Forum to focus on FDA requirements, potential hurdles and tips for developing therapeutic products derived from human stem cells

DIA will host a forum called “FDA Regulation of Therapeutic Products Derived From Human Stem Cells: Successfully Navigating the Regulatory Hurdles” during the DIA 2014 50th Annual Meeting at the San Diego Convention Center from June 15 to 19.

The Food and Drug Administration (FDA) regulates many therapeutic products derived from human stem cells. As part of the novel science of regenerative medicine, human stem cell research spans many FDA regulatory jurisdictions and poses particular challenges—like limited precedents from which to learn—for developing products safely and effectively. Understanding how to improve communications and interactions with FDA can help reduce risks for sponsors, more accurately identify FDA’s position on key issues and facilitate a smoother pathway to market.

“Our annual meeting is a global platform to better understand the full development and life cycle management process for all health care products, including therapeutics,” said Barbara L. Kunz, DIA global chief executive. “The unique regulatory challenges presented by human stem cells demand a more robust and efficient dialogue with the FDA. This forum will provide the insights needed to help navigate this process and successfully bring therapeutics to market.”

The forum, chaired by Dr. Ellen G. Feigal, senior vice president for research and development at the California Institute for Regenerative Medicine, will be held June 16 at 11 a.m. Feigal will describe the general FDA framework governing therapeutic products derived from human stem cells. She will also offer proven tips to identify and plan for successful management of specific regulatory issues that are likely to affect the development of these products.

 

 

Contact: Tiffany Cohen
+1.202.499.4411
tcohen@reingold.com

 

 

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