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A Platform for Platforms? The Intersection of the Platform Tech Designation and Prior Knowledge
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

The Platform Technology Designation program reflects longtime practice to leverage prior knowledge to speed development through advanced regulatory science, based on what's already known. But how will this practice and policy continue to evolve?

Learning Objectives

Describe how the FDA, other Health Authorities (HAs), and sponsors have historically leveraged prior knowledge to accelerate innovative product development and review; Examine the FDA’s perspective on applying prior knowledge to enhance the platform technology designation program and other regulatory science advancements or pathways; Discuss how the FDA plans to ensure the consistent application of these policies across review divisions and Centers.

Chair

Alexis Miller, JD

Speakers
avatar for Alexis Miller

Alexis Miller

Acting Global Lead, Global Regulatory Policy and Intelligence, Merck & Co., Inc., United States
Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping to shape the regulatory and policy environments on topics like evolution in regulatory science and policy frameworks, upholding expedited pathways, leveraging RWE and other tech opportunities, embedding... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

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