Medical Devices

Public Workshop - Complexities in Personalized Medicine: Harmonizing Companion Diagnostics Across a Class of Targeted Therapies, March 24, 2015

The purpose of the workshop was to facilitate an in-depth discussion of harmonization of companion diagnostic devices across a class of targeted therapies. The workshop aimed to foster collaborations in the clinical cancer research community; provide a deeper understanding of anticancer drug and device development related to personalized medicine; provide a unique perspective of personalized medicine; and help incorporate emerging scientific findings to harmonize companion diagnostics across a class of targeted therapies.

Date, Time and Location:

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


8:30–8:45Welcome 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
8:45–9:15Emerging 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
10:35–11:50Moderated Panel Discussion
Audience Q&A
Moderator: Debra Leonard, MD, PhD
Panel: All Session 1 Participants
11:50–13:00Lunch (on own) 
  • 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 R&D, Companion Diagnostics, Agilent Technologies
13:15–13:45Moderated 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 Q&A with AudienceModerator: Laura van ‘t Veer, PhD
  • 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 R&D at GlaxoSmithKline Pharmaceuticals; Co-chair, Cancer Immunotherapy Consortium
  • Kenneth Bloom, MD, FACP
Chief Medical Officer, GE Healthcare In Vitro Diagnostics
14:45–15:30Moderated 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              
  • 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 Group
15:30–16:00Q&A with Audience
16:00–16:30Discussion/Closing Remarks
  • Elizabeth Mansfield, PhD
  • Richard Schilsky, MD, FACP, FASCO
  • Laura van ‘t Veer, PhD

Registration to Attend the Workshop:

To register for the public workshop, please visit the following Web site:

Streaming Live Audiocast

To register for the streaming live audiocast, please use the following Web site:

Meeting Materials


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.

Regardless of attendance at the public workshop, interested persons may submit either electronic comments regarding this document to or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document.

Contact Us

For questions regarding workshop content please contact:

Kaitlyn Antonelli, American Society of Clinical Oncology, 2318 Mill Rd., suite 800, Alexandria, VA 22314, 571-483-1606,;

Pamela Bradley, Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-731-3734,;

Rasika Kalamegham, American Association for Cancer Research, 1425 K St. NW., Washington, DC 20005, 267-765-1029,

If you need special accommodations due to a disability, please contact Kaitlyn Antonelli (see Contact Persons), 571-483-1606,, no later than March 10, 2015.

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