FDA commish Hamburg looks to spur med-tech innovation

FDA commissioner Dr. Margaret Hamburg

Dr. Margaret Hamburg, the head of the FDA, put out a blueprint for spurring innovation in the life sciences today, saying there aren’t enough new products in the med-tech pipeline to suit her.

"The number of new products in the development pipeline is not where we would want it to be and it’s not commensurate with the medical and public health need," Hamburg said during a conference call this afternoon.

The blueprint, "Driving Biomedical Innovation: Initiatives for Improving Products for Patients," includes calls for the federal watchdog agency to improve "consistency and clarity in the medical device review process," rebuild its outreach offering for small businesses and focus on developing personalized medicine, according to a press release.

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"We know that investment in biomedical research and product development are at all-time highs – last year an estimated $100 billion from the public and private sector – but the return on investment, in terms of new products for people and to the companies, has not been what was expected," Hamburg said during the call. "Timelines are long, costs are high, rates of failure are distressingly high, so this is a critical time to come together to address this important issue for people and for our nation."

The FDA is launching an Entrepreneurs in Residence program to bring outside experts into the fold, including the recently retired CEO of Medtronic (NYSE:MDT), Bill Hawkins. Hamburg said the initiative is aimed at improving the agency’s understanding of "the business context that is important for us to better understand as we undertake our regulatory review."

"We think that it’s very, very important that we have this kind of cross-fertilization, with industry and academia and government all working together to help ensure that we have the understanding and the systems in place and the tools that we need to be able to translate from scientific discoveries into real-world product," she said during the call.

The blueprint, released during Hamburg’s appearance at the Washington Ideas Forum, drills down to seven areas of focus:

  • “rebuilding FDA’s small business outreach services
  • building the infrastructure to drive and support personalized medicine
  • creating a rapid drug development pathway for important targeted therapies
  • harnessing the potential of data mining and information sharing while protecting patient privacy
  • improving consistency and clarity in the medical device review process
  • training the next generation of innovators
  • streamlining and reforming FDA regulations”

In addition to Hawkins, EIR’s "strategic team" includes:

  • Jeff Allen, Friends of Cancer Research
  • Francis Beland, XPrize Foundation
  • Riley Crane, MIT Media Lab
  • John Driscoll, MEDCO
  • Dr. Elazer Edelman, MIT/Harvard Medical
  • Dr. Thomas Fogarty, Fogarty Institute for Innovation
  • Mark Jeffrey, Kellogg School
  • Mark Johnson, Innosight
  • Dean Kamen, DEKA Research
  • Anjali Kataria, Conformia
  • Thane Kreiner, Santa Clara University
  • Jack Lasersohn, The Vertical Group
  • Dr. Roger Lewis, UCLA Medical Center
  • Ken Miller, Change and Innovation Agency
  • Dr. Jeffrey E. Shuren, FDA (team leader)

The "tactical team" includes:

  • Dorothy Abel, CDRH
  • Patrick Axtell, CDRH
  • Frank Baitman, EIR Fellow
  • Dr. Michael Callahan, DARPA
  • Dr. David Chan, MIT
  • Siromi Gardina, CDRH
  • Telba Irony, CDRH
  • Megan Moynahan, CDRH (team leader)
  • Daya Ranamukhaarachchi, CDRH
  • Dr. Paul Sobotka, Ardian Inc.
  • Elizabeth Stafford, CDRH
  • Mr. Kwame Ulmer, CDRH
  • Maj. Gen. Tom Wilkerson, USMC (Ret.), EIR Fellow
  • David Windt, CDRH

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