80 FR 12498 - Complexities in Personalized Medicine: Harmonizing Companion Diagnostics Across a Class of Targeted Therapies; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 45 (March 9, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 45 (March 9, 2015)
| Page Range | 12498-12499 | |
| FR Document | 2015-05348 |
[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)] [Notices] [Pages 12498-12499] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05348] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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, 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; and Rasika Kalamegham, American Association for Cancer Research, 1425 K [[Page 12499]] St. NW., Washington, DC 20005, 267-765-1029, Rasika.Kalamegham@aacr.org. 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, Kaitlyn.Antonelli@asco.org, 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
![12498 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices
biological products, medical devices, to: Irene Stith-Coleman, Ph.D., Office for Dated: March 3, 2015.
and combinations thereof. Human Research Protections, 1101 David Clary,
To enhance human subject protection Wootton Parkway, Suite 200, Rockville, Program Analyst, Office of Federal Advisory
and reduce regulatory burden, the MD 20852. Committee Policy.
Department of Health and Human Comments received, including any [FR Doc. 2015–05305 Filed 3–6–15; 8:45 am]
Services Office for Human Research personal information, will be posted BILLING CODE 4140–01–P
Protections (OHRP) and FDA have been without change to http://
actively working to harmonize the www.regulations.gov.
agencies’ regulatory requirements and DEPARTMENT OF HEALTH AND
guidance for human subject research, FOR FURTHER INFORMATION CONTACT: HUMAN SERVICES
and the FDA draft guidance document Irene Stith-Coleman, Office for Human
was developed as a part of these efforts. Research Protections, Department of Food and Drug Administration
Although the document is issued by Health and Human Services, 1101 [Docket No. FDA–2015–N–0647]
FDA and is drafted as guidance that Wootton Parkway, Suite 200, Rockville,
would apply to FDA-regulated clinical MD 20852; phone 240–453–6900; email Complexities in Personalized
investigations, OHRP is considering Irene.Stith-Coleman@hhs.gov. Medicine: Harmonizing Companion
whether to adopt the positions and Dated: March 3, 2015. Diagnostics Across a Class of
recommendations proposed in this Targeted Therapies; Public Workshop
Jerry Menikoff,
guidance for research regulated under
the HHS protection of human subjects Director, Office for Human Research AGENCY: Food and Drug Administration,
regulations, 45 CFR part 46, and to issue Protections. HHS.
a joint OHRP and FDA guidance [FR Doc. 2015–05301 Filed 3–6–15; 8:45 am] ACTION: Notice of public workshop.
document on this topic when the final BILLING CODE 4150–36–P
The Food and Drug Administration
guidance document is developed. OHRP (FDA), in co-sponsorship with the
asks for public comment about whether American Association for Cancer
a joint guidance document would be DEPARTMENT OF HEALTH AND
HUMAN SERVICES Research (AACR) and the American
useful for the regulated community. In Society of Clinical Oncology (ASCO), is
particular, OHRP is interested in public announcing a public workshop entitled
comment regarding whether FDA’s draft National Institutes of Health
‘‘Complexities in Personalized
guidance would be appropriate for all Medicine: Harmonizing Companion
National Human Genome Research
research regulated under 45 CFR part Diagnostics Across a Class of Targeted
Institute; Notice of Closed Meeting
46, including research studies other Therapies.’’ The objective of the
than clinical investigations or clinical Pursuant to section 10(d) of the workshop is to facilitate an in-depth
trials, such as social and behavioral Federal Advisory Committee Act, as discussion of harmonization of
research studies. If different guidance amended (5 U.S.C. App.), notice is companion diagnostic devices across a
should apply to social and behavioral hereby given of the following meeting. class of targeted therapies. The
research, or other non-FDA-regulated workshop aims to foster collaborations
studies, OHRP asks that the public The meeting will be closed to the
public in accordance with the in the clinical cancer research
comments address how the guidance community; provide a deeper
should differ from the proposed provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C., understanding of anticancer drug and
guidance for FDA-regulated clinical device development related to
investigations. as amended. The grant applications and
the discussions could disclose personalized medicine; provide a
OHRP specifically welcomes feedback
confidential trade secrets or commercial unique perspective of personalized
regarding when it might or might not be
property such as patentable material, medicine; and help incorporate
appropriate, for studies other than
and personal information concerning emerging scientific findings to
clinical trials, for OHRP to recommend
individuals associated with the grant harmonize companion diagnostics
that researchers verify that the person
applications, the disclosure of which across a class of targeted therapies.
