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

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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]