This conference will explore pre-and post-market regulatory issues and potential solutions facing the cell and gene therapy industry, as well as defining jurisdictional boundaries for these burgeoning industries as evidenced by recent enforcement and litigation challenges. The conference will review FDA’s comprehensive regenerative medicine policy framework and expedited programs for regenerative medicine and discuss issues common to cell and gene therapy companies, such as trends in Regenerative Medicine Advanced Therapy (RMAT) designation and clinical trials, orphan exclusivity, and manufacturing hurdles. The conference will also explore approval and post-market challenges for gene and cell therapies. Recent enforcement and litigation addressing companies’ claimed exclusions from FDA regulatory authority, emerging issues, and access and reimbursement, will also be addressed.
Dr. Peter Marks, Director, Center for Biologics Evaluation and Research, FDA
- Speakers from FDA and other federal agencies
- Case studies from industry experts
- The latest on FDA policy, enforcement, litigation, and initiatives
- Pre-and post-market obstacles and solutions
Peer Interaction: Network with and learn from legal and regulatory experts.