signing the informed consent form is the Date and Time: The public workshop
subject participating in the research. would constitute a clearly unwarranted
invasion of personal privacy. will be held on March 24, 2015, from
OHRP and FDA will consider these 8:30 a.m. to 4:30 p.m.
comments in deciding whether to issue Name of Committee: National Human Location: The public workshop will
a joint OHRP/FDA guidance document Genome Research Institute Special Emphasis be held at the Mayflower Hotel, Grand
on this topic when the final guidance Panel Loan Repayment Program. Ballroom, 1127 Connecticut Ave. NW.,
document is developed. Date: April 30, 2015. Washington, DC 20036, 202–347–3000.
DATES: May 7, 2015. Time: 1:00 p.m. to 3:00 p.m. Contact Persons: Kaitlyn Antonelli,
Agenda: To review and evaluate grant
ADDRESSES: You may submit comments American Society of Clinical Oncology,
applications.
identified by docket ID number HHS– 2318 Mill Rd., suite 800, Alexandria,
Place: National Human Genome Research
OPHS–2015–0002 by one of the Institute, 3rd Floor Conference Room, 5635
VA 22314, 571–483–1606,
following methods: Fishers Lane, Rockville, MD, (Telephone Kaitlyn.Antonelli@asco.org; Pamela
Federal eRulemaking Portal: http:// Conference Call). Bradley, Center for Devices and
mstockstill on DSK4VPTVN1PROD with NOTICES
www.regulations.gov. Enter the above Contact Person: Keith McKenney, Ph.D., Radiological Health, Office of In Vitro
docket ID number in the Enter Keyword Scientific Review Officer, National Human Diagnostics and Radiological Health,
or ID field and click on ‘‘Search.’’ On Genome Research Institute, 5635 Fishers Food and Drug Administration, 10903
the next page, click the ‘‘Submit a Lane, Suite 4076, Bethesda, MD 20814, 301– New Hampshire Ave., Silver Spring, MD
Comment’’ action and follow the 594–4280, mckenneyk@mail.nih.gov. 20993–0002, 240–731–3734,
instructions. (Catalogue of Federal Domestic Assistance Pamela.Bradley@fda.hhs.gov; and
Mail/Hand delivery/Courier [For Program Nos. 93.172, Human Genome Rasika Kalamegham, American
paper, disk, or CD–ROM submissions] Research, National Institutes of Health, HHS) Association for Cancer Research, 1425 K
VerDate Sep<11>2014 18:04 Mar 06, 2015 Jkt 235001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1](https://thefederalregister.org/doc/80_FR_12543/page/1.svg)
![Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12499
St. NW., Washington, DC 20005, 267– submitting comments related to this the same (or closely related) within the
765–1029, Rasika.Kalamegham@ public workshop is April 23, 2015. drug class, there may be differences
aacr.org. Regardless of attendance at the public between the companion diagnostics in
Registration: Registration is free and workshop, interested persons may design and performance, such as use of
available on a first-come, first-served submit either electronic comments different antibodies or different cut-off
basis. Persons interested in attending regarding this document to http:// values leading to designation of
the ‘‘Complexities in Personalized www.regulations.gov or written different sets of marker-positive and
Medicine: Harmonizing Companion comments to the Division of Dockets marker-negative patients.
