hypertension, the American Society of Hematology, the American Evaluation Association, the American Thoracic Society, the American Association for the Surgery of Trauma, the Society for Critical Care Medicine, the American Academy of Pain Management, the European Cancer Conference, the Child Neurology Society, the National Hospice and Palliative Care Organization, the American College of Clinical Pharmacy, the Society for General Internal Medicine, the American Geriatrics Society, the Canadian Pharmacists Association, AcademyHealth, the Alzheimer’s Association, the American College of Obstetricians and Gynecologists, the American Epilepsy Society, AcademyHealth, the Pediatric Academic Society, and Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke.
Email Sean D Candrilli
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| Keith L Davis |
Keith L Davis, MA
Senior Director, Health Economics
MA, Applied Economics
The University of North Carolina at Greensboro BA, Economics
The University of North Carolina at Asheville Keith Davis, MA, is a Director of Health Economics at RTI Health Solutions. He has extensive experience in study design and data analysis for research projects using retrospective health care claims data, electronic medical records, cross-sectional and longitudinal survey data, and data from customized retrospective medical chart abstractions. Mr. Davis has conducted research to estimate the prevalence and economic burden of various medical conditions, including benign prostatic hyperplasia (BPH), diabetic microvascular complications, traumatic injury, melanoma, meningococcal disease, hepatitis C virus, respiratory diseases, and gastrointestinal disorders such as irritable bowel syndrome, constipation, ulcerative colitis, and Crohn’s disease. Mr. Davis also has extensive experience in claims-based analyses to evaluate patterns and cost implications of medication persistence and compliance among patients with various conditions, including Parkinson’s disease, epilepsy, ulcerative colitis, respiratory diseases, BPH, and HIV/AIDS. Mr. Davis’ research has been published in Applied Health Economics and Health Policy, Epilepsy and Behavior, Epilepsia, The Journal of Trauma, Medical Care, Journal of Diabetes and Its Complications, Journal of Studies on Alcohol, Journal of Behavioral Health Services and Research, and Journal of Pain and Palliative Care Pharmacotherapy. Mr. Davis’ research has been presented at numerous professional conferences and workshops including: the North American and European Congresses of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR); Academy of Managed Care Pharmacy (AMCP); American Public Health Association (APHA); European Federation of Neurological Societies (EFNS); Child Neurology Society (CNS); American Association for the Surgery of Trauma (AAST); Society for Critical Care Medicine (SCCM); Digestive Disease Week (DDW); American College of Gastroenterology (ACG); American Academy of Pain Management (AAPM); European Cancer Conference (ECCO); National Hospice and Palliative Care Organization (NHPCO); American Epilepsy Society (AES); American Society of Clinical Oncology (ASCO); the Canadian Pharmacists Association (CPhA); the Infectious Diseases Society of America (IDSA); the American Association for the Study of Liver Diseases (AASLD); the American Society of Consultant Pharmacists (ASCP); the Society for Medical Decision Making (SMDM); and the American College of Gastroenterology (ACG).
Email Keith L Davis
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| Raymond Farkouh |
Raymond Farkouh, PhD
Associate Director, Health Economics
PhD, Economics
MS, Economics
University of North Carolina, Chapel Hill, NC BA, Economics and Biochemistry
Washington University, St. Louis, MO Raymond Farkouh, PhD, is an Associate Director in Health Economics with RTI-HS. Dr. Farkouh has developed cost-effectiveness, budget-impact, and cost-consequence analysis models with user-friendly interfaces using the Visual Basic for Applications language in Excel. He is proficient with various other programming languages and mathematical and statistical software packages such as FORTRAN, STATA, Java, HTML, and SQL. Dr. Farkouh has developed models and performed analyses in the areas of atrial fibrillation, HIV, venous thromboembolism prophylaxis, oral contraceptives, Parkinson’s disease, pneumococcal vaccination, diverticulitis, stroke, rheumatoid arthritis, and medical device market feasibility. His technical experience includes extensive work in multi-equation discrete factor maximum likelihood estimation. As an applied micro-economist, he has experience modeling individual behaviors with a focus on health and labor decisions. In addition, he has extensive experience testing programs, training clients on the use of deliverables, and developing presentations. Dr. Farkouh’s experience at the University of North Carolina also includes 2 years of research experience for MEASURE, a research organization investigating program evaluation in developing countries. Before attending graduate school, Dr. Farkouh was a consultant for an information technology services firm.
Email Raymond Farkouh
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| Christopher N Graham |
Christopher N Graham, MSc
Associate Director, Health Economics
MSc, Clinical Epidemiology and Health Services Research
Wake Forest University, Winston-Salem, NC BS, Biology
University of North Carolina, Chapel Hill, NC Christopher Graham, MSc, is an Associate Director of Health Economics at RTI-HS and provides extensive knowledge and experience in health economics and outcomes research studies, including cost-effectiveness, cost-benefit, cost-minimization, and budget-impact modeling, as well as database analyses. Mr. Graham has developed decision tree, Markov, and Monte Carlo simulation models across numerous therapeutic areas, including metastatic colorectal cancer, osteoporosis, age-related macular degeneration, renal transplantation, human immunodeficiency virus, asthma, chronic pain, smoking cessation, and migraine. Results of his economic analyses have been used in publications (e.g., peer-reviewed manuscripts and presentations at scientific conferences) and to enhance marketing activities. Mr. Graham is an expert programmer in Microsoft Excel and Visual Basic for Applications and also has experience working in Decision Analysis by TreeAge (DATA), SAS, and Stata. Mr. Graham has used his programming skills to develop stochastic models using a Bayesian approach to model uncertainty to produce detailed sensitivity analyses around model parameters such as cost-effectiveness acceptability curves and net benefit analyses. He is a member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
Email Christopher N Graham
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| Jonathan Graham |
Jonathan Graham, BS
Research Health Economist
BS, Mathematics
North Carolina State University, Raleigh, NC Jonathan Graham is a Research Health Economist at RTI-HS. He received a Bachelor of Science in Mathematics from North Carolina State University and has experience in various mathematical applications such as Microsoft Excel, Visual Basic for Applications (VBA), Matlab, Maple, and HTML. He has conducted literature reviews, supported the writing and development of abstracts and manuscripts, and contributed to the development of cost-effectiveness, cost-utility, and budget-impact models. He has worked on decision analytic models in numerous therapeutic areas, including schizophrenia, bipolar I disorder, multiple sclerosis, cardiovascular disease, human immunodeficiency virus, Crohn’s disease, and chronic pain. He is a member of the International Society for Pharmacoeconomics and Outcomes Research.
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| Sukhvinder Johal |
Sukhvinder Johal, PhD
Health Economist
PhD, Optical Fibre Technology
Cranfield University, UK MSc, Instrumentation and Analytical Science
BEng, Electrical and Electronic Engineering
University of Manchester Institute of Science and Technology, Manchester, UK Sukhvinder Singh Johal, PhD, is a Health Economist at RTI-HS. Dr. Johal has previous experience in economic and business case modeling and product development. Prior to joining RTI HS, he worked at the Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) at the University of Nottingham in the field of value assessment of medical devices. At MATCH, he was engaged in developing a generic Excel-based health economics tool for medical device companies wishing to evaluate products primarily in the early stages of development to ascertain their feasibility for the marketplace. This included an element of training managers in the basics of health economics, and providing advice and guidance on the use of concepts such as the incremental cost-effectiveness ratio and quality-adjusted life years in evaluations of medical devices. Dr. Johal has carried out various consultancy projects for MATCH industrial partners to aid with their product development. His experience also covers more traditional approaches to business modeling such as net present value modeling, as well as a more innovative financial modeling approach called “real options” analysis. He also has more than 3 years of experience in product development in the telecommunications sector. Since working at RTI-HS, Dr Johal has developed cost-effectiveness, cost-utility, budget-impact, and capacity planning models in Excel, as well as project managing cost-effectiveness studies. He has also undertaken targeted reviews of economic evaluations. Therapeutic areas include diabetes, contraception, infectious diseases, and Parkinson’s disease.
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| Sudeep Karve |
Sudeep Karve, PhD
Associate Director, Health Economics
PhD, Pharmacy Administration
The Ohio State University, Columbus, OH MS, Pharmaceutical Evaluation and Policy
University of Arkansas for Medical Sciences, Little Rock, AR MBA, Marketing
B. Pharmacy
University of Pune, Pune, India Sudeep Karve, PhD, is an Associate Director of Health Economics at RTI-HS. He has extensive experience in analyzing retrospective health care claims data, and cross-sectional and longitudinal survey data. Dr. Karve has conducted research to estimate the utilization patterns for various disease conditions, including stroke, hypertension, hyperlipidemia, and gastrointestinal disorders such as irritable bowel syndrome and constipation. He has also evaluated the impact of preferred drug policies on health care utilization and costs for various drugs classes, including nonsedating antihistamines and proton pump inhibitors. Dr. Karve’s research focus has been in validating administrative claims-based adherence metrics and determining optimal adherence threshold. Dr. Karve also has extensive experience in claims-based analyses to evaluate patterns and cost implications of medication adherence among patients with various conditions, including hyperlipidemia, diabetes, schizophrenia, congestive heart failure, and hypertension. Dr. Karve’s research has been published in Medical Care, Value in Health, Journal of Human Hypertension, Journal of Drugs in Dermatology, and Health and Quality of Life Outcomes. Dr. Karve also coauthored a forthcoming article in Journal of the American Academy of Dermatology. Dr. Karve’s research has been presented at numerous professional conferences and workshops, including the North American Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Academy of Managed Care Pharmacy (AMCP), International Stroke Conference (ISC), Academy Health; Pediatric Academic Societies (PAS), and Southern Pharmacy Administration Conference (SPAC).
Email Sudeep Karve
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| Chris J Knight |
Chris J Knight, MSc
Director, Health Economics
MSc, Operational Research
University of Birmingham, Birmingham, UK BS, Hons (Mathematics, Statistics & Computing) (2:1)
De Montfort University, Leicester, UK Christopher Knight, MSc, is a Director of Health Economics at RTI-HS. He has more than 15 years of experience in operational research. His work has involved the management of projects using health economics, Markov modeling, simulation modeling, and statistical modeling techniques to explore disease progression and the impact of treatment across a range of areas, including hemophilia, rheumatoid arthritis, lymphoma, depression, schizophrenia, obesity, and infectious diseases. He has presented his work at professional conferences and has a number of health economic publications in peer-reviewed journals. Mr. Knight has developed innovative mathematical models, including Markov state transition models and Monte-Carlo simulation models both at cohort and individual patient level. He has extensive experience in Microsoft Excel and Visual Basic for Applications programming language. He was previously responsible for leading a team producing rapid review health technology appraisal report for the National Institute for Clinical Excellence (NICE) in the UK and for applying cost-effective modeling to pharmaceutical companies and service planning for the NHS. Prior to joining RTI-HS, Mr. Knight held operational research analyst positions at the School of Health and Related Research (ScHARR) at the University of Sheffield and the Trent Regional Health Authority. Mr. Knight is a member of the Operational Research Society and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
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Sarah Lock, BSc
Health Economist
BSc, Physiology
The University of Manchester, Manchester, UK Sarah Lock is a Trainee Health Economist at RTI-HS in the Manchester, UK, office. Prior to this, she studied physiology at The University of Manchester, graduating in 2009. Her studies focused on aspects of human and mammalian physiology, disease, and pharmacology. In her final year of study, she collaborated with the Centre for the History of Science, Technology, and Medicine, University of Manchester, to complete a project on the organization of English hospitals in the 1950s.
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| Louise McCrink |
Louise McCrink, MSc
Senior Health Economist
MSc, Economic Evaluation in Health Care: Distinction
City University, London, UK BA, Economics
Manchester University, Manchester, UK Louise McCrink, MSc, is a Senior Health Economist at RTI-HS. She has more than 8 years of professional experience applying health outcomes research of pharmaceutical and health data. She has conducted detailed literature reviews; supported the writing and development of abstracts, manuscripts, and poster presentations; and developed cost-effectiveness, cost-utility, and cost-minimization economic models in Microsoft Excel. She also has extensive experience in conducting health resource costing studies for European countries and has also been involved in conducting a time trade-off study and the analysis of health-related quality of life data, including a published regression analysis of SF-36. Therapeutic areas include vascular disease, depression/anxiety, non-small cell lunch cancer, restless leg syndrome, fibromyalgia, and diabetic neuropathic pain.
Email Louise McCrink
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| Cheryl L McDade |
Cheryl L McDade
Programmer Analyst
Computer Programming
Accounting
Technical College of Alamance, Haw River, NC Cheryl McDade is a Programmer Analyst at RTI-HS and provides knowledge and experience in health economics and outcomes research studies, including cost-effectiveness, cost-benefit, cost-utility, and benefit-risk, as well as budget-impact modeling. Ms. McDade has developed decision tree, Markov, and Monte Carlo simulation models across numerous therapeutic areas, including fungal infections; pediatric asthma; bipolar disorder; angiography technology; breast, colorectal, and prostate cancer; chronic idiopathic constipation; and ulcerative colitis. Ms. McDade is an expert programmer in Microsoft Excel and Visual Basic for Applications and also has experience working in Decision Analysis by TreeAge (DATA). Ms. McDade also provides extensive experience in programming graphical user interfaces (GUIs) for health economic models. Ms. McDade has developed GUIs for pediatric asthma, angiography technologies, HIV, and stroke models.
Email Cheryl L McDade
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| Juliana Meyers |
Juliana Meyers, MA
Research Health Economist
MA, Economics
BS, Biomedical Engineering
Boston University, Boston, MA Juliana Jackel, MA, is a Research Health Economist at RTI-HS. Prior to joining RTI-HS, Ms. Jackel worked as a research manager at Boston Health Economics. She has extensive experience analyzing retrospective health care claims data, cross-sectional and longitudinal survey data, and data from prospective clinical studies. Ms. Jackel has conducted research to estimate the prevalence and economic burden of various medical conditions, including acute coronary syndromes, invasive fungal infections, and complicated skin and skin structure infections. Ms. Jackel also has extensive experience in claims-based analyses to evaluate patterns and utilization implications of medication adherence among patients with schizophrenia. Ms. Jackel has coauthored research published in the American Journal of Health Systems Pharmacy and Current Medical Research and Opinions. Additionally, her research has been presented at numerous professional conferences and workshops, including the North American and European Congresses of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Academy of Managed Care Pharmacy (AMCP), Bone Marrow Transplantation (BMT), and the Intersciences Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
Email Juliana Meyers
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| Debanjali Mitra |
Debanjali Mitra, MA, MBA
Director, Health Economics
MA, Applied Economics
University of North Carolina, Greensboro, NC Postgraduate Diploma in Management (MBA)
Institute of Management Development and Research, Pune, India BA, Economics
University of Pune, India Debanjali Mitra, MA, MBA, is a Director of Health Economics at RTI-HS. She is a highly experienced health economist with expertise in many areas of health services research. She has extensive knowledge of health care claims database analysis, cross-sectional and longitudinal survey analysis, analysis of data from prospective clinical studies with patient-reported outcomes, analysis of data from retrospective chart abstractions, econometric modeling, and data management using a variety of statistical packages, including SAS and Stata. Ms. Mitra has conducted research to estimate the economic burden of various diseases and conditions, including hepatitis C, chronic constipation, Crohn’s disease, and irritable bowel syndrome. Ms. Mitra also has conducted research to characterize patterns of medication utilization, including adherence and persistence, titration, switching, and discontinuation in various therapeutic areas, including melanoma, kidney disease, hepatitis C, and ulcerative colitis. In addition, Ms. Mitra has assisted in the development of cost-effectiveness and budget-impact models for various medical conditions. In the past, she worked with the Behavioral Health Economics Program at RTI International where she conducted economic evaluations of substance abuse and mental health interventions for the federal government. She served as the project manager and economist for the cost-effectiveness study of COMBINE, a large multisite, randomized clinical trial sponsored by NIAAA for therapies for alcohol dependence. As part of this project, she wrote the analysis plan, designed data collection questionnaires, conducted data analyses, and coauthored manuscripts using the COMBINE trial data. She also has conducted research to estimate the effect of brief interventions for alcohol use on the health care utilization of problem drinkers. Ms. Mitra has coauthored research published in Medical Care, the Journal of Studies on Alcohol and Drugs, Archives of General Psychiatry, and Applied Health Economics and Health Policy. Her research has also been accepted for presentation at numerous professional conferences and workshops, including the Research Society on Alcoholism (RSA), Academy of Health’s annual meetings, the Society for Prevention Research (SPR), American Society of Health Economists (ASHE), North American and European Congresses of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Digestive Disease Week (DDW), American College of Gastroenterology (ACG), Academy of Managed Care Pharmacy (AMCP), Society for Medical Decision Making (SMDM), American Society of Clinical Oncology (ASCO), and American Society of Nephrology (ASN).
Email Debanjali Mitra
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| Deirdre Mladsi |
Deirdre Mladsi, BA
Head, Health Economics and Market Access
Graduate coursework (24 hours), Master of Health Sciences
Duke University School of Medicine, Durham, NC BA, Economics
University of North Carolina, Charlotte, NC Deirdre Mladsi is Head of Health Economics and Market Access at RTI-HS, applying methods and experience to support development and commercialization of pharmaceuticals, medical devices, and diagnostics. She has 20 years of experience conducting health economics and outcomes research, including 5 years in the Global Health Outcomes group of a leading research-based pharmaceutical company. As a consultant, Ms. Mladsi, one of the founding senior members of RTI-HS, has led several teams within the organization, starting with serving as a Director of Health Economics and including serving as Global Head of Health Outcomes Strategy and Global Head of Pricing and Reimbursement, before returning to organize the Health Economics and Market Access service offering. As Head of Health Economics and Market Access, Ms. Mladsi blends her technical skills in health economics with her experience conducting strategic pricing, reimbursement, and market access projects, both with a global focus, as well as working with local pricing and reimbursement experts in markets around the world. Areas of specialization that blend health economics and market access include threshold analysis to estimate price opportunity, given an expected product profile; valuation modeling to inform clinical development prioritization efforts; and decision support modeling targeted at payers and other health care market access decision makers. Ms. Mladsi also serves as a senior RTI-HS resource, bringing a market-oriented perspective to health economics and outcomes research projects, ensuring that they are conducted with an appreciation of the Value Messages that will result. She provides senior expertise to a team of health outcomes scientists and medical writers that specializes in designing and communicating the results of value-driven research. The team does this by developing and testing Value Messages, designing value-driven research strategies and plans, creating Value Dossiers, and preparing pricing and reimbursement dossiers for major markets. In addition to health economics, her interest is in bringing together scientists and marketing professionals to ensure that clear, concise, and relevant information is placed in the hands of marketplace decision makers, facilitating patient access to valuable new health care technologies. Her training is in economics and applied biostatistics, with an emphasis on clinical research. Although she has worked in all primary therapeutic areas, for several years her primary focus was oncology. She has published (also under the name Neighbors) in the Journal of Clinical Oncology, Journal of Pain and Symptom Management, Journal of Health Economics, Pharmacoeconomics, and Current Medical Research and Opinion, and has presented at numerous professional conferences. She has served as an adjunct faculty of Campbell University, responsible for their Health Economics course, offered as part of their Master’s in Clinical Research program.
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| Hediyyih Narula |
Hediyyih Narula, MA
Health Economist
MA, Applied Economics BS, Economics University of North Carolina, Greensboro, NC Hediyyih Narula, MA, is a Health Economist for the Health Economics group at RTI-HS. She assists in the development of cost-effectiveness and budget-impact models, literature reviews, modeling reports, and manuscripts. She also has experience developing various value and formulary submission dossiers and burden of illness reports, as well as conducting literature searches and data extractions. Additionally, she has extensive experience with the RTI-HS quality control processes that are performed to ensure the accuracy of information presented in deliverables. Ms. Narula graduated magna cum laude, with a BS in economics, followed by a Master’s in applied economics at the University of North Carolina at Greensboro.
