We are updating our Privacy Policy and Terms and Conditions to help you clearly understand how your personal information is collected, stored and managed. Learn More
Menu Back toRegenerative-Medicine-Advanced-Therapies-Efforts-to-Facilitate-Product-Development-and-Approval-at-the-Center-for-Biologics-Evaluation-and-Research

DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

Regenerative Medicine Advanced Therapies: Facilitating Product Development and Approval

    Session Chair(s)
      Peter W. Marks, MD, PhD

      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.
      Tejashri  Purohit-Sheth, MD

      FDA Perspective

      Tejashri Purohit-Sheth, MD

      • Director/DCEPT, Office of Tissues and Advanced Therapies, CBER
      • FDA, United States
      Robert W.  Mays, PhD

      Industry Perspective

      Robert W. Mays, PhD

      • Vice President of Regenerative Medicine and Head of Neuroscience Programs
      • Athersys, Inc., United States
      Jane S. Lebkowski, PhD

      Industry Perspective

      Jane S. Lebkowski, PhD

      • President of Research and Technology
      • Regenerative Patch Technologies, United States
      Joshua  Hare, MD, FACC


      Joshua Hare, MD, FACC

      • Founding Director, Interdisciplinary Stem Cell Institute; Professor of Medicine
      • University of Miami, United States
      Marie-Helene  Pinheiro, PharmD


      Marie-Helene Pinheiro, PharmD

      • Industry Stakeholder Liaison, Corporate Stakeholders Department
      • European Medicines Agency (EMA), United Kingdom