Thursday, July 16, 2009

The Next Phase For Regenerative Medicine: New Advocacy Group Will Focus on Regulatory, Reimbursement Policy

We are enthusiastic believers in the proposition that political capital and venture capital are both vital to successful business models in biopharmaceuticals, so we were intrigued to see the announcement of a new Washington, DC-based organization—the Alliance for Regenerative Medicine—devoted to advancing the science of tissue engineering.

ARM was put together by two former Biotechnology Industry Organization staffers—Michael Werner (formerly BIO VP-Bioethics and now a partner at Holland & Knight) and Morrie Ruffin (formerly EVP Capital Formation & Business Development at BIO, and now managing director of Adjuvant Global Advisors).

Founding members include biopharma companies big and small (Johnson & Johnson, Geron, Aldagen, iZumi, Fate Therapeutics and Maxcyte), venture capitalists (Kleiner, Perkins, Caufield & Byers and Proteus Ventures) as well as academic institutions (Wake Forest Institute for Regenerative Medicine, Stanford University, the University of Washington, and Georgia Tech University; the Genetics Policy Institute.)

The Alliance is “dedicated to promoting regulatory, research, and reimbursement policies that will foster innovation in regenerative medicine,” the press releases announcing its formation says. It will also “serve as a source of information about regenerative medicine for policy makers, the media, and the general public.”

What that really means, Werner explains, is that ARM is devoted to making sure the tremendous political capital expended on changing stem cell research policy does more than generate “research for research’s sake.”

The goal is to move to “the next phase” and create “a way to focus on commercialization issues,” he says. Goals include shaping “regulatory policies at FDA that are predictable and facilitate a pathway,” finding a “way to start talking to CMS about value” and to “talk to NIH about future funding of research.”

ARM will be a member-driven, non-profit corporation, with no full time staff. Nothing is finalized, but Werner is likely to be representing ARM in its lobbying and advocacy work, while Ruffin will be handling operations. And they hope to recruit more members (potentially including associations like BIO and the medical device organization AdvaMed). Look for a formal launch later this year.

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