Publications
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Tajima K, Zarkadoulas E, Simons J, Kurai D, Grace M, Graham J, Ho Y, Verelst F. Cost-effectiveness of the adjuvanted respiratory syncytial virus prefusion F protein (RSVPreF3) vaccine in Japanese adults aged 50–59 years at increased risk of severe RSV disease and those aged ≥60 years. Expert Rev Vaccines. 2026 Dec;25(1):2626921. doi: 10.1080/14760584.2026.2626921
Garcia de Albeniz X, Sanglier T, Vila-Guilera J. Biases that generate immortal time: a structural diagnosis and practical solutions for HTA submissions. Presentation to be given at the ISPOR Europe 2026; November 11, 2026. Vienna, Austria.
Gnanasakthy A, Doward L, Qin S, Crawford R, Rockwood N. Designing a patient-centered strategy for drug development and value. Presentation to be given at the ISPOR Europe 2026; November 8, 2026. Vienna, Austria. Previously presented at the ISPOR 2026.
Angulo FJ, Zhao G, Yuan W, Yin Z, Yang J, Khan S, Tran D, Gonzalez EN, Sun A, Shen S, Findlow J. Systematic literature review of the Clostridioides Difficile Infection (CDI) disease burden in mainland China. Poster presented at the 9th International C. difficile Symposium; September 8, 2026. Bled, Slovenia.
Singer D, Horn EK, La E, Steffens A, Gerber SI, Theiss-Nyland K, Fonseca MJ, Kawai A, Buikema AR, Johnson MG, Song R, Hague S, Brantly M, Falsey AR, Koppaka R, Bhatt DL, Layton JB. Adjuvanted RSVPreF3 vaccine effectiveness against cardiovascular events and disease exacerbations (2023-2025). Poster presented at the European Respiratory Society (ERS) Congress; September 6, 2026. Barcelona, Spain.
Mugwagwa T, Abramoff BA, Karanth S, Nham T, Goyal RK, Esterberg E, Sidhu GS, Yehoshua A, Mokgokong R. Real-world healthcare resource utilization and cost burden of COVID-19 in commercially insured adults at high-risk of severe disease in the US: a retrospective database analysis. J Med Econ. 2026 Sep 3. doi: 10.1080/13696998.2026.2725478
Mohammadi S, de Luise C, Manders E, Vaz TA, Laan W, Arnau JR, Moraga SM, Ryan O, Hoxhaj V, Weinrib R, Marsal J, Aguado J, Desalegn A, Lupattelli A, Zhao J, Tarazjani AD, Roy D, Lane S, Aurelius T, Morris D, Garcia-Albeniz X, Pala E, Pazos I, Yefimenko N, Brutau A, Martinez FV, Overbeek J, van den berg JA, Gaspersz J, Gimeno-Miguel A, Poblador-Plou B, Santos-Mejias A, Moreno-Juste A, Stona L, Barbieri E, Gini R, Arana A, Sturkenboom M. Natural history and clinical outcomes of myocarditis and pericarditis following Pfizer-BioNTech COVID-19 vaccine (Comirnaty): a multi-database European Post-Authorisation Safety Study (PASS) in the VAC4EU network. Poster presented at the ISPE 42nd Annual Meeting; September 2, 2026. Milan, Italy.
Rao S, Layton JB, Ziemiecki R, Kovesdy CP, Walsh M, Farjat AE, Wideman K, Liu F, Oberprieler NGG. Real-world effectiveness and safety of finerenone in patients with chronic kidney disease and type 2 diabetes in the United States: a FOUNTAIN platform analysis. Presented at the ISPE 42nd Annual Meeting; September 2, 2026. Milan, Italy.
Daniels K, Gutierrez L, Danysh H, Quimbo T, Overbeek J, Gilsenan AW, Aguado J, Baak BN, Verburg I, Lemmens LA, Penning-van Beest F, Bartsch J, Garbinsky D, Calingaert B, Khan AM, Karlsson C, Sjostrom CD, Subramani B, Chen H, Aibibula W, Beachler DC. Incidence of composite cancer outcomes among dapagliflozin initiators compared to other glucose lowering drugs in the US and Europe. Poster presented at the ISPE 42nd Annual Meeting; September 2, 2026. Milan, Itlay.
