5:11 PM
 | 
Nov 03, 2016
 |  BC Innovations  |  Strategy

The next (re)generation

Why investors both want and worry about regenerative medicine

Regenerative medicine is continuing to draw believers from the scientific and investment communities, who are putting stock in the technology’s potential to create transformational therapies. But while there’s plenty of enthusiasm for the scientific progress, stakeholders fear more clinical failures and company closures could send investors and regulators running.

Consequently, regenerative medicine appears to be heading to a Catch-22 in which stakeholders want industry to embrace the risks and drive progress, but fear too many failures might damage the field long term.

That was the upshot of the FUSION symposium held last month at Harvard University on “The Science and Business of Regenerative Medicine,” which brought together representatives from the academic, investor and biotech sectors to discuss whether the field is ready to produce game-changing breakthroughs.

The meeting was hosted by the university’s Blavatnik Biomedical Accelerator.

Vicki Sato, a professor of management practice at Harvard Business School who moderated a panel at the symposium, told BioCentury that while the biology is advancing impressively, a host of translational hurdles face drug developers, including both technical and commercial challenges that will dictate the pace of progress.

“Is the science moving at a rapid clip? Absolutely. Is the infrastructure for both manufacturing and returns worked out? I think not so much,” she said.

Sato is also a board member at Bristol-Myers Squibb Co. and was formerly president of Vertex Pharmaceuticals Inc.

“Is the science moving at a rapid clip? Absolutely. Is the infrastructure for both manufacturing and returns worked out? I think not so much.”

Vicki Sato, Harvard

Investment in regenerative medicine companies has risen, albeit in fits and starts, over the last decade, and more venture money has been raised since 2014 than during the previous decade combined (see “Regenerative Venture”).

However, the field has also been hit by recent commercial failures. At least three companies that had raised over $50 million since 2011 have shuttered or announced plans to wind down operations in the last two years (see “Going, Going, Gone”).


Figure: Regenerative Venture

In the last decade, VC investment in regenerative medicine companies has been highly variable, but the last three years have seen a big uptick in private investment. The shift started with two 2014 venture rounds from Juno Therapeutics Inc. (NASDAQ:JUNO) totaling $310 million. The chart includes venture financing for select active companies developing regenerative medicine products. * 2016 value includes venture financing through Nov. 1. Source: BCIQ:BioCentury Online Intelligence

For stakeholders, that record raises concerns that companies are trying to run before they can walk, and their errors could have broad, negative consequences.

“I’m afraid that if a lot of bad experiments go on, FDA will shut this field down,” Mark Fishman told the symposium. Fishman, a former president of Novartis AG’s Novartis Institutes for Biomedical Research (NIBR), is now professor of stem cell and regenerative biology at Harvard.

Kevin Eggan, a professor of stem cell and regenerative biology at the Harvard Stem Cell Institute, agreed with the concern. “Early clinical missteps in gene therapy set that field back. We’re afraid mistakes will do the same here.”

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