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#209: A Platform for Platforms? The Intersection of the Platform Tech Designation and Prior Knowledge
Tuesday June 17, 2025 8:30am - 9:30am EDT
145AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-559-L04-P; CME 1.00; RN 1.00

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

Speaker

Historic Application of Prior Knowledge
Rachel Turow, JD, MPH

Industry Perspective
Danielle Friend Economo, PhD


Speakers
avatar for Danielle Friend Economo

Danielle Friend Economo

Senior Director, US Head Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States
Dr. Danielle Friend received her Ph.D. in neuroscience in 2013 from the University of Utah. After completing her graduate work, Danielle conducted postdoctoral research at the National Institutes of Health. In 2016, Danielle was selected as a Science and Technology Policy Fellow with... Read More →
avatar for Alexis Miller

Alexis Miller

Head, 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 →
avatar for Rachel Turow

Rachel Turow

Of Counsel, FDA Regulatory Law, Skadden, United States
Rachel Turow is Associate General Counsel, Regulatory Law & Policy at Teva Pharmaceuticals and Head, U.S. Regulatory Policy. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses, and supports Teva’s drug-device combination... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

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