2026 Interactive 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.
Tuesday, October 20 | 2:35 PM
TABLE: Immunogenicity of Emerging Modalities - Discovery to Post Market
Faye Vazvaei, Executive Director, Merck
- Considerations around a holistic immunogenicity assessment strategy across the product lifecycle, including how ADA incidence, impact on PK, efficacy, and safety inform decisions around domain specificity characterization and NAb testing
- Regulatory and industry experience with risk-based approaches to domain specificity and NAb assessment, including circumstances where additional characterization may be reduced or waived
- Opportunities to streamline clinical ADA assessments through alternative data interpretation approaches, including evaluation of signal-to-noise versus titre and implementation of singlet testing strategies
- Leveraging emerging technologies and digital tools, including AI-enabled analyses and alternative analytical platforms such as LC-MS, to evaluate and interpret clinical immunogenicity data
- Addressing immunogenicity challenges associated with emerging modalities, including pre-existing reactivity, high ADA prevalence, and translating nonclinical immunogenicity findings to support development decisions
TABLE: Next Generation ADA Assays - Developing and Validating Continuous Response (S/N), Cut Point-Free ADA Assays
Lauren Stevenson, PhD, CSO & Head, Translational Sciences, Immunologix Labs
- Context of use considerations for development of continuous response S/N ADA assays
- Assay validation parameters and approaches for single-tier S/N ADA assays
- Limitations of PCs and pre-study analytical validation exercises
- Importance of in-study validation to support context of use
Thursday, October 22 | 10:05 AM
TABLE: Challenges and Developments in Immunogenicity and Immunotoxicities of Gene Therapy Products Including Viral Vectors and LNPs
Ronit Mazor, PhD, Principal Investigator, CBER, FDA
- Immunotoxicity signals in clinical and post-market settings
- Immunogenicity of genome editing components
- LNP-associated immunogenicity including immune response to DNA, anti-PEG, and repeat dosing
- Translational relevance of nonclinical immunogenicity models
TABLE: The Future of Immunogenicity: What's Working, What's Next?
Pooja Khanna, PhD, Senior Scientist, Merck
- What emerging regulatory expectations and industry practices should we be preparing for?
- Lessons learned from recent programs: Unexpected immunogenicity findings and how teams responded
- Opportunities for greater cross-functional collaboration between bioanalytical, clinical, PK/PD, and translational sciences
- Future technologies and innovations that could transform immunogenicity assessment
- How are novel modalities (TCEs, multispecifics, gene therapies, ADCs) changing immunogenicity risk assessment?
TABLE: Potency Assays for Complicated Biologics: Sharing Insights into Potency Assays and Strategies for Multi-Model and Complex Biologics
Gabriella Spitz-Becker, PhD, Principal Scientist, Bristol Myers Squibb
- What makes these products hard to measure in the first place compared to a “traditional” biologic?
- How do teams decide whether a single assay is sufficient, or whether a control strategy will require multiple potency assays
- What has been the biggest surprise or lesson learned from developing assays and strategies for complex products?
- What would make this easier industry-wide?
TABLE: Designing Assays Aligned to Mechanism-of-action (MoA) and Clinical Relevance
Ashley Moore, PhD, Research Scientist II, Discovery Biology, Alexion
- How can we ensure assays measure biological processes directly linked to the intended MoA, rather than simply providing convenient readouts?
- How can we identify assay outputs that reflect target engagement, pathway modulation, and potential clinical benefit?
- How should we balance assay complexity, speed, sensitivity, and clinical relevance as programs progress from exploratory research to clinical studies?
- How can assays and biomarker readouts capture disease biology and patient-subgroup differences to improve patient selection and clinical relevance?