Walking the walk: How one CTSA Program WG is taking action to advance the use of regulatory science in precision medicine

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“It’s important that we not only come together to discuss challenges and opportunities in precision medicine, but that we also take action on these specific regulatory science priorities that can produce improved outcomes for the public," - Scott Steele, Ph.D., UR CTSI. 

The CTSA Program’s Domain Task Forces (DTFs)* provide program members the opportunity to engage and connect across the national consortium. The DTFs advance the field of translational science through open discussions, project planning and metric assessment pertaining to five key areas:

  • Collaboration & Engagement
  • Informatics
  • Lifespan Integration
  • Methods & Processes
  • Workforce Development

Participation in these DTFs also allows program members to become involved in DTF-related Working Groups (WGs), which bring together individuals across multi-disciplinary sectors to collaborate.

And the WGs don’t just talk the talk – they also walk the walk.

In the fall of 2017, the Regulatory Science to Advance Prevision Medicine WG held a Forum for experts from academia, government, foundations and industry to examine the regulatory science challenges that come with advancements precision medicine. The WG was originally proposed by the University of Rochester Clinical and Translational Science Institute (UR CTSI) to help identify and address some of the key topics and opportunities that emerge from the relationship between regulatory science and precision medicine, ultimately helping enhance the overall translational research process and improve the development of safe and effective medical interventions.

The WG outlined two specific topics for the Forum:

  • 3D printing of medical products, combined with cell-based products (combination and Tissue Engineering/Regenerative Medicine products); and
  • Technologies and approaches that integrate and analyze genomic, proteomic, metabolomic, and/or epigenetic data for precision medicine.

Following the event, a sub-group of participants led by Joan Adamo, Ph.D., director of Regulatory Support Services at the UR CTSI, and Scott Steele, Ph.D., director of UR CTSI Regulatory Science Programs, published two papers sharing their findings and recommendations pertaining to the above areas in the Journal of Clinical and Translational Science.

“The WG and Forum provide a unique venue to address these critical issues with experts from the hubs, FDA, NIH, NIST, and the pharma and biotech industries,” noted Steele.  “It’s important that we not only come together to discuss challenges and opportunities in precision medicine, but that we also take action on these specific regulatory science priorities that can produce improved outcomes for the public. We’re excited for the broader research and regulatory communities to learn from the findings in these papers, and we hope to continue building off the momentum our WG and Forum has created.” 

Steele also emphasized the importance of the collaborative nature of this WG with diverse stakeholders, especially the partnership between the CTSA Program and the PhRMA Foundation. Eileen Cannon, president of the PhRMA Foundation, gave the opening remarks at the Forum and has been an active partner in the collaboration.

“Precision medicine holds tremendous promise for more effectively targeting patient treatments and achieving desired outcomes,” said Cannon. “But there are a number of regulatory science issues and challenges that arise with these emerging technologies, and these challenges can’t be addressed by government, academia or industry alone. By collaborating with this WG and hosting the Forum, we’re able to leverage different perspectives, take action, and better support the research and training of scientists to achieve translational medicine.” 

The Regulatory Science to Advance Precision Medicine WG reprised the Fall Forum in 2018 with an event focused on digital health, and will continue to publish the findings from these events. If you’re interested in learning more about or becoming involved with the Regulatory Science to Advance Prevision Medicine WG, please reach out to Scott Steele.

You can read more on the papers mentioned in this post via the links below:

*NCATS is working on rolling out a restructuring of the CTSA Program DTFs and WGs, in which DTFs will be renamed Enterprise Committees. This restructuring will be rolled out in January 2020. You can read more about these upcoming changes via the slides on the CLIC website.


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