80 FR 38210 - New Methods To Predict the Immunogenicity of Therapeutic Coagulation Proteins; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 127 (July 2, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 127 (July 2, 2015)
| Page Range | 38210-38210 | |
| FR Document | 2015-16365 |
[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)] [Notices] [Page 38210] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-16365] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] New Methods To Predict the Immunogenicity of Therapeutic Coagulation Proteins; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. ----------------------------------------------------------------------- The Food and Drug Administration (FDA) is announcing a public workshop entitled: ``New Methods to Predict the Immunogenicity of Therapeutic Coagulation Proteins''. The purpose of the public workshop is to discuss recent scientific progress in identifying the genetic determinants for an unwanted immune response to therapeutic coagulation proteins (immunogenicity), and to identify and discuss potential new methods to predict such immunogenicity. Immunogenicity results in the development of antibodies that target the therapeutic protein and can affect the safety and efficacy of the biological product. The workshop has been planned in partnership with the National Heart, Lung and Blood Institute, National Institutes of Health (NIH), the National Hemophilia Foundation, and the Plasma Protein Therapeutics Association. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government Agencies. Date and Time: The public workshop will be held on September 17, 2015, from 8:30 a.m. to 5 p.m. and on September 18, 2015, from 8:30 a.m. to 12 p.m. Location: The public workshop will be held at the Ruth Kirschstein Auditorium, Natcher Conference Center, Bldg. 45, National Institutes of Health Campus, 9000 Rockville Pike, Bethesda, MD 20892. The entrance for the public workshop participants (non-NIH employees) is through the NIH Gateway Center located adjacent to the Medical Center Metro, where routine security check procedures will be performed. Please visit the following Web site for location, parking, security, and travel information: http://www.nih.gov/about/visitor/index.htm. Please visit the following Web site for information on the Natcher Conference Center: http://www.genome.gov/11007522. Contact Person: Freddy Barnes, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-6943, [email protected]. For questions email: [email protected] (Subject line: FDA MPICPDT Workshop). Registration: Please visit the following Web site to register for the workshop by August 27, 2015: http://methodspredictimmunogenicity.eventbrite.com. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 8:15 a.m. If you need special accommodations due to a disability, please contact Freddy Barnes (see Contact Person) at least 7 days in advance. Supplementary Information: The development of unwanted immune responses to therapeutic coagulation protein products may affect both product efficacy and patient safety. In the case of replacement coagulation protein therapies, the inhibitory anti-drug antibodies also interact with the endogenous protein and may result in serious adverse events in patients. Both product and patient specific factors may affect the immunogenicity of therapeutic coagulation protein products. There are currently several initiatives underway to assess the genetic basis for developing unwanted immune responses to coagulation protein products in individuals with hemophilia, which will result in the accumulation of large data sets over the next few years. The workshop aims to address what patients, healthcare professionals and regulators may do with this information to improve patient outcomes. In addition, an unprecedented number of new engineered recombinant coagulation proteins are in development. This workshop will discuss the state-of-the art with respect to leveraging scientific progress to predict the immunogenicity of protein amino acid sequences that do not exist in nature, and whether there is a need for novel strategies in the design and conduct of clinical trials for these products. The first day of the workshop will include presentations and panel discussions on the following topics: (1) Overview of the current understanding of genetic factors that affect immunogenicity of therapeutic coagulation proteins; (2) recent advances in immunology relevant to immunogenicity; (3) emerging computational, in vitro and ex vivo tools to predict the immunogenicity of therapeutic coagulation proteins and how these tools may be evaluated in a clinical setting; and (4) initiatives to determine the genetic factors that affect immunogenicity of coagulation protein products in individuals with hemophilia and strategies to optimize the outcome data. The second day of the workshop will include presentations and panel discussions on the following topics: (1) Challenges related to the development of novel recombinant coagulation protein products; (2) a round-table discussion and question and answer session; and (3) workshop summary. Transcripts: Please be advised that as soon as possible after a transcript of this public workshop will be available, it will be accessible at: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm438035.htm. Transcripts of the public workshop may also be requested in writing from the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857. Dated: June 29, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-16365 Filed 7-1-15; 8:45 am] BILLING CODE 4164-01-P
![38210 Federal Register / Vol. 80, No. 127 / Thursday, July 2, 2015 / Notices
identified by the title of the information and panel discussions by experts from accumulation of large data sets over the
collection. academic institutions, industry, and next few years. The workshop aims to
The Department specifically requests government Agencies. address what patients, healthcare
comments on: (a) Whether the proposed Date and Time: The public workshop professionals and regulators may do
collection of information is necessary will be held on September 17, 2015, with this information to improve patient
for the proper performance of the from 8:30 a.m. to 5 p.m. and on outcomes.
