FDA Announces a Virtual Workshop Entitled “Model Informed Drug Development Approaches for Immunogenicity Assessments” on June 9, 2021

FDA will host a virtual public workshop on June 9, 2021

FDA Announces a Virtual Workshop Entitled "Model Informed Drug Development Approaches for Immunogenicity Assessments" on June 9, 2021 The U.S. Food and Drug Administration (FDA) will host a virtual public workshop entitled "Model Informed Drug Development Approaches for Immunogenicity Assessments" on June 9, 2021. The purpose of this public workshop is to discuss 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).   MIDD is an approach that involves developing and applying exposure-based, biological, and statistical models derived from preclinical and clinical data sources to inform drug development and decision-making. 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://go.usa.gov/xHtdN, see page 27). Each workshop focuses on current and emerging scientific approaches, including methodological limitations. This workshop 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. Topics for discussion in this workshop include the following: Current in silico methodologies used to assess drug immunogenicity; Available data resources and data needs for MIDD approaches to evaluate immunogenicity at various stages of drug development; Possible applications and limitations of MIDD approaches for desired immunogenicity of vaccine/allergenic products; and Insight into the possible future applications of MIDD and good modeling practices A detailed agenda for this workshop can be found at: https://go.usa.gov/xHzgy. The date, time, and location of the workshop are as follows: Date: June 9, 2021 Time:  8:00 AM - 5:00 PM ET Location: This public workshop will be held virtually via Adobe Connect. Webcast information will be provided upon completion of registration Meeting Registration: https://www.eventbrite.com/e/model-informed-drug-development-approaches-for-immunogenicity-assessments-tickets-138618787525 If you have any additional questions about this workshop, please contact CBERPublicEvents@fda.hhs.gov (include the subject line: MIDD Workshop). The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at https://public.govdelivery.com/accounts/USFDA/subscriber/topics and select Clinical Pharmacology Corner under Drugs. We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov. This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA