SW-3G - Precision Medicine and Pharmacoepidemiology Synergistic Approaches to Real-World Evidence

Background: Pharmacogenomics has contributed to drug development and clinical decision making for a number of important conditions, such as cancers, HIV, mental health, and seizures. While trials of prospective genomic testing in large populations have yielded mixed results, the promise of personalized medicine remains. The expertise of pharmacoepidemiologists in study design, data interpretation, and integrating information from diverse sources could significantly advance the Precision Medicine Revolution. By leveraging their skills, we can better translate genomic insights into improved patient outcomes and more effective therapies. What is missing is concrete strategies to bring combine these two areas of expertise for the betterment of both. There are now data and opportunities to do so.

Objectives: The objectives of this interactive workshop are to:
• Showcase the role of genomics to understand drug response and to highlight recent studies utilizing genomic data in RWD epidemiological
studies;
• Facilitate discussions on why genomics is has proven effective in drug development, but not nearly as effective in clinical medicine;
• Introduce national and international efforts for data and consortium activities relevant to this workshop;
• To begin exploring how pharmacoepidemiologists and other ISPE members might design and initiate collaborative studies

Moderator: Stanley Edlavitch, PhD, MA, FISPE Professor KU SOM, UMKC SOM

Introduction, Agenda, History and Scientific Challenge

Speakers:

1:10 Bruce Carleton, PharmD, FCP, FISPE – Professor, University of British Columbia

Pediatric pharmacoepi and precision medicine

1:25 Anke-Hilse Maitland Van der Zee, PharmD, PhD - Head of Department of Clinical Genetics, Prof of Personalized Medicine at the UMCG in Groningen

innovation collaborations for pharmacoepi precision medicine: asthma

1:40 Gillian Bartlett-Esquilant, PhD, Associate Dean for Graduate Studies, College of Medicine | Texas A&M University

Precision medicine in patients not included in clinical trials

1:55 Tara Dutka, Ph.D. - Program Director for the Genome Centers, All of Us (AoU) Research Program, National Institutes of Health (NIH)

NIH All of US

2:10 Panel Discussion and Audience Participation

Upon completion, participants will be able to:
1. Explain the role of genomics in understanding drug response, citing recent examples of studies utilizing genomic data within real-world
epidemiological research.
2. Analyze the gap between the demonstrated effectiveness of genomics in drug development and its comparatively limited impact on clinical
medicine, contributing to potential solutions.
3. Identify and describe key national and international data and consortium initiatives relevant to advancing pharmacogenomics, and propose
potential collaborative research projects that pharmacoepidemiologists and ISPE members could undertake.