[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12498-12499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05348]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0647]


Complexities in Personalized Medicine: Harmonizing Companion 
Diagnostics Across a Class of Targeted Therapies; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA), in co-sponsorship with the 
American Association for Cancer Research (AACR) and the American 
Society of Clinical Oncology (ASCO), is announcing a public workshop 
entitled ``Complexities in Personalized Medicine: Harmonizing Companion 
Diagnostics Across a Class of Targeted Therapies.'' The objective of 
the workshop is to facilitate an in-depth discussion of harmonization 
of companion diagnostic devices across a class of targeted therapies. 
The workshop aims 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 and Time: The public workshop will be held on March 24, 2015, 
from 8:30 a.m. to 4:30 p.m.
    Location: The public workshop will be held at the Mayflower Hotel, 
Grand Ballroom, 1127 Connecticut Ave. NW., Washington, DC 20036, 202-
347-3000.
    Contact Persons: Kaitlyn Antonelli, American Society of Clinical 
Oncology, 2318 Mill Rd., suite 800, Alexandria, VA 22314, 571-483-1606, 
[email protected]; 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, [email protected]; and 
Rasika Kalamegham, American Association for Cancer Research, 1425 K

[[Page 12499]]

St. NW., Washington, DC 20005, 267-765-1029, 
[email protected].
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending the ``Complexities 
in Personalized Medicine: Harmonizing Companion Diagnostics Across a 
Class of Targeted Therapies'' public workshop must register online by 
March 17, 2015, 5 p.m. Registration will be handled through ASCO. Early 
registration is recommended because facilities are limited and, 
therefore, we may limit the number of participants from each 
organization. If time and space permits, onsite registration on the day 
of the public workshop will be provided beginning at 7 a.m.
    If you need special accommodations due to a disability, please 
contact Kaitlyn Antonelli (see Contact Persons), 571-483-1606, 
[email protected], no later than March 10, 2015.
    To register for the public workshop, please use the following Web 
site: https://www.surveymonkey.com/s/FDACompanionDiagnostics2015. 
Please provide complete contact information for each attendee, 
including name, title, affiliation, email, and telephone number. Those 
without Internet access should contact Kaitlyn Antonelli to register. 
Registrants will receive confirmation after they have been accepted. 
You will be notified if you are on a waiting list.
    Streaming Audiocast of the Public Workshop: This public workshop 
will also be audiocast. Persons interested in accessing the audiocast 
must register online using the following Web site: https://www.surveymonkey.com/s/FDACompanionDiagnostics2015. FDA has verified 
the Web site addresses in this document, but FDA is not responsible for 
any subsequent changes to the Web sites after this document publishes 
in the Federal Register. Early registration is recommended because 
audiocast connections are limited. Organizations are requested to 
register all participants but to view using one connection per 
location. After registration, participants will be sent technical 
system requirements and connection access information after March 19, 
2015.
    Comments: 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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday and will be posted to the docket at http://www.regulations.gov.
    Transcript: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (see Comments). A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857. A link to the transcripts will also be available 
approximately 45 days after the public workshop on the Internet at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)

SUPPLEMENTARY INFORMATION: Multiple manufacturers are developing 
therapeutic products that rely on a particular biomarker and that may 
require contemporaneous approval/clearance of a companion diagnostic if 
biomarker detection or measurement is necessary for the safe and 
effective use of the therapeutic product. Therapeutic product 
developers working in the same target space can use different methods 
and measures for the biomarker, and then partner with various sponsors 
to implement distinct companion diagnostics. These development programs 
can lead to approval/clearance of multiple therapeutic product-
companion diagnostic pairs for a single class of therapeutic products. 
For example, understanding of the Programmed Death Ligand 1 (PD-1) 
checkpoint pathway underlies current development of multiple targeted 
therapies and potential companion diagnostics targeting and measuring 
PD-1 pathway biomarkers. Although the biomarker being detected/measured 
is the same (or closely related) within the drug class, there may be 
differences between the companion diagnostics in design and 
performance, such as use of different antibodies or different cut-off 
values leading to designation of different sets of marker-positive and 
marker-negative patients.
    Comparison of the results from different tests is not part of the 
companies' development program for each drug/test pair. Likewise, 
differences in results from distinct tests are typically not examined 
for their effect on efficacy of products within the drug class. With no 
assurance that all the tests identify the populations most likely to 
respond to all of the drugs, problems may arise if various companion 
diagnostics for the same biomarker are used in clinical practice to 
direct treatment with all the targeted therapies in the drug class. 
Using multiple companion diagnostics to determine therapy for each 
patient is costly, inefficient, and challenging when dealing with a 
limited biological specimen. Even if it were practical, multiple 
testing might lead to suboptimal use of the drugs. Likewise, use of one 
companion diagnostic might not adequately inform the use of all of the 
targeted therapies. In such scenarios, where multiple targeted therapy-
companion diagnostic pairs exist, patients may not be able to receive 
optimal care. FDA believes this is an important public health issue 
that is not easily resolved. Thus, FDA is convening this workshop in 
association with AACR and ASCO to foster a collaborative examination of 
the problem as it relates to various stakeholders and to identify 
potential solutions or paths to solutions for the problem.

    Dated: March 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05348 Filed 3-6-15; 8:45 am]
 BILLING CODE 4164-01-P