November 14, 2017
Disruption In Biopharma
The Ritz-Carlton, Washington D.C.
1150 22nd Street, NW
On Tuesday, November 14, 2017, Friends of Cancer Research (Friends) and Prevision Policy hosted the third annual BioPharma Congress. This year’s event focused on disruption in biopharma and featured speakers such as former FDA Commissioner Dr. Mark McClellan and former Senate Majority Leader Tom Daschle. The event brought together regulators, industry, patient advocacy groups and congressional staff, as well as payment and reimbursement organizations.
This year’s BioPharma Congress was split into nine sessions covering numerous topics. Friends’ President & CEO, Jeff Allen, participated in a morning session that covered PDUFA VI, new drug approvals and biosimilars. The panelists discussed the use of real world evidence (RWE) and a more structured approach to collecting and using RWE. The newly created FDA Oncology Center of Excellence was also discussed as a potential model for enhanced integration of review in other disease areas; however, it was noted that the Center needs to be fully funded in order to operate optimally.
Panel on PDUFA VI, new drug approvals, and biosimilars
From L-R: Anna Abram, Peter Stein, Sandra Milligan, Steve Galson, Mathias Hukkelhoven, Jeff Allen
Allen moderated a different panel comprised of Director of the FDA Oncology Center of Excellence, Richard Pazdur, Director of FDA’s Center for Drug Evaluation and Research, Janet Woodcock, and Director of FDA’s Center for Biologics Evaluation and Research, Peter Marks. The directors had a forward-looking conversation on the FDA in 2020. They mentioned how drug development has changed over time and discussed the need for the agency to evolve in order to best respond to emerging science and technologies. As part of this, the need for streamlining documentation, such as shorter guidance documents, was mentioned. They also touched on the current clinical trials system and how it is unsustainable and how there needs to be a commitment to master protocols.
FDA Director’s discuss FDA in 2020
From L-R: Peter Marks, Janet Woodcock, Richard Pazdur, Jeff Allen
The final conversation of the day was between Former Senate Majority Leader Tom Daschle and Former FDA Commissioner Mark McClellan and was moderated by Friends’ Vice President of Public Affairs Ryan Hohman. The pair discussed unprecedented cost and coverage issues facing the U.S. healthcare market in 2017. Daschle was optimistic about the future of healthcare citing areas for bipartisan potential such as the 21st Century Cures Act and Children’s Health Insurance Program (CHIP).
Former FDA Commissioner Dr. Mark McClellan, Former Senate Majority Leader Tom Daschle,
and Ryan Hohman discuss where health reform in biopharma is headed
Other sessions covered: operationalizing patient input into approval decisions; the second year of the Trump presidency in regard to tax reform, a government shutdown, and handicapping 2020; state health reform priorities for 2018; the application of value data; and pharmaceuticals and the ACA. Throughout the day issues regarding drug pricing, how the current administration will impact healthcare, and the future of the FDA were discussed.