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Session 4: Challenges in the Design and Development of Companion Diagnostics- Part Two - A ROUNDTABLE DISCUSSION
Session Chair(s)
Rosanne Welcher, PHD, MBA, RAC
Senior Director, Quality Assurance, Regulatory and Clinical Affairs
Dako North America, an Agilent Technologies Company, United States
Miu Chau, PHD
Senior Regulatory Program Director
Genentech, A Member of the Roche Group, United States
Jeffrey N. Stuart, PHD
Associate Vice President, Global Regulatory Affairs
Merck Sharp & Dohme LLC , United States
This session will be an interactive session with the audience. Various challenges in clinical trial design and regulatory strategies will be presented to the audience. During group discussions facilitated by moderators, participants will provide their perspective, experience and possible solutions to overcome the challenges. Roundtable discussions include:
Impact of Local Testing on Clinical Trials for Drug/Companion Diagnostics (Pre-Screening)
Moderator: Douglas M. Robinson, PhD
Global Head Biomarkers and Diagnostics Biometrics
Novartis Institute for Biomedical Research Inc.
Specific Challenges in Bridging Studies
Moderator: Yuying Jin
Mathematical Statistician, CDRH
FDA
How to Minimize the Impact to Patient Care from Multiple Companion Diagnostics Assays to the Same Biomarker
Reena Philip, PhD
Division Director, Division of Molecular Genetics and Pathology, CDRH
FDA
Challenges for LDT’s in Post-Market of Approved Companion Diagnostics Assays
Moderator: Joshua Levin, PhD, RAC
Postmarket Team Lead, Division of Molecular Genetics and Pathology, CDRH
FDA