Email Hediyyih Narula
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| Miny Samuel |
Miny Samuel, MS
HTA Systematic & Evidence Reviewer
MS, Immunology National University of Singapore, Singapore
PhD, Biological Sciences
MS, Zoology
Maharshi Dayanand University, India BS (Hons.), Zoology University of Madras, India
Miny Samuel, PhD, MS, is Health Technology Appraisal Systematic and Evidence Reviewer at RTI HS. Dr. Samuel has more than 10 years of experience in the field of epidemiology. Prior to RTI HS, Dr. Samuel was an evidence-based medicine analyst at the Clinical Trials and Epidemiology Research Unit at the National Medical Research Council in Singapore. She also served as codirector of the Australasian Cochrane Center in Singapore, where she supported Cochrane reviewers by providing consultation on reviews and meta-analyses, as well as methodologic help and statistical analysis and support in writing systemic reviews. Her work includes development of evidence-based clinical practice guidelines for Singapore’s Ministry of Health and increasing the awareness of evidence-based medicine practices among the medical community in Singapore. She has presented her research at numerous international symposia. She also has published extensively in journals and research publications, including The Cochrane Library (Systematic Reviews) and BMJ Clinical Evidence.
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| Sandra Talbird |
Sandra Talbird, MSPH
Associate Director, Health Economics
MSPH
University of North Carolina, Chapel Hill, NC BA, Bachelor of Business Administration (Finance)
University of Notre Dame, Notre Dame, IN Sandra Talbird, MSPH, is an Associate Director of Health Economics at RTI-HS. Her experience at RTI-HS includes developing advanced economic models, such as cost-effectiveness, cost-utility, cost-benefit, and budget-impact models, using Microsoft Excel and Visual Basic for Applications. Her primary research focus has been in infectious disease, including both treatment and prevention strategies. Her experience at GlaxoSmithKline included conducting detailed literature reviews and supporting the writing and development of abstracts and manuscripts. Ms. Talbird also has experience in health policy in the public sector, working directly with state US Medicaid departments on developing 1915(c) waivers, conducting cost surveys, setting reimbursement rates for services, and working on an independent evaluation of a State Children’s Health Insurance Program. Ms. Talbird’s academic experience is grounded in finance, economics, and public health. Therapeutic areas include influenza, malaria, HIV, pneumococcal disease, and women's health, including leiomyoma (uterine fibroids) and reproductive health.
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| Birgitta von Scheele |
Birgitta von Scheele, MS, MSc PHARM
Senior Health Economist
MS, Pharmacy Policy and Evaluative Science
University of North Carolina, Chapel Hill, NC MSc, Pharmacy
School of Pharmacy, Uppsala University, Sweden Birgitta von Scheele, MS, MSc, is a Senior Health Economist at RTI-HS. She has 10 years of professional experience applying health outcomes research of pharmaceutical and health data and more than 10 years of professional experience managing international clinical research projects, ranging from phase 1 to phase 4 trials, in the pharmaceutical industry. She has experience in developing product-specific health economic and outcome research (HEOR) analysis plans for core markets and application letters for pricing and reimbursement in Sweden and the United Kingdom, as well as in preparing several meta-analytic and cost-economic reports comparing different drugs within therapeutic areas. Ms. von Scheele also has prepared product value assessment documents and worked on epidemiologic projects since joining RTI-HS. Her experience includes depression, analgesics, oncology, hyperlipidemia, obstetrics, wound care, and cardiovascular disease. She has designed and managed international phase 3 and phase 4 clinical programs according to GCP standards and ICH harmonization, including study designs, study protocols, case record forms, clinical report writing, cost-economic modeling, and decision analysis.
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| Michele Wilson |
Michele Wilson, MSPH
Associate Director, Health Economics
PhD in progress, Health Policy and Management
University of North Carolina, Chapel Hill, NC MSPH, Health Policy and Administration
University of North Carolina, Chapel Hill, NC BSE, Biomedical Engineering (BS Economics)
Duke University, Durham, NC Michele Wilson, MSPH, is an Associate Director of Health economics at RTI-HS. During his tenure at RTI-HS, Mr. Wilson has worked extensively in the development of advanced economic models, such as cost-effectiveness, cost-benefit, cost-utility, and budget-impact models, using Microsoft Excel and Visual Basic for Applications. Other experience at RTI-HS includes conducting detailed literature reviews and supporting the writing and development of abstracts and manuscripts. Mr. Wilson also has experience in health economic research in a government research setting, including econometric analysis. Mr. Wilson’s academic experience is grounded in applied health economics and public health policy. Mr. Wilson’s experience includes research in therapeutic areas such as bipolar disorder, diabetes, COPD, schizophrenia, stroke, cardiovascular disease, cancer, myelofibrosis, Parkinson’s disease, Alzheimer’s disease and dementia, and HIV. Mr. Wilson has coauthored research published in Stroke, Managed Care Interface, Review of Economics of the Household, Value in Health, Respiratory Medicine, and the Journal of Health and Economic Issues. Mr. Wilson’s work has also been presented at the International Society for Pharmacoeconomics and Outcomes Research, Chest, the Winter Workshop on Schizophrenia and Bipolar Disorders, the American Academy of Managed Care Pharmacy, the International Stroke Conference, the American Thoracic Society, the World Congress on Parkinson’s Disease and Related Disorders, International Congress of Parkinson’s Disease and Movement Disorders, and AcademyHealth.
Email Michele Wilson
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| Sorrel Wolowacz |
Sorrel Wolowacz, PhD
Director, Health Economics
PhD, Biotechnology
Cambridge University, Cambridge, UK
Dissertation: Novel Immobilisation Techniques in Amperometric Biosensors BSc, Biochemistry
Birmingham University, Birmingham, UK Sorrel Wolowacz, PhD, is a Director of Health Economics at RTI-HS with 8 years of experience in heath economics consulting and more than 18 years of experience in the health care industry, including health outcomes, clinical research, and product development. She has researched in the areas of modeling, analysis of resource use and cost data (collected alongside trials, by medical record abstraction, or within databases), formal health technology appraisal submissions, systematic reviews, and compilation of value dossiers. She has experience in various therapeutic areas, including oncology (specifically lung, breast, ovarian, and hematological cancers), cardiology, VTE, arthritis, chronic pain, ophthalmology, and dermatology, She has participated in health technology appraisals in several markets, including the UK (NICE and SMC), Australia (PBAC), and Canada (CADTH). Dr. Wolowacz acts as peer reviewer for Pharmacoeconomics, European Journal of Health Economics, American Journal of Clinical Oncology, Value in Health and Therapeutics, and Clinical Risk Management.
Email Sorrel Wolowacz
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| Evelina A Zimovetz |
Evelina A Zimovetz, MSc
Health Economist
MSc, Operational Research and Applied Statistics
University of Salford, Salford, UK BSc (Hons), Management Science with Economics
University of Northampton, Northampton, UK Evelina Zimovetz, MSc, has more than 2 years of experience working as a Health Economist at RTI-HS. During this time, she has contributed to the development of cost-effectiveness, cost-utility, and budget-impact models in Microsoft Excel; undertaken systematic literature reviews; supported the writing and development of abstracts, manuscripts, and poster presentations; and managed a number of health economics and pricing and reimbursement projects. Her experience includes the therapeutic areas of rheumatoid arthritis, neuropathic pain, fibromyalgia, hemophilia, prostate cancer, lung cancer, and human immunodeficiency virus. Prior to joining RTI-HS, Ms. Zimovetz worked as an Economic Analyst within the United Kingdom’s Strategy Directorate of the Commission for Social Care Inspection, where she was responsible for extracting, analyzing, and interpreting complex data and information relevant to the social care market; writing briefings and reports on social care provision; and conducting ad hoc studies on the social care sector in England.
Email Evelina A Zimovetz
Patient-Reported Outcomes
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| Sheri Fehnel |
Sheri Fehnel, PhD
Vice President, Patient-Reported Outcomes
PhD, Quantitative Psychology
MA, Clinical Psychology
University of North Carolina, Chapel Hill, NC BS, Mathematics and Psychology
Duke University, Durham, NC Sheri Fehnel, PhD, is Vice President of Patient-Reported Outcomes in RTI-HS. Since joining the RTI staff in 1988, she has combined the study of clinical psychology and psychometrics with practical research and clinical experience. She specializes in the development and evaluation of questionnaires designed to measure health-related quality of life, functional status, patient satisfaction, resource utilization, and other patient-reported outcomes. This work has involved a wide range of therapeutic areas, including depression, attention-deficit disorder, bipolar disorder, schizophrenia, insomnia, incontinence, irritable bowel syndrome, oncology, cardiovascular disease, women’s health, diabetes, asthma, COPD, sexual dysfunction, obesity, cystic fibrosis, chronic pain, and sexually transmitted diseases such as herpes, HPV, and HIV/AIDS. As part of the questionnaire-development process, Dr. Fehnel has moderated countless focus groups, conducted cognitive interviews with a wide variety of patient and professional populations, and assessed potential sources of measurement error through cognitive forms appraisal. She has also evaluated the psychometric properties of many survey and clinical instruments using techniques such as factor analysis, structural equations modeling, and item response theory. Dr. Fehnel is a frequent presenter at annual conferences held by organizations such as the International Society for Quality of Life Research (ISOQOL) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), as well as at various Drug Information Association (DIA) symposia. She also has published a number of articles related to questionnaire development and psychometric evaluation in Quality of Life Research, Medical Care, and Pharmacoeconomics.
Email Sheri Fehnel
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| Cheryl Coon |
Cheryl Coon, PhD
Director, Psychometrics
PhD, Quantitative Psychology PhD, Quantitative Psychology
MA, Quantitative Psychology
BA, Psychology and French
University of North Carolina, Chapel Hill, NC Cheryl Coon, PhD, is a Director of Psychometrics in RTI-HS. She has several years of experience in psychometric research, with particular concentration in item response theory and factor analysis. She has applied these and other statistical techniques to a variety of therapeutic areas, including respiratory and reproductive disorders, anxiety, schizophrenia, mood disorders, overactive bladder, and movement disorders. Much of her project experience involves the assessment of reliability, validity, factor structure, responsiveness, and minimal important difference. Dr. Coon has used these methods in the development and psychometric evaluation of scales measuring a number of outcomes such as health-related quality of life, treatment satisfaction and efficacy, patient preference, and symptom severity. She has several publications and presentations in the fields of quantitative psychology and patient-reported outcomes, including manuscripts in Medical Care, the Journal of Clinical Epidemiology, and the Journal of Psychiatric Research and presentations at the International Society for Quality of Life Research and the International Society for Pharmacoeconomics and Outcomes Research.
Email Cheryl Coon
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| Marci Clark |
Marci Clark, PharmD
Director, Patient-Reported Outcomes
Pharmacoeconomic and Outcomes Research Fellowship
PharmD
University of Michigan, Ann Arbor, MI Marci Clark, PharmD, is a Director of Patient-Reported Outcomes at RTI-HS. Dr. Clark is an established scientist with more than 7 years of industry experience in clinical drug development and global health outcomes research with Pfizer. She is skilled at developing outcomes research strategy and key value messages/claims to differentiate developmental compounds in phases 1-3B for women’s health, oncology, dermatology, and respiratory indications. Dr. Clark also has expertise in the evaluation, selection, development, and validation of patient-reported outcome questionnaires, specifically quality of life, treatment satisfaction, and symptom assessment; and the development of FDA evidence dossiers to support labeling claims for patient-reported outcome endpoints. She also has built strong positive relationships with key clinical experts and instrument developers in several therapeutic areas. Dr. Clark has presented research at both clinical and outcomes research-related national meetings.
Email Marci Clark
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| Kimberly H Davis |
Kimberly H Davis, MS
Director, Patient-Reported Outcomes
MS, Pharmaceutical Policy and Evaluative Sciences
BS, Pharmacy
University of North Carolina, Chapel Hill, NC Kim Davis, MS, is a Director of Patient-Reported Outcomes at RTI-HS. She worked in the pharmaceutical industry for 4 years as a Global Health Outcomes manager before joining RTI-HS in 2003. In her current role at RTI-HS, she combines her clinical experience as a pharmacist, industry experience, and study of pharmaceutical policy with practical research. She has worked with various multidisciplinary teams in the pharmaceutical industry, including commercial, clinical, global pricing, epidemiology, biomedical data sciences, international product development, and clinical trial project teams. She has excellent interpersonal skills and is highly motivated, organized, and efficient, with strong oral and written communication skills that allow her to build and maintain rapport with team members, key opinion leaders, and experts. Ms. Davis has extensive experience leading and serving as a project manager for multiple types of projects, including large international data collection studies. In addition, she has assisted with the development of protocols and physician and patient surveys for risk evaluation and minimization strategy (REMS) plans to support new drugs in development for the treatment of pain and arthritis as required by the Food and Drug Administration (FDA). She also specializes in the development and evaluation of questionnaires designed to measure health-related quality of life, patient satisfaction, resource utilization, and other patient-reported outcomes. As part of the questionnaire-development process, Ms. Davis has assisted with the moderation of focus groups and cognitive interviews with a variety of patient populations and with physicians. Ms. Davis has also served as a consultant for various health outcomes projects (e.g., large data collection, literature reviews, clinical trials) across a number of therapeutic areas, including ADHD, allergic rhinitis, asthma, bipolar disorder, blood disorders, cancer, depression, diabetes, gastrointestinal disorders, insomnia, migraine, obesity, and women’s health portfolios. She has also developed economic models and value proposition dossiers to assist international operating companies with reimbursement submissions to assure optimal reimbursement of products at launch.
Email Kimberly H Davis
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| Carla Demuro-Mercon |
Carla Demuro-Mercon, PhD
Senior Director, Patient-Reported Outcomes
PhD Candidate, Public Health
Walden University MS, Community Health and Education
Arcadia University, Glenside, PA BS, Applied Computer Science/Communications
Chestnut Hill College, Philadelphia, PA Carla DeMuro-Mercon, MS, is a Senior Director of Patient-Reported Outcomes in RTI-HS. Ms. DeMuro-Mercon has extensive experience in the rigorous development and validation of patient-reported outcome measures for use in clinical trials, as well as large scale epidemiologic and population-based studies. She joined RTI-HS after 15 years of working in the pharmaceutical industry and brings her experience with and understanding of the newly drafted FDA Guidance for Patient Reported Measures. Ms. DeMuro-Mercon has worked to developed measures across a wide span of therapeutic areas, including but not limited to respiratory illness (asthma, COPD, allergic rhinitis, influenza), oncology (non-small cell and small cell lung cancer), Alzheimer’s disease, infectious disease (including sexually transmitted disease), sleep disorders, hair loss (male and female), menopausal symptoms, cognition, acne, benign prostatic hyperplasia, diabetes, and migraine. Measures have included multiple types of patient-reported outcomes, including quality of life, treatment satisfaction, symptom severity, daily event logs, patient diaries, and utility measures. She has specialized in both the qualitative and quantitative aspects of instrument design and has worked toward creating a clear path from measure development to interpretation.
Email Carla Demuro-Mercon
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| Dana B DiBenedetti |
Dana B DiBenedetti, PhD
Head, Patient-Reported Outcomes
PhD, Clinical Psychology MS, Clinical Psychology Oklahoma State University, Stillwater, OK BA, Psychology Millsaps College, Jackson, MS Dana Britt DiBenedetti, PhD, Head of Patient-Reported Outcomes at RTI-HS, is a licensed clinical health psychologist with extensive experience in psychosocial assessment of adults and children in numerous therapeutic areas. Her broad clinical and assessment experience includes expertise in psychiatry, women’s health (e.g., menopause, vaginal atrophy, endometriosis), sexual medicine (e.g., erectile dysfunction, female sexual dysfunction, Peyronie’s disease), nicotine dependence, obesity, chronic pain, virology, oncology, and neurology/neuropsychology. Currently, Dr. DiBenedetti specializes in the development of questionnaires designed to measure quality of life, patient satisfaction, and other PROs. As part of the questionnaire-development process, Dr. DiBenedetti has facilitated numerous patient, caregiver, and physician focus groups and conducted cognitive interviews with a wide variety of patient and professional populations. Dr. DiBenedetti has considerable experience in both academic and pharmaceutical settings with instrument development and validation; coordination of instrument translations; and protocol design, functional status and quality of life assessment, and study implementation in phase 2 through phase 4 clinical studies. Dr. DiBenedetti has authored or coauthored numerous manuscripts and scientific presentations on quality of life, treatment satisfaction, and other outcomes in various patient populations, and she has served as a reviewer for several journals, including Journal of Consulting and Clinical Psychology, Health Psychology, Annals of Behavioral Medicine, International Journal of Behavioral Medicine, Addictive Behaviors, and Medical Care.
Email Dana B DiBenedetti
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| Claire Ervin |
Claire Ervin, MPH
Director, Patient-Reported Outcomes
MPH, Public Health Leadership
University of North Carolina, Chapel Hill, NC BA, Communications
College of Wooster, Wooster, OH Claire Ervin, MPH, is a Director in the Patient-Reported Outcomes division with RTI-HS. Ms. Ervin has more than 7 years of health care experience, including project management, patient and site recruitment, survey design and implementation, literature reviews, investigator and interviewer training, data collection and management/auditing, and analysis and reporting. Therapeutic areas in which she has worked include irritable bowel syndrome, women’s sexual/reproductive health, obesity, stroke, heart disease, anxiety disorders, depression, and autism. Ms. Ervin also specializes in the development, evaluation, and validation of questionnaires designed to measure health-related quality of life, patient satisfaction, and other patient-reported outcomes. As part of the questionnaire-development process, Ms. Ervin has led and assisted with the moderation of both focus groups and cognitive interviews with a variety of patient populations. Prior to her role at RTI-HS, Ms. Ervin served as the project manager for a multicenter, Center for Disease Control and Prevention (CDC)–funded continuous quality-improvement initiative focused on improving stroke care in North Carolina. Her work has been presented at national conferences.
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John Ervin III, BS
Project Manager
BS, Psychology
Guilford College, Greensboro, NC John Ervin is a Health Outcomes Specialist focusing on survey research in the Patient-Reported Outcomes division of RTI-HS. Mr. Ervin has a strong background in clinical and observational study proposal development and in project management. His experience includes the design of patient-reported outcome studies, prospective epidemiologic studies, and risk management studies. Prior to working at RTI-HS, Mr. Ervin led the development of large multinational clinical trial proposals and managed cross functional project teams in multimillion dollar projects.
Email John Ervin III
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| Theresa Gilligan |
Theresa Gilligan, MS
Senior Health Outcomes Analyst
MS, Analytics
North Carolina State University, Raleigh, NC BS, Psychology
Appalachian State University, Boone, NC Theresa Gilligan, MS, is a Senior Health Outcomes Analyst in the Patient-Reported Outcomes group within RTI-HS. Ms. Gilligan’s professional experience with SAS over the past 6 years includes a Base Programming Certification for SAS®9 and training in SAS Enterprise Miner and SAS Text Miner. Her statistical analysis has covered topics in depression, anxiety, exercise, asthma, diabetes, rhinitis, HCV, COPD, influenza vaccination programs, postsecondary education, and customer behaviors in the marketing field. Ms. Gilligan has more than 4 years of survey-specific experience with methodological and data quality analyses, survey instrument development, survey data collection, and data reporting and technical writing for both small-scale and national longitudinal studies. Her statistical survey analysis experience includes response rate analyses, respondent behavior analysis, interview burden analyses, prevalence, and psychometrics. In addition to survey development, Ms. Gilligan has provided survey administration training for national longitudinal studies.
Email Theresa Gilligan
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| Diana M Goss |
Diana M Goss, AS
Senior Project Manager
AS, Medical Secretarial Science
Hardbarger Junior College, Raleigh, NC SAS Institute courses - 2000: SAS Fundamentals: A Programming Approach, SAS Macro Language Diana Goss is a Senior Project Manager with 20 years of experience in data collection and health-related research. Her project management experience includes designing and producing case report forms, editing and producing study protocols, supervising data collection staff to ensure compliance with study procedures, tracking site visits, and producing study progress reports. She also has conducted focus groups and cognitive interviews with a variety of populations to inform the development of survey instruments, as well as the refinement of item wording, formatting, and response scales. Ms. Goss currently plays a key role in nationwide data collection efforts, performing daily activities such as monitoring survey distribution and receipt, supervising data collection staff, site management, data abstraction management, and reporting spontaneous adverse events with an emphasis on confidentiality and participants’ rights.
