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Session Chair(s)
Jennifer Shen, PhD
Director, Regulatory Affairs
ORIC Pharmaceuticals, United States
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