TUESDAY, OCTOBER 3 | 2:10 PM
TABLE 1: 2022 FDA Guidance on Immunogenicity in Drug Product Labeling
Robert Kubiak, PhD, Associate Director, Clinical Pharmacology & Quantitative Pharmacology, AstraZeneca
- What is your understanding of adequate vs inadequate methodology for immunogenicity evaluation?
- In addition to ADA incidence, have you considered including characterization of ADA response such as titer, time of onset, persistency? If so, what was the FDA response?
- When is it appropriate to include ADA incidence for drug-naïve subjects (placebo or at baseline)?
- No clinically significant effect of ADA vs clinical effect of ADA is unknown – how do you tell the difference?
TABLE 2: Authoring of Integrated Summary of Immunogenicity (ISI)
Faye Vazvaei, Executive Director, Merck
Linlin Luo, PhD, Director, Merck
- What’s the best process/approach in authoring ISI with respect to:
- when should it be initiated?
- who should be contributing?
- what should be included in the document?
- should an SAP (i.e., Statistical Analysis Plan) be prepared prior to ISI?
- whether consulting Regulatory Agency on contents and ADA analysis strategies of ISI is recommended prior to filing?
- Given that ISI is a living and evolving document, what’s the best approach to update it after its initial submission in the filing upon the availability of new data?
- If ISI is not provided, but all immunogenicity related information is included in eCTD in different modules, will this be an issue during submission?
- Please share your experience and lessons learned in ISI preparation and submission
TABLE 3: Mastering Assay Troubleshooting: Overcoming Challenges in ADA and NAb Assays
Zifeng Mai, Senior Manager, Clinical Pharmacology Lead, CRISPR Therapeutics
- Opinions are my own and not the views of my employer
- Commonly used assay formats and the most common issues observed
- Critical reagent generation and monitoring in supporting ADA and NAb assays
- Secreted markers or cellular markers for cellular immunogenicity
- “Fit for purpose” assay performance and lack of function mitigation
- Future trend on assay platform testing strategy
THURSDAY, OCTOBER 5 | 9:30 AM
TABLE 1: Immunogenicity Considerations for Therapeutic Proteins used in Patients with COVID and Other Hyperinflammatory Disorders
Amy Rosenberg, MD, Senior Director of Immunology and Protein Therapeutics, Epivax
- Effects of the inflammatory miliieu on protein structure, function and immunogenicity
- COVID 19 hyper inflammation and induction of autoantibodies and autoimmune disease
- Actions to consider in reassessing immunogenicity of therapeutic proteins in inflammatory contexts
TABLE 2: Advantages and Implementation of AI
Daniel Leventhal, PhD, Head of Immunogenicity, Generate Biomedicines
- What is Artificial Intelligence and Machine Learning
- Practical applications for use of AI tools for Immunogenicity Risk Assessment and Mitigation
- Structuring your data to integrate with AI tools
TABLE 3: Cell-Based Assays for Product Development and Release
Brian Meyer, PhD, Principal Scientist, Merck
- Cell-based reporter assays for potency vs. plaque potency (or other potency methods)
- Cell-based assays for determining/demonstrating Mechanism of Action (MoA)
- Releasing drug products for clinical studies or commercial use with cell-based methods
- Perspectives on the use of cell-based vs. physical methods to characterize and release products
TABLE 4: Customer Feedback on the USP Bioassay Chapters
Tim Schofield, Owner & Consultant, CMC Sciences LLC
- What are some of the strengths of the USP chapters?
- What are their weaknesses?
- What topics would you like to see added or removed from the chapters?
- If regulators are using the chapters, how might they be strengthened to bring bioassay development closer to regulatory expectations?