Rosmarin D, Soliman AM, DiBenedetti D, Greenblatt A, Sen R, Patterson S, Ezzedine K. Development of items to assess noticeability and sun sensitivity among patients with non-segmental vitiligo. J Dermatolog Trea. 2026 Sep 2. doi: 10.1080/09546634.2026.2709934
Gini R, Hyeraci G, Nardoni V, Lippi M, Marinai S, Perna R, Nunziata A, Limoncella F, Arana A, Lucenteforte E, Mohammadi S, Roberto G, Weibel D, Dehghan Tarazjani A, Virgili G. Estimating sensitivity of a highly specific algorithm for myocarditis using a screening algorithm: results from the VAC4EU SeValid project. Poster presented at the ISPE 42nd Annual Meeting; September 1, 2026. Milan, Italy.
Gutierrez L, Danysh HE, Daniels K, Overbeek J, Aguado J, Bartsch J, Quimbo T, Baak BN, Garbinsky D, Calingaert B, Khan A, Lemmens L, Verburg I, Penning-van Beest F, Karlsson C, Chen H, Subramani B, Sjostrom CD, Aibibula W, Beachler DC, Gilsenan AW. A post-authorization safety study on the risk of in situ and invasive bladder cancer in real-world use of dapagliflozin in patients with type 2 diabetes. Presented at the ISPE 42nd Annual Meeting; September 1, 2026. Milan, Italy.
Gutierrez L, Danysh HE, Daniels K, Overbeek J, Aguado J, Bartsch J, Quimbo T, Baak BN, Garbinsky D, Calingaert B, Khan AM, Lemmens LA, Verburg I, Penning-van Beest F, Karlsson C, Chen H, Subramani B, Sjostrom CD, Aibibula W, Beachler DC, Gilsenan AW. A post-authorization safety study on the risk of invasive breast cancer in real-world use of dapagliflozin in patients with type 2 diabetes. Presented at the ISPE 42nd Annual Meeting; September 1, 2026. Milan, Italy.
Fuller CC, Kawai AT, Daniels K, Iyer GS, Koram N, Avula R, Brown JS, Cai B, Clasen SC, Hawrusik R, Layton JB, Love SAM, Martinez K, Messenger-Jones E, Paullin M, Rabbani R, Reynolds JS, Wideman K, Uribe W, Platt R, Gilsenan AW. Validation of a claims-based algorithm for Myocarditis/pericarditis and assessment of the impact of outcome misclassification in a US postapproval study of COVID-19 vaccine safety. Poster presented at the ISPE 42nd Annual Meeting; September 1, 2026. Milan, Italy.
Weibel D, de Luise C, De Jong H, Cid Royo A, Ryan O, Manders E, Choi J, Mildiner Moraga S, Mohammadi S, Dehghan Tarazjani A, Hoxhaj V, Riera-Arnau J, Aguado J, Marsal J, Garcia de Albeniz X, Weinrib R, Pazos I, Pala E, Haugh M, Poblador-Plou B, Gimeno-Miguel A, Santos-Mejias A, Marconi E, Barbieri E, Stona L, Gaspersz J, Overbeek J, Roy D, Lane S, Fry C, Morris D, Hyeraci G, Lupattelli A, Desalegn A, Martinez FV, Bissacco CA, Rubino H, Sturkenboom M, Arana A. Results from the vaccine monitoring collaboration for Europe (VAC4EU) post-authorisation safety study for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty®) in Europe. Presented at the ISPE 42nd Annual Meeting; September 1, 2026. Milan, Italy.
Daniels K, Danysh HE, Gutierrez L, Kaye JA, Garcia-Albeniz X, Schmid R, Gilsenan AW, Quimbo T, Beachler DC. Validation of algorithms for breast cancer and bladder cancer among new users of antidiabetics in real world data. Poster presented at the ISPE 42nd Annual Meeting; September 1, 2026. Milan, Italy.
Riera-Arnau J, Paoletti O, Gini R, Thurin NH, Souverein PC, Abtahi S, Salinas CD, Pajouheshnia R, Roberto G. CreateDoT: A standardized framework for terminology, calculation and reporting of estimation of days of treatment associated with electronic drug records. Poster presented at the ISPE 42nd Annual Meeting; September 1, 2026. Milan, Italy.
