In-Person Group Discussions

These in-person group discussions are open to all attendees, speakers, sponsors, and exhibitors. Participants choose a specific discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion. All group discussions will be offered IN-PERSON ONLY.



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



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?