Wed, 27 Sep 2017 9:00 am - 3:30 pm


Regulatory Science to Advance Precision Medicine Forum
A Meeting by University of Rochester, PhRMA Foundation, and University of Virginia

Wednesday, September 27, 2017
9:00am – 3:30pm

PhRMA Foundation
950 F Street NW
Washington, DC 20004

Background: Regulatory Science to Advance Precision Medicine

Regulatory Science is defined by the FDA as “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality and performance of FDA regulated products”, ultimately enhancing the overall translational research process and improving the development of safe and effective medical interventions. The increased focus on precision medicine holds tremendous promise to more effectively target treatments to those individuals most likely to have a benefit, however there are a number of regulatory science challenges to ultimately develop and utilize personalized medicine technologies.

A working group under the Clinical and Translational Science Award Network was proposed by the University of Rochester to help identify and address some of the key topics and opportunities for regulatory science to advance precision medicine. The working group identified potential areas where regulatory science could help accelerate precision medicine. These topics and background information will be provided to participants in advance of the Regulatory Science to Advance Precision Medicine Forum, where ~ 30-40 participants will further evaluate these key topics and identify regulatory science gaps, specific regulatory considerations (and inform potential approaches and decision tools), and suggestions for the development of educational resources.

Objective and Specific Aims for the Forum
The working group has identified two areas for consideration at the 2017 Forum:

1. 3D printing of medical products, combined with stem cell products
2. Technologies and approaches that integrate and analyze genomic, proteomic, metabolic, and epigenetic data for precision medicine

Forum Topic Templates have been developed for each of these topics and will be included as part of the background materials for the Forum, along with additional materials. The Forum will include two breakout sessions with subject matter experts in these areas to have focused discussions; and specific questions to consider will be provided in advance. The overarching questions for the Forum include:

1. Within this field, what are the emerging methods or approaches that might present Regulatory Science challenges/opportunities to advance Precision Medicine?
2. What are the key regulatory considerations that may not already be addressed under current frameworks (and what are the current relevant regulatory paths)?
3. What are the potential roadblocks to advancement?

At the conclusion of the Forum and through work that will follow from the working group and feedback from the Forum participants, we plan to:

1. Identify and describe any Regulatory Science gaps/needs for these two areas to advance Precision Medicine.
2. Develop a white paper to help inform considerations for regulatory approaches and reviewer tools.
3. Identity and develop educational materials (e.g., case studies, use cases) for academia, government and industry as a valuable training resource that can be utilized in several ways, from integration into existing courses to serving as stand-alone modules.

The Forum is free, but registration is required due to the limited space. If you are interested in participating or have any questions, please contact Scott Steele (This email address is being protected from spambots. You need JavaScript enabled to view it.) or Joan Adamo (This email address is being protected from spambots. You need JavaScript enabled to view it.)

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