Webinar: Scaffolding

CIRM / Regenerative Medicine Consortium (RMC) Scaffolding Webinar

Webinar Registration

The webinar was held September 12, 2011. See below for slides and a video of the webinar:


Webinar recording of Lee and Jain presentations
Audio recording of Q&A session [mp3]

See the agenda page for links to the presenters’ slides as well as background information.


Webinar Topic & Agenda

Moderator: Ellen Feigal, MD, CIRM, Vice President of Research and Development


  • Mark Lee, Ph.D., Product Reviewer, Office of Cellular, Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA)
  • Robert Langer, Sc.D, David H. Koch Institute Professor, Department of Chemical Engineering, Massachusetts Institute of Technology
  • Deepak Jain, Ph.D., Senior Vice President, Bioprocess Research & Development, Tengion, Inc.

Topics to be covered:

  • Presentation by FDA
    • Overview of FDA Regulatory Process
    • Considerations for Cell-Scaffold Combination Products used in Regenerative Medicine
  • Overview of Scaffolding in relation to Regenerative Medicine
  • Neo-Organs and Neo-tissues
  • Examples of issues and challenges of taking this type of product through the regulatory pathway to the clinic
  • Questions and Answers