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#454: Accelerating Pediatric Innovation: Leveraging Extrapolation and Global Policy to Transform Drug Development for Children
Monday June 15, 2026 4:00pm - 5:00pm EDT
201AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-550-L04-P; CME 1.00; RN 1.00

This session will explore innovative regulatory approaches, including the ICH E11A guideline, to accelerate access to effective treatments for children with chronic conditions such as pediatric multiple sclerosis.

Learning Objectives

Identify innovative regulatory strategies for pediatric drug development, including the ICH E11A guideline; Evaluate the impact of extrapolation and trial design on accelerating access to treatments for children with chronic conditions; Recognize ways to engage in collaborative discussion to propose actionable solutions for reducing approval lag times for children.

Chair

Christina Bucci-Rechtweg, MD

Speaker

Panelist
Laura Jawidzik, MD

Panelist
Lauren Krupp, MD

Panelist
Lynne Yao, MD


Speakers
avatar for Christina Bucci-Rechtweg

Christina Bucci-Rechtweg

Global Head, Maternal Health and Pediatric Regulatory Policy, Novartis , United States
Christina is Global Head of Pediatric & Maternal Health Policy at Novartis. She graduated from the U Rochester Sch of Medicine & Dentistry and trained in Peds/Pediatric Critical Care Medicine at SUNY Buffalo. She has 20+ yrs of experience in Clinical Development and Regulatory Policy... Read More →
LJ

Laura Jawidzik

Division Director, Division of Neurology 2 (DN2), OND, CDER, FDA, United States
Dr. Jawidzik is a board-certified neurologist and the director of the Division of Neurology 2 (DN2) at FDA. She joined the Agency in 2015 in DN2 as a clinical reviewer on the migraine/TBI/stroke team. In 2020, she moved from DN2 to DN1 and has served in various positions in DN1 including... Read More →
LK

Lauren Krupp

Director, Multiple Sclerosis Comprehensive Care Center, NYU Langone Health, United States
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 →
Monday June 15, 2026 4:00pm - 5:00pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   02: ClinicalTrialOps-Innovation, Forum

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