Topic 1:

Regulatory Agencies' support for Risk-based Approaches for Immunogenicity Assessment & Neutralizing ADA (NAb); Current strategies of using PD Biomarkers as Surrogate for assessing NAbs; Clinically meaningful neutralization and direct PD biomarker response potentially making the NAb assay unnecessary; Importance of early Interaction with Regulators when proposing PD Biomarker to replace NAb assays and development of a Strong Scientific Justifications; Evaluation of concordance/discordance between NAb and PD Biomarker Assays; When cannot PD Biomarkers replace NAb assays?

Topic 2:

To which extent can in-silico immunogenicity prediction tools and in-vitro assays for Immunogenicity Risk Assessment contribute to streamlined Biosimilar development? Importance of Immunogenicity Assessment in new Streamlined Biosimilar Development without Clinical Efficacy and Safety Studies/endpoint; Are there other/higher expectations from regulators on analytical and physio-chemical characterization? Alignment on immunogenicity package in streamlined Biosimilar development across/within Regulatory Agencies; Current need to setup the right global strategy for Biosimilar developers.

Topic 3:

Immunogenicity Mitigation by Design by integrating Immunogenicity Risk Assessment and protein engineering activities to select lead candidates with the most favorable immunogenicity risk profileWell-established in silico & in vitro tools applied to guide immunogenicity de-risking; Innovative application of Screening Funnel to mitigate immunogenicity at the drug design phase; Current thinking on Clinical Relevance of non-clinical immunogenicity risk assessment tools and on-going efforts to improve their potential predictive power. 

Topic 4:

Present landscape for ADC Immunogenicity Evaluation; Bioanalytical challenges/considerations for how to deploy a fit-for-purpose, Risk-based immunogenicity testing strategy; Immunogenicity rate of ADC vs mAb/Bispecifics and systematic evaluation of approved ADC; Immunogenicity Risk Assessment (IRA) to evaluate extent of bioanalysis; Technical considerations when developing ADC bioanalytical strategy: platform, limitations, and interpretation; Lessons Learned IRA, ADA assay Development, and Immunogenicity Interpretation of ADCs.

Topic 5:

Future directions to evaluate Peptides immunogenicity: AI-driven Prediction & integrated experimental strategies; Challenges and Innovations in Peptide Therapeutics Immunogenicity Risk Assessment; Focus on unnatural peptides with non-canonical amino acids or modified backbones, unique chemical structures, peptide-related impurities, lack of standardized regulatory thresholds; Key methodologies: in silico prediction tools, in vitro assays, proteomics and Mass Spectrometry; Current Regulatory Requirements, gaps, Emerging FDA Guidance; Lessons learned from approved drugs.

Topic 6:

Peptides Immunogenicity: What is the potential impact on PK/PD, Efficacy, and Safety? The exiting US FDA guidance refers to protein products. What information can be extrapolated when we evaluate peptide immunogenicity? Immunogenicity sampling in peptide therapeutics clinical studies. What is the sampling recommendation for high versus low level immunogenicity risk products? Integrated Summary of Immunogenicity (ISI) for peptide therapeutics. Is there any benefit of developing ISI for peptide therapeutics? 

Topic 7:

New Trends & Innovations in Immunogenicity Assessment for Biotherapeutics; Understanding the Recent Changes in the need, value and methodologies needed to assess immunogenicity response; Critical importance to keep immunogenicity assessment relevant to Compound Specific Risks; Proposed solutions to Simplify & Streamline Immunogenicity Assessment for non-clinical and clinical studies; Growing demand on advancing drug development as cost and resource efficient as possible translates in part into changing the approach for immunogenicity assessment.

Topic 8:

Novel approach using Positive Control (PC) ADA by combining Sensitivity, Prozone and S/N versus Titer correlation assessments during method validation; Use of sensitivity assessment to define concentrations for LPC and HPC; Selected LPC target S/N values between 2-3 and  same LPC for both screening and confirmatory tiers; Data evaluated from Phase 1-3 Clinical Programs presenting Correlations between titer and S/N, which includes both signal saturation and relative assay sensitive assessments. senting correlations between titer and S/N, which includes both signal saturation and relative assay sensitive assessments.

Topic 9:

Evidence of Divergence: In highly immunogenic programs, S/N underestimates ADA magnitude versus Titer; Titers better mirror exposure loss and align with PK, PD, Clinical Relevance. Why does it happen? Impact of Drug/matrix interference at MRD, hook (prozone) effects, signal saturation, and run-to-run drift on S/N; What worked methodologically? How to use each metric? Working together on a Industry/Regulators' consensus Decision Tree for when S/N can Complement/Replace Titer. reporting language, titer bins, and in-study cut-point verification to enable comparability and White Paper adoption.

Topic 10:

Why should the Industry/Regulators consider moving from the Traditional 3-Tier to 1-Tier Approach? What is the Actual Science to support the 1-Tier approach? Regulatory Feedback from a Type D meeting; Extensive clinical data demonstrating Tier 1 vs Tier 3 and Tier 2 vs Tier 3 correlations; Current strategies, experience, and challenges Implementing Reduced Tier Testing in early and late-stage clinical development. Regulatory interaction and feedback when using S/N versus Titer.

Topic 11:

Up-to-date data driven view for Omitting the Confirmatory Tier for immunogenicity testing versus the highly standardized 3-Tier Approach in line Regulatory Agencies' Expectations; Understanding the controversial proposal for 1-Tier Approach to omit the confirmatory assay and to identify ADA positive samples based on a 99.9% CP prediction interval; Risk of decreasing assay sensitivity creating False Negatives and impair assay specificity as False Positives due to matrix effects will no longer get eliminated.

Topic 12:

Are Cut Points (CP) and 3-Tier Approach for immunogenicity Flawed Concepts? Is it possible to validate ADA assays and reporting immunogenicity results without using CP? CP may not improve the ability to detect ADA and have negative impact on assay sensitivity; CP are extremely resource-intense and limit the ability to understand clinical immunogenicity data; Why should we omit the confirmatory and titration tiers and base immunogenicity assessments only on 1-Tier?

Topic 13:

Comprehensive strategy for assessing ADA assay Cut Points to ensure accurate immunogenicity evaluation; Understanding Regulatory Guidelines on confirming CP suitability for the specific study population; Statistical method for confidence intervals used to compare newly derived study-specific CP to previously established validation CP. Fit-for-Purpose approach to ensure the appropriateness of key assay performance parameters; In-study confirmatory CP using study baseline samples outside of confidence interval within 2-11% false positive rate. 

2026 White Paper on Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance

Consensus & Conclusions on Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance for 2026 White Paper

Panel Discussion with All the Regulators:

Have an Open Dialogue with the Regulators including US FDA, UK MHRA, Austria AGES / EU EMA, Health Canada
Ask the Regulators any Questions You Have on Immunogenicity of Biotherapeutics and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes