FDA Commissioner, Industry Leaders Gather to Discuss Most Pressing Life Sciences Issues

March 15, 2013

MassBio Annual Meeting Convenes Industry Stakeholders

March 15, 2013 (CAMBRIDGE, MA) — Nearly 400 biotechnology industry leaders gathered this week at the Royal Sonesta Hotel in Cambridge, right in the heart of the state’s biotech cluster, to participate in MassBio’s 2013 Annual Meeting.

The meeting took place across two days, and included discussions on healthcare reimbursement, what’s next in oncology research, the future of biosimilars and research resources sharing.

“These conversations go to the very heart of what we do and how we as an industry will operate into the future,” said Robert K. Coughlin. “We must understand our role in a shifting economic and regulatory environment and attempt to answer these big, complicated questions. Our only way forward is to address them together.”

The event’s keynote speakers included FDA Commissioner Margaret Hamburg and John Crowley, Chairman & CEO of Amicus Therapeutics. Commissioner Hamburg spoke on Friday and addressed industry concerns on time to approval, the threat of sequestration and other budget cuts, and recent successes in industry-FDA collaboration.

“I am committed to working with all of you—and many others—on the broad-based national strategy to advance biomedical product innovation that I believe is so very much needed at this critical time,” Hamburg said. “I think I can say that at FDA we are striving to do our part. Success will require regulatory flexibility, advancing regulatory science, and true collaboration among health professionals, industry, government, academia, and our global health partners.”

She shared examples of Massachusetts companies who had successfully navigated FDA approval pathways, and discussed the possibility of a new pathway in the future—one utilized for for “special limited use,” in cases where a population of patients may require additional methods of treatments than others in with the same disease or diagnosis.

“Such an approach – which would require working with Congress for the creation of a new drug approval pathway -- could permit a more appropriate risk-benefit evaluation for conditions such as serious, drug resistant infections or a chronic disease problem like obesity, where there is a significant range of patients and associated risks,” Hamburg said. “We are exploring this new pathway because we think it could enable potentially lifesaving medicines to be made available to patients in a more timely way.”

The full text of Commissioner Hamburg’s speech is online at http://www.fda.gov/NewsEvents/Speeches/ucm343949.htm.

Crowley delivered his address on Thursday where he shared his experiences as a biotech executive, father, and patient advocate.

"We didn’t pick to be here because ‘boy you can make a lot of money in this industry '. I’ve never seen a biotech plan where the vision was - last slide- we’re all gonna get rich. That’s not what we do. Most of us don’t because it’s just so hard in this business to make money. In some respects it may just be the hardest business there is. It’s a tall order to succeed, but to …[those]… in this world who have succeeded so very well, it is a remarkable example of why this is such a unique industry and the impact it can have on people’s lives.”

Josef von Rickenbach, Founder, CEO and Chairman, PAREXEL International received the Henri A. Termeer Innovative Leadership Award for his commitment and contributions to the biotechnology industry at the Awards Luncheon on Friday.

For inspiring students to explore life sciences careers through progressive biotechnology education and exemplary science career programming, Gloucester was chosen as the Joshua Boger Innovative School of the Year.

To recognize its commitment to growing the life sciences supercluster in Massachusetts, Massachusetts Biomedical Initiatives (MBI) of Worcester was honored with MassBio's Leading Impact Award.

18 companies and organizations sponsored the Annual Meeting including AT&T, Fisher Scientific, Pfizer and Sanofi.


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