Transcript Added to Public Workshop

This meeting was held March 24, 2015, beginning at 8:30 a.m. at the following location:

Mayflower Hotel
Grand Ballroom
1127 Connecticut Avenue, NW
Washington, DC 20036
(202) 347-3000

TimeTopicSpeaker/Panelist8:30–8:45Welcome and Opening RemarksWorkshop Co-chairs:

• Elizabeth Mansfield, PhD
  Deputy Office Director for Personalized Medicine, Office of In Vitro Diagnostics and Radiological Health (OIR), CDRH, FDA
• Richard Schilsky, MD, FACP, FASCO

Chief Medical Officer, ASCO

• Laura van ‘t Veer, PhD
  Chair, Diagnostics Policy Subcommittee, AACR; Associate Director, Applied Genomics, UCSF Helen Diller Family Comprehensive Cancer Center

SESSION 1: DEFINING THE PROBLEM8:45–9:15Emerging Issues in Companion Diagnostics

• Reena Philip, PhD
  Director, Division of Molecular Genetics and Pathology, OIR, CDRH, FDA

9:20–10:20Stakeholder PresentationsPerspectives:

• Nancy Roach
  Chair, Fight Colorectal Cancer
• Suzanne Topalian, MD
  Director, Melanoma Program, Johns Hopkins Kimmel Cancer Center
• Debra Leonard, MD, PhD
  Chair, Department of Pathology and Laboratory Medicine, University of Vermont Medical Center and College of Medicine
• Steve Averbuch, MD

Vice President, Development, Oncology Pharmacodiagnostics, Bristol-Myers Squibb Company

• Doug Ward
  Vice President General Manager, Companion Diagnostics, Ventana Medical Systems, Inc.
• Gideon Blumenthal, MD
  Medical Officer, Lung Cancer Team Leader, CDER, FDA
• Girish Putcha, MD, PhD
  Director of Laboratory Science, MolDX, Palmetto GBA LLC

10:20–10:35Break 10:35–11:50Moderated Panel Discussion
Audience QAModerator: Debra Leonard, MD, PhD
Panel: All Session 1 Participants11:50–13:00Lunch (on own) SESSION 2: COMPARING THE TESTS13:00–13:05Introduction

• Laura van ‘t Veer, PhD

13:05–13:15Presentation: Industry Working Group Proposal on Comparing the Analytical Performance of the PDL-1 tests

• Dave Stanforth, on behalf of the working group

Director, Head of RD, Companion Diagnostics, Agilent Technologies13:15–13:45Moderated Panel Discussion: Industry Working Group Discussion of ProposalModerator:  Debra Rasmussen, MBA RAC
Senior Director, Diagnostic Global Regulatory Affairs, Janssen Pharmaceutical
Industry Working Group Participants:

• Steven Averbuch, MD
  Vice President, Development, Oncology Pharmacodiagnostics, Bristol-Myers Squibb
• Kenneth Emancipator, MD

Executive Medical Director, Merck

• Ian McCaffery, PhD
  Oncology Biomarker Development and Companion Diagnostics, Genentech
• Dave Stanforth
• Jill Walker, PhD
  Executive Director, Companion Diagnostic Development, Immuno-Oncology, AstraZeneca
• Doug Ward

13:45–14:30Moderated Panel Discussion: Reactions and Discussion QA with AudienceModerator: Laura van ‘t Veer, PhD
Perspectives:

• Fred Hirsch, MD, PhD
  Professor of Medicine and Pathology, University of Colorado; Chief Executive Director, International Association for the Study of Lung Cancer (IASLC)
• Elizabeth Hammond, MD
  Professor, Pathology, University of Utah; College of American Pathologists (CAP)
• Daniel Hayes, MD, FASCO

Stuart B. Padnos Professor of Breast Cancer Research Clinical Director, Breast Oncology Program, University of Michigan Comprehensive Cancer Center; President-Elect, ASCO

• Axel Hoos, MD, PhD
  Vice President, Oncology RD at GlaxoSmithKline Pharmaceuticals; Co-chair, Cancer Immunotherapy Consortium
• Kenneth Bloom, MD, FACP

Chief Medical Officer, GE Healthcare In Vitro Diagnostics14:30–14:45Break SESSION 3: CLINICAL PRACTICE/EDUCATION14:45–15:30Moderated Panel Discussion: This panel will focus on the type of information and prior knowledge a clinician needs to provide optimal care.Moderator: Richard Schilsky, MD, FACP, FASCO              
Perspectives:

• Edward Kim, MD
  Chair, Solid Tumor Oncology Investigational Therapeutics, Levine Cancer Institute – Carolinas HealthCare System
• Stacy Gray, MD, AM
  Medical Oncologist, Dana Farber Cancer Institute, Assistant Professor of Medicine, Harvard Medical School
• Elizabeth Hammond, MD

Professor, Pathology, University of Utah

• Daniel Hayes, MD, FASCO
• Jamie Von Roenn, MD

Senior Director, Education, Science and Professional Development, ASCO

• Michael Kolodziej, MD

National Medical Director, Oncology Solutions, Aetna

• Jane Perlmutter, PhD

President and Founder, Gemini Group15:30–16:00QA with Audience16:00–16:30Discussion/Closing Remarks

• Elizabeth Mansfield, PhD
• Richard Schilsky, MD, FACP, FASCO
• Laura van ‘t Veer, PhD

FDA is holding this public workshop to obtain information on harmonization of companion diagnostics across a class of targeted therapies. To permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop. The deadline for submitting comments related to this public workshop is April 23, 2015.