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
- Federal Register
- Registration (In-Person and Audiocast)
- Meeting Materials, Presentation Slides, and Transcript
- Contact Us
This meeting was held March 24, 2015, beginning at 8:30 a.m. at the following location:
1127 Connecticut Avenue, NW
Washington, DC 20036
|8:30–8:45||Welcome and Opening Remarks||Workshop Co-chairs: |
|SESSION 1: DEFINING THE PROBLEM|
|8:45–9:15||Emerging Issues in Companion Diagnostics|
|9:20–10:20||Stakeholder Presentations||Perspectives: |
|10:35–11:50||Moderated Panel Discussion |
|Moderator: Debra Leonard, MD, PhD|
Panel: All Session 1 Participants
|11:50–13:00||Lunch (on own)|
|SESSION 2: COMPARING THE TESTS|
|13:05–13:15||Presentation: Industry Working Group Proposal on Comparing the Analytical Performance of the PDL-1 tests|
|13:15–13:45||Moderated Panel Discussion: Industry Working Group Discussion of Proposal||Moderator: Debra Rasmussen, MBA RAC|
Senior Director, Diagnostic Global Regulatory Affairs, Janssen Pharmaceutical
Industry Working Group Participants:
|13:45–14:30||Moderated Panel Discussion: Reactions and Discussion Q&A with Audience||Moderator: Laura van ‘t Veer, PhD |
|SESSION 3: CLINICAL PRACTICE/EDUCATION|
|14:45–15:30||Moderated 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 |
|15:30–16:00||Q&A with Audience|
To register for the public workshop, please visit the following Web site: https://www.surveymonkey.com/s/FDACompanionDiagnostics2015
Streaming Live Audiocast
To register for the streaming live audiocast, please use the following Web site: https://www.surveymonkey.com/s/FDACompanionDiagnostics2015
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 http://www.regulations.gov 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.
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, Kaitlyn.Antonelli@asco.org;
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, Pamela.Bradley@fda.hhs.gov;
Rasika Kalamegham, American Association for Cancer Research, 1425 K St. NW., Washington, DC 20005, 267-765-1029, Rasika.Kalamegham@aacr.org.
If you need special accommodations due to a disability, please contact Kaitlyn Antonelli (see Contact Persons), 571-483-1606, Kaitlyn.Antonelli@asco.org, no later than March 10, 2015.