Tuesday, May 10, 2011

Biomedical Innovation: Can the U.S. Keep Its Edge?

by Adam Clark, Ph.D., Director of Scientific and Federal Affairs, FasterCures
Over the past decade, international investments in life sciences research and development (R&D) in the in the private-sector have shifted away from the U.S. An expert panel at the 2011 Milken Institute Global Conference examined this shift and explored policies that influence biomedical innovation in the U.S.

Ross DeVol of the Milken Institute framed the issue by noting that it was not until the late 1990s that the U.S. began to dominate global pharmaceutical R&D. U.S. leadership can be attributed to a number of factors, he said, including a more predictable regulatory framework and adoption of intellectual property policies such as the Bayh-Dole Act, which encouraged entrepreneurship. However, DeVol said that “our regulatory approval process has gotten more cumbersome,” which has resulted in a risk-averse environment that inhibits medical innovation.

Edward Holmes of Singapore’s Agency for Science, Technology, and Research (A*STAR) said that Singapore has made the biomedical industry a top priority and developed policies that have resulted in a four-fold growth in the biomedical industry in the past decade. Such policies created an environment with sound intellectual property strategies, efficient regulatory programs, effective ethical frameworks for clinical trials, and an educational infrastructure that strongly supports science and math education to secure a strong scientific workforce. Singapore continues to focus on biomedical manufacturing and a strong effort to build up efforts in R&D.

Michael Leavitt, former Secretary of the U.S. Department of Health and Human Services, emphasized that the next decade of U.S. biomedical innovation will be built upon the “Era of the Value Proposition” in which “the future innovation will have to involve a value proposition that will demonstrate to a payor that the innovation will result in a change in the cost curve.”

Bijon Dorri of General Electric, explained GE’s interest in the healthcare sector and highlighted GE’s Healthymaginations program as an area in which GE is increasing its global competitiveness in healthcare. For projects supported through the Healthymaginations, it must address at least one of three pillars of healthcare: reduce cost, improve quality, or increase access. These guiding principles, he said, are “driving a change in the value proposition of healthcare innovation.”

The panel discussed the growing costs of clinical trials as one of the primary drivers to move R&D out of the U.S. to countries where such costs are significantly lower.

Collaboration was another key theme the panel deliberated on. Partnerships between the private and public sectors are key to moving therapies forward. There needs to be open communication channels between industry and the National Institutes of Health, the FDA, and the Centers for Medicare and Medicaid to ensure a seamless continuum of R&D innovation from discovery to development to dissemination and access.

Lesa Mitchell of the Kauffman Foundation moderated this panel. Watch a video of this session.

No comments: