Biotech leaders discuss collaborative approach, better communication with FDA Commissioner in Boston

July 11, 2011

Sen. Kerry brought together federal regulatory team, MassBio member companies

Life sciences leaders encouraged U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg and other federal regulators to work collaboratively with industry to improve the drug approval process at a roundtable in Boston today. Hamburg

The discussion, led by Sen. John Kerry and MassBio President & CEO Robert K. Coughlin, focused on the FDA review process, biosimilars, personalized medicine and companion diagnostics, innovation policy and orphan drugs.

“We were thrilled with the candor and insight offered by Commissioner Hamburg and her team,” Coughlin said. “We continue to be encouraged that the FDA, which plays such a vital role in the research, development & commercialization of life-changing therapies, is committed to working with industry in balancing safety and innovation.”

More than 50 MassBio member CEOs and regulatory heads attended the event, which was held at Boston University.Hamburg

Other participants from the FDA included Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research, and Jeffrey E. Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health.

The roundtable was the result of a series of conference calls and in-person meetings between Sen. Kerry and leaders in the biotechnology and medical device industries.  Following those discussions, the Senator personally invited Commissioner Hamburg to Boston to facilitate direct talks with the Massachusetts industries.

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