[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]
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