MacDonald SC, Seals RM, Bell EJ, Delahanty M, Franklin J, Hardy JR, Lanes S, Margulis AV, Parlett LE, Rivero-Ferrer E, Seeger JD, Asomaning K. A cross-sectional patient survey study to inform ascertainment of rimegepant indication in administrative healthcare claims: acute or preventive migraine treatment? Poster presented at the ISPE 42nd Annual Meeting; September 1, 2026. Milan, Italy.
MacDonald SC, Seals R, Bell EJ, Delahanty M, Franklin J, Hardy JR, Lanes S, Margulis AV, Parlett LE, Rivero-Ferrer E, Seeger JD, Asomaning K. Assessing patient use metrics for migraine medication taken daily or as needed: a cross-sectional survey. Poster presented at the ISPE 42nd Annual Meeting; September 1, 2026. Milan, Italy.
Andaur Navarro CL, de Luise C, Cid Royo A, Mildiner Moraga S, Ryan O, Hoxhaj V, Vila Guilera J, Garcia de Albeniz Martinez X, Carsin AE, Weinrib R, Bertran Melines S, Aguado J, Pala E, Pazos I, Haugh M, Poblador-Plou B, Gimeno-Miguel A, Santos-Mejias A, Barbieri E, Stona L, Lysen T, Gaspersz J, Overbeek J, Roy D, Lane S, Fry C, Morris D, Aurelius T, Desalegn A, Lupattelli A, Villalobos Martinez F, Bissacco CA, Far M, Sturkenboom M, Arana A. Interim results from post-authorisation safety study (PASS) for the Pfizer-BioNTech COVID-19 vaccine(Comirnaty) bivalent/omicron BA.1 and BA.4-5 in Europe: a study in the VAC4EU network. Presented at the ISPE 42nd Annual Meeting; September 1, 2026. Milan, Italy.
Kawai AT, Fuller CC, Hawrusik R, Iyer GS, Koram N, Agan AA, Alam S, Avula R, Brown JS, Burk J, Connolly JG, Daniels K, DeFor T, DeVries A, Diessner BJ, Djibo DA, Ezzy S, Cai B, Layton JB, Dea K, Tetreault-Langlois P, Lyons JG, Love SAM, Mayer SE, Ma Q, McMahill-Walraven CN, Nolan MB, Oyedele N, Peters A, Reynolds JS, Taggert E, Wideman K, Ziyadeh NJ, Gilsenan AW, Platt R. Risk of myocarditis/pericarditis after receipt of Pfizer-BioNTech COVID-19 vaccine: results from a post-approval safety study in the US. Presented at the ISPE 42nd Annual Meeting; September 1, 2026. Milan, Italy.
Kawai AT, Bell E, Cosgrove A, Koram N, Avula R, Barrett K, Cai B, Daniels K, Dea K, DeFor T, DeVries A, Diessner BJ, Djibo DA, Ezzy SM, Hawrusik R, Kempner ME, Layton JB, Love SAM, Ma Q, McMahill-Walraven CN, Messenger-Jones E, Michaelidis M, Nolan MB, Platt R, Shinde MU, Taggert E, Tetreault-Langlois P, Wang X, Wideman K, Ziyadeh NJ, Gilsenan AW, Fuller CC. Associations of Pfizer-BioNTech COVID-19 vaccine with birth outcomes: results from a post-approval safety study in the US. Presented at the ISPE 42nd Annual Meeting; September 1, 2026. Milan, Italy.
Mohammadi S, Hyeraci G, Arana A, Tarazjani AD, Lippi M, Nardoni V, Limoncella G, Lucenteforte E, Marinai S, Roberto G, Virgili G, Weibel D, Gini R, Nunziata A, Dini CS. Developing sensitive diagnostic codelists using clinician interviews: a methodological framework illustrated by myocarditis within the VAC4EU Sevalid study. Poster presented at the ISPE 42nd Annual Meeting; August 31, 2026. Milan, Italy.
Mohammadi S, Becker B, Arnau JR, Salinas CD, Rebordosa C, Fortuny J, Arana A, Ehrenstein V, Hoxhaj V, Navarro CLA, Margulis AV, Weibel D, Sturkenboom M. A semantic harmonisation workflow for multinational vaccine studies: the VAC4EU codemapper approach. Poster presented at the ISPE 42nd Annual Meeting; August 31, 2026. Milan, Italy.
