Use of Induced Pluripotent Stem Cells as Screening Tools and Therapeutics Presentations from FDA and Leading Experts

 

Use of Induced Pluripotent Stem Cells

as Screening Tools and Therapeutics

 

Presentations from FDA and Leading Experts

 

This webinar was held on September 11, 2014

 

Slide decks and a recording of the webinar are now available (see below).
 

WEBINAR TOPIC & AGENDA

MODERATOR:

Ellen Feigal, MD, Senior Vice President of Research and Development, CIRM

Speakers:

  • Keith Wonnacott, Ph.D., Chief, Cellular Therapies Branch, Office of Cellular, Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA)
  • Steve Finkbeiner, MD, Ph.D., Professor, Departments of Neurology and Physiology, University of California, San Francisco
  • Kyle Kolaja, Ph.D., Vice President, Business Development, Cellular Dynamics
  • Melissa Carpenter, Ph.D., Principal, Carpenter Group Consulting

Topics to be covered:

The focus of this webinar is on the use of Induced Pluriopotent Stem Cells (iPSCs)– used as a tool for disease modeling, target identification, or toxicity assessment, or as a cell therapy intervention.  Speakers will cover preclinical and manufacturing regulatory challenges in moving an iPSC forward as a cell therapy, and challenges along the regulatory pathway in use of iPSCs as tools. 

  • Presentation by FDA - Donor Eligibility and the testing required for iPSCs and hESCs
  • Lessons learned  and regulatory issues for use of iPSC for tools and therapies
  • Questions and Answers

Resources:

Link to Webinar Recording
Question & Answers from September 11, 2014 iPSC Webinar

Slide Decks of Presentations:
Kyle Kolaja: Humanizing the Tissue Chip: Use of Stem Cell Derived Tissues to Develop Biological Platforms [pdf]
Melissa Carpenter: Preclinical Development of iPSC Therapies [pdf]
Keith Wonnacott: Donor Eligibility and Testing of iPSCs and hESCs For Therapeutic Use [pdf]
Steven Finkbeiner: Patient-­Derived Induced Pluripotent Stem Cells as a Therapeutics Discovery Platform: Challenges and Opportunities [pdf]

© 2013 California Institute for Regenerative Medicine