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Regenerative Medicine Advanced Therapies: Facilitating Product Development and Approval
Session Chair(s)
Peter W. Marks, MD, PhD
Director, Center for Biologics Evaluation and Research
FDA, United States
Regenerative medicine therapies include certain cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products, including genetically modified cellular therapies and gene therapies that produce durable effects. Challenges in the development of these products range from establishing a consistent manufacturing process to demonstrating efficacy in clinical trials. This session will address the regulatory framework for regenerative medicine products, Regenerative Medicine Advanced Therapy designation, and will also suggest potential pathways sponsors can take to address issues related to manufacturing and clinical trial design.
Learning Objective : Describe the regulatory framework for regenerative medicine products; Identify potential pathways sponsor can take for issues related to manufacturing and clinical trial design.
Speaker(s)
Regenerative Medicine Advanced Therapy Designation Pathway
Tejashri Purohit-Sheth, MD
FDA, United States
Director/DCEPT, Office of Tissues and Advanced Therapies, CBER
Advancements in Product Manufacturing: Lessons Learned from Developing Cellular Therapies
Robert W. Mays, PhD
Athersys, Inc., United States
Vice President of Regenerative Medicine and Head of Neuroscience Programs
Preclinical Program Development to Support Early-Phase Clinical Trials
Jane S. Lebkowski, PhD
Regenerative Patch Technologies, United States
President of Research and Technology
EMA Approach to Regulating Advanced Therapies
Marie-Helene Pinheiro, PharmD
European Medicines Agency, Netherlands
Industry Stakeholder Liaison, Corporate Stakeholders Department
Panelist
Iwen Wu, PhD
FDA, United States
Director, Office of Pharmacology and Toxicology Cell and Gene Therapies CBER
Panelist
Donald Wright Fink, PhD
FDA, United States
Cell Therapies Branch, Division of Cellular and Gene Therapies, OTAT, CBER
Panelist
Joshua Hare, MD, FACC
University of Miami, United States
Founding Director, Interdisciplinary Stem Cell Institute; Professor of Medicine
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