Hyeraci G, Nardoni V, Lippi M, Marinai S, Perna R, Nunziata A, Limoncella F, Arana A, Lucenteforte E, Mohammadi S, Roberto G, Virgili G, Weibel D, Dehghan Tarazjani A, Gini R. How good is a large language model in a validation study? Application to a screening phenotype for myocarditis using hospital discharge records validated with medical charts in the VAC4EU SeValid project. Poster presented at the ISPE 42nd Annual Meeting; August 31, 2026. Milan, Italy.
Beckmeyer-Borowko A, Scotto J, Guleria S, Ighamdi EA, Andrade SE, Grandi SM, Molgaard-Nielsen D, Le Noan-Laine M, Rivero-Ferrer E, Espin MS, Lopez-Leon S. Algorithms to identify preeclampsia in real-world healthcare data: a systematic review. Poster presented at the ISPE 42nd Annual Meeting; August 31, 2026. Milan, Italy.
Pajouheshnia R, Li L, Moriello C, Platt RW, Setoguchi S, Hall G, Burcu M, Bennett D, Kaplan S, Wientzek-Fleischmann A, Roberto G, Gulea C, Abtahi S, Zhu L, Wen X, Gini R. A standardised tool to describe data source diversity: the DIVERSE tool. Presented at the ISPE 42nd Annual Meeting; August 31, 2026. Milan, Italy.
MacDonald SC, Rivero-Ferrer E, Bell EJ, Franklin J, Hardy JR, Margulis A, Seals R, Seeger JD, Asomaning K. A retrospective cohort database study to evaluate the safety of rimegepant exposure during pregnancy: data from the fourth interim report. Poster presented at the ISPE 42nd Annual Meeting; August 31, 2026. Milan, Italy.
Tarazjani AD, de Luise C, Manders E, Ryan O, Hoxhaj V, Aguado J, Weinrib R, Marsal JR, Desalegn A, Lupattelli A, Zidan M, Mohammadi S, Roy D, Lane S, Aurelius T, Morris D, Pala E, Pazos I, Yefimenko N, Brutau A, Martinez FV, Overbeek J, van den berg JA, Gaspersz J, Garcia RP, Sanz MP, Poblador-Plou B, Santos-Mejias A, Gutierrez AG, Gimeno-Miguel A, Moreno-Juste A, Stona L, Barbieri E, Gini R, Arana A, Sturkenboom M. Validation of algorithms for the identification of myocarditis and pericarditis in real-world data to evaluate the safety of the Pfizer-BioNTech COVID-19 vaccine (COMIRNATY): a post-authorisation safety study in the VAC4EU network. Presented at the ISPE 42nd Annual Meeting; August 31, 2026. Milan, Italy.
Latour C, Platt RW, Margulis AV, Wood ME, Ahlqvist VH, Caniglia EC. Timing is everything: leveraging time-to-event approaches in perinatal pharmacoepidemiology. Presented at the ISPE 42nd Annual Meeting; August 31, 2026. Milan, Italy.
Shinde MU, Kawai A, Cosgrove A, Koram N, Hawrusik R, Rajbhandari R, Kempner ME, Avula R, Barrett K, Daniels K, DeFore T, DeVries A, Diessner BJ, Djibo DA, Ezzy S, Cai B, Layton JB, Mayer SE, Messenger-Jones E, Michaelidis M, Love SAM, Ma Q, Nolan MB, Selvan M, Taggert E, McMahill-Walraven CN, Wang X, Wideman K, Ziyadeh NJ, Platt R, Bell EJ, Fuller CC, Gilsenan AW. Pregnancy outcomes after Pfizer-BioNTech monovalent COVID-19 vaccination during pregnancy in the United States. Presented at the ISPE 42nd Annual Meeting; August 31, 2026. Milan, Italy.
Engel P, Solorzano M, Joas E, Martinez FV, Pajouheshnia R. Bridging the gap between guidance and practice: the mandate of the new ENCePP special interest group to supplement the good practice guide for the use of the HMA EMA RWD catalogues. Poster presented at the ISPE 42nd Annual Meeting; August 31, 2026. Milan, Italy.