Email Diana M Goss
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| Kelly Hollis |
Kelly Hollis, MBA
Head, Survey Research
MBA
Kenan Flagler Business School, University of North Carolina, Chapel Hill, NC BA, Mass Communication, Minor in Zoology
North Carolina State University, Raleigh, NC Kelly A. Hollis, MBA, Senior Director of Survey Research for RTI-HS, has a strong background in project management and a proven track record in the successful design, implementation, and leadership of global research studies. During her 10 years at RTI International, she has provided successful leadership and oversight of research in a number of therapeutic areas, including IBS, oncology, diabetes, and depression. She has particular expertise in planning and managing large-scale prospective observational studies, including health economic and epidemiologic studies, patient outcomes research, risk management programs, and patient registries. Her results-oriented, client-focused approach to project management includes strategic planning, financial management, process development, and resource allocation.
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| Laurin Jackson |
Laurin Jackson, MA
Project Manager
MA, Sociology
BA, Psychology, minor in Sociology
East Carolina University, Greenville, NC Laurin Jackson, MA, is a Project Manager in the Patient-Reported Outcomes division of RTI-HS. Ms. Jackson has more than 10 years of professional experience in survey research methodology, data reporting, and field management. She has been involved in survey design, instrument development, data collection, data tabulation, and data analysis. Since joining RTI in 1999, Ms. Jackson has been responsible for data collection tasks, including field interviewer training, field staff recruiting, and managing field interviewing staff for a large national study.
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| Sandy Lewis |
Sandy Lewis, BSN
Director of Patient-Reported Outcomes
BSN
Gwynedd-Mercy College, Gwynedd Valley, PA Sandy Lewis is a Director of Patient-Reported Outcomes at RTI-HS. She has more than 15 years of experience in the pharmaceutical industry, half of which has been focused on the development and validation of patient-reported outcome (PRO) measures and implementation of PROs within clinical trial programs. Ms. Lewis has assisted with the development of PRO evidence dossiers for submission to the FDA to support label claims. Throughout the span of her career, Ms. Lewis has worked in numerous therapeutic areas, including gastroenterology, neuropsychology, infectious diseases, respiratory, endocrinology, orthopedics, urology, and vaccines. Ms. Lewis has a strong interest in pediatric patient populations and has conducted numerous interviews with children between the ages of 6 and 18. Additionally, Ms. Lewis has extensive experience in the standardization and development of training materials and instruction for the administration of multiple instruments, including, but not limited to, the HAMD, HAMA, and MADRS in psychiatry and the BDI/TDI in respiratory disease. Ms. Lewis has strong project management skills and has experience in all aspects of data collection from protocol development through report writing. While at Merck, Ms. Lewis supported 12 clinical trials that used electronic (ePRO) technology and was part of the Business Process Implementation team, which developed the guidance documents, working instructions, joint validation plan, and business processes for incorporation of ePRO technology at the company. Prior to entering the pharmaceutical arena, Ms. Lewis received her BSN from Gwynedd-Mercy College and worked for 3 years in a step-down critical care unit as a primary care nurse.
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| Susan Martin |
Susan Martin, MSPH
Senior Director, Patient-Reported Outcomes
MSPH, Health Policy and Administration
University of North Carolina, Chapel Hill, NC BS, Political Science
College of Charleston, Charleston, SC Susan Martin, MSPH, is a Senior Director of Patient-Reported Outcomes at RTI-HS. Ms.Martin has more than 16 years of experience in the health care sector. Before joining RTI-HS, Ms. Martin held various posts at Pfizer, Parke Davis, Henry Ford Health System, Burroughs Wellcome, and the South Carolina Department of Health and Environmental Control. Most recently, she was a Director at Pfizer Global Outcomes Research where she was responsible for the pain and inflammation therapy areas, including designing and implementing product and therapy level strategies. Ms. Martin has extensive outcomes research experience in numerous types of conditions, including fibromyalgia, postherpetic neuralgia, diabetic painful neuropathy, Alzheimer’s disease, low back pain, and arthritis. She has been an active participant in pain research collaborations spanning industry, academia, and regulatory agencies, including the IMMPACT group—which has published recommendations in the area of pain clinical research—as well as leading the first OMERACT workshop held on fibromyalgia.
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| Lori D McLeod |
Lori D McLeod, PhD
Head, Psychometrics
PhD, Quantitative Psychology
MA, Quantitative Psychology
University of North Carolina, Chapel Hill, NC BS, Statistics, Mathematics Education (graduated Summa Cum Laude)
North Carolina State University, Raleigh, NC Lori McLeod, PhD, is Head of Psychometrics at RTI-HS. Dr. McLeod is a psychometrician with more than 10 years of experience in instrument development and validation, as well as experience conducting systematic assessments of clinical and economic literature and developing appropriate health outcome strategies. In her Psychometrics role, she has conducted many psychometric evaluations of both paper-and-pencil and computer-administered instruments. These investigations have included the assessment of scale reliability, validity, responsiveness, and work to identify PRO responders. Dr. McLeod has published numerous related manuscripts in Applied Psychological Measurement, Pharmacoeconomics, Journal of Educational Measurement, and Psychometrika. She has experience in a wide variety of therapeutic areas, including chronic pain, dermatology, oncology, psychiatry, respiratory, sleep disorders, urology, and sexual dysfunction
Email Lori D McLeod
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| Lauren Nelson |
Lauren Nelson, PhD
Director, Psychometrics
PhD, Quantitative Psychology
MA, Quantitative Psychology
MS, Physics
BS, Physics
University of North Carolina, Chapel Hill, NC BS, Psychology
University of North Carolina, Charlotte, NC Lauren Nelson, PhD, is a Director of Psychometrics. She has over 10 years of experience applying psychometric and statistical methods to address research questions. At RTI-HS, Dr. Nelson has conducted the psychometric evaluation of patient-reported outcome instruments for a variety of therapeutic areas, including irritable bowel syndrome, diabetes, gynecological disorders, chronic sinusitis, asthma, and COPD. She has expertise in applying modern psychometric methodology such as item response theory, factor analysis, and structural equation modeling. Dr. Nelson has several publications and presentations in the fields of psychology and patient-reported outcomes, including manuscripts in Pediatrics, American Journal of Mental Health, and Developmental Psychology and papers and posters presented to the International Society for Quality of Life Research and the International Society of Pharmacoeconomics and Outcomes Research.
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| Mark Price |
Mark Price, MA, MEd
Director, Psychometrics
PhD, coursework in Educational Research Methodology (with Statistics minor)
MEd, Educational Research Methodology (with Statistics minor)
MA, French
University of North Carolina at Greensboro, Greensboro, NC BA, English and French
Emory and Henry College, Emory, VA Mark Price, MEd, MA, is a Director of Psychometrics in the Patient-Reported Outcomes group, where he works on both qualitative and quantitative tasks supporting questionnaire development. Mr. Price has more than 15 years of experience in the design, collection, analysis, interpretation, and reporting of high-stakes data. In the past, Mr. Price was a senior psychometrician for the New York Stock Exchange, where he provided expertise for the development and enhancement of examination programs. In addition, Mr. Price has designed, coordinated, and analyzed data for qualitative studies in the specific disease areas of male sexual dysfunction, HIV, prostate cancer, obesity, diabetes, schizophrenia, gastrointestinal disorders, cardiovascular disorders, multiple sclerosis, and asthma. Mr. Price’s areas of expertise include both qualitative and quantitative research design and implementation (focus groups, patient interviews, surveys, online data collection), statistical analysis, item response theory, factor analysis, and technical writing and editing. He has experience with major statistical analysis, qualitative data analysis, and database programs. His language skills include fluency in French and an intermediate knowledge of Spanish, and he has designed parallel bilingual data collection protocols.
Email Mark Price
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| Carolyn Sweeney |
Carolyn Sweeney, MPH
Health Outcomes Scientist
MPH, Epidemiology
Eastern Virginia Medical School, Norfolk, VA BS, Health Sciences
James Madison University, Harrisonburg, VA Carolyn Sweeney, MPH, is a Health Outcomes Scientist in the Patient-Reported Outcomes group at RTI-HS. Ms. Sweeney has more than 4 years of health care experience, including literature reviews, project management, survey design and implementation, developing protocols and claims-based research, patient and site recruitment, investigator and study coordinator training, data collection and management, reviewing documentation for quality control purposes, and analysis and reporting. Prior to joining RTI-HS, Ms. Sweeney worked in the pharmaceutical industry where she provided strategy support for both marketed and products in development within the gastrointestinal, metabolic, and cardiovascular disease areas. She also has several years of experience working in local health departments in environmental health services and epidemiology.
Email Carolyn Sweeney
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| Megan Thomas |
Megan Thomas, MTSC
Health Outcomes Scientist
Master of Technical and Scientific Communication
Miami University, Oxford, OH BS, Biological Science, Honors Program/Cum Laude
North Carolina State University, Raleigh, NC Megan Thomas, MTSC, is a Health Outcomes Scientist in the Patient-Reported Outcomes (PRO) group within RTI-HS. Ms. Thomas worked in the pharmaceutical industry for 5 years. She developed clinical-trial publications (abstracts and posters) for worldwide conferences and managed a multiyear project to revise and review laboratory data documents across eight analytical chemistry and microbiology departments. In her current role with RTI-HS, she combines her knowledge of industry with her project management and graphic communication services. Ms. Thomas has experience serving as a project manager for multiple types of projects, including patient-reported and health outcomes projects. She develops institutional review board (IRB) materials and assists in the moderation of cognitive interviews with a variety of patient populations for PRO and survey projects. She has supported various health outcomes projects (e.g., patient and physician surveys, literature reviews, dossiers, and clinical trials) across a number of therapeutic areas, including allergic rhinitis, blood disorders, cardiology, cancer, depression, gastrointestinal, and women’s health. Ms. Thomas also develops graphics for reports, and in previous roles, has developed marketing materials and conducted laboratory bench research. Ms. Thomas is a member of the American Medical Writers Association (AMWA) and attends local AMWA conferences.
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| Michelle Thompson |
Michelle Thompson, MPH
Director, Project Manager
MPH
University of Connecticut, Storrs, CT PMP
Project Management Institute, Newtown Square, PA BA, Microbiology
University of New Hampshire, Durham, NH Michelle Thompson, MPH, PMP, is a Senior Project Manager in the Patient-Reported Outcomes group at RTI-HS. Ms. Thompson worked in the pharmaceutical industry as a microbiologist for 12 years prior to joining RTI-HS. She has combined her industry experience and study of public health with practical research, placing a strong emphasis on project management. As a project manager, she supports a wide range of studies, including patient-reported outcomes studies, prospective epidemiological studies, and database studies. Ms. Thompson has experience managing both electronic and paper-and-pencil-based data collection efforts and has worked on several data collection projects involving multidisciplinary teams. Ms.Thompson’s project experience includes study design and implementation, questionnaire development and pretesting, patient and site recruitment, investigator training, and management of data collection activities. As part of the questionnaire development process, Ms. Thompson has assisted with moderating focus groups and has conducted cognitive interviews with a variety of patient populations. Her industry experience includes providing health outcomes support for a melanoma clinical trial and coordinating and managing timelines for technical projects.
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| Valerie Williams |
Valerie Williams, PhD
Senior Director, Psychometrics
PhD, Quantitative Psychology
BA, Psychology
University of North Carolina, Chapel Hill, NC MA (summa cum laude), Psychology
North Carolina Central University, Durham, NC Valerie Williams, PhD, is a Senior Director of Psychometrics at RTI-HS. She has 20 years of experience applying psychometric and statistical methods to topics in measurement. Her work at RTI-HS has involved a number of therapeutic areas, including respiratory and gynecological disorders, obesity, sexual dysfunction, bipolar disorder, anxiety, and chronic pain. Dr. Williams has developed scales and surveys for a range of applications, including substance abuse, health care utilization, and various psychological disorders; she has designed and directed the psychometric evaluation and statistical analysis of instruments related to health care, quality of life, educational achievement, and a variety of psychological constructs, using specialized techniques such as factor analysis, structural equations modeling, hierarchical modeling, and item response theory. She has published and presented widely on topics related to measurement and quantitative psychology.
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| Laurie J Zografos |
Laurie J Zografos, BS
Director of Survey Research
BS, Psychology
University of North Carolina, Chapel Hill, NC Semester Abroad at the University of Sussex, Brighton, England Laurie Zografos is a Director of Survey Research in the Patient-Reported Outcomes division of RTI-HS. Ms. Zografos has a strong background in survey research, both in the public and private sector. She has extensive experience designing and managing Web, telephone, mail, field, and mixed-method studies. Her experience includes the design and conduct of patient-reported outcome studies, prospective epidemiologic studies, risk management studies, and consumer use studies. While at RTI, she has worked on several large longitudinal studies involving multidisciplinary teams with primary data collection in the United States. Ms. Zografos has experience with all aspects of data collection, including project management, survey design and implementation, questionnaire development, patient and site recruitment, investigator and interviewer training, biospecimen collection, data collection and management, and reporting. Ms. Zografos also has experience in the development and evaluation of questionnaires designed to measure patient-reported outcomes. As part of the questionnaire development process, Ms. Zografos has conducted cognitive interviews with a variety of patient populations.
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Regulatory and Health Outcomes Strategy
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| Kati Copley-Merriman |
Kati Copley-Merriman, MS, MBA
Vice President, Regulatory and Health Outcomes Strategy and Market Access
MBA, Marketing
Indiana University, Indianapolis, IN MS, Organic Chemistry
Purdue University, Indianapolis, IN BA, Chemistry and German
Smith College, Northampton, MA Kati Copley-Merriman, MS, MBA, is Vice President of Regulatory and Health Outcomes Strategy/Market Access at RTI-HS. Ms. Copley-Merriman has more than 25 years of industry experience, including leadership roles in Global Outcomes Research at Eli Lilly, Parke-Davis, and Pfizer. She has experience in all aspects of Outcomes Research (OR), including clinical trial design with PRO endpoints, economic evaluations, OR strategic plans, and regulatory strategy. In her outcomes research and regulatory role, she leads a team of scientists responsible for developing OR strategic plans for phase 2/3 compounds, developing PRO dossiers for the FDA for Label Claims, and designing clinical trials with OR endpoints. Ms. Copley-Merriman has experience in many therapeutic areas, including oncology, pain and inflammation, dermatology, respiratory, urology, and CNS.
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| Amy Barrett |
Amy Barrett, MSPH, MA
Director, Regulatory and Health Outcomes Strategy
MSPH, Health Policy and Administration
University of Alabama, Birmingham, AL MA, English
University of North Carolina at Chapel Hill, Chapel Hill, NC BA, English and Pre-medicine
University of Alabama, Tuscaloosa, AL Amy Barrett, MA, MSPH, is a Director of Regulatory and Health Outcomes Strategy with RTI-HS. She has more than 10 years of experience analyzing and writing about issues related to health care delivery. Ms. Barrett has developed global value dossiers and has led large, multicountry burden-of-illness literature reviews. She also has experience in payer research, including designing interview guides, conducting interviews with payers, and analyzing results for their impact on pricing and reimbursement strategy. Her experience in performing patient-reported outcomes research includes developing questionnaires and conducting focus group and cognitive interviews. She offers knowledge in several therapeutic areas, including Alzheimer’s disease, Parkinson’s disease, mood disorders, bipolar disorder, benign prostatic hyperplasia, obesity, non-small cell lung cancer, and endometrial cancer. Prior to joining RTI-HS, Ms. Barrett served as an editor-in-chief for a health care publisher. She wrote a national newsletter for the assisted living industry, which required analysis of federal, state, and local regulations, as well as compliance, liability, and long-term care delivery models. She also wrote about topics related to the provision of skilled nursing and rehabilitation.
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| Stephanie Barrows |
Stephanie Barrows, MPH
Director, Regulatory and Health Outcomes Strategy
MPH, Health Management and Policy
University of Michigan, Ann Arbor, MI MA, Health Promotion and Program Management
BS, Health Education
Central Michigan University, Mt. Pleasant, MI Stephanie Barrows, MA, MPH, is a Director in the Regulatory and Health Outcomes Strategy group at RTI-HS. Ms. Barrows has several years of industry experience in outcomes research (OR) with Pharmacia and Pfizer, including clinical trials with patient-reported outcome (PRO) endpoints, development of PROs, creating OR strategic plans, and collecting health resource utilization data. Her expertise includes work in several areas of psychiatry, including schizophrenia, bipolar disorder, ADHD, and depression; oncology; infectious diseases; pain; inflammation; migraine; movement disorders; and dermatology. In her role at RTI-HS, Ms. Barrows has responsibility for developing OR strategic plans for phase 2/3 compounds, value positioning of new products, conducting literature reviews, creating global value dossiers, conducting competitive overviews, and developing FDA dossiers for PRO endpoints.
Email Stephanie Barrows
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| Ann Colosia |
Ann Colosia, PhD
Senior Health Outcomes Scientist
PhD, Molecular Physiology and Biophysics
BS, General Biology
Vanderbilt University, Nashville, TN Ann Colosia, PhD, is a Senior Health Outcomes Scientist in the Regulatory and Health Outcomes Strategy group. She has more than 10 years of experience in communicating pharmaceutical drug value to payers and physicians. She has experience conducting literature reviews, including systematic literature reviews, and developing product value dossiers and AMCP dossiers. Before joining RTI-HS, she developed science and business materials with an educational focus for sales training programs. Prior to beginning her career in health care communications, her laboratory research dealt with glucoregulatory mechanisms affected by diabetes and autoimmune mechanisms causing autoantibody development. Dr. Colosia’s writing experience includes the therapeutic areas of diabetes, cancers, gastrointestinal diseases, hypercholesterolemia, cardiovascular disease, Parkinson’s disease, pulmonary diseases, hematoproliferative disorders, and autoimmune diseases.
Email Ann Colosia
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| Kristen Hinson |
Kristen Hinson, BA
Associate Research Coordinator
BA, Journalism
University of Kentucky, Lexington, KY Kristen Hinson is a Research Coordinator at RTI-HS. Ms. Hinson assists in writing, conducting literature reviews, data entry, and the coordination of research materials for various groups in RTI-HS. She graduated from the University of Kentucky with a BA in Journalism and a minor in political science.
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| Melissa Juniper |
Melissa Juniper, MS
Director, Regulatory and Health Outcomes Strategy
MS, Developmental Psychology
North Carolina State University, Raleigh, NC BA, Psychology
Susquehanna University, Selinsgrove, PA Certificate (in process), Core Public Health Concepts
University of North Carolina, Chapel Hill, NC Melissa Juniper, MS, is a Director of Regulatory and Health Outcomes Strategy at RTI-HS. Ms. Juniper develops Value Strategies and Value Dossiers to help ensure pharmaceutical access and reimbursement and successful product commercialization. She has completed an Expert Workshop at the Centre for Health Economics at the University of York, as well as training sponsored by the Academy of Managed Care Pharmacy (AMCP) on formulary submission dossier preparation, and training sponsored by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). She is currently completing coursework toward her certificate in Core Public Health Concepts through the University of North Carolina. Ms. Juniper’s research and writing experience has been in the areas of cardiovascular disease, diabetes, osteoporosis, fibromyalgia, non-small cell lung cancer, glioblastoma multiforme, macular degeneration, hepatitis B, psoriasis, opioid-induced bowel dysfunction, major depressive disorder, and generalized anxiety disorder.
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| Shahnaz Khan |
Shahnaz Khan, MPH
Senior Director, Regulatory and Health Outcomes Strategy
MPH, Maternal and Child Health
BS, Clinical Laboratory Science
University of North Carolina, Chapel Hill, NC Shahnaz Khan, MPH, is a Senior Director of Regulatory and Health Outcomes Strategy. Ms. Khan is responsible for the development of pricing and reimbursement dossiers. She has more than 9 years of experience working in medical communications and has earned a certificate in medical writing from the American Medical Writers Association. Prior to joining RTI-HS, she served as a Medical Writer for a contract research organization. Her extensive clinical writing experience includes preparation of protocols, clinical study reports, and manuscripts in the areas of ophthalmology, infectious diseases, cardiovascular disease, endocrinology, urology, gynecology, oncology, hematology, and neurology. In addition to her focus on pricing and reimbursement dossiers, she has considerable experience in the production of corporate health economics and outcomes research communication materials. Ms. Khan attends AMCP meetings and AMCP/FMCP-sponsored seminars on a regular basis in order to remain up-to-date on the latest news regarding AMCP dossiers
Email Shahnaz Khan
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| Mary Levine |
Mary Levine, BA
Associate Research Coordinator
BA, Zoology
University of California, Santa Barbara, CA Mary Levine is a Research Resource Specialist at RTI-HS. She assists in writing, conducting literature reviews, data entry, and coordinating research materials for various groups in RTI-HS. She graduated from the University of California, Santa Barbara with a BA in Zoology. She developed her skills in leadership and client management as a pension consultant and human resources/office manager. Ms. Levine is also fluent in Mandarin Chinese.
