From Data to Recovery: Integrating EHR, Omics, and Pragmatic Clinical Trials for Faster Drug Development

Session Description

This session explores the potential of integrating electronic health records (EHR), omics, and pragmatic clinical trials to advance patient-centric drug discovery and precision medicine. The current landscape faces several challenges and/or gaps:

1. The availability of massive EHR and omics datasets that requires novel approaches for effective analysis and integration;
   
2. The translation of research findings into clinical practice can be slow due to the reliance on traditional, randomized clinical trials;
   
3. Needs for regulatory frameworks to better incorporate real-world evidence for drug development decisions. This session will address these gaps by showcasing how the combination of real-world EHR data and omics can uncover novel drug targets, repurpose existing medications, and accelerate the development of safer, effective, patient-centric therapies.

The session will discuss the potential of precision medicine and pragmatic clinical trials to expedite the adoption of pharmacogenomics findings in clinical practice.

Learning Objectives

1. Evaluate the potential of integrating electronic health record (EHR) data and omics to identify novel drug targets, repurpose existing medications, and accelerate patient-centric drug discovery.
2. Summarize how pragmatics clinical trials can be leveraged to facilitate research and enhance the implementation of precision medicine; And discuss experiences from the recently completed trials from the IGNITE Pragmatic Trials Network.
3. Discuss considerations for regulatory assessment of uncontrolled clinical data in in the evaluation of therapeutic benefits and risks; And define opportunities for regulatory use of EHR systems, EHR-linked biobanks and pragmatic clinical trials.

Session Schedule

Introduction
Nihal El Rouby, PharmD, PhD and Mai Mehanna, MSc, PhD

Real-World, Precision Medicine Pragmatic Trials
Julie A. Johnson, PharmD

The Power of Integrating Omics and Electronic Health Record (EHR) Data within the Pharmaceutical Industry
Alan Shuldiner, MD

Advancing Precision Medicine: Beyond Randomized, Controlled Trials
Michael Pacanowski, MPH, PharmD

Panel Discussion