Created by on 12/18/2012

On December 11, 2012, the National Center for Advancing Translational Sciences (NCATS) held a workshop to help the center’s leadership understand how policy research and analysis can inform translational science. A discussion about what role NCATS could play in developing policies aimed at overcoming barriers related to translational science also took place during the session. The meeting focused on the policy challenges associated with four aspects of advancing the NCATS mission: informing regulatory science, navigating intellectual property challenges, streamlining clinical research, and forming efficient strategic alliances. Participants were asked to consider specific questions in these domains, such as how three dimensional human tissue chips developed for drug screening could be integrated into the nation’s pharmaceutical regulatory framework, how to encourage researchers to develop new uses for existing compounds that have may have limited patent exclusivity, and overcoming the human subjects protections barriers that hamper the efficiency of multi-site clinical trials. Attendees stated that it would be useful for NCATS to contribute to developing the guidance documents and standards that will be necessary for assessing the risk and benefits of new tools.
To help address intellectual property challenges, participants urged the Center to work with other stakeholders to define the boundaries of the so-called pre-competitive space, develop policies that would allocate rewards effectively among those involved in drug rescue and repurposing, and manage the cost burden associated with patenting secondary uses of previously developed therapeutics. Addressing these issues could facilitate NCATS’s goal to forge strategic alliances since many potential collaborations fail over intellectual property negotiations.
With regard to human subjects protections, participants noted that NCATS could require its Clinical and Translational Science Award (CTSA) institutions to develop metrics for improving Institutional Review Board (IRB) processes and include an improvement plan in their applications. The Center could also facilitate research into alternative IRB models used in academia and industry and encourage CTSAs to share information that would make it easier to recruit and enroll research participants. The meeting agenda and related information are available on the NIH website.