Process Improvement and Accelerated CMC Development Workshop

Sponsored by PCT, A Caladrius Company and GE Healthcare

PROCESS IMPROVEMENT AND ACCELERATED CMC DEVELOPMENT WORKSHOP
The objective of this workshop is to discuss the needs of continuous process improvement for cell therapy manufacturing compared to major process changes for traditional drug/biologic manufacturing, the thinking or rethinking on comparability assessment and the need for potential regulatory mechanisms to help with accelerated CMC development to match accelerated clinical development under various existing regulatory pathways (conditional approval etc.).

Panel I: Process Improvement and Comparability Assessment
Chair: Robert Preti, Ph.D., Chairman, Alliance for Regenerative Medicine (ARM); President, PCT, A Caladrius Company; SVP, Manufacturing and Technical Operations, Caladrius Biosciences

Panel II: Accelerated CMC Development
Chair: Jiwen Zhang, Ph.D., Senior Director, Regulatory Affairs, Cell Therapy and Regenerative Medicine, GE Healthcare

Expert Panelists from Regulatory Agencies:
Nicolas Ferry, M.D., Ph.D., Former Member, Committee for Advanced Therapies (CAT), European Medicines Agency (EMA); Founder and President, NF Consulting
Steven S. Oh, Ph.D., Chief, Cell Therapies Branch, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA)
Yoshiaki Maruyama, Ph.D., Review Director, Office of Cellular and Tissue-based Products (OCTP), Pharmaceuticals and Medical Devices Agency (PMDA)

Expert Panelists from Industry:
Stewart Abbot, Ph.D., Chief Development Officer, Fate Therapeutics
Francis Meacle, Ph.D., Director, Cell Therapy Manufacturing, Janssen R&D
Keith Wonnacott, Ph.D., Director, Regulatory Affairs, Novartis

Closing Remarks
Michael Mendicino, Ph.D., Owner and Chief Consultant/Advisor, Hybrid Concepts International