• June 16-19, 2025
  • Boston Convention & Exhibition Center

Sessions

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Altering the Regulatory Ecosystem for Pediatric Clinical Programs: Intended and Unintended Consequences

Monday, June 03, 2024
Breakout Session
Regulatory Innovation
31C
In 2023, the US Food and Drug Administration (FDA) released draft guidance concerning marketing exclusivity extensions for studies conducted in response to written request (WR) studies under the Best Pharmaceuticals for Children Act (BPCA). For Sponsors that develop novel pediatric drugs, BPCA provides a six-month extension of exclusivity before generic versions of the drugs can be brought to market if they fulfill the terms of a WR from FDA. The recent guidance states that FDA no longer plans to issue WRs “solely for studies or planned studies that are required under PREA” (Pediatric Research Equity Act) which will affect Sponsors who develop molecules in adults. Session attendees will learn the importance of BPCS and PREA working together and the consequences of these draft guidance which may reduce the overall number of pediatric studies being conducted and the number of WRs being sought for pediatric indications.
Moderator
Catherine Lee, DrPH
Associate Director, Global Regulatory Policy and Intelligence
Johnson & Johnson
Speakers
Laurie Conklin, MD
Senior Director, Pediatric Development
Johnson & Johnson
Dionna Green, MD, FCP
Director, Office of Pediatric Therapeutics
FDA
Thomas Miller, PhD, MBA
Global Head, Acute, Chronic & Pediatric Disease Nucleus
Bayer
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