Live from BIO: Alliance gives regenerative medicine a voice

CHICAGO - During first day of the 2010 BIO convention I met with Morrie Ruffin, managing director and one of the founding members of the Alliance for Regenerative Medicine. Last year Ruffin and co-founder Michael Werner saw a need--the burgeoning field of regenerative medicine faced issues separate from other areas of drug development, and lacked a unanimous voice to represent its interests with legislators and regulators. Not long after that, the Alliance for Regenerative Medicine was founded with 17 charter members made up of Big Pharma, biotech, research institutions and investors.

"We understood that the community of companies in the regenerative medicine field--as well as major research institutions--were all becoming politically active," said Ruffin. But these groups were having one-off conversations with legislators and regulators about an incredibly complex field that doesn't lend itself to unstructured information. The Alliance's objective: offer policymakers a credible source of information about regenerative medicine and advocate positive funding, regulation and reimbursement policy for its members.

"We wanted to make sure that the leading companies in this space, including pharma and research institutions, were all supportive of the idea," notes Ruffin. The reaction from the industry, he says, was unanimous: Representation was desperately needed.

Companies that proactively organize their regenerative medicine efforts are the most likely to be interested in joining the Alliance, says Ruffin. "The two pharma companies who have made the biggest commitment to this space are Pfizer and Johnson & Johnson," which each have internal groups that are exclusively committed to pursuing regenerative medicine. Baxter, Genzyme, Roche, Sanofi-Aventis and AstraZeneca have also spoken with the Alliance about membership.

"We're moving out aggressively with our legislative agenda," Ruffin notes. The Alliance is working with members of the Congress on a bill expected to be introduced in the next month or so. The primary objective will be to support funding for research at non-profits, as well as establish matching grants for companies. Additionally, the Alliance is working closely with the FDA to formulate a regulatory pathway for regenerative medicine treatments that straddle the line between drugs and devices.

Since its inception the Alliance has tripled in size, and Ruffin thinks the group will one day grow to 200 or more members.