The U.S. biomedical “innovation ecosystem”—encompassing the universe of stakeholders and activities directed toward understanding disease areas and developing novel treatments for them—is in a period of stress. As noted in the September release of a report by the President’s Council of Advisors on Science and Technology (PCAST), significant scientific advances over the last 25 years have moved us toward a better understanding of the biologic underpinnings of some of the most debilitating diseases that affect the U.S. population. While novel treatment options for many of these disease areas have been developed over this time period, recent history has demonstrated that advances in basic research have not consistently translated into substantial progress in the production of novel treatments and cures. The rate at which new biomedical products are entering the market has remained relatively constant over the last few decades, while the cost and time associated with the development of new products appears to have steadily increased. Seeing the advances in novel treatments that have been made during this time may lead many to believe that increased funding for early stage research and development can relieve the stress on the innovation ecosystem. In today’s economy, however, this notion may well prove unachievable as additional public funds are unlikely to be available and private investment is constricted. These trends point toward the need for novel strategies to improve productivity in biomedical innovation and efficiently move medical products from scientific discovery to clinical practice.
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