Presentations from FDA and Leading Experts
Webinar Information- September 11 from 11 am to 1 pm (Pacific Time)
Fee: None
Webinar Registration: Available Here (advanced registration required)
WEBINAR TOPIC & AGENDA
Use of Induced Pluripotent Stem Cells
as Screening Tools and Therapeutics
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)
• Melissa Carpenter, Ph.D., Principal, Carpenter Group Consulting
• Kyle Kolaja, Ph.D., Vice President, Business Development, Cellular Dynamics
Topics to be covered:
The focus of this webinar is on the use of iPSC cells– 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 as tools and therapies
• Questions and Answers
To test your system setup in advance of the September 11 webinar, please go to:
http://www.webex.com/lp/jointest/
The website will simulate joining a Webex meeting and test if you are missing any software, etc. If you have any technical issues with Webex, please call Webex support at 866.229.3239.
For more information, please see the CIRM website at www.cirm.ca.gov
