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Tuesday, June 18 • 1:15pm - 2:15pm
#249: Topics Related to the Oncology Real-Time Oncology Review Process

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-587-L04-P; CME 1.00; RN 1.00

This session focuses on the oncology real-time oncology review (RTOR) process and the considerations compared to a standard oncology submission, medical writing processes, and potential time savings.

Learning Objectives

Describe Real Time Oncology Review (RTOR) and how RTOR can impact global submission planning; Discuss lessons learned and where plans may not match reality; Define how RTOR best-practices can apply to other submissions and accelerated approval pathways.

Chair

Britta Jacobsen, PhD

Speaker

Introduction
Britta Jacobsen, PhD

Industry Update
Michael Gyulay

Industry Update
Linda Bowen, MSc, RAC

FDA Update
Jennifer J. Lee, PharmD, RAC


Speakers
avatar for Linda Bowen

Linda Bowen

Chief of Staff, Oncology Regulatory Strategy, Pfizer Inc, United States
Linda has spent the last 30 years in regulatory strategy, policy, and intelligence roles at Seagen, Sanofi, Bayer, and GSK. She most recently was Chief of Staff, Pfizer Oncology Regulatory Strategy, a role she also had at Seagen. She has also been an Assistant Adjunct Professor in... Read More →
avatar for Michael Gyulay

Michael Gyulay

Director, Medical Writing, Oncology and I-Oncology, EMD Serono, United States
Michael has nearly 20 years of industry experience in Medical Writing and currently is a manager of oncology medical writing leads, leading staff to deliver high quality operational and regulatory documentation and driving best writing and review practices. Prior to his time at EMD... Read More →
avatar for Britta Jacobsen

Britta Jacobsen

Medical Writer and Consultant, Whitsell Innovations, Inc. , United States
Britta is a scientist and medical writer with 26 years of experience in medical research and oncology. Her postdoctoral training piqued her interest in in steroid hormone receptors and preclinical breast cancer research. The opportunity to work on efficacy testing of novel drug combinations... Read More →
avatar for Jennifer Lee

Jennifer Lee

Sr. Health Scientist, Oncology Center of Excellence, FDA, United States
Jennifer J. Lee, PharmD, RAC is a Sr. Health Scientist in the Oncology Center of Excellence (OCE) at the US Food & Drug Administration (FDA). In this role, she provides regulatory and strategic support for several of the OCE’s initiatives, including the Pediatric Oncology program... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  04: MedAffairs-SciComm, Session