functions of the agency, including September 18, 2015, from 8:30 a.m. to
12 p.m. In addition, an unprecedented
whether the information shall have
practical utility; (b) the accuracy of the Location: The public workshop will number of new engineered recombinant
agency’s estimate of the burden of the be held at the Ruth Kirschstein coagulation proteins are in
proposed collection of information; (c) Auditorium, Natcher Conference Center, development. This workshop will
the quality, utility, and clarity of the Bldg. 45, National Institutes of Health discuss the state-of-the art with respect
information to be collected; and (d) Campus, 9000 Rockville Pike, Bethesda, to leveraging scientific progress to
ways to minimize the burden MD 20892. The entrance for the public predict the immunogenicity of protein
information to be collected; and (d) workshop participants (non-NIH amino acid sequences that do not exist
ways to minimize the burden of the employees) is through the NIH Gateway in nature, and whether there is a need
collection of information on Center located adjacent to the Medical for novel strategies in the design and
respondents, including through the use Center Metro, where routine security conduct of clinical trials for these
of automated collection techniques or check procedures will be performed. products.
other forms of information technology. Please visit the following Web site for
location, parking, security, and travel The first day of the workshop will
Consideration will be given to include presentations and panel
comments and suggestions submitted information: http://www.nih.gov/about/
visitor/index.htm. Please visit the discussions on the following topics: (1)
within 60 days of this publication. Overview of the current understanding
following Web site for information on
Robert Sargis, the Natcher Conference Center: http:// of genetic factors that affect
Reports Clearance Officer. www.genome.gov/11007522. immunogenicity of therapeutic
[FR Doc. 2015–16285 Filed 7–1–15; 8:45 am] Contact Person: Freddy Barnes, coagulation proteins; (2) recent
BILLING CODE 4184–01–P Center for Biologics Evaluation and advances in immunology relevant to
Research, Food and Drug immunogenicity; (3) emerging
Administration, 10903 New Hampshire computational, in vitro and ex vivo
DEPARTMENT OF HEALTH AND Ave., Silver Spring, MD 20993, 240– tools to predict the immunogenicity of
HUMAN SERVICES 402–6943, William.Barnes@fda.hhs.gov. therapeutic coagulation proteins and
For questions email: how these tools may be evaluated in a
Food and Drug Administration CBERPublicEvents@fda.hhs.gov (Subject clinical setting; and (4) initiatives to
[Docket No. FDA–2015–N–0001]
line: FDA MPICPDT Workshop). determine the genetic factors that affect
Registration: Please visit the following
immunogenicity of coagulation protein
New Methods To Predict the Web site to register for the workshop by
August 27, 2015: http:// products in individuals with
Immunogenicity of Therapeutic hemophilia and strategies to optimize
Coagulation Proteins; Public methodspredictimmunogenicity.
eventbrite.com. There is no registration the outcome data.
Workshop
fee for the public workshop. Early The second day of the workshop will
AGENCY: Food and Drug Administration, registration is recommended because include presentations and panel
HHS. seating is limited. Registration on the discussions on the following topics: (1)
ACTION: Notice of public workshop. day of the public workshop will be Challenges related to the development
provided on a space available basis of novel recombinant coagulation
The Food and Drug Administration beginning at 8:15 a.m. protein products; (2) a round-table
(FDA) is announcing a public workshop If you need special accommodations discussion and question and answer
entitled: ‘‘New Methods to Predict the due to a disability, please contact session; and (3) workshop summary.
Immunogenicity of Therapeutic Freddy Barnes (see Contact Person) at
Coagulation Proteins’’. The purpose of least 7 days in advance. Transcripts: Please be advised that as
the public workshop is to discuss recent Supplementary Information: The soon as possible after a transcript of this
scientific progress in identifying the development of unwanted immune public workshop will be available, it
genetic determinants for an unwanted responses to therapeutic coagulation will be accessible at: http://
immune response to therapeutic protein products may affect both www.fda.gov/BiologicsBloodVaccines/
coagulation proteins (immunogenicity), product efficacy and patient safety. In NewsEvents/WorkshopsMeetings
and to identify and discuss potential the case of replacement coagulation Conferences/ucm438035.htm.
new methods to predict such protein therapies, the inhibitory anti- Transcripts of the public workshop may
immunogenicity. Immunogenicity drug antibodies also interact with the also be requested in writing from the
results in the development of antibodies endogenous protein and may result in Division of Freedom of Information
that target the therapeutic protein and serious adverse events in patients. Both (ELEM–1029), Food and Drug
can affect the safety and efficacy of the product and patient specific factors may
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Administration, 12420 Parklawn Dr.,
biological product. The workshop has affect the immunogenicity of Rockville, MD 20857.
been planned in partnership with the therapeutic coagulation protein
Dated: June 29, 2015.
National Heart, Lung and Blood products. There are currently several
Institute, National Institutes of Health initiatives underway to assess the Leslie Kux,
(NIH), the National Hemophilia genetic basis for developing unwanted Associate Commissioner for Policy.
Foundation, and the Plasma Protein immune responses to coagulation [FR Doc. 2015–16365 Filed 7–1–15; 8:45 am]
Therapeutics Association. The protein products in individuals with BILLING CODE 4164–01–P
workshop will include presentations hemophilia, which will result in the
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Document Created: 2015-12-15 13:14:59
Document Modified: 2015-12-15 13:14:59
| 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 38210 |
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