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Wednesday, June 19 • 8:00am - 9:00am
#309: FDA Oncology Center of Excellence: Are Sponsors Taking Full Advantage of OCE Regulatory Policy “Projects?”

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-630-L04-P; CME 1.00; RN 1.00

The FDA Oncology Center of Excellence "Projects" address gaps in oncology drug development and present opportunities as well as challenges for industry. Learn from FDA and industry experts the value of these initiatives and how and when to join in.

Learning Objectives

Recognize high-value FDA OCE priorities and projects that impact industry; Identify how and when to engage with these FDA initiatives to produce optimal results for industry, patients, and other stakeholders; Describe how to advance opportunities for harmonization of these high-value OCE Projects with global Health Authorities.

Chair

Sabrina Girty, JD

Speaker

FDA Overview and Perspective on OCE Projects
Tamy Kim, PharmD

From Policy to Practice: Maximizing Collaboration to Support Oncology Innovation
Mark Stewart, PhD

Industry Case Study: Project Optimus and Project Orbis
Vandana Pathak, MS, RAC


Speakers
avatar for Megan Doyle

Megan Doyle

Global Policy Lead, Digital Health, Diagnostics, Oncology, Amgen, United States
Megan Doyle is an attorney and policy professional with 15 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public health... Read More →
avatar for Sabrina Girty

Sabrina Girty

Executive Director, Global Regulatory Affairs, Oncology, Merck & Co., Inc., United States
Sabrina Girty is an Executive Director in Global Regulatory Affairs, Oncology at Merck & Co. Inc and leads a team of global regulatory strategy professionals across the esophageal, gastric, colorectal and head & neck cancer programs. At Merck, her team secured global marketing authorizations... Read More →
avatar for Tamy Kim

Tamy Kim

Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence, FDA, United States
Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including... Read More →
VP

Vandana Pathak

Global Regulatory Affairs, Amgen, United States
avatar for Mark Stewart

Mark Stewart

Vice President, Science Policy, Friends of Cancer Research, United States
Mark Stewart is vice president of science policy at Friends of Cancer Research (Friends), an advocacy organization based in Washington, DC that drives collaboration among partners of every healthcare sector and creates and implements policies ensuring patients receive the best treatments... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session