Saltus CW, Calingaert B, Johannes CB, Ogilvie RP, Kaye JA, Wang X, Franklin J, Djibo DA, Moore K, Seeger JD, MacKay R, Nataline T, Casty F, Brooks A, Margulis AV. Risk of endometrial cancer in postmenopausal women who have been prescribed very low dose vaginal estrogen products in the US. Poster presented at the ISPE 42nd Annual Meeting; August 31, 2026. Milan, Italy.
Gilsenan A, Mazzaglia G, Tcherny-Lessenot S, DiSantostefano R. Weighing the benefits & risks: the science and methods of benefit-risk assessment in drug development. Presented at the ISPE 2026 Annual Meeting; August 30, 2026. Milan, Italy. Previously presented at the 2025 International Society for Pharmacoepidemiology (ISPE) Annual Meeting.
Rao S, Layton JB, Ziemiecki R, Kovesdy CP, Walsh M, Farjat AE, Wideman K, Liu F, Oberprieler NG. Real-world effectiveness and safety of finerenone in patients with chronic kidney disease and type 2 diabetes in the United States: a FOUNTAIN platform analysis. Poster presented at the European Society of Cardiology (ESC) Congress 2026; August 29, 2026. Munich, Germany.
Bots SH, Schultze A, Pajouheshnia R, Douglas IJ, Gini R, Klungel OH, Groenwold RHH. Negative controls and how to use them: a guidance paper. Int J Epidemiol. 2026 Aug 18;55(5):dyag163. doi: 10.1093/ije/dyag163
Harrison JE, Jafri SM, Vemulapalli R, Kumpf V, Mitchell G, Boules M, Yang MM, Jackson L, Wang J, Zografos L, Wolin D, Winkler MF. Multifaceted burden of short bowel syndrome for patients and caregivers: the landmark survey. Nutr Clin Pract. 2026 Aug 10. doi: 10.1002/ncp.70162
Limoncella G, Girardi A, Bartolini C, Hyeraci G, Roberto G, Paoletti O, Messina D, Villalobos F, Bisacco CA, Van den Berg J, Houben E, Santaca K, Ingrasciotta Y, Trifiro G, Pellegrini G, Ientile V, Hoxhaj V, Duran C, Riera-Arnau J, Garcia-Poza P, Martin-Perez M, Llorente-Garcia A, Cea-Soriano L, Huerta-Alvarez C, Sanchez-Saez F, Sanfelix-Gimeno G, Rodriguez-Bernal CL, Jove J, Bernard MA, Thurin NH, Jordan S, Thayer D, Evans HT, Coldea AI, Manfrini M, Van Gelder M, Tari M, Pajouheshnia R, Afonso Maciel AS, Le Noan-Laine M, Molgaard-Nielsen D, Cunnington M, Dodd C, Grilli L, Andaur Navarro CL, Sturkenboom M, Nordeng H, Gini R. Identifying pregnancies in population-based data sources: development and application of the concePTION pregnancy algorithm. Drug Saf. 2026 Aug;35(8):e70438. doi: 10.1002/pds.70438
Jafri SM, Harrison JE, Kumpf V, Mitchell G, Wolin D, Zografos L, Yang M, Jackson L, Wang J, Boules M, Vemulapalli R. Patient and healthcare professional perspectives on short bowel syndrome management and preferred treatment attributes: results from the Landmark survey study. Clin Nutr ESPEN. 2026 Aug;74:103310. doi: 10.1016/j.clnesp.2026.103310
Mehta K, Hughes JH, Zhou J, Muluneh B, Gnanasakthy A. Tutorial on analyzing patient-reported outcome measures in clinical development. Clin Transl Sci. 2026 Aug;19(8):e70675. doi: 10.1111/cts.70675
Romano (DeMuro) C, Bratlee-Whitaker E, Hartry A, Taylor J, Callahan LF, Monks D, Kremer I, Lappin D, Frangiosa T, Sangodkar S, Lee J, Shirneshan E, Slowiejko D, DiBenedetti D, Herring WL, Bussberg C, Dardis GJ, Goss D, Edwards T, McLeod L, Poulos C, Paulsen R. Priorities of people living with Alzheimer's and care partners: what matters most? Alzheimers Dement. 2026 Aug;22(8):e71554. doi: 10.1002/alz.71554
Halpin SN. Constructing reassurance and alignment: a discursive study of nurse-patient communication in transplant preparation. J Commun Healthc. 2026 Jul 31. doi: 10.1080/17538068.2026.2712006
Wenger CD, Esterberg L, Karanth S, Goyal RK, Walchak A, Dahodwala B. Treatment patterns and lipid lowering in patients initiating an advanced lipid-lowering therapy: a retrospective cohort study in an integrated healthcare system. Poster presented at the American Society for Preventive Cardiology (ASPC) 2026 Congress on CVD Prevention; July 31, 2026. Scottsdale, AZ.
