New Thinking, New Competencies, New Results
Driving New Paradigms in Cancer Research
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 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.
