Stakeholder Summit: February 20, 2020

Federal Regulation of Pharmacogenomic Testing

Dates & Details

On February 20, 2020, the UF Precision Medicine Program and Precision Medicine Advisors will bring together stakeholders to discuss recent regulation by the FDA and formulate solutions for improving the safety and efficacy of pharmacogenomic tests.

Summit Objectives

  • Discuss how the current regulatory landscape is affecting the industry, physicians and patients.
  • Review evidentiary standards for pharmacogenomics in an effort to ensure continued access to safe and efficacious pharmacogenomic testing.
  • Provide a set of priorities to recommend to the FDA.


February 20, 2020
8:00 am – 12:00 pm
Lunch to follow; reception in evening


University of Florida Lake Nona Campus
Orlando, Florida



Guidewell CORE theater

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Stay for the Precision Medicine Conference

This highly-interactive summit will be held in conjunction with the University of Florida Precision Medicine Conference (PMC) as a pre-conference event. Attendees are encouraged to participate in the PMC as well in order to learn, network, and gain a broader understanding of the implications and applications of pharmacogenomic testing.

Proposed Agenda

The Summit will be an opportunity for pharmacogenomic stakeholders to make progress on addressing the following regulatory topics.  This interactive summit will include small breakout working groups, followed by sharing and synthesis of information.

8:00 – 8:20 amOpening Remarks - Setting the Stage
8:20 – 9:10 amSession I
  • Table group introductions

  • What are the most pressing issues facing pharmacogenomics in current regulatory climate from different stakeholder perspectives?
9:10 – 9:40 amSession I continued
  • Align on definitions of analytical validity and clinical validity for pharmacogenomics.
9:40 – 10:20 amGroup Reports: Share and Synthesize
10:20– 10:40 amBreak
10:40 – 11:15 amSession II
  • What are the evidentiary standards/framework that should be used to establish the clinical validity of pharmacognomics tests?

  • What is the role of CPIC guidelines? Where do they fall short?
11:15 am – 12:00 pmGroup Reports: Share and Synthesize
12:00 – 1:00 pmWorking Lunch
  • Next steps on summarizing and bringing recommendations back to the FDA

Additional Resources

February 20, 2020

Clinical Pharmacogenomics Preconference

Starting directly after the summit will be the Clinical Pharmacogenomics Preconference which will provide the latest update on emerging topics in pharmacogenomics.

guidewell stage

February 21-22, 2020

UF Precision Medicine Conference

Starting the following day will be the start UF Precision Medicine Conference where attendees learn about the latest strategies and technologies for bringing genomic medicine and pharmacogenomics into the clinic.

2019 PMC


Precision Medicine Advisors

Continue your education about pharmacogenomics and precision medicine through our online courses, workshops, resources and blog posts.

Jeanette McCarthy of Precision Medicine Advisors gives a presentation
2019 PMC

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