Keynote: Takeaways from Translational Science Sharpshooters: Simple Strategies for Accuracy, Efficiency, and Impact

Monday, October 21, 2024

1:30 PM – 2:30 PM MT

Location:251 ABC

Keynote Speaker(s)

Sam Raney, PhD (he/him/his)

Associate Director for Science & Chief Scientific Advisor
US Food and Drug Administration
Silver Spring, Maryland

Handouts

Moderator(s)

Sebastian Polak, Professor

Senior Scientific Advisor
Certara UK / Simcyp
Sheffield, England, United Kingdom

This presentation will discuss FDA's GDUFA Science & Research Program and will illustrate how a few simple strategies helped ensure that scientific advances using orthogonal approaches accurately converged on translational science targets for generic drugs, including complex generics. In addition, this presentation will discuss how the research program strategically focused on practical hurdles and knowledge gaps limiting generic product development or assessment, and on building scientific bridges that established efficient new pathways for developing generics. This translational science research program successfully supported scientific publications, posters, presentations, workshops, meetings with FDA, product-specific guidances (PSGs), guidances for industry (GFIs), approvals of complex generic products, economic savings, and enhanced patient access to critical medicines.

Learning Objectives:

Upon completion, participants will be able to discuss FDA's GDUFA Science & Research Program and explain how a few simple strategies helped ensure that scientific advances using orthogonal approaches accurately converged on translational science targets for generics drugs, including complex generics.
Upon completion, participants will be able to describe how the research program strategically focused on practical hurdles and knowledge gaps limiting generic product development or assessment, and on building scientific bridges that established efficient new pathways for developing generics.
Upon completion, participants will be able to identify how the GDUFA Science & Research program translational science research program successfully supported scientific publications, posters, presentations, workshops, meetings with FDA, product-specific guidances (PSGs), guidances for industry (GFIs), approvals of complex generic products, economic savings, and enhanced patient access to critical medicines.