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Session 1: Evolving FDA Regulations of Genetic Tests
Session Chair(s)
Jennifer Shen, PhD
Director, Regulatory Affairs
ORIC Pharmaceuticals, United States
FDA has co-approved a number of companion diagnostics and targeted therapeutics in the last few years. It has also become apparent that multiple biomarker analyses are increasingly utilized to predict outcomes, select patients for treatment, or provide prognostic values in oncology patient care. This session will focus on regulatory strategies and development considerations when employing a companion diagnostic in a therapeutic development program. Examples will be discussed to illustrate how regulatory policies are developed to keep pace with the fast-evolving field of genomic testing. A case study about the recent co-approvals of BRACAnalysis CDx and olaparib will be presented, and a panel discussion will follow to share the different perspectives of a successful co-development program.
Speaker(s)
Office of In Vitro Diagnostics and Radiological Health - Developments
Aaron Schetter, PhD
FDA, United States
Scientific Reviewer; Division of Molecular Genetics and Pathology, CDRH
Case Study: BRACAnalysis CDx and Olaparib Co-approvals
Maria C. M, Orr, PhD
AstraZeneca, United Kingdom
Head of Precision Medicine, Biopharmaceuticals
Gwynn Ison, MD
FDA, United States
Medical Officer, Office of Oncology Drug Products, CDER
Jolette Franco
Myriad Genetic Laboratories, Inc., United States
Regulatory Affairs Manager
Panelist
Eunice Lee, PhD
FDA, United States
Senior Scientific Advisor
Reena Philip, PhD
FDA, United States
Associate Director, Biomarkers and Precision Oncology, OCE
Case Study Participants
Panel Discussion
All Session Speakers, United States
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