Session 4: Building a 21st Century Regulatory Environment
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Tuesday, December 14, 2010
4:30 pm - 5:25 pm
Expert panelists representing government, industry, and nonprofit research foundations agree that expediting review and approval of new medical solutions will require improved collaboration and communication – both within and across the FDA, as well as with external partners. Stakeholders should take advantage of the current political climate to show that innovation in medical science is not only good for public health, but also for the economy.
"We shouldn't be satisfied with the status quo," said Dr. Randall Carpenter, Co-Founder, President and CEO of Seaside Therapeutics. The key, he argued, is in finding new ways to overcome roadblocks to openness and transparency – both pre-competitively across industry, and also at FDA. "If our goal is improving public health, we need to think of ways to take the shackles off of FDA; FDA is sitting on treasure trove of information."
Cynthia Rice, Vice President of Government Relations at the Juvenile Diabetes Research Foundation talked about their experience with the artificial pancreas as an example of how collaborating with the FDA early on in the development process can lead to promising results for patients. "As soon as JDRF realized the potential of the insulin pump and what it could do for patients, we marched ourselves into FDA and started a dialogue about how to work together on a pathway to commercialization," she said. "We now have highly promising results from proof-of-concept, and are working together towards a well-defined guidance."
According Dr. Luciana Borio, Senior Advisor for Medicine and Public Health in the Office of the Chief Scientist at FDA, industry representatives often tell her that the strongest asset for them is a strong, well-resourced FDA. She pointed out that the new medical countermeasures initiative is an example of how FDA is working to enhance and improve regulatory review and respond to the needs of the patient community, and she offered to return next year to report on their progress.
John Castellani, President & CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA) raised the point that no matter how streamlined and collaborative the regulatory process becomes, unless we also focus on changing the way that payors value medical innovation, progress for patients will continue to be slow. "If the payer that defines the rule doesn't reward it, it won't happen" he said. "We have to make sure the reimbursement model matches the scientific model."
Moderator Steve Usdin, Senior Editor of BioCentury closed the session by highlighting common themes such as a desire to expand the pre-competitive space, and a clear appetite for new incentives like the orphan drug act that encourage innovation and collaboration in the industry. Following the panelists' discussion, the highly engaged audience stayed to ask questions and discuss possible opportunities and next steps moving forward.
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Moderator:Steve Usdin
Senior Editor (Washington)
BioCentury |
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Luciana Borio, M.D.
Senior Advisor for Medicine and Public Health, Office of the Chief Scientist, Office of the Commissioner
U.S. Food and Drug Administration |
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Randall L. Carpenter, M.D.
Co-Founder, President and CEO
Seaside Therapeutics
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John Castellani
President & CEO
Pharmaceutical Research and Manufacturers of America (PhRMA) |
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Cynthia Rice, M.P.P.
Vice President of Government Relations
Juvenile Diabetes Research Foundation |
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