Ask the Experts: Building an Immunogenicity Strategy That Holds Up at Submission

Wed, Oct 14, 2026 | 10:30 AM – 11:00 AM (CDT)

Stephanie Pasas-Farmer, PhD & Joleen T. White, PhD

Live at Microsoft Teams Town Hall

Immunogenicity strategy begins long before a submission is assembled.

The decisions made during risk assessment, assay planning, sampling, data integration, and clinical interpretation can influence whether immunogenicity evidence is clear, connected, and defensible when it matters most.

Join BioData Solutions for a 30-minute, live Ask the Experts discussion on building an immunogenicity strategy that holds up at submission.

Along with the questions, we will discuss:

• Making early immunogenicity risk-assessment and assay-strategy decisions that support fit-for-purpose evidence throughout development
• Identifying product, patient, treatment, and program factors that should shape a proportionate immunogenicity testing plan
• Understanding assay limitations and interpret ADA and neutralizing-antibody findings in the context of PK, safety, efficacy, and clinical relevance
• Building a connected evidence strategy across bioanalysis, clinical development, biostatistics, and regulatory functions before critical decisions become difficult to revisit
• Recognizing and addressing common planning, documentation, data-integration, and interpretation gaps that can weaken submission readiness

Bring your questions or submit them when you register. This is a moderated, educational discussion for professionals involved in biologics and biotherapeutic development.