Email Mary Levine
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| Lisa Lines |
Lisa Lines, MPH
Senior Health Outcomes Scientist
MPH
University of Massachusetts, Amherst, MA BS, Technical Communications
Northeastern University, Boston, MA Lisa Lines, MPH, is a Senior Health Outcomes Scientist in the Regulatory and Health Outcomes Strategy group at RTI-HS. She has experience with analyzing claims and government survey data, building decision-analytic models, developing utility instruments, and performing comprehensive literature reviews. Ms. Lines has experience in numerous therapeutic areas, including oncology, nephrology, neurology, ophthalmology, and immunology. She has earned both a medical writing certificate and a professional development certificate from the American Medical Writers Association and has been certified as an Editor in the Life Sciences by the Board of Editors in the Life Sciences. Her research has been presented at numerous conferences and published in peer-reviewed journals, including BMC Health Services Research, BMC Cancer, Expert Reviews in Pharmacoeconomics and Outcomes Research, and Clinical Gastroenterology and Hepatology.
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| Catherine Masaquel |
Catherine Masaquel, MPH
Associate Director, Regulatory and Health Outcomes Strategy
MPH, Health Policy and Administration
Yale University, New Haven, CT BS, Psychobiology
University of California, Los Angeles, CA Catherine Masaquel, MPH, is an Associate Director in the Regulatory and Health Outcomes Strategy group at RTI-HS. Ms. Masaquel has several years of industry experience in outcomes research and health economics with Pfizer and Amgen. She has extensive experience with health care claims database analysis, managed care communication plans, pharmacoeconomics, and patient-reported outcomes. Her previous work has focused on therapeutic areas such as cardiology, nephrology, diabetes, and infectious diseases. Ms. Masaquel is responsible for the development of health economic and outcomes research strategic plans for phase 2/3 compounds, literature reviews, global value and AMCP dossiers, and value message positioning.
Email Catherine Masaquel
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| Margaret Mordin |
Margaret Mordin, MS
Senior Director, Regulatory and Health Outcomes Strategy
MS, Public Policy
BA, Political Science
University of Rochester, Rochester, NY Margaret Mordin, MS, is a Senior Director of Regulatory and Health Outcomes Strategy at RTI HS. Ms. Mordin has nearly 20 years of experience in conducting and managing outcomes research, including designing and implementing outcomes assessments in prospective trials for regulatory submission and as postmarketing studies. Her areas of expertise include study design, including designing observational postmarketing studies, designing patient-reported outcomes for use in clinical development programs, patient health-related quality of life and satisfaction surveys, analyses of outcomes data, publication development, and outcomes-related regulatory submission strategies. Her experience also includes directing health economic evaluations (prospective economic trials and billing studies). In addition, Ms. Mordin has conducted outcomes research for multiple medical devices, including drug/device combination products, transdermal delivery systems, blood glucose monitoring systems, intravenous patient-controlled analgesia, multiple medication inhalation devices, photodynamic therapy, and digital mammography. Ms. Mordin regularly presents at conferences and has numerous publications in peer-reviewed journals, including the Journal of Managed Care Pharmacy, American Journal of Clinical Dermatology, Clinical Cardiology, Quality of Life Research, Transplantation, Oncology, and New England Journal of Medicine. Ms. Mordin’s therapeutic expertise includes age-related macular degeneration, asthma, cardiology, chronic pain, diabetes, Gaucher disease, HIV/AIDS, kidney transplantation, oncology, ophthalmology, orthopedics, Parkinson’s disease, psoriasis, and schizophrenia.
Email Margaret Mordin
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| Catherine Rycroft |
Catherine Rycroft, PhD
Senior Health Outcomes Scientist
PhD, Microbiology
BSc, Food Science
University of Reading, Reading, UK Catherine Rycroft, PhD, is a Senior Health Outcomes Scientist in the Regulatory and Health Outcomes Strategy group at RTI-HS, involved in preparing value dossiers, NICE and SMC submissions, systematic literature reviews, burden of illness reviews, and gap analyses. Dr. Rycroft has more than 9 years of experience in scientific research, medical communications, and health outcomes. She has experience in a range of disease areas, including cardiovascular disease, depression, anxiety, Crohn’s disease, breast cancer, diabetes, influenza, gout, and overactive bladder disorder. Before joining RTI-HS, Dr. Rycroft was a medical writer at Prime Medica Limited, where her responsibilities included the communication of scientific information through primary manuscripts, reviews, meeting reports, abstracts, posters, slide sets, competitor monitor reports, and newsletters, in a range of therapy areas. Previously, she was a senior research scientist at a biotechnology company, where she studied novel antifungal drug targets. In addition, Dr. Rycroft has published her work in several books and journals, including Current Medical Research and Opinion, the Journal of Applied Microbiology, and the World Journal of Microbiology and Biotechnology.
Email Catherine Rycroft
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| Catherine Siersma |
Catherine Siersma, BS
Project Manager
BS, Zoology
Michigan State University, East Lansing, MI Catherine Siersma is a Project Manager in the Regulatory and Health Outcomes (RHOS) group at RTI-HS. Ms. Siersma is responsible for preparing for the project kickoff, organizing the project meeting schedule, maintaining project timelines, and ensuring team members stay on budget. She also is responsible for setting up consultant contracts and invoicing, both to clients and consultants or subcontractors. In addition, Ms. Siersma serves in a project administrative capacity internally to the RHOS team to draft proposals and track workload capacity. She also has experience working on projects with Patient-Reported Outcomes and Market Access teams within RTI-HS. Ms. Siersma came to RTI-HS from Pfizer, where she was a Project Manager and Scientist, with the responsibilities of maintaining project plans, templates, and departmental resource data, and acting as a liaison between scientists and project management
Email Catherine Siersma
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| Jeffrey Walter |
Jeffrey Walter, PhD
Senior Health Outcomes Scientist
PhD, Genetics
Duke University, Durham, NC BS, Biotechnology
Rochester Institute of Technology, Rochester, NY Jeffrey Walter, PhD, is a Senior Health Outcomes Scientist at RTI-HS. Dr. Walter contributes to strategic planning services on behalf of pharmaceutical industry clients and also develops product value dossiers, formulary submission dossiers, and other health outcomes documents. Dr. Walter’s graduate and postgraduate research dealt with the genetics underlying diverse disorders, including Parkinson’s disease, glaucoma, and vascular tumors. Following his postdoctoral training, Dr. Walter became involved with scientific writing and has implemented publication planning on behalf of numerous pharmaceutical industry clients. Dr. Walter’s areas of professional writing expertise include genetics, oncology, neurologic disorders, gastrointestinal disease, cardiovascular disease, and autoimmune disorders.
Email Jeffrey Walter
Market Access
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| Stephen M Beard |
Stephen M Beard, MSc
Global Head of Health Economics, Europe
MSc, Operational Research
University of Birmingham, UK BSc, Mathematics
University of London, UK Stephen Beard, MSc, is Global Head of Heath Economics Europe and is based in RTI HS’s UK office in Manchester. He has more than 20 years of experience in the application of mathematical modeling, optimization, and decision analysis techniques to business problems gained in academic, government, and industrial organizations. He has worked specifically within the health research sector for the past 11 years, having previously held a senior project management and research position within the University of Sheffield, UK, where he headed a team producing rapid review health technology appraisal reports for the National Institute for Health and Clinical Excellence (NICE) in the UK. His work has involved the management of projects using health economics, Markov modeling, and statistical modeling techniques to explore disease progression and the impact of treatment across a range of areas, including colorectal cancer, ovarian cancer, breast cancer, schizophrenia, depression, and infectious diseases. He is a member of the International Society of Pharmacoeconomics Outcomes Research and the Institute for Operations Research and the Management Sciences. He has presented his work at professional conferences and has published in several peer-reviewed journals, including European Journal of Health Economics, British Journal of Cancer, and Pharmacoeconomics.
Email Stephen M Beard
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| Kati Copley-Merriman |
Kati Copley-Merriman, MS, MBA
Vice President, Regulatory and Health Outcomes Strategy and Market Access
MBA, Marketing
Indiana University, Indianapolis, IN MS, Organic Chemistry
Purdue University, Indianapolis, IN BA, Chemistry and German
Smith College, Northampton, MA Kati Copley-Merriman, MS, MBA, is Vice President of Regulatory and Health Outcomes Strategy/Market Access at RTI-HS. Ms. Copley-Merriman has more than 25 years of industry experience, including leadership roles in Global Outcomes Research at Eli Lilly, Parke-Davis, and Pfizer. She has experience in all aspects of Outcomes Research (OR), including clinical trial design with PRO endpoints, economic evaluations, OR strategic plans, and regulatory strategy. In her outcomes research and regulatory role, she leads a team of scientists responsible for developing OR strategic plans for phase 2/3 compounds, developing PRO dossiers for the FDA for Label Claims, and designing clinical trials with OR endpoints. Ms. Copley-Merriman has experience in many therapeutic areas, including oncology, pain and inflammation, dermatology, respiratory, urology, and CNS.
Email Kati Copley-Merriman
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| Salome de Cambra |
Salome de Cambra, MD
Senior Consultant, European Pricing and Reimbursement
MD
Universidad Autónoma de Barcelona, Barcelona, Spain MIR (Medical Internal Resident), Specialization in Preventive Medicine and Public Health
Board of Specializations, Ministry of Health, Spain MBA
Columbia University, New York, New York Salomé de Cambra, MD, MBA, is a Senior Consultant for European Pricing and Reimbursement at RTI-HS in the Barcelona office. Dr. de Cambra holds a Medical Degree, specializing in public health and preventive medicine, and an MBA. She has 18 years of experience in the health care industry and health public administration. During her professional career, Dr. de Cambra has collaborated with major pharmaceutical companies and governmental agencies through internal positions and as an external consultant. Her main areas of expertise are health management and policy, health promotion, and vaccines, although she has been involved in many other areas, including depression, Alzheimer disease, pain and analgesia, workplace health promotion, and health communication. Previous to joining RTI-HS, Dr. de Cambra was responsible for drug price negotiation with the Ministry of Health and promoting institutional projects focused on patients and health management at Esteve (Spanish pharmaceutical company) where she also supported and defended the pharmaceutical company interests against the new Medicines Law and the Autonomous Governments cost control policies. Dr. de Cambra participated in developing and writing the first Health Plan and the Year 2000 Health Objectives of the Catalan Ministry of Health. While at Diversified (Smithkline Beecham), she started a disease management program on depression (achieving a reduction of 40 days on the average sick leave), a patient management project for primary health care, and a pharmacy benefit project for primary health care.
Email Salome de Cambra
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| Stephanie R Earnshaw |
Stephanie R Earnshaw, PhD
Vice President, US Health Economics
PhD, Industrial Engineering, concentrating in the areas of Operations Research and Management, Dissertation: Determining an Allocation of Trainers and Field Representatives to Training Sites and Start Times
MS, Industrial Engineering concentrating in Operations Research
North Carolina State University, Raleigh, NC BS, Mathematical Science concentrating in Operations Research
University of North Carolina, Chapel Hill, NC Stephanie Earnshaw, PhD, is Vice President of US Health Economics at RTI-HS. Dr. Earnshaw applies mathematical modeling, optimization, and decision-analysis techniques to industry-related issues and health care problems. Her areas of specialization include systems optimization and solving resource allocation problems. She has developed innovative mathematical models to determine pricing strategy, budget impact, and cost-effectiveness of new products. Dr. Earnshaw has developed a variety of mathematical models, including Markov models, Monte Carlo simulation models, and other state transition models, to analyze the effect of new medical drugs and devices. She has developed innovative mathematical models to determine allocations of HIV prevention interventions and trainers and field representatives to training sites. To solve these models, she has used various heuristic, linear programming, and integer programming techniques. In addition to her modeling background, Dr. Earnshaw has extensive programming experience. She has programmed cost-effectiveness, budget-impact, and allocation models along with operations research algorithms such as genetic algorithms, simulated annealing algorithms, linear and integer programming algorithms, and network algorithms. She also has led programmers in developing user interfaces for health surveys and for pharmacoeconomic models. More recently, Ms. Earnshaw provided expert guidance on the creation of an economic model predicting AIDS survival by adherence level, which was highlighted in the December 2006 issue of AIDS Alert. Dr. Earnshaw has experience in quality management, machine scheduling, linear and integer programming, network optimization, stochastic modeling, and personnel-assignment models. She is a member of the International Society of Pharmacoeconomics Outcomes Research and the Institute for Operations Research and the Management Sciences. She has presented her work at professional conferences and has published in several peer-reviewed journals, including Annuals of Internal Medicine, Medical Decision Making, Journal of American Society of Nephrology, Stroke, and Pharmacoeconomics.
Email Stephanie R Earnshaw
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| Eric Faulkner |
Eric Faulkner, MPH
Senior Director, Pricing and Reimbursement, Market Access
MPH
University of North Carolina, Chapel Hill, NC BS, Biology
Radford University, Radford, VA Eric C. Faulkner, MPH, is Senior Director of Pricing and Reimbursement, Market Access at RTI-HS. He has approximately 15 years of experience focusing on health technology assessment, product reimbursement and commercialization, health care management, and health policy analysis for medical devices, diagnostics, and biopharmaceuticals. Mr. Faulkner has recently served as an expert advisor to the Personalized Medicine Subcommittee of the President’s Council of Advisors on Science and Technology and the Personalized Healthcare Initiative of the US Department of Health and Human Services. He serves on the Leadership Committee of the Health Technology Assessment Special Interest Group, including the working groups on Pharmaceuticals and for Medical Devices and Diagnostics and as the Chair of ISPOR’s Personalized Medicine Special Interest Group. He is also a member of the Leadership Committee of the Business Models and Reimbursement Working Group of the International Society for Cellular Therapy (ISCT). Mr. Faulkner has significant experience in evidence-based practice and policy. He has served as a project manager for the AHRQ Evidence-Based Practice Center program and US Preventive Services Task Force (USPSTF) initiatives. He has managed multiple public and commercial health technology assessments of drugs, medical devices, and diagnostics. He also has led health policy assessments, including CMS’s Coverage with Evidence Development (CED) and Clinical Trial Policy, value-based purchasing, competitive bidding, cost-effectiveness, comparative effectiveness, pharmacogenomics, and health care transparency for life sciences manufacturers, industry and medical professional associations, and government agencies, including HHS, NIH, FDA, CDC, and ASPE. Prior to joining RTI-HS, Mr. Faulkner was a senior consultant at the Littell Group and The Lewin Group. In these positions, he managed a portfolio of consulting projects, including reimbursement strategy analysis, design of clinical trials to meet requirements of third-party health decision makers, life sciences stakeholder surveys, burden of illness studies, and analysis of key health policy initiatives. In previous positions, he provided intellectual property consulting services and managed a variety of genomic and molecular research initiatives for the NIH and Duke University. Mr. Faulkner is often sought after as an expert working/advisory group member and speaker on topics relevant to emerging technology adoption and diffusion, including as an invited speaker on reimbursement topics for the Advanced Medical Technology Association’s (AdvaMed) Medical Technology Learning Institute (MTLI) and currently serves as the Executive Director of the Genomics Biotech Institute of the National Association of Managed Care Physicians and Editor-in-Chief of the GBI special section of the Journal of Managed Care Medicine. He also serves as an adjunct Assistant Professor for the Institute for Pharmacogenomics and Individualized Therapy at the Eshelman School of Pharmacy of the University of North Carolina at Chapel Hill and on the advisory board of the Center for Translational and Policy Research in Personalized Medicine of the University of California at San Francisco.
Email Eric Faulkner
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| A Brett Hauber IV |
A Brett Hauber IV, PhD
Global Head of Health Preference Assessment and Market Access
PhD, Economics
MA, Economics
University of Delaware, Newark, DE Bachelor of Business Administration (summa cum laude)
Temple University, Philadelphia, PA A. Brett Hauber, PhD, is Senior Economist and Global Head of Health Preference Assessment at RTI-HS. He has more than 10 years of academic, research, and government experience in health and environmental economics. His primary area of specialization is discrete choice analysis of revealed- and stated-preference data. He also has extensive experience in conducting benefit-risk analysis of patients and other health care decision makers and in estimating health-state utilities. His most recent applied work has included discrete-choice experiments of patient and physician benefit-risk preferences for treatments for conditions, including Alzheimer’s disease, HIV, vasomotor symptoms, Crohn’s disease, idiopathic thrombocytopenia purpura, type 2 diabetes, and irritable bowel syndrome. He has also studied the theoretical and empirical relationships among various health utility measures. Dr. Hauber regularly teaches courses on conjoint analysis and health-state utility estimation. Dr. Hauber’s research has been published in numerous health and medical journals, including Value in Health, Pharmacoeconomics, Quality of Life Research, Journal of Women’s Health, Medical Care, Clinical Therapeutics, ISPOR Connections, The Patient, Supportive Care in Cancer, AIDS Patient Care and STDs, and Alzheimer Disease and Associated Disorders
Email A Brett Hauber IV
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| Deirdre Mladsi |
Deirdre Mladsi, BA
Head, Health Economics and Market Access
Graduate coursework (24 hours), Master of Health Sciences
Duke University School of Medicine, Durham, NC BA, Economics
University of North Carolina, Charlotte, NC Deirdre Mladsi is Head of Health Economics and Market Access at RTI-HS, applying methods and experience to support development and commercialization of pharmaceuticals, medical devices, and diagnostics. She has 20 years of experience conducting health economics and outcomes research, including 5 years in the Global Health Outcomes group of a leading research-based pharmaceutical company. As a consultant, Ms. Mladsi, one of the founding senior members of RTI-HS, has led several teams within the organization, starting with serving as a Director of Health Economics and including serving as Global Head of Health Outcomes Strategy and Global Head of Pricing and Reimbursement, before returning to organize the Health Economics and Market Access service offering. As Head of Health Economics and Market Access, Ms. Mladsi blends her technical skills in health economics with her experience conducting strategic pricing, reimbursement, and market access projects, both with a global focus, as well as working with local pricing and reimbursement experts in markets around the world. Areas of specialization that blend health economics and market access include threshold analysis to estimate price opportunity, given an expected product profile; valuation modeling to inform clinical development prioritization efforts; and decision support modeling targeted at payers and other health care market access decision makers. Ms. Mladsi also serves as a senior RTI-HS resource, bringing a market-oriented perspective to health economics and outcomes research projects, ensuring that they are conducted with an appreciation of the Value Messages that will result. She provides senior expertise to a team of health outcomes scientists and medical writers that specializes in designing and communicating the results of value-driven research. The team does this by developing and testing Value Messages, designing value-driven research strategies and plans, creating Value Dossiers, and preparing pricing and reimbursement dossiers for major markets. In addition to health economics, her interest is in bringing together scientists and marketing professionals to ensure that clear, concise, and relevant information is placed in the hands of marketplace decision makers, facilitating patient access to valuable new health care technologies. Her training is in economics and applied biostatistics, with an emphasis on clinical research. Although she has worked in all primary therapeutic areas, for several years her primary focus was oncology. She has published (also under the name Neighbors) in the Journal of Clinical Oncology, Journal of Pain and Symptom Management, Journal of Health Economics, Pharmacoeconomics, and Current Medical Research and Opinion, and has presented at numerous professional conferences. She has served as an adjunct faculty of Campbell University, responsible for their Health Economics course, offered as part of their Master’s in Clinical Research program.
