Scientific discoveries must be translated into practical applications to improve patients' health

Experts gathered on Capitol Hill today to address the impact of policies related to translational research and U.S. medical innovation. The briefing, titled Translational Research: From Bench to Bedside, was sponsored by the Council for American Medical Innovation as the second in a three-part series, Recovery Through Discovery, which examines medical innovation as a driver of U.S. economic recovery and enhanced global leadership in science.

Scientific discoveries must be translated into practical applications in order to improve the health of patients. Medical discoveries typically begin with basic research at the "bench," where scientists study disease at a molecular or cellular level. Translational research is required for these discoveries to advance to the clinical level, or the patient's "bedside."

"Translational research is beginning to gain much-needed attention, and it could not come at a more critical time," said Debra Lappin, president of the Council for American Medical Innovation. "America is at risk of losing its competitive edge as a leader in medical innovation. We will only continue to lead the world if we develop an infrastructure that supports the essential research that transforms basic scientific discoveries into practical treatments."

Clinical trials are part of translational research, helping advance medical breakthroughs into working medicines and cures. Yet there is a growing shortfall of U.S. patients participating in clinical trials. Industry research reports only 6% of eligible patients in the U.S. actually participate in clinical trials. As a result, 87% of trials in the U.S. are behind in their recruitment and enrollment.

Simultaneously, the rate at which U.S. innovators have been able to bring new drugs from the research pipeline into the market has slowed considerably. According to a GAO Report, the number of new drug applications submitted to the FDA each year increased by 74% between 1993 and 1999 (from 74 applications to 129 applications), but then generally declined after 1999. In 2004, applications to the FDA had decreased by 21% from the 1999 level.

The Council for American Medical Innovation came together this year, its members sharing a common goal of adopting and promoting a national policy agenda aimed at preserving U.S. leadership in medical innovation. As part of its national agenda, the Council is advocating for policy improvements that will increase incentives for investment in research, development and its application, and increase investment in the life sciences - including:

• Developing a robust infrastructure that makes translational research a top priority.
• Supporting regulatory reforms that can improve the process of developing and approving safe and effective drugs, biologics, medical devices and diagnostics.
• Increasing federal budgets, especially at the National Institutes of Health and the National Science Foundation, to significantly increase basic and translational research programs in the life sciences.

"The Council for American Medical Innovation believes that supporting medical innovation - including translational research - will not only make us healthier, but will also help lift the U.S. economy," said Former Democratic Leader Richard Gephardt, chairman of the Council for American Medical Innovation. "We need to make sure that the incredible discoveries made by our scientists are translated into useful medical applications. This can not happen fast enough, and the policies we implement today will greatly affect the output of new medicines and cures in the future."

Debra Lappin moderated today's briefing, where participants discussed the challenges involved in moving basic research out of the lab and through the development pipeline. Panelists also explored policy changes that should be considered to accelerate the translation of research into safe and effective drugs, biologics, medical devices and diagnostics. Participants in the forum included:

• Amy Comstock Rick, CEO of the Parkinson's Action Network
• Debra Lappin, President of the Council for American Medical Innovation
• Alan Leshner, Ph.D., CEO of the American Association for the Advancement of Science
• Lesa Mitchell, Vice President of the Ewing Marion Kauffman Foundation

Video of the event will be made available at: www.americanmedicalinnovation.org. The Council will host its third briefing on Capitol Hill, Incentives for American Medical Innovation - Protecting America's Greatest Innovators on October 5th.