Mark McClellan MD, PhD, Director of the Engelberg Center for Health Care Reform opened the Brookings Institution event “New Policy Directions for Biomedical Innovation” November 19th in Washington D.C. by saying that biomedical innovation has made medicine more precise and produced safer treatments that have added to the length of life.
However, as he pointed out that there are challenges restricting innovation that includes a strained fiscal environment that puts limits on research. More financial resources will enable more good ideas to develop and make it possible for biomedical science and innovation to be beneficial and affordable for the entire population.
Keynoter Ed Penhoet Director Alta Partners recently appointed to President Obama’s Council of Advisors on Science and Technology (PCAST) discussed PCAST and the Committee’s report to the President on “Propelling Innovation in Drug Discovery, Development, and Evaluation”. The report is available at www.whitehouse.gov/administration/eop/ostp/pcast/docsreports. PCAST has not yet been able to brief the President on the Report but is planning to do in the near future.
According to the report, clinical trials constitute the largest single component of the R&D budget of the biopharmaceutical industry at approximately $31.1 billion representing nearly 40 percent of the R&D budget of major companies. The PCAST report stresses the need for industry, the Federal Government, academic researchers, and the medical community to work collectively to create efficient clinical trial networks and trial designs.
The report recommends that FDA improve tools for monitoring and communicating clinical benefits and risks. FDA should strengthen capabilities for post-marketing surveillance, and Congress should authorize line-item appropriations of $40 million per year to expand FDA’s Sentinel System. FDA should work with stakeholders to develop new tools to effectively communicate risks and benefits to patients and the broader public.
Next, a panel on “Finding the Path Forward for Biomedical Innovation” that included senior thought leaders participated in a discussion on actionable steps needed to improve biomedical innovation.
Panelists want to see more funds for research, more of a focus on translational and collaborative research, improvement in the speed of clinical trials, development of safer drugs, increase the role of the patient in drug development and have the patient play a more active role, better coordination across FDA, develop advance analytics and IT, and make better use of national language processing and machine mining.
· Christopher Austin, Director, National Center for Advancing Translational Sciences
· Debi W. Brooks MBA, MS, Co-Founder and Executive Vice Chairman, for the Michael J. Fox Foundation
· Robert Conley MD, Regulatory Leader and distinguished Lilly Scholar, Eli Lilly and Company
· John Mendelsohn MD, Director of the Khalifa Institute for Personalized Cancer Therapy at the University of Texas MD Anderson Cancer Center in Houston
· Earl P Steinberg MD, MPP, Executive Vice President of Innovation and Dissemination and Chief of Healthcare Solutions Enterprise at Geisinger Health System
Go to www.brookings.edu/events/2012/11/19-biomedical-innovation to view a video of the event.