Topic 1:

How many times should an ADA Sample be Tested before Trusting the Result? Current industry standards on ADA testing/validation, ADA LBA evolution and novel platforms, considerations on Regulatory Expectations on ADA assay format, number of replicates/validation, ADA Single Well Analysis (Singlicate) implications for method development, validation and sample testing
Dr. George Gunn, Senior Director, Head of Immunogenicity, GlaxoSmithKline

Topic 2:

Recent Regulatory Agencies Questions on ADA Assays Drug Tolerance and PK Assays ISR: Does more drug tolerant ADA assays improve understanding of immunogenicity impact on clinical response? How does ISR performed in multiple different populations improve PK assay performance? Considerations on drug tolerance and Positive Control, statistical analysis of longitudinal ISR performance
Dr. Michael Partridge, Senior Director, Regeneron

Topic 3:

Biosimilar Immunogenicity and Advanced Approaches to Demonstrate Similarity: Tailored test strategy based on immunogenic risk class, when ADA isotyping makes sense in biosimilar development, immunogenicity in silico and in vitro prediction tools, further demonstrating superiority of S/N vs Titer in a biosimilar immunogenicity studies, insights on how to test drug tolerance and impact of drug to titer and S/N parameter
Dr. Johann Poetzl, Head Bioanalytics, Sandoz

Topic 4:

Hypersensitivity Reactions and Contribution of Immunogenicity, IgG ADA, IgE ADA and Innate Immunity Factors: Bioanalytical approaches and considerations, challenges in development/validation of drug-specific IgE ADA assays, how bioanalysis can be incorporated in clinical studies and CLIA assay regulations, lessons learned in sample collection timing, results interpretation and limitations
Dr. Susan Richards, Vice President, Translational Medicine and Early Development, Sanofi

Topic 5:

The rise of Olink Technology: An unbiased evaluation of this ET, explanation of the off-the-shelf and flex panels, Can the methodology be validated? What is required to use the panels in a regulated environment? Considerations on BAV strategy for Olink, comparison between Olink vs MSD in terms of absolute values and relative changes, how to integrate Olink into a comprehensive Biomarker Plan
Dr. Rachel Palmer, Head of Biomarkers and Clinical Bioanalysis, Sanofi

Topic 6:

The Inherently Problematic Free Target Assays: Impact of the dynamic equilibrium, Can Total Assay & Modeling replace Free Assays for PK/PD? Implementation of a tiered approach for cross validation of free target assay in multiple labs, dealing with free assay variability due to drug presence, understanding the assay performance and how the data are used to support PK/PD modeling and decision-making
Dr. Huaping Tang, Executive Director & Global Head of Immunoassay Bioanalysis and Biomarkers, GlaxoSmithKline

Topic 7:

LDT/IVD/CDx Assays Development/Validation and Changing Regulations Impacting Biomarker Assays for Patient Care: Understanding of the intent of the Regulators, impact to bioanalytical/central laboratories, industry interpretation of regulatory changes, CDx strategies for early phase to registrational studies, requirements/risks for collecting samples, generating data for patient selection/stratification
Dr. Kristina McGuire, Executive Director & Head of Precision Medicine and Companion Diagnostics, Regeneron

Topic 8:

EU IVDR Impact on Clinical Trials in Europe: What is the landscape 2 years after full Implementation? What IVDR path to choose for Predictive Biomarkers? EU Health Institution exemption, Device Performance Study or CE marking, considerations on US FDA oversight of LDTs, Is US following EU now after the EU followed US? Single biomarkers method development for multinational clinical trials, Can one size fit it all?
Dr. Gerard Sanderink, Global Head Biomarkers and Clinical Bioanalyses, Sanofi

Topic 9:

Beyond Current NAb/TAb Correlation in AAV Gene Therapy: Criteria for excluding patients with high levels of pre-existing TI Abs to the AAV capsid, strategies/assays for increasing patients with IdeS, an IgG cleaving enzyme, is it still necessary to screen patients with TI Ab assay after IdeS treatment? Is it possible to substitute TI assay with a TAb assay? What are the operational and CDx development challenges?
Dr. Uma Kavita, Director, Regulated Bioanalysis, Spark

Topic 10:

Unanticipated Unique Bioanalytical Challenges with RNA-Lipoplex with Encapsulated mRNA Encoding Patient Specific Neoepitopes: Establishing sensitive and robust method in plasma for PK, overcoming issues during method development from sample collection/storage to samples testing for new drug modalities for individualized neoantigen-specific therapy under development
Dr. Kate Peng, Senior Director, BioAnalytical Sciences, Genentech

Topic 11:

Further Developments/Understanding of qPCR vs dPCR Performance: Need for sensitive Cell Therapy PK Assay for solid organ due to circulating CAR-Treg, development/validation of qPCR to quantify CAR-Treg vector copy numbers from whole blood; dPCR Rare Event Detection increasing the amount of DNA input without interference from matrix DNA and combining multiple wells into one measurement
Dr. Yanmei Lu, Vice President, Biomarker and BioAnalytical Sciences, Sangamo

Topic 12:

Understanding the Relationship between LBA & NAb Assay responses and Cell-Based Assays (CBA)/Cell-Mediated Immunity (CMI): Considerations on type of assay may or may not represent the responses captured in another assay, immunogenicity thresholds, correlation of protection, interpretation of vaccine-induced immune responses in lieu of efficacy studies, what assay to use for defining meaningful immunogenicity response?
Dr. Ingrid Scully, Executive Director, Head of Clinical Immunology, Pfizer

Topic 13:

Novel approaches for Pneumococcal Serotyping from Molecular Serotyping Assays to Multiplex Luminex Assays: Use of serotype-specific monoclonal antibodies to identify the infecting serotype, evaluation of sample matrix, sample volume and direct vs. culture-enriched methodologies, technology selection based on intended use of the assay and feasibility to validate in regulated vaccine clinical assays
Dr. Katrina Nolan, Director, Vaccine Regulated Bioanalysis, Merck

Topic 14:

Advanced use of Multiplexed LBA to Quantify Antibody Levels in Serum from Multiple SARS CoV2 Variants: Novel study design to assess SARS CoV2 antibody levels after different mRNA vaccination regimens, use of Patient Centric Technologies via self-collected capillary blood draw device and shipment to central lab, data from titers and response duration post-vaccination segregated by vaccine regimen received
Dr. Victor Hou, Senior Director, Head of Infectious Disease, Clinical Biomarkers, Moderna

2024 White Paper on Ligand-Binding, Cell-Based, and Molecular Assays

Consensus & Conclusions on Ligand-Binding, Cell-Based, and Molecular Assays for 2024 White Paper