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Wednesday, June 30 • 2:00pm - 3:00pm
#341 SL: How Has FDARA Section 504 (RACE Act) Changed the Pediatric Oncology Landscape?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-621-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Scott Greenfeder, PhD

Speaker

FDA Update
Pamela Balcazar, MS

Industry Update
David Nguyen, PharmD, MBA

Measuring, Managing, and Moving Forward
Melodi J McNeil, MS, RPh

FDA Update
Gregory Reaman, DrMed, MD



Speakers
avatar for Scott Greenfeder

Scott Greenfeder

Vice President, Oncology Regulatory Affairs, Bayer US LLC, United States
Scott Greenfeder, PhD is currently VP Head, Regulatory Affairs Oncology Group II at Bayer Pharmaceuticals. Prior to joining Bayer Scott has held various positions within Regulatory Affairs at Daiichi Sankyo, Regeneron and Merck. Prior to his roles in Regulatory Affairs Scott worked... Read More →
avatar for Melodi McNeil

Melodi McNeil

Director, Regulatory Policy and Intelligence, 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, United States
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 →
PB

Pamela Balcazar

Health Scientist, Oncology Center of Excellence, OC, FDA, United States
Pamela Balcazar is a Health Scientist in the Oncology Center of Excellence at the FDA. In the OCE, her responsibilities include developing policies and overseeing regulatory initiatives related to the review of oncology products including guidances and process management.
avatar for David Nguyen

David Nguyen

Associate Director, Global Regulatory Lead - Oncology, Bristol-Myers Squibb Company, United States
David Nguyen, PharmD, MBA, is currently an Associate Director, Global Regulatory Strategy at Bristol-Myers Squibb. He is a Global Regulatory Lead for several programs and is the US regulatory lead for pediatric drug development in Oncology. Prior to joining BMS, David was a post-doctoral... Read More →


Wednesday June 30, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session