Why Attend?

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.


Keynote Speaker
Dr. Peter Marks, Director, Center for Biologics Evaluation and Research, FDA



Conference Highlights:

  • 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.


Industry & Firms

  • +$300 for non-members


  • +$100 for non-members


  • +$100 for non-members


  • +$100 for non-members


  • transcripts required

COVID-19 Update

In light of travel restrictions due to COVID-19 and out of concern for the safety of our community, FDLI will solely be holding its upcoming programs as virtual events. The registration process remains unchanged. FDLI will contact all registrants with more information regarding virtual access closer to each program’s respective event date.

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Need to Get Up to Speed?

Add the two-day training course, Introduction to Biologics and Biosimilars Law and Regulation to your registration to gain a comprehensive overview of the laws and regulations affecting the biologics and biosimilars industries before diving in deeper at the conference.


Sponsorship opportunities are available. Please let us know if you would like more information.

Planning Committee

Melissa Scales (Staff Liaison), FDLI
Mantej (Nimi) Chhina, BioMarin Pharmaceutical Inc.
Catherine M. Cook, Greenleaf Health, Inc.
Paul Gadiock, Wilson Sonsini Goodrich & Rosati
Todd Halpern, Venable LLP
Katie Laney, Validant
Deborah L. Livornese, Hyman, Phelps & McNamara, PC
Daniel Orr, Womble Bond Dickinson (US) LLP
Lance L. Shea, BakerHostetler
Julia Tierney, CBER, FDA
Michael Werner, Holland & Knight LLP