Email Deirdre Mladsi
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| Barbara Rivera |
Barbara Rivera, MBA
Director of Commercial Services
MBA
St. John’s University, New York, NY BS, Biology
Siena College, Loudonville, NY Barbara Rivera, MBA, is Director of Commercial Services at RTI-HS. She is a senior-level marketing professional with a track record of managing the development and execution of strategic marketing and product launch plans for pharmaceutical product portfolios. Ms. Rivera has led cross-functional, multidisciplinary teams in navigating regulatory, patent, business development, and manufacturing issues to achieve business objectives. She has experience developing and deploying branding, professional/consumer marketing, and sales training programs. This experience includes strategic and tactical planning, market research, forecasting, P&L management, and budgeting. Ms. Rivera’s recent projects include leading the United States team in the early commercialization stage for the monoclonal antibody Bosatria (mepolizumab), the first GlaxoSmithKline-developed biologic, and participating as a core team member in bringing Lotronex (alosetron HCl) back to the market. In that endeavor, she established first-of-kind risk management, physician education, sales programs, and a corresponding Web site. Ms. Rivera also led a first-of-its-kind multidiversity marketing initiative that included designing a targeted marketing plan exclusively for the Asian American population that is a predominant population for hepatitis B. In addition, she was a key member of the team that implemented a distribution agreement for Ceftin (cefuroxime axetil) with LifeCycle Ventures, allowing GlaxoSmithKline to move resources from this mature product to other growth products.
Email Barbara Rivera
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| Allan Scott |
Allan Scott, MHA
Director, Market Access
MHA
BA, Economics
University of North Carolina at Chapel Hill, Chapel Hill, NC Allan Scott, MHA, is Director of Market Access at RTI-HS. In this role, he assists clients with the pricing and reimbursement strategies for their pharmaceutical product offerings in both the US and Europe. Prior to joining RTI-HS, Mr. Scott led pricing and reimbursement research for the boutique consulting firm Thought Leader Select, LLC. Mr. Scott’s in-depth understanding of health insurance and the role third-party payers play in the global health care system grows out of his years of experience in the BlueCross BlueShield system, most recently as a Senior Manager at BlueCross BlueShield of Tennessee.
Email Allan Scott
Health Preference Assessment
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| A Brett Hauber IV |
A Brett Hauber IV, PhD
Global Head of Health Preference Assessment and Market Access
PhD, Economics
MA, Economics
University of Delaware, Newark, DE Bachelor of Business Administration (summa cum laude)
Temple University, Philadelphia, PA A. Brett Hauber, PhD, is Senior Economist and Global Head of Health Preference Assessment at RTI-HS. He has more than 10 years of academic, research, and government experience in health and environmental economics. His primary area of specialization is discrete choice analysis of revealed- and stated-preference data. He also has extensive experience in conducting benefit-risk analysis of patients and other health care decision makers and in estimating health-state utilities. His most recent applied work has included discrete-choice experiments of patient and physician benefit-risk preferences for treatments for conditions, including Alzheimer’s disease, HIV, vasomotor symptoms, Crohn’s disease, idiopathic thrombocytopenia purpura, type 2 diabetes, and irritable bowel syndrome. He has also studied the theoretical and empirical relationships among various health utility measures. Dr. Hauber regularly teaches courses on conjoint analysis and health-state utility estimation. Dr. Hauber’s research has been published in numerous health and medical journals, including Value in Health, Pharmacoeconomics, Quality of Life Research, Journal of Women’s Health, Medical Care, Clinical Therapeutics, ISPOR Connections, The Patient, Supportive Care in Cancer, AIDS Patient Care and STDs, and Alzheimer Disease and Associated Disorders
Email A Brett Hauber IV
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| Lauren Donnalley |
Lauren Donnalley, BA
Associate Research Economist
BA, Economics, University of North Carolina, Greensboro, NC Lauren Donnalley is an Associate Research Economist in the Health Preference Assessment group at RTI-HS. Ms. Donnalley assists in scheduling pretest interviews, preparing IRB packages, conducting literature reviews, producing descriptive statistics for health preference assessment surveys, and setting up data and drafting memos and reports summarizing the results. She graduated magna cum laude from the University of North Carolina at Greensboro, with a BA in economics and minors in psychology and public health studies. She has had two introductory courses each in SAS and Stata.
Email Lauren Donnalley
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| Juan Gonzalez |
Juan Gonzalez, PhD
Research Economist
PhD, Agricultural and Resource Economics
Colorado State University, Fort Collins, CO MS, Resource Economics
University of Nevada, Reno, NV BA, Economics and Finance
Universidad de Puerto Rico, RÃo Piedras, Puerto Rico Juan Marcos Gonzalez, PhD, is a Research Economist at RTI-HS. Dr. Gonzalez has developed valuation models that bring together revealed- and stated-preference methods to deal with shortcomings of each data type. His models have been used to assess the value of access to recreational sites in El Yunque National Forest (formerly Caribbean National Forest), Puerto Rico. They have been used for similar valuation efforts along the Snake River area in Jackson Hole, Wyoming, and Off-Highway Vehicles Parks in North Carolina. As part of the Puerto Rico Biocomplexity Project, sponsored by the National Science Foundation, Dr.Gonzalez helped develop recreational visitors’ behavioral rules. These rules were used in the creation of a regional SWORM model designed to look at interactions among humans, forest biota, and hydrologic components of two river basins in the northeastern part of Puerto Rico. In the past, Dr. Gonzalez worked for the Tourism Development Fund (TDF), a branch of the Puerto Rico Government Development Bank. During his time there, he helped in the creation of the fund’s private financing credit ranking system.
Email Juan Gonzalez
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| F Reed Johnson |
F Reed Johnson, PhD
Distinguished Fellow and Principal Economist
PhD, Economics
MA, Economics
State University of New York, Stony Brook, NY BA, Economics
Occidental College, Los Angeles, CA F. Reed Johnson, PhD, has more than 35 years of academic and research experience in health and environmental economics. He has served on the faculty of several universities in the United States, Canada, and Sweden. As a staff member in the US Environmental Protection Agency’s environmental economics research program during the 1980s, Dr. Johnson helped pioneer development of basic nonmarket valuation techniques. These techniques are now widely used for cost-benefit analysis in health and environmental economics. He has designed and analyzed numerous surveys for measuring willingness to pay for health-risk reduction and improved environmental quality. He also has developed and researched various value elicitation methods, including direct questions, discrete choice, graded pairs, and other approaches. Dr. Johnson has extensive experience in using advanced statistical techniques to analyze censored, truncated, and discrete survey data. Dr. Johnson has more than 85 publications in books and peer-reviewed journals. His research has been published in various clinical journals, the Review of Economics and Statistics, Journal of Health Economics, Medical Decision Making, Health Economics, Value in Health, Journal of Environmental Economics and Management, Journal of Policy Analysis and Management, Land Economics, and other journals. He has coauthored a recent book on various techniques for using existing environmental and health value estimates for policy analysis. His current research involves estimating general time equivalences among health states and patients’ willingness to accept side-effect risks in return for therapeutic benefits.
Email F Reed Johnson
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| Vikram Kilambi |
Vikram Kilambi, BA, BS
Associate Research Economist
BA, Economics
BS, Mathematics
The University of Chicago, Chicago, IL Vikram Kilambi is an Associate Research Economist at RTI-HS. Mr. Kilambi assists with developing and analyzing models to elicit patients’ preferences for health interventions. In the past, Mr. Kilambi worked in economic consulting and helped model market structures for antitrust litigation in the Internet services, telecommunications, and insurance industries. He also served as a Research Assistant and helped conduct economics research about HIV in sub-Saharan Africa.
Email Vikram Kilambi
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| Ateesha Mohamed |
Ateesha Mohamed, MA
Research Economist
MA, Applied Economics & Policy Analysis
North Carolina State University, Raleigh, NC BA, Business Economics
The College of Wooster, Wooster, OH Ateesha Mohamed, MA, Research Economist at RTI-HS, has 9.5 years of experience in research economics. With respect to health economics, she has worked on discrete-choice experiments to investigate patients’ and physicians’ treatment preferences in several therapeutic areas, including Alzheimer’s disease, HIV, type 2 diabetes, cancer, osteoporosis, osteoarthritis, hepatitis B, hepatitis C, asthma, obesity, migraines, hemophilia, antiplatelet therapies, genetic testing, kidney transplants, and vaccine-preventable diseases. She has experience in survey development, experimental design, data analysis, and report writing. With respect to environmental economics, she specialized in natural resource damage assessment, property value diminution, and travel cost models of recreation demand. Ms. Mohamed’s research has been published in Health Economics, AIDS Patient Care and STDs, Diabetic Medicine, Alzheimer’s Disease and Associated Disorders, Supportive Care in Cancer, and Land Economics. Her research has been presented at various professional conferences, including the International Society for Pharmacoeconomics and Outcomes Research, American Society of Health Economists, and American Academy of Neurology meetings.
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Christine Poulos, PhD
Senior Research Economist
PhD, Public Policy
University of North Carolina, Chapel Hill, NC BA, Environmental Studies
University of Rochester, Rochester, NY Christine Poulos, PhD, is a Senior Research Economist in RTI-HS. Dr. Poulos has more than 10 years of academic, government, donor, and commercial experience in health and environmental economics. Her area of expertise is survey research to support the assessment of preferences, willingness to pay and demand for products and services, cost-benefit analyses, and impact evaluation studies to support health and environmental policy decision making. She has directed research projects funded by the World Bank, the Acumen Fund, PATH, the International Vaccine Institute, the US Environmental Protection Agency, and the Coastal Response Research Center. She has led or participated in survey research in the United States, Ethiopia, Bangladesh, Vietnam, China (Hebei and Guangxi provinces), Indonesia, and India (in the city of New Delhi and the states of Andhra Pradesh, Maharashtra, and Orissa). Her most recent work has included conjoint studies of preferences for HPV vaccines in the United States and Vietnam, and for household water treatment products in India. Dr. Poulos has published her research in peer-reviewed journals, including Health Policy and Planning; Value in Health; Bulletin of the World Health Organization; Journal of Development Economics; Environmental Science and Technology; Resource and Energy Economics; Journal of Health, Nutrition, and Population; and the Journal of Water and Health.
Email Christine Poulos
Jui-Chen Yang, MEM
Research Economist
MEM, Resource Economics and Policy
Duke University, Durham, NC BS, Environmental Science (summa cum laude)
Tunghai University, Taichung, Taiwan Jui-Chen Yang, MEM, is a Research Economist in the Health Preference Assessment group at RTI-HS. She has 9 years of experience in conducting socioeconomic evaluation of health, environmental, and resource programs and policies for various federal government agencies, Acumen Fund, Inc., the Asian Development Bank (ADB), PATH, and the World Bank. Her most recent work has included (1) assessing household demand for HPV vaccines in Vietnam, for water treatment and storage products in India, and for improved water and sanitation services in Nepal and Sri Lanka using stated preference methods; and (2) estimating health and socioeconomic impacts of improvements in water and sanitation sector in India. Ms. Yang also coauthored a guideline paper to assist ADB project officers in implementing stated preference studies (i.e., contingent valuation and conjoint analysis) in preparation of rolling out large-scale water supply and sanitation projects. She has been involved in several program evaluation studies using randomized and quasi-experimental research designs in the water and sanitation sector, and has played instrumental roles in the design and implementation of large-scale surveys, including extensive fieldwork in India, Sri Lanka, and Vietnam. In the past, she conducted analyses for EPA-funded studies on children’s asthma and ground-level ozone exposure in the United States, as well as several meta-analyses of valuation of water quality improvements, valuation of avoided morbidity events, and forestry and agroforestry technology adoption. In addition, Ms. Yang has reviewed manuscripts using contingent valuation on environmental health and environmental services in Asia, and has published her work in Health Economics, Bulletin of the World Health Organization, Journal of Water and Health, Water Resources Research, Water Policy, Land Economics, Forest Policy and Economics, and Agroforestry Systems.
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Pharmacoepidemiology and Risk Management
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| Susana Perez-Gutthann |
Susana Perez-Gutthann, MD, PhD
Vice President, Global Head of Epidemiology
MD, PhD Universitat de Barcelona, Barcelona, Spain MPH, Postdoctoral Fellowship Johns Hopkins University, Baltimore, MD, USA Susana Perez-Gutthann, MD, MPH, PhD, FISPE, FRCP, is Vice President and Global Head of Epidemiology at RTI HS. Dr. Perez-Gutthann holds medical and doctoral degrees from the University of Barcelona, and a Master of Public Health with a concentration in epidemiology from Johns Hopkins University. Her prior positions include Global Head of epidemiology at Pharmacia, Novartis, and Ciba-Geigy; European Head of epidemiology at Pfizer; and a postdoctoral fellow in the Division of Clinical Epidemiology at Johns Hopkins. Dr. Perez-Gutthann has 19 years of experience in the research-driven international pharmaceutical environment, developing and leading teams of epidemiologists and driving strategy and research programs for safety, pharmacovigilance, risk management, development, and regulatory activities applying public health and epidemiologic methods. Dr. Perez-Gutthann is an active leader and Past President of the International Society of Pharmacoepidemiology (ISPE). She is a Fellow of ISPE and of the Royal College of Physicians, Edinburgh. She is invited to teach in several programs, to speak and chair conferences and symposia, which have included DIA, TOPRA, Australian National Prescribing Service Symposium, Asian Pacific Regulatory Safety Sciences Meeting, International Conference of Pharmacoepidemiology & Risk Management, and World Congress of Pharmacology and Clinical Therapeutics. Dr. Perez-Gutthann’s roles as an advisor and in international working groups have included WHO TRD Product Development and Evaluation, International Scientific Advisory Board to MHRA General Practice Research Database, ISPE Working Groups on Risk Management Guidances (FDA, EMEA), Good Pharmacoepidemiology Practice, and confidentiality of patient databases in Europe; working groups on gastrointestinal complications associated with NSAIDs, IMBRF on drug-induced disease, and HRT and breast cancer risk. Currently, Dr. Perez-Gutthann serves as a member and chair of several scientific advisory boards for studies, research programs, strategic, and regulatory risk management topics.
Email Susana Perez-Gutthann
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| Elizabeth B Andrews |
Elizabeth B Andrews, PhD
Vice President, Pharmacoepidemiology and Risk Management
PhD, Epidemiology
MPH, Health Policy and Administration, North Carolina School of Public Health
BA
University of North Carolina, Chapel Hill, NC Elizabeth Andrews, PhD, is the Vice President of Pharmacoepidemiology and Risk Management at RTI-HS. She provides consultation for pharmaceutical companies and the US Food and Drug Administration (FDA) on therapeutic risk management and pharmacoepidemiology, and she directs research programs that evaluate drug safety and compliance with prescribing and treatment guidelines. She oversees the conduct of large, prospective patient registries, Web-based surveys, and studies using large existing databases. Dr. Andrews currently serves as principal investigator on several large risk management studies, and serves on various study advisory boards and data safety monitoring boards. Her experience has spanned most therapeutic areas, although she has worked extensively in the areas of HIV and sexually transmitted diseases; birth defects and neonatal health; asthma and COPD; and irritable bowel syndrome. Dr. Andrews is involved in the design of observational research programs within RTI-HS to assure that the methods chosen provide a robust and cost-effective approach to address the study questions and to assure appropriate linkages are forged with academic and governmental partners. Previously, Dr. Andrews was Vice President, Worldwide Epidemiology, at GlaxoSmithKline and conducted epidemiologic research in a variety of therapeutic areas, including rheumatoid arthritis, genital herpes, HIV, asthma, migraine, and irritable bowel syndrome. She initiated the first pharmaceutical pregnancy registry, the Acyclovir Pregnancy Registry, and multiple registries for other medications. She began her career in the pharmaceutical industry at Burroughs Wellcome in 1982 and subsequently built a strong international epidemiology program at Glaxo Wellcome. Prior to joining Burroughs Wellcome, she managed the Statewide Regionalized Perinatal Care Program and directed the non-Medicaid health care reimbursement programs for the State Health Department of North Carolina. She is a Fellow and Past President of the International Society for Pharmacoepidemiology, a member of the editorial board of the Journal of Pharmacoepidemiology and Drug Safety, and coeditor of Pharmacovigilance. She is an Adjunct Associate Professor of the University of North Carolina School of Public Health and School of Pharmacy, a member of the Scientific Advisory Board Observational Medical Outcomes Partnership, senior consultant and investigator with the UNC Center for Education and Research on Therapeutics, and a consultant to the FDA in epidemiology and risk management. .
Email Elizabeth B Andrews
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| Christine L Bui |
Christine L Bui, MPH
Research Epidemiologist
MPH
Yale University School of Medicine, New Haven, CT BS, Biology and Society
Cornell University, Ithaca, NY Christine L. Bui, MPH, is a Research Epidemiologist within the Epidemiology Research Group at RTI HS. She has experience as a clinical research coordinator and project manager for a variety of large clinical and epidemiologic research projects, both domestically and internationally. Her primary areas of interest are cancer epidemiology and behavioral/social epidemiology. Ms. Bui has managed large, multiyear, multisite prospective cohort studies for the National Cancer Institute and Department of Defense. She also has experience working in a quality improvement and research setting, providing her with practical knowledge of quality assurance, clinical intervention studies, and disease management programs. Ms. Bui has experience supervising multidisciplinary teams involved in complex study designs. She has considerable experience in developing study protocols and in assuring the protection of human subjects. In addition, she has experience coordinating information across multiple research collaborators. She has provided oversight for the operational direction of large study components and their implementation in the field, and for the development of field procedures and data collection tools.
Email Christine L Bui
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| Brian Calingaert |
Brian Calingaert, MBMA
Epidemiology Analyst
MBMA
North Carolina State University, Raleigh, NC MS, Biostatistics
BA, Economics
University of North Carolina, Chapel Hill, NC Brian Calingaert, MS, MBMA, is an Epidemiology Analyst at RTI-HS whose research focus is primarily on pharmacoepidemiology. His principal area of therapeutic experience is oncology, but he has worked in several other therapeutic areas, including osteoporosis, asthma, and cardiovascular disease. He has experience in data management and analysis, creation of statistical analysis plans, and production of tables, listings, reports, and manuscripts for numerous epidemiologic studies. He has extensive experience in the analysis of observational studies, including building statistical models using logistic regression and proportional hazards regression. Recent experience includes managing the epidemiologic data for 18 studies that comprise the international Ovarian Cancer Consortium (OCAC) and being the primary analyst on the North Carolina Ovarian Cancer Study. Much of this analysis involved the molecular epidemiology of ovarian cancer. Mr. Calingaert’s research experience covers a broad range of topics, and he has published extensively, with articles appearing in more than 20 different peer-reviewed journals. Prior to joining RTI-HS, Mr. Calingaert was a Senior Statistician in the Epidemiology Program at the Duke Comprehensive Cancer Center, where he worked for 9 years. He also previously worked at RTI International as a Research Economist in pharmacoeconomics.
Email Brian Calingaert
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| Jordi Castellsague |
Jordi Castellsague, MD, MPH
Director, Epidemiology
MPH
Yale University School of Medicine, Department of Epidemiology and Public Health, New Haven, CT, USA MD
School of Medicine, Autonomous University, Barcelona, Spain Jordi Castellsague, MD, MPH, is a Director of Epidemiology at RTI-HS. Dr. Castellsague has 11 years of research experience in pharmacoepidemiology in the international pharmaceutical setting, 4 years in respiratory and environmental epidemiology, and 7 years of clinical practice. Dr. Castellsague has led safety research and strategy for products in development and marketed drugs driving epidemiologic, pharmacovigilance, and risk management plans; he has conducted pharmacoepidemiologic studies on the natural history of disease, and the use and safety of medications in the general population. He has coordinated regulatory safety epidemiologic activities in the area of COX-2 inhibitors, including the preparation of the FDA advisory committee and EMEA oral hearings. Dr. Castellsague has produced epidemiologic research in the areas of asthma and COPD, allergic rhinitis, liver injury, renal failure, serious skin disorders, gastroenterology, and cardiology related to a variety of products, including COX-2 inhibitors and NSAIDs, monoclonal antibodies, inhaled bronchodilators, oral antifungals, and HRT. He has coordinated and participated as an investigator in several international, multicenter epidemiologic field studies in the areas of asthma and COPD.
