A successful strategy for Regenerative Medicine Advanced Therapy (RMAT) designation requires a strong understanding of the FDA/CBER defined designation criteria and potential pitfalls. Attendees will have a better understanding of the possible outcomes from RMAT designation requests, be better positioned to determine if a clinical indication is ready for request of RMAT designation, understand how they can use RMAT designation to expedite clinical development, and explore additional avenues for product development. Equally important to the RMAT strategy is understanding how/if/when regulatory flexibility applies, including GMP challenges to overcome and understanding of the effect of potential government agency interactions. Attendees will understand the sequence of meetings that follow the RMAT designation including the comprehensive interdisciplinary meeting that provides an overview of development program for the product. The RMAT designation is a useful pathway to promote the use of regenerative products to treat, reverse, or cure serious conditions with unmet medical needs.
Discuss key content to submit for RMAT consideration including clinical data requirements to ensure clinical evidence aligns with product characteristics.Identify potential flexibility around clinical and CMC approaches, and associated challenges.
Explain regulatory options that exist for RMAT designated products including frequent interactions with agency.
Explore additional opportunities that may exist for RMAT products which may include department of defense programs.