Advancing the landscape of drug repurposing: Diverse perspectives and solutions from the field

4:15 PM - 5:15 PM (PDT), Wednesday, June 15, 2022 ・ Upper Level, Session Room 4

Developing new therapeutics takes significant time and resources. Even when Federal agencies and academic institutions step up to conduct clinical studies to demonstrate efficacy and value of a drug for a new indication to individuals with rare/infectious conditions, these institutions would have a difficult if not impossible road to sponsor an application for review by the FDA. For off-patent drugs it can be even more challenging and even less appealing to seek FDA approval for new indications.

Regulators do not carry this burden alone.

It is well known that evidence is discovered via biomedical research and pharmaceutical companies, throughout the drug development process that could justify use of therapeutics for additional indications/diseases. It is also well known that physicians, using their professional judgment, prescribe drugs for different populations beyond the doses and diseases listed on the approved label. Finally, it is also known that fewer clinical studies are supported for rare and infectious conditions and often lacked participant diversity furthering disparities in healthcare.

Analytical frameworks and models have potential to deliver immediate value through data-driven identification of candidate therapeutics for additional clinical studies, informed selection and recruitment of clinical study participants, simulation of clinical trials using real-world data from clinical practice, and evidence generation for regulatory decision making, collectively closing gaps in populations with unmet therapeutic needs.

During this interactive session, attendees will hear diverse perspectives and solutions on:
• Barriers preventing industry, research, and regulatory progress
• Discuss potential solutions for leading challenges and the anticipated roadblocks
• Identify opportunities from cross-stakeholder collaboration to advance the field

Sponsored By
Moderator
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Senior Director, US Life Sciences
SAS Institute, Inc.
Speakers
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Principal Consultant
SAS Institute Inc.
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Health Science Policy Analyst
FDA
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ORISE Fellow, CDER, OMP
The Food & Drug Aministration
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Associate Professor
University of North Carolina at Chapel Hill