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DIA 2021 Global Annual Meeting

How Has FDARA Section 504 (RACE Act) Changed the Pediatric Oncology Landscape?

Session Chair(s)

Scott Greenfeder, PhD

Scott Greenfeder, PhD

  • Vice President, Oncology Regulatory Affairs
  • Bayer US LLC, United States
The implementation of FDARA Section 504 (RACE Act) requires a paradigm shift in pediatric oncology. Sharing experience and exploring potential room for improvement is essential to allow timely access to cancer treatments for children.
Learning Objective : Discuss how the RACT Act has affected pediatric oncology programs since implementation; Explore where further guidance might be helpful in pediatric oncology drug development; Discuss what else might be needed for timelier access to pediatric cancer treatments.

Speaker(s)

Pamela Balcazar, MS

FDA Update

Pamela Balcazar, MS

  • Health Scientist, Oncology Center of Excellence, OC
  • FDA, United States
David Nguyen, PharmD, MBA

Industry Update

David Nguyen, PharmD, MBA

  • Associate Director, Global Regulatory Lead - Oncology
  • Bristol-Myers Squibb Company, United States
Melodi J McNeil, MS, RPh

Measuring, Managing, and Moving Forward

Melodi J McNeil, MS, RPh

  • Director, Regulatory Policy and Intelligence
  • AbbVie, Inc., United States
Gregory Reaman, DrMed, MD

FDA Update

Gregory Reaman, DrMed, MD

  • Associate Director for Pediatric Oncology , OCE, OC
  • FDA, United States