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Tuesday, June 21 • 2:00pm - 3:00pm
#254: Overcoming Challenges in Pediatric Product Development

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-576-L04-P ; CME 1.00; RN 1.00

This session will discuss complexities in pediatric drug development including identification of appropriate endpoints and biomarker, challenges in extrapolation from adults and across age ranges, and best practices to overcome key development challenges.

Learning Objectives

Identify key challenges that may delay development of products for pediatric diseases; Discuss via case studies of historical development programs; Identify approaches to overcome challenges including the role of developers, regulators and patient groups.

Chair

Adora Ndu, JD, PharmD

Speaker

Industry Update
Andrew Mulberg, MD

FDA Update
Lynne Yao, MD



Speakers
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →
avatar for Andrew Mulberg

Andrew Mulberg

Senior Vice President, Neurogene, United States
Andrew is currently Senior Vice President, Regulatory Affairs at Neurogene Inc, a company devoted to gene therapy approaches to management of neurodegenerative disorders in children and adults. Formerly, he served Senior Vice President, Global Regulatory Affairs at Amicus Therapeutics... Read More →


Tuesday June 21, 2022 2:00pm - 3:00pm CDT
Room 187 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Session