The New Role of Academia in Drug Development

Executive Summary

A recent town hall meeting offered an opportunity to explore how government, nonprofit organizations, and academic institutions can define new models of working with the private sector to enhance drug development efforts and bring safer, more effective drugs to the market more efficiently. While the challenge to innovative drug development can be great, our investments in biomedical research are providing promising opportunities to capitalize on emerging science. The following recommendations are based on a series of expert panel discussions and can ensure that the promise of scientific research translates into reality, benefiting the health of the nation.

Academic Institutions

• Universities, in collaboration with industry, should establish models for intellectual property (IP) 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.
• Universities should develop translational research training programs so current students, who will be future scientists, will be trained in next-generation techniques, applications, project management, collaboration models, and regulatory science.
• University science leaders must identify areas in which external expertise is needed from nonprofits, industry, and government, and establish a focus on entrepreneurship.
• Universities must support new models from the top (Chancellor level) down.
• Research institutions and commercial entities should establish policies to enable pre-competitive and timely sharing of critical data that will aid target development and future drug discoveries.

Congress

• Congress should fully fund the Cures Acceleration Network (CAN).
• The federal government should empower the Food and Drug Administration (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.

Food Drug & Administration (FDA)

• The FDA should define necessary parameters that take into consideration the differences for the development of therapies for rare and neglected diseases.4 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.

National Institutes of Health (NIH)

• The National Institutes of Health (NIH) should invest in additional clinical and translational science awards (CTSAs) across the country and fund CTSA centers that bring unique capabilities and translational research and academic commercialization contributions to the consortium.
• Federal agencies that fund translational research programs also should provide or require education about commercialization, including opportunities, challenges, and regulatory mandates.

Stakeholders

• All stakeholders (academia, industry, government, and disease philanthropy) in collaboration should develop streamlined, standardized clinical trial processes.
• Organizations with a vested interest in commercializing new therapies for patients should promote “team science” incentives for translational research.