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FDA’s regeneration

What the regenerative medicine industry wants from FDA this September

With $500 million and a bipartisan mandate to innovate regulatory science courtesy of the 21st Century Cures Act, FDA Commissioner Scott Gottlieb has made regenerative medicine a focal point of the agency’s Innovation Initiative, and promised to issue comprehensive guidelines for cell therapies in September. That is music to the ears of companies looking for clear boundaries and new ways to demonstrate efficacy for their regenerative therapies.

In a July 7 post on the agency’s blog, Gottlieb wrote the framework will “delineate our policies for appropriate and efficient regulatory oversight of regenerative medicine products.” He said the proposed suite of guidance documents will use FDA’s existing regulations as a foundation to provide clarity to sponsors, and that they will build upon the current framework and work toward implementing the provisions of the 21st Century Cures Act.

Stakeholders who spoke with BioCentury welcome the attention from Gottlieb, and think the field might be reaching an inflection point for regulatory progress.

Companies have long bemoaned the lack of clarity from the agency for emerging regenerative technologies like stem cells, induced pluripotent stem (iPS) cells and engineered tissues. As the biology races ahead and investors begin to place big bets, the concern has been that the innovations would go nowhere -- or would go overseas -- without a proper regulatory pathway stateside.

But 12 investors, companies, patient advocates and KOLs expressed optimism that the noises from FDA, prompted by the Cures Act, signify meaningful change.

“The seniority and levels from which statements are coming within the FDA, and the consistency of focus on this area against the background of political change, sends a pretty strong message,” said Jerel Davis, a managing director at Versant Ventures. Versant invested in regenerative medicine company BlueRock Therapeutics, for which it co-led a $225 million series A round in 2016.

FDA declined a request to comment; the main clues to the issues it’s addressing are in a June 6 report to Congress required by the Cures Act, in which the two sections dedicated to regenerative

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