Gnanasakthy A, Mordin M, Chang J, Mazar I, Di Rosa A, Banjara B, Lusk J, Harrington M. A review of methods used to assess treatment tolerability in clinical trials. Patient. 2026 Jul 30. doi: 10.1007/s40271-026-00834-1
Desai A, Dong OM, Gautier SCZ, Johnson T, Wong A, Osman AMY, Harvey J, Tran TH, Holladay Ford DM, Kerr KW, ISPOR Nutrition SIG Key Project Working Group. Systematic review of health economic evaluations of oral nutritional supplement interventions in older adults: an ISPOR special interest group report. Value Health. 2026 Jul 29. doi: 10.1016/j.jval.2026.06.024
Visnyei K, Metzner AA, Gelow II RS, Aloysius KK, Pilgrim N, Swygard h, Rab S, Cole KA, Boyle K, Reynolds M, Sherif B, Richardson D, Morris R, Sullivan M, Zografos L. Operational insights for long-acting cabotegravir for HIV-1 pre-exposure prophylaxis: findings from the CAPTIVATE United States healthcare provider survey. Poster presented at the 26th International AIDS Conference; July 26, 2026. Rio de Janeiro, Brazil.
Brizzi M, Metzner AA, Van Dam C, Birnbaum JM, Harbison C, Garbinsky D, Cole KA, Rab S, Boyle K, Reynolds M, Sherif B, Richardson D, Morris R, Swygard h, Sullivan M, Zografos L. Real-world experience using cabotegravir long-acting for HIV-1 pre-exposure prophylaxis in the United States from cross-sectional surveys and retrospective chart reviews: results from the CAPTIVATE study. Poster presented at the 26th International AIDS Conference; July 26, 2026. Rio de Janeiro, Brazil.
Burkard TM, Lopez-Guell K, Catala M, Burn E, Delmestri A, Khalid S, Jodicke AM, Dedman D, Oyinlola J, Abellan A, Perez-Crespo L, Mercade-Besora N, Duarte-Salles T, Prieto-Alhambra D, Arinze J, Mosseveld M, Kolde R, Melendez J, Lopez-Blasco R, Martinez A, Valdivieso B, Delseny D, Mercier G, Kim C, Kim JW, Kostka K, Ramirez-Anguita JM, Mayer MA, Trinh NTH, Nordeng H, Paredes R, Uuskula A, Nishimura A, Loste C, Mateu L, Xie J. Risks of autoimmune and inflammatory post-acute COVID-19 conditions: a network cohort study in six European countries, the USA and Korea. BMJ Public Health. 2026 Jul 24;4(3):e001686. doi: 10.1136/bmjph-2024-001686
Singer D, Steffens A, La EM, Buikema AR, Horn EK, Theiss-Nyland K, Fonseca MJ, Gerber SI, Kawai A, Johnson MG, Song R, Hague S, Layton JB. Effectiveness of the adjuvanted RSVPreF3 vaccine in preventing major adverse cardiovascular events and severe exacerbations of chronic obstructive pulmonary disease and asthma among US adults aged ≥60 years. Chest. 2026 Jul 23. doi: 10.1016/j.chest.2026.06.059
Singer D, Steffens A, La EM, Buikema AR, Horn EK, Theiss-Nyland K, Fonseca MJ, Gerber SI, Kawai A, Johnson MG, Song R, Hague S, Layton JB. Real-world effectiveness of adjuvanted RSVPreF3 vaccination in the prevention of RSV-related hospitalization among US adults aged ≥60 years. Chest. 2026 Jul 16. doi: 10.1016/j.chest.2026.07.5002