Weekly Wisdom from Kauffman: The role of academia in drug development
A half-century ago, the U.S. Food and Drug Administration was approving roughly the same number of drugs it approves today. But at the same time, the cost of funding a breakthrough medical treatment has increased by about 13 percent each year.
A Kauffman Foundation town hall meeting explored how the government, nonprofits and academic institutions could help enhance drug development and bring more effective drugs to market. Recommendations from the report, The New Role of Academia in Drug Development, include:
- Universities, in collaboration with industry, should establish models for intellectual property and technology transfer processes that will become widely adapted and trusted, removing many of today's hurdles to licensing and other opportunities to commercialize early innovation to translational outcomes.
- The federal government should empower the FDA with the scientific capabilities and resources to conduct robust review and approval processes that ensure a thorough evaluation of the risks and benefits of new therapies.
- The FDA should define necessary parameters that take into consideration the differences for development of therapies for rare and neglected diseases. The FDA should define new regulatory paths that accommodate the shifts in translational science, including emerging ideas associated with the incorporation of biomarkers, nanotechnology, personalized medicine, and informatics.
- The National Institutes of Health should invest in additional clinical and translational science awards across the country and fund CTSA centers that bring unique capabilities and translational research and academic commercialization contributions to the consortium.
- All stakeholders in collaboration should develop streamlined, standardized clinical trial processes.
Weekly Wisdom from Kauffman is a regular feature on eMed highlighting insightful research from the Kauffman Foundation. Do you have a favorite Kauffman research insight that could help life science entrepreneurs? Send it to mailto:firstname.lastname@example.org.