Stay on Track
The paradigm of regenerative medicine development is changing. Expedited approvals can help get your much-needed therapy to patients earlier, but only if you are timely with your strategic planning.
You need to fully explore endpoints, start planning for reimbursement, and begin developing a market access strategy before your gene or cell therapy or tissue engineered product gets regulatory approval.
If your advanced-therapy product has received fast-track designation, like the US FDA’s Regenerative Medicine Advanced Therapies (RMAT) or the EMA’s Advanced Therapy Medicinal Products (ATMP) designations, getting a jump on this planning is even more critical.
We Can Help
Our experienced team can help you stay on track. We’ll put together an integrated team of experts to help you ask relevant questions and gather the right data to build an informed strategy. Giving you the best opportunity to get your gene therapy treatment or drug product market access as quickly as possible.
A Wealth of Experience
We have collaborated with our clients on projects to research a variety of cell and gene therapies. Our experience with these therapies includes several disease areas:
- Sickle cell disease
- Neuronal ceroid lipofuscinosis type 2 (CLN2) disease
- Duchenne muscular dystrophy
- Spinal muscular atrophy
Types of Projects
We have implemented studies to help our clients develop strategies and gain market access for regenerative therapies. Projects have included: