Tuesday, July 10, 2012

State of Biomedical Innovation

Mark McClellan MD, PhD, Director of the Engelberg Center for Health Care Reform at Brookings, opened the June 27th “State of Biomedical Innovation Conference” by discussing how U.S current policies and practices affect the current state of biomedical innovation and the need to more efficiently move promising medical products forward.

Looking at biomedical innovation from the legislative side, U.S Senator Michael Bennet (D-CO) expressed his pleasure at seeing the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) in the Senate by 96 votes. The legislation will help develop innovative new therapies by increasing transparency and more scientific discussions.

However, as the Senator told the conference attendees that even with the passage of FDASIA, there is still much more work to be done. As he said “Innovative therapies aren’t at war with our concerns about good health but they have to be regulated in a way that makes them available for patients.”

Margaret Hamburg MD, Commissioner of the FDA understands the need for investment and strong regulations concerning biomedical discoveries. As one of four panelists to discuss “Strategies for Stimulating Biomedical Innovation through Policy”, she emphasized, “FDA is faced with challenges and a changing role in order to advance biomedical innovation in terms of safety and efficiency.”

Also on the panel, the Director of NIH Francis S. Collins, MD, PhD oversees the largest support for biomedical research in the world spanning from basic to clinical research. He explained how the new NIH National Center for Advancing Translational Science (NCATS) Center operates as a hub for catalyzing innovations in translational science. NCATS works closely with partners from government, academia, nonprofits, and biotechnology and pharmaceutical companies to identify and overcome hurdles that slow down the development of effective treatments and cures.

Dr. Collins described how NIH is designing a 3-D tissue chip to use for drug screening since the current process for developing new drugs to test and prevent disease takes too much time and costs too much money. With the 3-D tissue chip, researchers would be able to predict the performance of a candidate drug, vaccine, or biologic agent quickly and inexpensively. The human tissue models mimicking human physiology would be designed to detect signals of safety and effectiveness early in the translational pipeline.

To design and develop the tissue chip, NCATS is harnessing resources and brain power in a novel collaboration between NIH, Defense Advanced Research Project Agency (DARPA), and FDA. NIH’s role will be to research the underlying biology, pathology, and mechanisms for tissue chips.

At the same time, DARPA will conduct a separate but parallel program to develop the chip but DARPA’s program will focus on developing engineering platforms and establishing biological proof-of-concept for the project Both the NIH and DARPA programs will run simultaneously. FDA will operate as a non-funding partner and will provide guidance to both NIH and DARPA in terms of drug safety and efficacy.

For more information, go to www.brookings.edu/events. A video is available for the panel discussion.