Email Jordi Castellsague
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| Alicia W Gilsenan |
Alicia W Gilsenan, PhD
Senior Director, Epidemiology
PhD, Epidemiology
MS, Pharmacy Administration
BS, Pharmacy
University of North Carolina, Chapel Hill, NC Alicia Gilsenan, PhD, is a Senior Director of Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan’s primary area of expertise is pharmacoepidemiology and therapeutic risk management. Since joining RTI in 1997, she has applied state-of-the-art approaches to the design, conduct, and analysis of both retrospective and prospective epidemiologic studies focused on evaluating disease natural history and incidence of and risk factors for adverse outcomes potentially associated with use of medications. She has directed multidisciplinary international teams for large primary data collection studies in the United States and Europe. Currently she leads an international safety surveillance study and a US-based patient registry that are both part of a mandated risk management program and is involved in several Risk Evaluation and Mitigation Strategy (REMs) projects. Dr. Gilsenan has also led retrospective database studies designed to examine differences in risk factors and health care resource utilization between subgroups. She has led and conducted systematic reviews of the literature. Dr. Gilsenan has published within multiple therapeutic areas, including mental health, oncology, sexual functioning, cardiovascular health, respiratory health, and smoking cessation.
Email Alicia W Gilsenan
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| Lia Gutierrez |
Lia Gutierrez, MPH
Director, Epidemiology
MPH
University of Texas School of Public Health, Houston, TX BSc
School of Nursing, Universidad Nacional de Colombia, Bogotá, Colombia Lia Gutiérrez, MPH, BSc, is a Director of Epidemiology at RTI-HS. Ms. Gutiérrez has more than 10 years of clinical and epidemiologic research experience in various epidemiology departments of multinational pharmaceutical companies. Prior to joining the pharmaceutical industry, she held clinical and research positions at MD Anderson Cancer Center in Houston. Her focus in epidemiology research has encompassed various therapeutic areas, including oncology, endocrinology, and bone metabolism. She has expertise in the design and implementation of registry studies involving several international sites and in leading communications with health authorities for regulatory mandated studies. Ms. Gutiérrez has been in charge of the preparation of epidemiologic reports for orphan drug applications and other key regulatory submissions and for the implementation of safety evaluations and risk management activities during the pre- and postapproval phases of drug development. Her primary research areas of interest include studies on disease natural history, evaluation of cancer-related outcomes associated with the use of drugs, and drug-safety epidemiology in general.
Email Lia Gutierrez
Catherine Johannes, PhD
Director, Epidemiology
PhD, Epidemiology
Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD MS, Microbiology
Harvard University School of Public Health, Cambridge, MA BS, Biology
Florida State University, Tallahassee, FL Catherine (Kay) Johannes, PhD, is a Director of Epidemiology at RTI-HS. She has considerable experience in the design, conduct, analysis, and reporting of epidemiologic studies and has over 8 years of experience in the field pharmacoepidemiology. Dr. Johannes has experience with the use of large health care claims databases to conduct drug safety research, including the development of claims-based disease algorithms and validation of outcomes using medical records. She has experience in a number of clinical areas, including rheumatoid arthritis, fracture, diabetes, cardiovascular disease, chronic pain, and sexual function. She also is experienced with primary data collection, including telephone, mailed, in-person, and Web-based surveys. Before joining RTI-HS, Dr. Johannes worked as a pharmacoepidemiologist for i3 Drug Safety (formerly Ingenix Epidemiology), and for 7 years at New England Research Institutes with the design, analysis, reporting, and management of several population-based longitudinal studies of aging men and women funded by the National Institutes of Health. Her areas of expertise included the menopausal transition, erectile dysfunction, sexuality in aging adults, and hormone therapy. In addition, she obtained several grants to develop data collection software using hand-held computers for recording daily information about headache and menstrual cycle symptoms. Before receiving her PhD, Dr. Johannes worked for a number of years in the field of hospital infectious disease epidemiology.
Email Catherine Johannes
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| James Kaye |
James Kaye, MD, DrPH
Director of Epidemiology
MD
Stanford University School of Medicine, Stanford, CA DrPH
Harvard School of Public Health, Boston, MA James Kaye, MD, DrPH, is a medical oncologist/hematologist, epidemiologist, and Director of Epidemiology at RTI-HS. After graduating from medical school, Dr. Kaye completed an internship and residency in internal medicine at the Beth Israel Hospital and a fellowship in medical oncology/hematology at the Dana-Farber Cancer Institute. Dr. Kaye remained on the faculty in the Department of Medicine at Harvard Medical School for the next 5 years while practicing medical oncology/hematology and coordinating the clinical research program at Harvard Community Health Plan. After leaving Harvard, Dr. Kaye joined the clinical development group at Genetics Institute, Inc. (later Wyeth, now Pfizer) where he directed clinical studies on several hematology/oncology products, two of which were approved for marketing, and participated in numerous FDA interactions, including IND and BLA submissions, Advisory Committee presentations, and label negotiations. Dr. Kaye subsequently completed doctoral training in epidemiology, where his research focused on pharmaceuticals and cancer risk. During the following decade, he was senior epidemiologist at the Boston Collaborative Drug Surveillance Program and a member of the faculty at Boston University School of Public Health, where he continues to serve as adjunct associate professor of epidemiology. In addition to conducting his own epidemiology research on a wide variety of drug safety issues, Dr. Kaye has chaired or participated in numerous independent data monitoring committees for advanced phase clinical trials and consulted on clinical development strategy for several new drugs with cancer and hematologic diseases as target indications. He has authored more than 50 articles in the peer-reviewed medical literature.
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| Amy R Ladner |
Amy R Ladner, MPH
Senior Research Epidemiologist
MPH, Epidemiology
Emory University, Atlanta, GA BS, Mathematics
Salem College, Winston-Salem, NC Amy Ladner, MPH, is a Senior Research Epidemiologist within the Epidemiology Research Group at RTI-HS. She has experience as a project director and manager for epidemiologic research projects domestically and internationally. Her primary area of interest is cancer epidemiology. Ms. Ladner has managed large longitudinal studies for the National Institute of Child Health and Human Development and National Institute of Aging. She also has experience working on a variety of safety studies ranging from active surveillance approaches for signal detection to retrospective database analyses. Ms. Ladner also has been involved in risk evaluation and mitigation strategy (REMS) projects. Ms. Ladner has broad experience supervising multidisciplinary teams involved in complex study designs. She has experience developing study protocols and with all aspects of data collection, including questionnaire development, patient and site recruitment, investigator and interviewer training, biospecimen collection, data management and data quality control, and reporting. She has provided oversight for the technical direction of large study components and their implementation in the field, and for the development of field procedures manuals.
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| Lee Lanza |
Lee Lanza, ScD
Director, Epidemiology
ScD, Epidemiology & Biostatistics
MPH, Epidemiology & Biostatistics
Boston University School of Public Health, Boston, MA BA, Psychology, cum laude
Brandeis University, Waltham, MA Lee Lanza, MPH, ScD, is a Director in Epidemiology at RTI-HS. She has more than 25 years of experience in designing, conducting, analyzing, and reporting epidemiologic studies. Dr. Lanza is particularly experienced in postmarketing drug safety surveillance and use of large automated insurance claims databases for safety studies. Dr. Lanza worked for 2 years at Ingenix, Epidemiology Division in studies describing health care utilization for overactive bladder, atopic dermatitis, and erectile dysfunction. At Decision Resources Inc., she developed and led a team of epidemiologists who produced more than 50 reports per year describing major drug indications and estimating incidence, prevalence, and trends in the United States, Europe, and Japan. There she focused on the descriptive epidemiology of cognitive disorders such as anxiety, depression, bipolar disorder, insomnia, and mild cognitive impairment. Prior to this, she worked for 12 years at Epidemiology Resources Inc. in occupational and drug safety epidemiology. There she conducted and authored reports from a study of gastrointestinal safety of nonsteroidal anti-inflammatory drugs and a study of mortality and suicide risk in users of clozapine. Dr. Lanza entered the field of epidemiology working at the Vincent Memorial Hospital and Massachusetts General Hospital in three studies of cancer risk following prenatal exposure to the drug diethylstilbestrol. She coauthored a study of breast cancer risk in mothers who received this drug during pregnancy. Published reports of Dr. Lanza’s work appeared in the Archives of Internal Medicine, Epidemiology, and New England Journal of Medicine.
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| Lisa J McQuay |
Lisa J McQuay, BS
Senior Research Epidemiologist
Currently enrolled in Master’s program in Bioinformatics
North Carolina State University, Raleigh, NC BS, Biology
University of North Carolina, Chapel Hill, NC.
Degree awarded with distinction, with highest honors in biology. Phi Eta Sigma, Phi Beta Kappa Associate Degree, Computer Programming
North Carolina State University, Raleigh, NC C/C++ Programming Language Certificate, Durham Technical Community College, Durham, NC Lisa McQuay is a Senior Research Epidemiologist in the Epidemiology division of RTI-HS. She assists in the design and conduct of epidemiologic and health outcomes studies, with her particular expertise being longitudinal database analysis. Some of the projects on which she has worked include the following: · Comparative Study of the Effect of Depo-Medroxyprogesterone Acetate on the Incidence of Bone Fracture · Evaluating the Risk of Serious Ventricular Arrhythmia and Sudden Cardiac Death Among Users of Domperidone · Characterization of Users of Antihypertensive Medications Used in the Management of Heart Failure · The Impact of Influenza Vaccination on Household Members of Vaccinated Children in the United Kingdom: A Study of Herd Immunity · Study of the Epidemiology of Pain and Development of a Chronic Pain Screening Tool for Use in a Primary Care Setting · Prevalence of Type 2 Diabetes Mellitus in the United States (includes projection models of the prevalence of diagnosed and undiagnosed T2DM for years 2001 through 2021) · Study of Male Attitudes Regarding Sexual Health · Dyslipidemia in HIV/AIDS Patients: Impact of Protease Inhibitor Therapy
Prior to joining RTI-HS, she was a Principal Programmer/Analyst in the Worldwide Epidemiology department at GlaxoSmithKline (GSK), where she worked on epidemiologic studies that used large longitudinal databases (e.g., LNEI administrative claims or GPRD medical records) or population-based survey databases (e.g., NHANES III). Her responsibilities include database management and analysis, as well as protocol development, project management, and report/manuscript writing. Due to the focus of many of the projects on which she has worked at both GSK and RTI-HS, she has obtained a great deal of experience working in the respiratory therapeutic area. However, over the course of more than 20 years in health care–related research, she has worked in a wide range of clinical/therapeutic areas, including infectious disease (HIV/AIDS, influenza), rheumatology/immunology, orthopedics (TKR), gastrointestinal disease (IBS), cardiovascular disease (stroke, severe arrhythmia, sudden cardiac death), metabolic disease (diabetes, hyperlipidemia), mental health, and substance abuse. She has acquired expert SAS skills on multiple platforms, and has a strong background in computer science and systems management.
Email Lisa J McQuay
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| Kirk Midkiff |
Kirk Midkiff, MPH
Senior Research Epidemiologist
MPH, Epidemiology
University of New Mexico, Albuquerque, NM BA, Human Biology
University of Kansas, Lawrence, KS Kirk Midkiff, MPH, is a Senior Research Epidemiologist within the Epidemiology Research Group at RTI-HS. He has experience as a project director and manager for a variety of clinical and epidemiologic research projects domestically and internationally. His primary area of interest is cancer epidemiology. Mr. Midkiff has managed and contributed to the technical direction of large multiyear, multisite prospective cohort studies for the National Cancer Institute. He also has experience working on a variety of safety studies ranging from active surveillance approaches for signal detection to retrospective database analyses. Mr. Midkiff has considerable experience supervising large multidisciplinary teams involved in complex study designs. He has broad experience developing study components while harmonizing the information received from multiple stakeholders. He has provided oversight for the development of various research pieces, including study protocols, statistical analysis plans, and study reports, and played a key role in dissemination of the research findings. Mr. Midkiff has also provided oversight for field research implementation, and the development of field procedures manuals and technical users’ guides. Mr. Midkiff has traveled extensively in order to coordinate and participate in national and international trainings and meetings, and for study initiation and auditing visits. .
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| Nuria Riera |
Nuria Riera, PhD
Research Epidemiologist
PhD, Epidemiology
Heidelberg University, Germany BS, Pharmacy
Barcelona University, Barcelona, Spain Nuria Riera, PhD, is a Research Epidemiologist at RTI-HS. During her years as a pharmacy student she conducted a student research project at the University of Bonn in the department of Pharmaceutical Microbiology, gaining experience in different laboratory methods. Dr. Riera has experience in clinical pharmacy, including drug distribution, central cytostatic preparation, compounding of total parenteral nutrition, and therapeutic drug monitoring. During her PhD, Dr. Riera acquired experience in the epidemiology of cardiovascular diseases and diabetes, as well as in the development of study protocols, data analysis, and laboratory methods. She has experience with large longitudinal studies from the German Cancer Research Center. She also has experience with literature reviews and preparing manuscripts for publication.
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| Kenneth Rothman |
Kenneth Rothman, DrPH
Distinguished Fellow, Vice President of Epidemiology Research
DrPH
MPH
Harvard School of Public Health, Boston, MA DMD
Harvard School of Dental Medicine, Boston, MA AB
Colgate University, Hamilton, NY Kenneth J. Rothman, DrPH, is a Distinguished Fellow and Vice President for Epidemiology Research at RTI-HS. He is also Professor of Epidemiology and Medicine at Boston University. His main career interest has been the development and teaching of the concepts and methods of epidemiologic research. He has authored or coauthored more than 250scholarly publications, most of which are original epidemiologic research studies. His research has spanned a wide range of health problems, including cancer, cardiovascular disease, neurologic disease, birth defects, injuries, environmental exposures, and adverse effects of pharmaceutical agents. In addition to publishing original research, he has devoted time to several other efforts related to the conduct of research. He has written extensively on ethical issues relating to the conduct of science. He regularly teaches intensive courses on epidemiologic research principles in the US and abroad. He has also dedicated a large proportion of his professional effort to editorial activities and publishing. He was the founding editor of the journal Epidemiology, and has served as Assistant Editor of the American Journal of Public Health, Editor of the American Journal of Epidemiology, a member of the Editorial Board of the New England Journal of Medicine and the International Advisory Board of the Lancet. He is a Past President of the Society for Epidemiologic Research, an Honorary Fellow of the American College of Epidemiology, Fellow and member of the Board of Directors and Fellow of the International Society for Pharmacoepidemiology. He has written two widely read epidemiologic textbooks: Modern Epidemiology, first published in 1986 by Little, Brown and Co., which is a comprehensive advanced text of epidemiologic methods, and Epidemiology: An Introduction, published in 2002 by Oxford University Press.
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| Catherine Saltus |
Catherine Saltus, MA, MPH
Research Epidemiologist
MA, Medical Science
Boston University School of Medicine, Boston, MA MPH, Epidemiology
Boston University School of Public Health, Boston, MA BS, Behavioral Neuroscience
Northeastern University, Boston, MA Catherine (Kate) Saltus, MA, MPH, is a Research Epidemiologist at RTI-HS. Ms. Saltus has clinical experience as a medical assistant and training as an EMT-Basic. In addition, she has worked in the hospital setting both to provide patient care and to conduct studies of clinical effectiveness. Her previous work as a data analyst for the Boston Public Health Commission’s Research and Evaluation Office included analysis, interpretation, and dissemination of local public health data. Ms. Saltus has been responsible for managing the daily operation of the Massachusetts Center for Birth Defects Research and Prevention, which includes a multistate birth defects surveillance network, and participation in the National Birth Defects Prevention Study (NBDPS). Ms. Saltus’ prior research includes studies of cocaine addiction, chronic inflammatory disease and experimental treatments, and gender-based differences in health and disease.
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| Pat Tennis |
Pat Tennis, PhD
Senior Director, Epidemiology
MPH, Epidemiology
University of North Carolina, School of Public Health, Chapel Hill, NC PhD, Biology
MS, Biology
Case Western Reserve University, Cleveland, OH BS, Zoology
University of Wisconsin, Madison, WI Patricia Tennis, PhD, MPH, is Senior Director of Epidemiology at RTI-HS and was previously Senior Director of Safety Epidemiology at a large international pharmaceutical company, where she designed and implemented safety studies and risk management activities to evaluate medications within the therapeutic areas of neurology, psychiatry, respiratory, and metabolic diseases. Dr. Tennis was the lead epidemiologist on international pregnancy exposure registries. At RTI-HS and elsewhere, she has overseen the conduct of numerous epidemiology studies and participated in discussions of drug safety issues with regulatory agencies in the US, Canada, and Europe. She is a fellow of the International Society of Pharmacoepidemiology and has numerous publications. Dr.Tennis’s graduate education involved a minor in population genetics, and while within the pharmaceutical industry, she provided epidemiologic consultation for genetic studies. She brings to RTI-HS her decades of experience and expertise to clients facing issues of drug safety and risk management.
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| Abenah Vanderpuije |
Abenah Vanderpuije, MPH
Research Epidemiologist
MPH, Maternal & Child Health
University of North Carolina, Chapel Hill, NC BA, Sociology
University of North Carolina, Chapel Hill, NC Abenah Vanderpuije, MPH, is a Research Epidemiologist with the Epidemiology Research Group within RTI-HS. Ms. Vanderpuije has expert project management, data management, and data analysis skills. She has over eight years of research experience focusing on data management and epidemiological research. Ms. Vanderpuije has experience managing numerous types of data, such as survey, vital statistics, and biochemical data. Her data management skills encompass all stages of the data management process from receipting of completed survey forms to analysis of the final analytical data file. Ms. Vanderpuije has experience with a variety of research areas including maternal, perinatal and child health; Native American health; occupational health; and asthma. She has experience with literature reviews and preparing manuscripts for publication.
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| Cristina Varas-Lorenzo |
Cristina Varas-Lorenzo, MD, PhD
Director, Epidemiology
PhD, Medicine, Cardiology Department
MD
Bachelor in Nursing, School of Nursing Santa Madrona
University of Barcelona, Barcelona, Spain MS, School of Public Health
University of Texas, Health Science Center, Houston, TX Cristina Varas-Lorenzo, PhD, MD, is a Director of Epidemiology at RTI-HS. Dr. Varas-Lorenzo has almost 20 years of experience in research focused on the epidemiology and prevention of cardiovascular diseases. She has worked with population-based surveys, registries, and field and automated databases studies. This experience includes 10 years in multinational pharmaceutical companies where she conducted and evaluated research programs for safety, risk management, development, and regulatory activities applying public health and epidemiological methods; developed and mentored team epidemiology members; and led cardiovascular safety and epidemiology strategy.
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Drug Safety and Pharmacovigilance
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| Maria Vazquez-Gragg |
Maria Vazquez-Gragg, MD, MPM
Global Head, Safety and Pharmacovigilance
MD, Universidad de Buenos Aires
Buenos Aires, Argentina MPM, UADE University
Buenos Aires, Argentina Maria (Ale) Vazquez-Gragg, MD, MPM, is Global Head of Safety and Pharmacovigilance at RTI-HS. Following her completion of her medical training, Dr. Vazquez-Gragg worked as a pediatric surgeon in the Pediatric Hospital of San Isidro. After Dr. Vazquez-Gragg left clinical practice, she joined the regulatory affairs department at Merck, where she was responsible for safety and regulatory activities. Following this, she held positions in the areas of drug safety and pharmacovigilance throughout her career, including at Wyeth, Johnson & Johnson, and PAREXEL. Over her 10 years of experience, Dr. Vazquez-Gragg has authored numerous articles on a wide array of topics, including pharmacovigilance, and has given several presentations at biopharmaceutical industry conferences, as well as at meetings held by health authorities
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| Cristy Burnette |
Cristy Burnette, MS
Manager, Medical Product Safety
MS, Nursing
Duke University, Durham, NC BS, Nursing
Lenoir-Rhyne College, Hickory, NC Cristy Burnette, RN, MSN, has 13 years of industry experience, including 10 years in drug safety and pharmacovigilance and 5 years of nursing experience in cardiology. In her position at RTI-HS, she is responsible for managing the daily activities of Medical Product Safety, including direct supervision of Medical Product Safety Specialists and general management and administrative duties. Additional duties include assistance with AE/SAE case processing, QC, oversight of Safety Management Project Plan development, assistance with/preparation of proposals and contracts, budget oversight for department projects, and coordination of pharmacovigilance activities with other departments. Ms. Burnette’s experience also includes postmarketing pharmacovigilance and a knowledge of foreign regulatory reporting requirements. Her disease state experience includes cardiology, peripheral vascular disease, oncology, central nervous system disorders, ophthalmology, women’s health, and endocrinology.
