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Tuesday, June 25 • 8:00am - 9:15am
#214: Global Pediatric Policy Update: Are You Ready to Implement FDARA Section 504?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-582-L04-P; CME 1.25; IACET 1.25; RN 1.25

The new requirements in FDARA Section 504 represent a significant paradigm shift in pediatric oncology development. This session will review these requirements and their likely global impacts, as well as possible mitigation strategies.

Learning Objectives

Describe and explain the new provisions in FDARA Section 504 that will impact pediatric oncology development in the US within the context of the EU requirements; Analyze the implications and assess the impact of these new provisions on global pediatric oncology development; Describe the use of Master Protocols as a possible mitigation strategy.


Melodi J McNeil, MS, RPh


Industry Perspective: Industry Perspective: Master Protocols as an Option to Design and Conduct Pediatric Oncology Studies under FDARA, Sec 504
Pamela Simpkins, MBA

FDARA 504 Overview/Implementation Planning
Gregory Reaman, DrMed, MD

Lessons Learned from Two Public-Private Partnership Master Protocols
Stacey J. Adam, PhD

avatar for Stacey Adam

Stacey Adam

Director, Cancer Reserach Partnerships, Foundation for the National Institutes of Health (FNIH)
Dr. Stacey Adam is the Director of Cancer Research Partnerships at the Foundation for the National Institute of Health (FNIH). She oversees major partnerships, including the Partnership for Accelerating Cancer Therapies (PACT), the Lung Master Protocol (Lung-MAP) clinical trial, and... Read More →
avatar for Melodi McNeil

Melodi McNeil

Director, AbbVie, Inc.
Melodi J. McNeil, R.Ph., M.S. Ms. McNeil is currently a Director in AbbVie’s Rockville, Maryland Regulatory Policy and Intelligence office. She identifies, assesses, and comments on proposed regulatory policies, and ensures appropriate AbbVie personnel are aware of emerging and... Read More →
avatar for Gregory Reaman

Gregory Reaman

Associate Director for Pediatric Oncology , OCE, OC, FDA
Dr. Gregory Reaman is a pediatric oncologist with a long career in clinical investigation and translational research. Prior to joining the FDA in 2011, he was the inaugural Chair of the Children's Oncology Group and was previously the Associate Chair for Scientific Affairs and the... Read More →
avatar for Pamela Simpkins

Pamela Simpkins

Senior Director & Strategy Lead, Child Health Innovation Leadership Dept. (CHILD, Johnson & Johnson
Pamela L. Simpkins, MBA is a biopharmaceutical business leader with 20+ years of experience in leading strategic initiatives and departments across R&D, corporate strategy, regulatory, marketing, business development and finance. She leads internal and external innovation programs... Read More →

Tuesday June 25, 2019 8:00am - 9:15am
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Precision Medicine,Advanced Therapies,Rare Disease,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session