21st Applied Pharmaceutical Analysis (APA) Conference
September 14-15-16, 2026
Sanofi, Cambridge
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Plenary Speaker Chongwoo Yu, PhD DCEP/OCP/OTS/CDER @ US Food and Drug Administration Regulatory Perspectives on Biomarker Bioanalysis
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Heather Myler, PhD Senior Director, Head of Immunogenicity & New Modalities @ Takeda The degree of validation needed for quantitative decision-making biomarkers vs more exploartory biomarkers - title TBA |
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Ronald Bowsher, PhD Partner & CSO @ B2S Life Sciences Immunogenicity of peptides - method development, positive control generation dealing with low positive rates - title TBA |
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Jenny Valentine, PhD Senior Principal Scientist @ Regeneron A Streamlined Approach to Immunogenicity Assessment: From Analysis to Submission |
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Jason DelCarpini, PhD Director, Bioanalysis & Molecular Assays @ Moderna Real-world applications of AI in BA for small and large molecules - title TBA |
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Sarah Bean, PhD Senior Director Laboratory Sciences @ Charles River Laboratories |
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Jeongsup Shim, PhD Senior Principal Scientist @ Genentech Simplifying PK and Biomarker Analysis: High-Sensitivity Single-Dilution Assays With The NULISA Platform |
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2026 Regulated Bioanalysis Workshop
Session I: Regulatory & Agency Perspectives
Session II: Emerging Technologies in Bioanalysis & Next Generation Modalities
Session III: Immunogenicity & ADA in Regulated Context
Session IV: AI/ML in Regulated Bioanalysis
2026 Discovery Bioanalysis and New Technologies Workshop
Session I: Discovery BA for Oligonucleotide Therapeutics & Antibody-Conjugated Platforms
Session II: Discovery BA for Complex & Emerging Therapeutic Modalities
Session III: Biomarkers & Multi-Omics in Discovery
Session IV: Case Studies on Novel Technologies & Implementation
2026 Mechanistic ADME Workshop
Session I: New Approach Methodology for Drug Metabolism & Toxicity
Session II: Mechanistic Insights Into Drug Metabolism, Human Metabolites, and Predictive Models
Session III: Mechanistic ADME of Emerging Therapeutic Modalities
Session IV: Mechanistic ADME for Dose and Exposure Prediction
DOWNLOAD 2025 APA PROGRAM GUIDE
APA 2026 Program
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PLENARY LECTURE
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PLENARY LECTURE
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