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| Susan Bartone |
Susan Bartone, MS
Medical Product Safety Specialist
MS, Nursing, Minor in Information Science
University of North Carolina, Chapel Hill, NC BS, Nursing
Nazareth College, Kalamazoo MI Susan Bartone, MSN, RN, is a Medical Product Safety Specialist at RTI-HS. She has 7 years of industry experience, all in the area of drug safety and pharmacovigilance. Prior to joining this industry in 2002, Ms. Bartone was a pediatric staff nurse for 15 years, first in a children’s hospital and subsequently in a pediatric intensive care unit. As a staff nurse, Ms. Bartone’s specialties included pediatric medical and surgical nursing, and a strong background in pediatric hematology and oncology. Since joining the pharmaceutical industry in 2001, Ms. Bartone has been responsible for managing the daily activities of adverse event/serious adverse event case processing for both clinical and postmarketing clients. Additionally, she has experience in quality-control processing, writing narratives, and preparation of client-specific management plans. She has extensive expertise using a validated safety database, including data entry, query searches, and creating client-specific CIOMS line listings from the database. Ms. Bartone is well versed and skilled in using MedDRA and has participated in the coordination of pharmacovigilance activities with other departments. She has mentored and trained other personnel in the roles and processes within the area of pharmacovigilance
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Jan Beam
Medical Product Safety Specialist
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| Cecile Berner |
Cecile Berner, DVM
Director, Medical Services
DVM
Louisiana State University School of Veterinary Medicine, Baton Rouge, LA BS, Biology Major, Chemistry Minor
Nicholls State University, Thibodaux, LA Cecile “Skippy” Berner, DVM, is Director, Medical Services, for the Safety and Pharmacovigilance group at RTI-HS. Since 1988, she has participated in the global development of cardiovascular, antiobesity, antidepressant, immunomodulatory, and genitourinary pharmaceutical agents. She has held several clinical research and managerial positions with Boots Pharmaceuticals, Inc. (BPI), La Jolla Pharmaceutical Company (LJPC), PPD Pharmaco (PPD), and Integrated Safety Systems, Inc. (ISS, Inc.). Dr. Berner has consulted on, managed the production of, and written clinical protocols, Investigators’ Brochures, clinical study reports, subject narratives, INDs, IND annual reports, Periodic Safety Update Reports, and major nonclinical and clinical summaries (including the Common Technical Document Sections 2.7.3 and 2.7.4) for regulatory submissions worldwide. Dr. Berner also consulted and trained on effective coding practices and data standards and performed coding of adverse events and medical histories (MedDRA, WHO-ART, Costart) and concomitant medications (WHO-Drug). At PPD, she advised development teams on scientific/regulatory and clinical aspects relating to product development, prepared strategic plans, and participated in meetings and discussions with staff of multinational regulatory affairs departments. At LJPC, Dr. Berner developed and directed the toxicology and clinical research programs for an oligonucleotide B cell toleragen for systemic lupus erythematosus, and represented the clinical research department to the Board of Directors, corporate partners, and the investment community. She also managed a Senior CRA and a full-service CRO; prepared, filed, and maintained an IND; managed communications with the US Food and Drug Administration; and participated in regulatory and corporate strategic planning. At BPI, she performed routine monitoring of clinical research studies, wrote study reports, and integrated safety summaries for the United States and Europe and managed a staff of nine medical writers and all writing projects. She also managed a team and project activities for a cardiorenal advisory committee presentation. Prior to joining the pharmaceutical industry, she was a staff veterinarian responsible for health care of patients, routine surgery, and general veterinary office management.
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| Timothy Cartwright |
Timothy Cartwright, BS
Director, Pharmacovigilance Systems
BS, Math and Computer Science
McGill University, Montreal, Canada Tim Cartwright is a Director of Pharmacovigilance Systems at RTI-HS. He has 20 years of experience as an IT business analyst, working within IT organizations in the pharmaceutical industry. His primary areas of experience are toxicology systems, GxP validation, and drug safety systems. For the last 7 years, Mr. Cartwright has worked with the Argus Adverse Event system, working initially with the software vendor, Relsys, followed by consulting work with drug safety departments at several companies that use the Argus system.
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| Lisa Keith |
Lisa Keith, BFA
Manager, Pharmacovigilance Systems
BFA, Commercial Design
Barton College, Wilson, NC AA, Commercial Design
Chowan College, Murfreesboro, NC Lisa Keith has more than 12 years of experience in the pharmaceutical industry. She has 10 years of experience directly related to working in the areas of drug safety/pharmacovigilance, with 8 of those years specializing in safety database administration and support. Prior to joining RTI-HS, she assisted in the design, development, and implementation of tracking and drug safety database systems at two pharmaceutical companies. At RTI-HS, Ms. Keith manages technology used within the Drug Safety and Pharmacovigilance group and is responsible for managing system validation activities in compliance with domestic and foreign regulations. As the Argus Safety Administrator, she manages global implementation, administration, troubleshooting, data migration, and end user training for both internal personnel and external clients. As part of database management, Ms. Keith is responsible for configuration and testing of electronic reporting with domestic and foreign regulatory agencies/competent authorities
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| Carmela Skillman |
Carmela Skillman, PhD
Director, Medical Services
PhD, Pharmacology and Toxicology
MS, Pharmacology and Toxicology
Purdue University, West Lafayette, Indiana BS, Pharmacy, Rutgers, The State University of New Jersey, New Brunswick, NJ Carmela Skillman, RPh, PhD, has 23 years of professional experience in the pharmaceutical industry encompassing the areas of clinical research, safety reporting, and medical writing. She has experience in clinical research, including cardiovascular, neurology, diabetes, and infectious diseases (antifungals). Her consulting experience includes the clinical areas of women’s health, gastrointestinal disorders, hemophilia, depression, schizophrenia, oncology, infectious diseases (antibiotics and antiretrovirals), cardiovascular, neurology, ophthalmology, obesity, gout, and insomnia. Her responsibilities have included consulting with clients in various aspects of safety such as in developing, writing, or coordinating integrated clinical summaries (e.g., Clinical Safety Summary, Clinical Efficacy Summary, Clinical Pharmacology) of the NDA or CTD; reviewing and advising on coding for safety integration; developing a template, writing, and reviewing clinical study reports, periodic safety update reports (PSURs), IND annual reports, subject narratives, and other safety-related documents; writing manuscripts for journal publications; and presenting at training workshops for industry personnel on preparing safety reports, clinical study reports, and integrated safety summaries. Dr. Skillman’s earlier pharmaceutical experience included the management of CRA staff involved in the conduct of clinical studies and work with an international project team in the clinical development of compounds. Her responsibilities included developing clinical plans, protocols, and budgets; recruiting appropriate investigators; managing CRA activities in the progression of the studies; reviewing, editing, or writing reports; preparing abstracts for presentations; and reviewing and/or preparing manuscripts for publication.
Email Carmela Skillman
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| Donna Ward |
Donna Ward, BS
Medical Product Safety Specialist
BS, Health Information Management
East Carolina University, Greenville, NC Donna Ward, RHIA, is a Medical Product Safety Specialist at RTI-HS. She has 7 years of experience in the pharmaceutical industry specific to safety and pharmacovigilance activities, including serious adverse event (SAE) handling; data entry of SAEs; and quality control and quality assurance of SAEs, periodic reports, and other safety-related reports. She also had 17 years of experience in an acute care hospital setting fulfilling diagnostic/procedural data requests for physicians, hospital administration, and outside agencies.
Email Donna Ward
Biometrics
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| Beth H Sherrill |
Beth H Sherrill, MS
Global Head, Biometrics
MS, Statistics
North Carolina State University, Raleigh, NC NC Science Teacher Certification
University of North Carolina, Chapel Hill, NC BS, Biology
Davidson College, Davidson, NC Beth Sherrill, MS, is Global Head of Biometrics at RTI-HS. She has more than 15 years of professional experience analyzing pharmaceutical and health-related data. Ms. Sherrill brings insight and expertise to statistical issues in drug development and outcomes research to multiple clients in the pharmaceutical industry. Ms. Sherrill started her career as an industry biostatistician designing and analyzing phase 2/3 clinical trials for international submissions and is familiar with regulatory requirements for drug approval. In the past 10 years, she has broadened her experience in postmarketing studies such as epidemiologic analyses from disease registries, econometric work with claims databases, and large patient surveys. She has extensive experience with the use of propensity scoring and proportional hazards modeling with time-dependent covariates, working in such complex disease areas as oncology and HIV. She has training from the Cochrane Collaboration for performing meta-analyses that may include indirect comparisons and network analysis. Ms. Sherrill continues to publish and represent her clients at Advisory Board meetings. She provides senior leadership to a team of statisticians in the US and the UK, applying advanced biostatistical techniques to issues in pharmaceutical development, epidemiology, health care utilization, and outcomes research.
Email Beth H Sherrill
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| Shaun Abeysinghe |
Shaun Abeysinghe, PhD
Senior Statistician
PhD, Biostatistics
Certificate, JAVA Programming
Cardiff University, Cardiff, UK BSc, Neurobiology
Sussex University, Brighton, UK Shaun Abeysinghe, PhD, is a Senior Statistician with RTI-HS. He has 10 years of experience as a biostatistician within pharmaceutical, academic, and health care environments. Dr. Abeysinghe is experienced in the application of novel and standard statistical methodologies to large medical/biologic datasets in diverse therapeutic areas. His role at RTI-HS includes planning, executing, and interpreting the analysis of a variety of studies, including epidemiology, health economics, and clinical trials. While at RTI-HS, Dr. Abeysinghe has conducted many types of statistical analyses such as meta-analyses, database and survival analyses, bootstrapping, and parametric and multivariate modeling. His previous positions have involved the statistical epidemiology of infectious disease, statistical genetics investigating human mutation in cancer and genetic disease, and an understanding of all aspects of the clinical trial process and associated ICH GCP requirements, attributable to 3 years of experience coordinating and managing phase 2 and 3 oncology trials.
Email Shaun Abeysinghe
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| Lee Bennett III |
Lee Bennett III, MS
Senior Statistician
PhD (in progress), Biostatistics
University of North Carolina, Chapel Hill, NC MS, Statistics
University of Georgia, Athens, GA BS, Chemistry
Georgia Institute of Technology Lee Bennett, MS, is a Senior Statistician in the Biostatistics group. He has 10 years of experience in statistical planning and analysis, and has worked in many therapeutic areas, including oncology, gastroenterology, and neurology. Mr. Bennett has provided statistical expertise for a large breast cancer registry, a regulated comprehensive pharmaceutical risk management program, quality of life studies in clinical trials, and numerous surveys. His duties have included the creation of statistical analysis plans and study reports, as well as the development of programs to manage data and produce study tables, listings, and figures. His experience in statistical modeling includes linear and logistic regression, mixed effects models, pattern mixture models, and proportional hazards models. He has extensive experience with statistical programming in SAS. Mr. Bennett is a member of the American Statistical Association, the International Biometric Society, and the International Society of Pharmacoeconomics and Outcomes Research.
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| Costel Chirila |
Costel Chirila, PhD
Manager Statistics
PhD, Statistics
MS, Statistics
University of Kentucky, Lexington, KY BA, Economics
BA, Mathematics
“Al. I. Cuza” University, Iasi, Romania Costel Chirila, PhD, is a Manager in Statistics in RTI-HS. Dr. Chirila worked for several years as a statistician with pharmaceutical companies designing and analyzing clinical trials (including phase 1) and writing statistical analysis plans and statistical reports. More recently, he provided biostatistical support for the development of diagnostic products from biomarker identification to FDA submission. Dr. Chirila has experience with various statistical methods, including linear and logistic regression, variable and model selection using resampling techniques (e.g., cross-validation, bootstrapping), nonparametric modeling, mixed modeling, meta-analyses, and ROC curves. He also has programming experience with SAS and R/S-Plus. He has worked cross-functionally and has exposure to numerous disease areas, including ALS, diabetes, and prostate cancer.
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| Dawn Odom |
Dawn Odom, MS
Director, Biostatistics, US
MS, Biostatistics Dawn Odom, MS, is a Director of Biostatistics, US. Ms. Odom has over 10 years of professional experience working with public health and clinical trial data. During this time, she has worked as a clinical statistician in numerous therapeutic areas, including pregnancy registries, respiratory, oncology, gastroenterology, medical devices, and HIV. Her responsibilities include protocol development, creation of statistical analysis plans, and production of analysis tables and listings. She has designed and implemented randomization plans for clinical trials. She has extensive experience in the analysis of both randomized and observational studies, including building statistical models using logistic regression, Cox’s regression, and linear mixed models. In addition, Ms. Odom has worked as a survey statistician on a large national household survey where she was responsible for sample selection, item imputation, analysis tables, and report writing. She has experience with the SAS programming language, including the macro language, as well as SUDAAN. Ms. Odom is a member of the American Statistical Association and the International Society of Pharmacoeconomics and Outcomes Research.
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| Yasmin Pendergraft |
Yasmin Pendergraft, MBA
Senior Data Manager
MBA
Meredith College, Raleigh, NC BA, Economics
University of North Carolina, Chapel Hill, NC Yasmin Pendergraft is a Senior Data Manager at RTI-HS. Ms. Pendergraft has more than 17 years of experience in the pharmaceutical industry, including 13 years in data management across multiple trial phases and therapeutic areas, and 4 years in project management, including portfolio analytics and metrics, with a broad drug development knowledge. She is proficient in a variety of data management software systems, including Clintrial 3.3.3, PQRS v.4, Oracle Clinical v.4.0.4 and v.4.5, and Business Objects. She has extensive, diverse experience in managing phase 1, 2, 3, 3b, and 4 clinical trial studies. Ms Pendergraft also has experience in electronic data capture studies, using Oracle Clinical RDS, etrials, Phase Forward, and Medidata. Her therapeutic experience includes immune globulin intravenous (human) (IGIVs) and antithrombin III (AT III) therapies, depression, bipolar disorder, GERD, erosive esophagitis, chemotherapy-induced nausea and vomiting, urine incontinence, migraine, epilepsy, smoking cessation, asthma, COPD, RSV, HIV, sinusitis, bronchitis, otitis media, pneumonia, UTI, psoriasis, and herpes zoster. Ms. Pendergraft is a member of the Society of Clinical Data Management.
Email Yasmin Pendergraft
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| Neil Roskell |
Neil Roskell, MSc
Director of Biostatistics, UK
MSc, Medical Statistics
London School of Hygiene & Tropical Medicine, London, UK BSc, Mathematics and Statistics
University of Newcastle upon Tyne, UK Neil Roskell, MSc, is Director of Biostatistics, UK, at RTI-HS. Mr. Roskell has more than 13 years of professional experience analyzing pharmaceutical and health-related data. Mr. Roskell has extensive experience in the application of statistical analyses to pharmaceutical development and epidemiologic projects. As an International Project Statistician in the pharmaceutical industry, Mr. Roskell was responsible for all statistical input to a clinical dossier and accountable for statistical integrity, timelines, and quality of output for individual studies and regulatory submissions. Mr. Roskell has been responsible for data analysis planning and execution, and protocol and study report development. His experience spans an array of complex therapeutic areas such as HIV, metabolic diseases, musculoskeletal and connective tissue disorders, oncology, psychiatric disorders, and urologic diseases. Mr. Roskell has managed clinical databases and SAS programming efforts on multiple computing platforms. He provides budget estimates and contributes to proposals for large-scale complex studies. Mr. Roskell has a wealth of experience in the use of GPRD and THIN in support of large-scale epidemiologic studies. Mr. Roskell has experience in different meta-analysis techniques, including meta-regression and mixed treatment comparisons. He has experience in many statistical aspects related to economic evaluations for medical compounds and has been involved in successful submissions to NICE and SMC in the UK.
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| Paul Shannon |
Paul Shannon, BSc
Programmer Analyst
BSc, Applied Statistics
Sheffield Hallam University, Sheffield, UK Paul Shannon is a Senior Statistical Programmer for RTI-HS with more than 5 years of experience in the pharmaceutical industry. In this time, he has worked in pharmaceutical market research specializing in the development of quantitative research projects, in particular conjoint and multivariate analyses, providing critical input to study design and analysis methods. His programming expertise has been applied to creating advanced Excel models as key deliverables for such studies. He has also worked as a biostatistician and SAS programmer in clinical trial design and analysis as part of a respiratory team. Mr. Shannon has worked in several therapeutic areas, including oncology, rheumatology, and respiratory, as well as cardiovascular and metabolic diseases. Since joining RTI-HS, Mr. Shannon has qualified as a certified base SAS programmer while working on general practice database studies and trial-based economic analyses. He also has worked with various teams within RTI-HS do develop advanced graphical interfaces for Excel-based models, as well as creating online surveys for data collection.
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| Bintu Sherif |
Bintu Sherif, MS
Statistician
MS, Biostatistics
BS, Interdisciplinary Studies
University of Pittsburgh, Pittsburgh, PA Bintu Sherif, MS, is a Statistician at RTI-HS. She has experience with different types of projects, including observational studies, clinical trials, and meta-analyses, as well as analyses of health-related outcome data. Ms. Sherif has developed statistical analysis plans and written study reports. Her experience includes longitudinal data analysis, survival analysis, and programming in SAS and R.
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| Jianmin Wang |
Jianmin Wang, PhD, MD
Director, Biostatistics, US
PhD, Biostatistics
MPH, Biostatistics
University of North Carolina, Chapel Hill, NC MS, Biostatistics
Chinese Academy of Preventive Medicine, Beijing, China MD
Xinjiang Medical College, Xinjiang, China Jianmin Wang, PhD, MD, is a Director of Biostatistics, US, in RTI-HS. He has more than 19 years of experience in research and in the use of applied statistics, including 18 years of experience using SAS software and extensive collaborative research experience with medical and public health professionals. Before joining RTI-HS, Dr. Wang was the Senior Biostatistician at the Gynecological Oncology Group (GOG), where he developed the statistical sections for numerous research protocols and analyzed data from clinical trials and experimental medicine studies. He was a research assistant professor in the Department of Biostatistics at the University of Buffalo from 2004 to 2005. Dr. Wang developed an extensive background in clinical trials while participating in the China Health and Nutrition Study, which collected data from approximately 16,000 individuals of 3,800 households in 190 communities. Dr. Wang conducted the training sessions of interviewers, cleaned data, and calculated the sample weights. Dr. Wang’s work on the risk of development of advanced prostate cancer, on radiation and chemotherapy after radical hysterectomy, on disease progression in patients with epithelial ovarian cancer, and on patient survival in lung cancer has been widely published.
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| Yun Wu |
Yun Wu, MAS
Senior Statistician
MAS, Applied Statistics
Pennsylvania State University, University Park, PA BS, Biology NanKai University, Tianjin, China Yun Wu, MAS, is a Senior Statistician with RTI-HS. She has experience with different types of projects, including traditional clinical trial, epidemiological analyses from surveillance study, meta-analyses and psychometric analysis involving health-related survey data, public payor claims databases, and SEER-Medicare data. She has conducted analyses involving regression, structure equation model, and factor analysis and is adept with a number of statistical programming languages, including SAS, SPSS, S+, and WinBUGS. Ms. Wu works as a contributing partner on research teams involving physicians, epidemiologists, physiologists, and biologists.
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| Jie Zhang |
Jie Zhang, MSPH
Statistician
MSPH, Biostatistics
University of South Carolina, Columbia, SC MS, Biochemistry
Beijing Forestry University, Beijing, China BS, Chemistry
Beijing University of Chemical Technology, Beijing, China Jie “Jessica” Zhang, MSPH, MS, is a Statistician at RTI-HS. Ms. Zhang is a recent graduate of the University of South Carolina (USC). At USC, she worked as a research assistant and also as a teaching assistant in the Department of Epidemiology and Biostatistics. As a research assistant, she was involved in several health-related projects, doing data management and statistical analysis. She has experience with the SAS programming language, including the macro and iml languages. In addition, she is familiar with R, Stata, Winbugs, and Minitab.
