Model Informed Drug Development Approaches for Immunogenicity Assessments June 9, 2021

Public | Virtual

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• Date: June 9, 2021

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The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), in collaboration with the Center for Drug Evaluation and Research (CDER), are announcing the following public workshop entitled “Model Informed Drug Development Approaches for Immunogenicity Assessments.”

PURPOSE OF THE PUBLIC WORKSHOP:

The purpose of this public workshop is to discuss best practices and future directions of quantitative methods for predicting immunogenicity of biologic 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).

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.

TOPICS FOR DISCUSSION:

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

Model Informed Drug Development Approaches for Immunogenicity Assessments Agenda

LECTURE VIDEOS:

Opening Remarks

• Peter Marks, MD. PhD. – Welcome Remarks
• Rajanikanth Madabushi, PhD. – Integration of MIDD into Drug Development and Regulatory Decision-Making

Session 1

• Aleksander Popel, PhD. – Quantitative Systems Pharmacology: Applications to Immuno-Oncology 
• Xiaoying, Chen, PhD. – A Systems Pharmacology Modeling Approach to Immunogenicity Prediction
• Andrzej Kierzek, PhD. – Quantitative Systems Pharmacology to Predicting and Managing Impact of Immunogenicity on Pharmacokinetics of Therapeutic Proteins
• Lora Hamuro, PhD. – Quantitative Assessment of the Immunogenicity Impact on Safety and Efficacy for a Nivolumab & Ipilimumab Combination in 1L Melanoma

Session 2

• Atul Butte, MD, PhD. – Translating a Trillion Points of Data into Therapies, Diagnostics, and New Insights into Immunological Disease
• Malachi Griffith, PhD. – Bioinformatics and Immunogenomics Approaches for Neoantigen Target Identification
• Morten Nielsen, PhD. – The Use of HLA Class II Antigen Presentation Prediction in the Context of Immunogenicity Assessment of Biologics
• Brandon Dekosky, PhD. – Exploring Personalization of Human Immune Responses with High-Throughput Immune Receptor Data

Session 3

• Yongqun He, Ph.D. – COVID-19 Vaccine Machine Learning, Ontology Modeling, and Cov19VaxKB
• Peter Gilbert, PhD. – Learning Immune Correlates of Protection from Vaccine Efficacy Trials
• Richard White, PhD. and Sophie Rhodes, Ph.D – Using Epidemiological and Immunostimulation/Immunodynamic Modelling to Estimate TB Vaccine Impact and Optimise Vaccine Dose
• Ryoko Sawamura, PhD. – QSP Application to COVID-19 Vaccine Clinical Development

Session 4

• Guangping Gao, PhD. – Vector-Related Immunogenicity as a Potential Roadblock to AAV Gene Therapy - Assessment and Mitigation
• Nirjal Bhattarai, PhD. – Immunogenicity of Chimeric Antigen Receptor T Cells
• Jochem Gokemeijer, PhD. – Pre-Clinical Immunogenicity Risk Assessment Tools and Strategies for Novel Modalities

LOCATION:

The public workshop will be held virtually via Adobe Connect. Webcast information will be provided upon completion of registration.

REGISTRATION:

OMB Control No. 0910-0429

Expiration Date: 5/31/2023

Paperwork Reduction Act Statement:  According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number.  The valid OMB control number for this information is 0910-0429 and the expiration date is 5/31/2023.  The time required to complete this information collection is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestion for reducing burden to PRAStaff@fda.hhs.gov.

To register for this public workshop, please visit the following website:  https://www.eventbrite.com/e/model-informed-drug-development-approaches-for-immunogenicity-assessments-tickets-138618787525.

TRANSCRIPTS:

Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov.  It may be viewed at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A link to the transcript will be available on the internet at https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/default.htm.

QUESTIONS:

Please submit any questions you may have during the workshop to: MIDDWorkshop@fda.hhs.gov

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).

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Event Materials

Title	File Type/Size
Model Informed Drug Development Approaches for Immunogenicity Assessments Agenda	pdf (180.06 KB)