Model Informed Drug Development Approaches for Immunogenicity Assessments; Public Workshop
The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research, in collaboration with the Center for Drug Evaluation and Research, is announcing the followi...
The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research, in collaboration with the Center for Drug Evaluation and Research, is announcing the following public workshop entitled “Model Informed Drug Development Approaches for Immunogenicity Assessments.” The purpose of this public workshop is to discuss the best practices and future directions of quantitative methods for predicting immunogenicity of biological products. This public workshop is also being conducted to satisfy one of FDA's performance goals included in the sixth reauthorization of the Prescription Drug User Fee Amendments (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA), to hold a series of workshops related to model-informed drug development (MIDD).
DATES:
The public workshop will be held virtually on June 9, 2021, from 8 a.m. to 5 p.m., Eastern Time. See the
SUPPLEMENTARY INFORMATION
section for registration date and information.
ADDRESSES:
Please note that due to the impact of the COVID-19 pandemic, all participants will be joining this public workshop via an online teleconferencing platform. The public workshop will be held virtually via Adobe Connect. Webcast information will be provided upon completion of registration.
FOR FURTHER INFORMATION CONTACT:
Loni Warren Henderson or Sherri Revell, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1118, Silver Spring, MD 20993, 240-402-8010,
CBERPublicEvents@fda.hhs.gov
(subject line: MIDD Workshop).
SUPPLEMENTARY INFORMATION:
I. Background
Under FDARA, and in accordance with section I, part J of the PDUFA VI Performance Goals, FDA agreed to convene a series of workshops to identify best practices for MIDD (
https://www.fda.gov/media/99140/download,
see page 27). Each workshop focuses on current and emerging scientific approaches, including methodological limitations. The workshop announced in this notice fulfills FDA's performance commitment under PDUFA VI, specifically for modeling immunogenicity and correlates of protection for evaluating biological products, including vaccines and blood products.
II. Topics for Discussion at the Public Workshop
Topics for discussion include the following:
1. Current in silico methodologies used to assess drug immunogenicity;
2. Available data resources and data needs for MIDD approaches to evaluate immunogenicity at various stages of drug development;
3. Possible applications and limitations of MIDD approaches for desired immunogenicity of vaccine/allergenic products; and
4. Insight into the possible future applications of MIDD and good modeling practices.
If you need special accommodations due to a disability, please contact Loni Warren Henderson or Sherri Revell (see
FOR FURTHER INFORMATION CONTACT
) no later than May 26, 2021. Please note, Computer Aided Realtime Translation/captioning will be available.
Streaming Webcast of the Public Workshop:
This public workshop will be streamed via webcast only.
Use this for formal legal and research references to the published document.
86 FR 21753
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Model Informed Drug Development Approaches for Immunogenicity Assessments; Public Workshop,” thefederalregister.org (April 23, 2021), https://thefederalregister.org/documents/2021-08487/model-informed-drug-development-approaches-for-immunogenicity-assessments-public-workshop.