Diagnostics Across a Class of Targeted Management (HFA–305), Food and Drug Comparison of the results from
Therapies’’ public workshop must Administration, 5630 Fishers Lane, rm. different tests is not part of the
register online by March 17, 2015, 5 1061, Rockville, MD 20852. It is only companies’ development program for
p.m. Registration will be handled necessary to send one set of comments. each drug/test pair. Likewise,
through ASCO. Early registration is Identify comments with the docket differences in results from distinct tests
recommended because facilities are number found in brackets in the are typically not examined for their
limited and, therefore, we may limit the heading of this document. Received effect on efficacy of products within the
number of participants from each comments may be seen in the Division drug class. With no assurance that all
organization. If time and space permits, of Dockets Management between 9 a.m. the tests identify the populations most
onsite registration on the day of the and 4 p.m., Monday through Friday and likely to respond to all of the drugs,
public workshop will be provided will be posted to the docket at http:// problems may arise if various
beginning at 7 a.m. www.regulations.gov. companion diagnostics for the same
If you need special accommodations Transcript: Please be advised that as biomarker are used in clinical practice
due to a disability, please contact soon as a transcript is available, it will to direct treatment with all the targeted
Kaitlyn Antonelli (see Contact Persons), be accessible at http:// therapies in the drug class. Using
571–483–1606, Kaitlyn.Antonelli@ www.regulations.gov. It may be viewed multiple companion diagnostics to
asco.org, no later than March 10, 2015. at the Division of Dockets Management determine therapy for each patient is
To register for the public workshop, (see Comments). A transcript will also costly, inefficient, and challenging
please use the following Web site: be available in either hardcopy or on when dealing with a limited biological
https://www.surveymonkey.com/s/ CD–ROM, after submission of a specimen. Even if it were practical,
FDACompanionDiagnostics2015. Please Freedom of Information request. Written multiple testing might lead to
provide complete contact information requests are to be sent to the Division suboptimal use of the drugs. Likewise,
for each attendee, including name, title, of Freedom of Information (ELEM– use of one companion diagnostic might
affiliation, email, and telephone 1029), Food and Drug Administration, not adequately inform the use of all of
number. Those without Internet access 12420 Parklawn Dr., Element Bldg., the targeted therapies. In such scenarios,
should contact Kaitlyn Antonelli to Rockville, MD 20857. A link to the where multiple targeted therapy-
register. Registrants will receive transcripts will also be available companion diagnostic pairs exist,
confirmation after they have been approximately 45 days after the public patients may not be able to receive
accepted. You will be notified if you are workshop on the Internet at http:// optimal care. FDA believes this is an
on a waiting list. www.fda.gov/MedicalDevices/ important public health issue that is not
Streaming Audiocast of the Public NewsEvents/WorkshopsConferences/ easily resolved. Thus, FDA is convening
Workshop: This public workshop will default.htm. (Select this public this workshop in association with
also be audiocast. Persons interested in workshop from the posted events list.) AACR and ASCO to foster a
accessing the audiocast must register SUPPLEMENTARY INFORMATION: Multiple
collaborative examination of the
online using the following Web site: manufacturers are developing problem as it relates to various
https://www.surveymonkey.com/s/ therapeutic products that rely on a stakeholders and to identify potential
FDACompanionDiagnostics2015. FDA particular biomarker and that may solutions or paths to solutions for the
has verified the Web site addresses in require contemporaneous approval/ problem.
this document, but FDA is not clearance of a companion diagnostic if Dated: March 3, 2015.
responsible for any subsequent changes biomarker detection or measurement is Leslie Kux,
to the Web sites after this document necessary for the safe and effective use Associate Commissioner for Policy.
publishes in the Federal Register. Early of the therapeutic product. Therapeutic [FR Doc. 2015–05348 Filed 3–6–15; 8:45 am]
registration is recommended because product developers working in the same BILLING CODE 4164–01–P
audiocast connections are limited. target space can use different methods
Organizations are requested to register and measures for the biomarker, and
all participants but to view using one then partner with various sponsors to DEPARTMENT OF HEALTH AND
connection per location. After implement distinct companion HUMAN SERVICES
registration, participants will be sent diagnostics. These development
technical system requirements and programs can lead to approval/clearance National Institutes of Health
connection access information after of multiple therapeutic product-
March 19, 2015. companion diagnostic pairs for a single National Institute of Diabetes and
Comments: FDA is holding this public class of therapeutic products. For Digestive and Kidney Diseases; Notice
of Closed Meeting
mstockstill on DSK4VPTVN1PROD with NOTICES
workshop to obtain information on example, understanding of the
harmonization of companion Programmed Death Ligand 1 (PD–1) Pursuant to section 10(d) of the
diagnostics across a class of targeted checkpoint pathway underlies current Federal Advisory Committee Act, as
therapies. To permit the widest possible development of multiple targeted amended (5 U.S.C. App.), notice is
opportunity to obtain public comment, therapies and potential companion hereby given of the following meeting.
FDA is soliciting either electronic or diagnostics targeting and measuring PD– The meeting will be closed to the
written comments on all aspects of the 1 pathway biomarkers. Although the public in accordance with the
public workshop. The deadline for biomarker being detected/measured is provisions set forth in sections
VerDate Sep<11>2014 18:04 Mar 06, 2015 Jkt 235001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1](https://thefederalregister.org/doc/80_FR_12543/page/2.svg)
Document Created: 2015-12-18 12:05:19
Document Modified: 2015-12-18 12:05:19
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public workshop. | |
| FR Citation | 80 FR 12498 |
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