This conference will explore the latest pre-and post-market regulatory, legal, and compliance issues facing the cell and gene therapy industry. FDA and other speakers will provide updates on agency initiatives intended to expedite the development of cell and gene therapies. Speakers will also discuss issues such as standard setting for regenerative medicine terms and products; clinical development challenges; supply chain, liability, and other manufacturing issues; and FDA’s global regulatory harmonization initiative. The latest compliance and enforcement trends for regenerative therapies will also be discussed.

To increase understanding about cell and gene therapies, the agenda will feature a bonus session on the underlying science. 

Conference Highlights:

• Keynote: Dr. Peter Marks, Director, Center for Biologics Evaluation and Research;
• Featured Speaker: Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, University of Pennsylvania;
• Real-life examples from industry experts;
• The latest on FDA policy, initiatives, and compliance, directly from FDA;
• Pre-and post-market obstacles and solutions.

Planning Committee

Julie Allickson, Wake Forest University
Mantej Nimi Chhina, BioMarin Pharmaceutical Inc.
Jennifer Devine, U.S. Pharmacopeia
Lynn Ensor, Parexel International Corporation
Allison Fulton, Sheppard Mullin Richter & Hampton LLP
Colleen M. Heisey, Jones Day
Chin C. Koerner, Novartis Pharmaceuticals Corporation
Diane M. Maloney, FDA – CBER
Sung Park, Reed Smith LLP
Kathleen M. Sanzo, Morgan, Lewis & Bockius LLP
Michael Werner, Holland & Knight LLP