CIRM / Regenerative Medicine Consortium (RMC) Scaffolding Webinar
Monday, September 12, 2011 - 10:00am to 12:00pm
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:
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