Webinar: Preclinical Animal Model Considerations for Stem Cell Therapies

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CIRM / Regenerative Medicine Consortium

Webinar: Preclinical Considerations for Stem Cell Therapies

Presented by RMC, FDA and Industry Leaders
Fee: None

Overview

CIRM will host this webinar as the sponsor of the Regenerative Medicine Consortium’s (RMC’s) webinar series on IND readiness. The mission of the RMC is to accelerate the development and regulatory approval of stem cell and regenerative medicine therapies.

For more information please see the Regenerative Medicine Consortium page.

Webinar Topic & Agenda

Preclinical Considerations for Stem Cell Therapies

• Regulatory review principles
• Adult stem cell (allogeneic and autologous) and hESC derived therapies to be presented
• Lessons learned

Moderator: Elona Baum, CIRM, General Counsel and RMC Chair

For additional information please contact: cschaffer@cirm.ca.gov

Speakers:

• Mercedes Serabian, M.S., DABT, Chief, Pharmacology/Toxicology Branch (PTB), Division of Clinical Evaluation & Pharmacology/Toxicology (DCEPT), Office of Cellular, Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA) See Slides [pdf]
• Robert Deans, PhD., Senior Vice President Regenerative Medicine, Athersys, Inc. See Slides [ppdf]
• Melissa Carpenter, PhD., Carpenter Group See Slides [pdf]

Video

• Watch the Webinar

 

 

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