09:00  Chairperson’s Opening
Emma Cheesman, Director of Development Consulting and Scientific Affairs, BioPharma Excellence, A Pharmalex Company

09:10  State of the Industry
Janet Lynch Lambert, Chief Executive Officer, Alliance for Regenerative Medicine

09:25  Top Ten Events of 2021

• 2021 was a year of resilience, strength and innovation in the advanced therapies sector.
• Cell and Gene therapy expanded despite the ongoing pandemic.
• 2021 was a year of advances in approvals, and delays in supply chain and clinical trial enrollment.  Rare Disease pipelines moved closer to approval and gene therapies experienced delays in clinical programs.  CMC dominated discussions and our high growth industry felt labor shortage growing pains.  What will this mean moving into 2022?

Susan Nichols, Chief Executive Officer, Propel Biosciences

09:40 The Regulatory Landscape for Cell and Gene Therapies (Live-Streamed)

• Review the regulatory framework for cell and gene therapy
• Describe regenerative medicine advanced therapy designation
• Discuss FDA’s efforts to facilitate the development of cell and gene therapies

Peter Marks, Director of the Center for Biologics Evaluation and Research, FDA

10:05  Speaker Q&A and Panel Discussion: The Next Five Years

Moderator:
Emma Cheesman, Director of Development Consulting and Scientific Affairs, BioPharma Excellence, A Pharmalex Company

Expert Panellists:
Janet Lynch Lambert, Chief Executive Officer, Alliance for Regenerative Medicine
Susan Nichols, Chief Executive Officer, Propel Biosciences
Shephard Mpofu, Chief Medical Officer, Novartis Gene Therapies
Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, University of Pennsylvania; President, International Society for Cell & Gene Therapy
Peter Marks, Director of the Center for Biologics Evaluation and Research, FDA (via Live Stream)
Tim Farries, Principal Consultant and Senior Director, Biopharma Excellence (via Live Stream)