CIRM translating research into therapies: Collaborating with the FDA and industry

Cynthia Schaffer is Contract Administrator and Compliance Officer at CIRM

One of the roles CIRM plays is in collaborating with outside groups to help our grantees get the information they need to move their possible therapies into clinical trials. That includes working closely with both the Food and Drug Adminstration (FDA) and the Alliance for Regenerative Medicine (ARM).

Our latest work with FDA will be a free webinar on September 27th, which will discuss the immune response in stem cell based therapy. Theresa Chen of the FDA is one of three speakers for the webinar. We hope you will join us and learn more about the regulatory perspective on immune rejection concerns as well as how to overcome the immune rejection challenge.

CIRM has held two of these free webinars each year for the past 3 years, all with FDA speakers. Recordings and reference materials from past webinars are available on our website. Scientists can join these online sessions from their own desk or from on the road and submit questions that are answered directly by the FDA and the two leading experts who present their research and current findings.

The FDA very graciously donates their time to speak on these webinars because they too have pledged to maintain an active dialogue with the industry and provide education on their regulatory expectations for product development in the regenerative medicine field. CIRM science officer Kevin Whittlesey recently wrote a paper with Celia Witten of the FDA about the role of the FDA in reaching out to regenerative medicine community, including webinars such as these.

In that paper they point out that the communication goes both ways:

Appropriate regulation requires a strong understanding of the latest scientific developments to meet current and future regulatory needs and challenges.”

 So the FDA benefits by learning from the other speakers in the webinar – what is the current state of the technology, what are investigator’s current thoughts on best practices and the latest research findings, etc. They also learn what the industry is facing by listening to the questions asked and the discussion of the challenges during the Q&A sessions. A group of FDA employees attend each of these CIRM sponsored webinars, and the wide variety of other workshops and meetings that CIRM hosts throughout the year.

These webinars with the FDA are just one way CIRM is trying to help our grantees get their therapies into clinical trials. We’re also partnering with ARM to sponsor the 2012 Stem Cell Meeting on the Mesa Investor & Partnering Forum and Scientific Symposium to be held in La Jolla on October 29-31. ARM was formed in 2010 and has since developed into an amazing advocacy organization dedicated to the advancement of regenerative medicine (see link to ARM website). CIRM will have six of its grantees presenting at the Investor & Partnering Forum (registration and more information is available here).

I’ve written in the past about the effort CIRM has made in the past year to reach out to industry and to help the entire community share best practices and resource. Efforts like these are part of how CIRM hopes to speed the pace of translating research into clinical trials and eventually bring new therapies to patients.

C.S.

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