CIRM / Regenerative Medicine Consortium (RMC)

Scaffolding Webinar

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

Slides:

Dr Mark Lee, FDA
Dr. Deepak Jain, Tengion, Inc.
Dr. Robert Langer, Massachusetts Institute of Technology

Video:

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

Webinar Topic & Agenda

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

Speakers:

• 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

Background material

CIRM Grants Targeting Scaffolding and Tissue Engineering

• DR1-01444 - Mark Humayun, University of Southern California
• TR1-01216 - Darryl D’Lima, Scripps Research Institute
• TR2-01787 - Roslyn Isseroff, UC Davis
• TR2-01821 - Bruno Peault, UC Los Angeles
• RT2-01938 - Sarah Heilshorn, Stanford
• RT1-01097 - Kit Lam, UC Davis
• RC1-00151 - Christopher Zairns, Stanford
• RB3-05232 - Song Li, UC Berkeley
• RM1-01707 - Gay Crooks, UC Los Angeles
• RT2-02022 - David Schaffer, UC Berkeley
• RN2-00946 - Tracey Grikscheit, Children’s Hospital Los Angeles

News and Information

• UCL technology used in windpipe transplant, 7 July 2011
• Children's Hospital Los Angeles Researchers Engineer Small Intestine in Laboratory Experiments
  Biological Scaffolds for ReGen Medicine: Generating Functional Tissue Constructs that Avoid Immunogenicity Remains Elusive but Not for Long

Resources

• FDA/NIST Sponsored Workshop: In Vitro Analyses of Cell/Scaffold Products, December 6-7, 2007
• Principles of Tissue Engineering, 3rd Edition [Hardcover], Robert Lanza (Author), Robert Langer (Author), Joseph Vacanti (Author) ISBN-10: 0123706157 | ISBN-13: 978-0123706157 | Publication Date: August 21, 2007 | Edition: 3
• Biological scaffold materials composed of extracellular matrix (ECM) have been used clinically in regenerative medicine for many years, McGowan Institute for Regenerative Medicine- Stephen Badylak Laboratory