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| Xiaolei Zhou |
Xiaolei Zhou, MS
Senior Statistician
PhD Candidate, Biostatistics
MS, Biostatistics
University of North Carolina, Chapel Hill, NC MS, Chemistry BS, Chemistry Peking University, Beijing, China Xiaolei Zhou, MS, is a Senior Statistician in the Biometrics group at RTI-HS. She has led statistical analysis for a wide range of projects, including health-related surveys, longitudinal epidemiology studies, quality of life data analysis in clinical trials, and post-hoc analysis of pooled data from multiple clinical trials. Ms. Zhou has been responsible for writing statistical analysis plans, performing or overseeing statistical programming and validation, and developing statistical reports. She managed databases for several large multinational, Web-based longitudinal studies and was involved in medical database studies. Her experience includes prevalence and incidence estimation, development of predictive models, longitudinal data analysis, analysis involving missing data (including random effect pattern-mixture model), survival analysis, factor analysis, sample size calculations, and programming in SAS and SUDAAN.
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| Ryan Ziemiecki |
Ryan Ziemiecki, MS
Statistician
MS, Statistics
University of North Carolina, Chapel Hill, NC BS, Statistics
BS, Mathematics–Operations Research
University of North Carolina, Wilmington, NC Ryan Ziemiecki, MS, is a Statistician at RTI-HS. Mr. Ziemiecki is a recent graduate of the University of North Carolina where he conducted research in evolutionary game theory. While at UNC, he also assisted in developing an outlier detection procedure for real-time QPCR analysis during a summer appointment as a research assistant in the Lineberger Comprehensive Cancer Center. He has experience with the SAS programming language, including the macro and iml languages, as well as the R-statistical package and Matlab.
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Preclinical Pharmaceutical Sciences
Irma Grossi, PhD
Senior Director, Preclinical Pharmaceutical Sciences
MBA Cert
Ohio State University, Fischer School of Business, Columbus, OH PhD, Cancer Biology
Wayne State University, School of Medicine, Department of Radiation Oncology, Detroit, MI Graduate Studies, Biochemistry/Molecular Biology
University of Nebraska, Lincoln, NE BS, Biological Sciences
Central Michigan University, Mt. Pleasant, MI Dr. Irma M. Grossi is Senior Director of Preclinical Pharmaceutical Sciences at RTI-HS, where she is responsible for managing professional and support staff in the planning and implementation of preclinical development programs for new lead candidates. She develops project plans and budgets and monitors technical and financial performance of LST projects, establishing and monitoring corrective action when required. Dr. Grossi has 12 years of experience in preclinical drug development toward investigational new drug (IND) application filings with responsibilities in Good Laboratory Practices (GLP) toxicology ranging from appointments as Study Director/Senior Study Director/Team Leader (IRDC/MPI Research and Battelle Memorial Institute), Laboratory Director (Liberty Research), and Program Manager/Toxicology Manager (Battelle Memorial Institute) to establishing and operating a GLP Toxicology Department for an animal health production and supply company (Liberty Research). Her experience includes conducting, supervising, and coordinating of individual acute, repeat dose, subchronic and chronic toxicology studies for the commercial industry and for the National Cancer Institute (NCI). Dr. Grossi has managed various preclinical toxicology programs and staff who provide drug development support for IND and new drug application (NDA) submissions to the US Food and Drug Administration (FDA), as well as support for the US Environmental Protection Agency (EPA) and European registrations for industrial and government clients. She has extensive experience with leading multidisciplinary teams in performing various programs for NCI, biotechnologies, and multinational pharmaceutical companies. Dr. Grossi has served as the Principal Investigator (PI) on multiyear contracts for anti-AIDS therapies and antineoplastic drugs for the NCI Toxicology and Pharmacology Branch, the Developmental Therapeutics Program, and the Division of Cancer Treatment and Diagnosis. She was the focal point of all program communications and was responsible for the technical and fiscal components for studies associated with each contract. Her work in toxicology and pharmacokinetics has appeared in many publications, including numerous peer-reviewed journal articles and abstracts, and she has authored or coauthored eight book chapters.
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Sherry L Black, BS
Senior Research Chemist
BS, Chemistry
Pennsylvania State University, University Park, PA Sherry Black is a Senior Research Chemist in the Preclinical Pharmaceutical Sciences at RTI-HS. Ms. Black joined RTI in 1985 as a Synthetic Organic Chemist responsible for preparing, purifying, and characterizing retinoids and other compounds. Since joining Preclinical Pharmaceutical Sciences (formerly Drug Metabolism and Pharmacokinetics) in 1989, her primary responsibility has been conducting absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetic studies in rodents both for National Toxicology Program (NTP)–sponsored compounds and for numerous other compounds for government and commercial clients. In addition to this in vivo work, she also had extensive experience with the study of drug metabolism in vitro. She has used her synthetic organic chemistry skills on numerous projects in preparing both radiolabeled test materials and analytical standards of proposed metabolites of the xenobiotics investigated. Ms. Black’s experience includes all aspects of conducting ADME studies in rodents using oral, dermal, and intravenous exposure routes. She has more than 20 years of experience in preparing, analyzing, and administering dose formulations; conducting vascular and bile duct cannulation; sampling blood; and performing euthanasia and necropsy of laboratory animals. She has worked extensively on the development of high performance liquid chromatography (HPLC) systems for analyzing xenobiotics and their metabolites in biological media. She also has experience in isolating metabolites and performing structural identification by using both 13C- and 1H-nuclear magnetic resonance (NMR) and mass spectrometry. Ms. Black has subsequently published the results of that work. Since 1997, Ms. Black has authored many publications about drug–drug interactions and pharmacokinetics. She has more than 10 years of experience in preparing hepatic microsomes and in developing assays for P450 enzymes in microsomes. She has conducted numerous in vitro studies of drug metabolism using liver slices and microsomal preparations from humans, monkeys, dogs, and rodents for cross-species comparisons. Those studies involved measuring the induction and inhibition of specific P450 enzymes by chemicals and the metabolism of chemicals by specific P450 enzymes. As Program Manager, Ms. Black has recently completed work on the validation of an endocrine disruption screening assay conducted for the US Environmental Protection Agency (EPA). For this work, she prepared microsomes and investigated all aspects of the kinetics and inhibition of the enzyme aromatase (CYP19) in placental and recombinant microsomes to validate the assay. RTI was the lead laboratory for the multilaboratory validation effort, and Ms. Black provided training and expertise to the other laboratories as requested by EPA. The kinetics of enzyme inhibition, including IC50 determination, were determined in that work, and Ms. Black calculated Ki values for a series of environmental contaminants. She has determined the Michaelis Menten constants, Km and Vmax, for a variety of P450 enzymes. She also performs P450 enzyme assays for current NTP projects in which the extent and nature of the inhibition of those enzymes by herbal extracts is determined. Ms Black also served as Study Director for RTI’s validation of the rat uterine cytosol estrogen receptor assay for EPA. Ms. Black has extensive experience in managing preclinical in vivo and in vitro studies in a regulated environment (FDA and EPA). She writes study protocols, standard operating procedures, and interim and final reports; creates and manages project budgets and study timelines; coordinates groups of technical staff to complete tasks on schedule; and currently manages a group of two staff members who conduct in vivo and in vitro ADME/pharmacokinetic studies.
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| Paul Borron |
Paul Borron, PhD
Business Development Specialist
PhD, Biochemistry
BS (with honors), Microbiology/Immunology
University of Western Ontario, London, ON, Canada MSc, Immunology
University of Toronto, Toronto, ON, Canada Paul Borron, PhD, MSc, is a world-class medical researcher with extensive experience in the areas of immunology, inflammation, cell biology, cardiovascular and pulmonary research, and assay development. He successfully obtained more than $700,000 in grant funding for anti-inflammatory and pulmonary research. These grants were awarded from National Institutes of Health, Bayer, The Ontario Thoracic Society, Canadian Lung Association, and the Parker B. Francis Foundation. Dr. Borron was the first to discover the anti-inflammatory properties of two lung proteins: surfactant protein-A (SP-A) and surfactant protein-D (SP-D). Dr. Borron has pharmaceutical industry experience in research and development, discovery, business development, and sales, including the following: § Developing drugs and diagnostics for clinical use § Working knowledge of prerequisites for obtaining government approval for drug commercialization § Preclinical toxicology proposal writing, business development, and in vivo pharmacology § Holds patent for vaccine development method § Establishing and maintaining productive collaborations with world-renowned scientists § Published in top research journals § Outstanding communicator with passion for fact finding and medical research
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| Sherri S Brown |
Sherri S Brown, BS
Research Chemist
BS, Chemistry (summa cum laude)
North Carolina State University, Raleigh, NC Sherri Brown is a Research Chemist in Preclinical Pharmaceutical Sciences at RTI-HS. Since 1999, Ms. Brown has participated in many projects and performed analyses using gas chromatography (GC)/mass spectrometry (MS), liquid chromatography (LC)/MS, LC/ultraviolet, and LC/fluorescence. She is responsible for maintaining and validating these instruments and has validated several analytical methods performed with these instruments. Ms. Brown also has experience extracting biological samples for both qualitative and quantitative analysis.
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| Alex Chao |
Alex Chao, BS
Chemist
BS, Chemistry
University of North Carolina at Chapel Hill, Chapel Hill, NC Alex Chao is a Chemist in Preclinical Pharmaceutical Sciences at RTI-HS. In this capacity, he provides qualitative analysis for submitted samples using gas chromatography/mass spectrometry (GC/MS) and liquid chromatography/mass spectrometry (LC/MS) techniques. He also prepares biological samples for qualitative and quantitative analysis via LC/MS, maintains instrumentation as required in accordance with approved procedures, and maintains records of analyses performed in accordance with approved procedures.
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Amy S Etheridge
Research Biochemist
BS, Science Education
BS, Biochemistry, Genetics Minor
North Carolina State University, Raleigh, NC Amy Etheridge is a Research Chemist in Preclinical Pharmaceutical Sciences at RTI-HS. She joined RTI in 1994 as an investigator in metabolic disposition studies of xenobiotics in mammals. Ms. Etheridge leads in vitro investigations of interspecies comparisons of metabolism using hepatocytes from humans and animal models in efforts to ascertain whether the species used in toxicology studies can give adequate internal exposure to parent drug and its metabolites, giving “coverage” in safety assessment. In studies to confirm the site and primary types of metabolism, she routinely uses hepatic in vitro systems, such as microsomes, purified enzymes, and isolated hepatocytes, and extrahepatic systems such as everted intestinal sacs (which have higher metabolic activity than isolated intestinal microsomes). Ms. Etheridge uses microsomal preparations from humans, dogs, monkeys, and rodents in in vitro studies of drug metabolism. Those studies involve measurement of the induction and inhibition of specific P450 enzymes by chemicals and metabolism of chemicals by specific P450 enzymes. She is skilled in the isolation of subcellular fractions, including mRNA, mitochondria, cytosol, and microsomes. She performs electrophoresis and Northern blotting using RNA samples. In work performed for the National Toxicology Program (NTP), Ms. Etheridge has taken a leading role in investigating the effects of herbal drugs on P450 enzymes and the transporter P-glycoprotein. In another project sponsored by the National Institute of Environmental Health Sciences (NIEHS), she investigated the monitoring of volatile compounds in breath as a means of assessing metabolic activity in vivo. Ms. Etheridge has experience in many in vitro assays of drug permeability and active transport. She measures P-glycoprotein and MRP2 efflux transport activity in human membrane vesicles. She also measures transporter-mediated uptake in Xenopus laevis oocytes expressing human organic anion-transporting polypeptides (OATP). She is skilled in the culture of Caco-2 and Madin-Darby canine kidney (MDCK) cell lines and in assays of drug permeability and active transport in these cellular systems. Ms. Etheridge has had primary responsibility for the conduct of the metabolism studies of benzene, heptachlor, and kava for the NTP. She is skilled in blood sampling, euthanasia, and necropsy of laboratory animals. Ms. Etheridge is proficient in formulating, analyzing, and administering dose formulations, as well as the development of HPLC systems for analyzing chemicals and their metabolites in biological media. Her responsibilities also include drug-drug and herb-drug metabolism and transport interaction studies in human liver microsomes, freshly isolated human hepatocytes, in vitro expression systems, and cell lines.
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Melody P Gower
Pharmacologist
Melody Gower is a Pharmacologist in Preclinical Pharmaceutical Sciences at RTI-HS. She joined RTI in 1981 as an Animal Laboratory Technician after 8 years of laboratory animal handling experience at Duke University Medical Center. During the next 4 years, Ms. Gower was involved in animal dosing, cannulations, blood collection, surgery, and necropsy. She then spent 2 years as a Laboratory Technician working with RTI’s Teratology Research Group. In 1987, she became a Laboratory Technician in RTI’s Metabolism Research Group. Ms. Gower has experience in a variety of procedures, including castrations; cerebrospinal fluid collection; intratracheal, intraintestinal, and intranasal instillation; cannulation of bile and lymphatic (thoracic and mesenteric) ducts; and vascular (venous and arterial) cannulations. She has worked with many laboratory animal models, including rats, mice, hamsters, rabbits, guinea pigs, dogs, and monkeys. She is proficient in dosing animals by oral, intravenous, intraperitoneal, intramuscular, subcutaneous, and dermal routes. In addition to her extensive experience with animal procedures, Ms. Gower has gained experience in radiochemical analysis, extraction and derivatization of drugs of abuse and other compounds, and data collection and analysis. Ms. Gower is also proficient in isolated perfused kidney and liver models. She has worked with a variety of therapeutic, environmental, and agricultural compounds.
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| Jennifer Hart |
Jennifer Hart
Manager, Business Development
Jennifer Hart
BS, Microbiology
BA, Chemistry
North Carolina State University, Raleigh, NC Jennifer Hart is a Manager of Business Development/Client Services at RTI-HS. She manages $8.5M sales for a 140-member unit that consists of a full spectrum of preclinical services (DMPK, toxicology, chemistry). Her primary responsibility is over 108 accounts (bioanalytical/analytical chemistry [cGMP release testing], and developmental and reproductive toxicology). Ms. Hart supervises a Business Development unit of three members that markets DMPK/general toxicology services and provides sales support (budgeting and quote preparation) across the unit. She creates detailed training plans and quarterly goals for employees, and has experience in constructing a detailed business plan for the unit, including revenue forecasts for all research groups and schedule of prospective targets, events, and the creation of new marketing material and services offered. She budgets creation and monitoring for travel, sales, and marketing activities for entire fiscal year. Ms. Hart participates in decisions for new equipment/hires/capabilities of analytical and bioanalytical chemistry labs. She leads onsite visits with potential clients, organizing quality assurance, lab staff, and accommodations for the client. Other duties include development of marketing materials, managing incoming requests for bids, growing new opportunities through detailed market research, and arranging meetings with target companies. Her major accomplishments include determining and marketing niche offerings of each group, serving as project manager for the Chemistry group’s largest client ($1M in the last year), facilitating communications between technical staff and clients, establishing solid relationships with a diverse client base from small biotech to large pharma companies in all roles from study director to CEO, and training staff to effectively market and maintain client relations.
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| Jonathon Holt |
Jonathon Holt, PhD
Senior Research Toxicologist Pharmacologist
Charles Jensen, PhD
Senior Research Biochemist
Postdoctoral Fellow, Laboratory of Biochemical and Molecular Toxicology
Department of Pharmacology, Medical University of South Carolina, Charleston, SC PhD, Pharmacology
University of Virginia, Charlottesville, VA BS, Biochemistry
Virginia Tech, Blacksburg, VA Charles Jensen, PhD, is a Senior Research Chemist in the Preclinical Pharmaceutical Sciences group at RTI-HS. Dr. Jensen has 18 years of experience in the pharmaceutical industry as an absorption, distribution, metabolism, and excretion (ADME) scientist, toxicokineticist, and toxicologist. At RTI-HS, he provides in vitro ADME and toxicology research studies to commercial clients in the pharmaceutical industry.
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Xiaojuan Li, BS
Chemist
BS, Chemistry (Biochemistry track)
University of North Carolina at Chapel Hill, Chapel Hill, NC Xiaojuan Li is a Chemist in the Preclinical Pharmaceutical Sciences group in RTI-HS. In this capacity, she provides qualitative analysis for submitted samples using gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS) techniques. Ms. Li prepares biological samples for qualitative and quantitative analysis via LC-MS, performs maintenance activities on instrumentation as required in accordance with approved procedures, and maintains records of analyses performed in accordance with approved procedures.
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Purvi Rajesh Patel
Chemist
Stephen Warren
Chemist
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| Qiao Zhan |
Qiao Zhan, PhD
Senior Manager, Chemistry
PhD, Analytical Chemistry
Swiss Federal Institute of Technology, Zurich, Switzerland BS, Chemistry and Chemical Engineering
TsingHua University, Beijing, China Qiao Zhan, PhD, is a Senior Manager in Bioanalytical in the Preclinical Pharmaceutical Sciences group at RTI-HS. With more than 20 years of training in chemistry and approximately 12 years of experience with LC/MS/MS bioanalytical, Dr. Zhan provides the necessary knowledge and hands-on experience with liquid chromatography/MS and gas chromatography/MS to ensure that RTI-HS’s analytical instruments are operating at maximum sensitivity and reproducibility. Dr. Zhan’s previous experience includes education and training in two prominent MS groups, and 5 years of experience performing method development, validation, and structural elucidation studies at Triangle Laboratory, Inc.
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Clinical and Medical Services
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| Allen Mangel |
Allen Mangel, PhD, MD
Executive Vice President, RTI Health Solutions
MD
Georgetown University School of Medicine, Washington, DC PhD, Physiology
MS, Physiology
BS, Physiology
University Of Illinois, Urbana, IL Allen Mangel, MD, PhD, is a gastroenterologist and Executive Vice President of RTI-HS. Following completion of his medical training, Dr. Mangel did his internship and residency in internal medicine at Duke University Medical Center and then completed his gastroenterology fellowship also at Duke. Following completion of his formal training, he remained on the faculty in the Department of Medicine, Division of Gastroenterology, at Duke for 3 years. Dr. Mangel also has a PhD from the University of Illinois, where his research focused on control of electrical and mechanical activity in gastrointestinal smooth muscle. After Dr. Mangel left Duke, he joined the gastroenterology clinical research department at Glaxo Wellcome, where he conducted numerous clinical trials and directed product development teams. After departing Glaxo Wellcome, he became Vice-President of Research and Development at Salix Pharmaceuticals. Dr. Mangel has led or participated in numerous FDA interactions, Advisory Committee Presentations, label negotiations, and NDA submissions, and he has authored more than 80 publications.
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| Jeff Buda |
Jeff Buda, BA
Director, Clinical and Medical Services
BA, Biology SUNY College, Buffalo, NY Jeffrey Buda is a Director of Clinical and medical Services with RTI-HS. Mr. Buda has helped design and has personally managed Phase I-IV clinical research trials in the therapeutic areas of gastroenterology, oncology, virology, and endocrinology. His experience in the field of clinical research included development of clinical protocols, design of interactive voice response systems (IVRS) to capture patient symptom data, development of data collection forms, interaction with key opinion leaders in various disciplines, operationalization of complex multicenter studies, and clinical monitoring. Mr. Buda has extensive experience in managing projects that involve multiple vendors and subcontractors, as well as an array of scientific and technical disciplines.
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| Chad Downey |
Chad Downey
Clinical Research Associate
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| Kifu Faruq |
Kifu Faruq, CCRA
Lead Clinical Research Associate
BS, Biological Sciences
North Carolina State University, Raleigh, NC Kifu Faruq, CCRA, is a Lead Clinical Research Associate with the Clinical and Medical Services Division of RTI-HS. Ms. Faruq has been involved in the operationalization of several phase 2-4, multicenter, global clinical trials in the therapeutic areas of cardiology and infectious diseases from startup to closeout. Her clinical operations experience includes assisting in development of clinical protocols, CRFs, and site management tools; acting as liaison for multiple vendors; and providing oversight, training, and mentoring for in-house and regional clinical research associates. Ms. Faruq has worked extensively with trials using electronic CRFs and IVR//IWR systems.
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