Applied Pharmaceutical Analysis 2025
In-Person Event
October 6 - 8, 2025
Sanofi, Cambridge, MA
Regulated Bioanalysis Workshop - Monday, October 6, 2025
Sciex's Mixer & Networking Reception (Mon., Oct 6th, Imediatly Following the Main Program)
Discovery Bioanalysis and New Technologies Workshop - Tuesday, October 7, 2025
The Boston Society Networking Reception (Tue., Oct. 7th. Imediately Following the Main Program)
Mechanistic ADME Workshop - Wednesday, October 8, 2025
APA 2025 Program
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PLENARY LECTURE Chandra Prakash, PhD Senior Research Fellow @ Agios Pharmaceuticals Human Mass Balance and Metabolite Profiling Studies: Regulatory Guidance, Technical Approaches and Clinical Implications |
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Sean Kassim, PhD Director, Office of Study Integrity and Surveillance, CDER, US Food and Drug Administration Oversight of Bioavailability and Bioequivalence Studies in Support of New and Generic Drugs and Therapeutic Biologics |
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PLENARY LECTURE Gary Jenkins, PhD Senior Director @ AbbVie AI/ML in bioanalysis and drug discovery - talk title TBA |
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Lyn Jones, PhD Principal Investigator @ Dana-Farber Cancer Institute Analytical Strategies for Covalent Drug Discovery - Targeting Residues Beyond Cysteine
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Kaushik Mitra, PhD Distinguished Scientist, Preclinical Safety & Translational Sciences @ Johnson & Johnson; Adjunct Professor, Dep. of Chemistry @ University of Missouri Hunan Dose Projection at the Point of Design
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Matthew Wagoner, PhD Global Head of Investigative Toxicology @ Takeda Pharmaceuticals Covalent Binding & TAK-994 Drug-Induced Liver Injury
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Patrick Breslin Principal Scientist @ Johnson & Johnson Innovative Medicine PK Cross Validation: Past, Present, Future |
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Wenkui Li, PhD Director Bioanalytics @ Novartis Metabolite Bioanalysis in Drug Development: Recommendations For the IQ Consortium Metabolite Bioanalysis Working Group |
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Brad Roadcap, PhD Director @ Merck Bioanalytical Immunogenicity Strategy for the Clesrovimab Program: A Case Study |
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Lindsay King, PhD Executive Director, Head Clinical and Translational Biomarkers, Translational Clinical Science @ Pfizer Biomarker Validation in Clinical Drug Development 2025 |
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Krisna Duong-Ly, PhD Principal Scientist @ Merck Identification of Critical Reagents for Novel Biotherapeutic Modalities: Considerations and Case Studies |
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Rosemary Lawrence-Henderson Principal Scientist @ Pfizer Characterization of Critical Reagents with Different New Modalities |
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Amy Li, PhD Principal Scientist @ Genentech Signal-to-Noise Ratio: A Streamlined Alternative to Titer for Anti-Drug Antibody Assessment |
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Kiyoto Aramis Tanemura, PhD Research Investigator, Quantitative Systems Pharmacology @ BMS ML Guided Selection of Chiral Supercritical Fluid Chromatography Conditions |
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Stephanie Pasas Farmer, PhD President and Founder @ BioData Solutions Consulting and Software Leveraging AI in Bioanalysis: Real-World Applications of Large Language Models |
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Jan Elias, PhD Principal Scientist @ Boehringer Ingelheim Mathematical Modeling for Human Dose Prediction of Degraders |
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Diana Cha, PhD Principal Scientist @ Alnylam Pharmaceuticals From Brain to Biofluids: Translational Readouts of Target Engagement for Tau-Lowering C16-siRNA |
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John Chen, PhD Senior Vice President @ NovaBioAssays LC-MS Bioanalytical Support for Oligonucleotide PK/PD Studies |
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Yunlin Fu, MS Senior Principal Scientist @ Novartis Bridging HELISA and LC-MS for Quantification of siRNA and Its Metabolite in Preclinical Studies |
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Emilee Knowlton, PhD Immunology Sales Specialist @ ProImmune, Inc. MHC-associated Peptide Proteomics (MAPPS) Assay for Characterization of Presented Peptide Epitopes |
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Xiaobin Zhang, PhD Associate Director @ Takeda Integrated Immunogenicity Risk Assessment in Protein-based Biotherapeutic Drug Development |
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Mark Niosi Principal Scientist @ Pfizer Bridging Traditional and Novel Compounds in Discovery: Permeability and ADME Challenges with Protacs |
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Jesse Yu, PhD DMPK Scientist @ Relay Therapeutics ADME Profiling of Clinical Stage PROTAC's |
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Martin Dowty, PhD Scientific Director, DMPK/Safety Development Biological Sciences @ AbbVie DMPK Considerations for the Development of Targeted Covalent Inhibitor Drugs: An IQ Consortium Assessment |
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Aimee Mattei, PhD Director of Immunoinformatics @ EpiVax In Silico Immunogenicity Risk Assessment: AI-Enhanced Prediction of Clinical Immunogenicity Outcomes with EpiVax's ISPRI Toolkit |
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Fabio Broccatelli, PhD Head of DMPK and Computational Chemistry @ Altos Labs Scoring Success in Molecule Making - From Idea Generation to PK Candidate Selection |
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Yipei Zhang, PhD Senior Scientist @ Takeda A Two -cycle Immunoaffinity Enrichment Strategy with Acid Treatment to Enhance Biotherapeutics Assay Sensitivity in Tissues |
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Maria Jadhav, PhD Director, GCP Team Lead, Bioanalysis @ Novartis Unraveling xRNA Immunogenicity: Insights and Future Horizons |
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Brittany Youngs, Senior Scientist, Translational DMPK & Clinical Pharmacology @ Stoke Therapeutics Overcomig Challenges Associated with Anti-drug Antibody (ADA) Assay Development for Antisense Oligonucleotides (ASO's) |
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Jinsong Yang, PhD Director, Bioanalytical Group Head @ Keros Pharmaceuticals Clinical Immunogenicity Monitoring of an Fc Fusion Protein Drug with Two Endogenous Counterparts: From Screening to Domain Specificity and Cross-Reactivity |
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Afsana Trini, PhD Principal Scientist, Clinical Pharmacology, Pharmacometrics & Bioanalysis @ BMS Exploration of AI and ML-Powered Models for Predicting Immunogenicity in Preclinical Tox Studies |
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Reilly Eason, PhD Senior Scientist @ Merck Basics of Machine Learning and Its Applications in Drug Discovery |
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Wei Liang, PhD Senior Scientist @ AbbVie Leveraging AI in Computational Toxicology |
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Qinying Yu, PhD Senior Scientist @ Genentech Covalent Protein Modifications By Reactive Metabolites: Evidence for Drug-Induced Liver Toxicity |
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Lionel Cheruzel, PhD Senior Principal Scientist @ Genentech AI-aided Drug Design From Drug Metabolism Perspectives |
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Paddy Eangoor, PhD Senior Principal Scientist/Lab Head, TMU Lab Sci @ Sanofi Strategic Bioanalytical Approaches for Complex Biologics: Tools and Case Studies
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Douglas Donaldson, PhD Senior Scientist, Biomolecular Assay Group @ Moderna When Singlicate and Duplicate Diverge: Evaluating Risk, Performance, and Feasibility in Ligand Binding Assays
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Jason Hamilton, PhD Associated Director, Method Validation @ Worldwide Clinical Trials Application of LC-MS/MS Methods for Characterization of Low-abundance Peptides, Proteins, and Biomarkers in Biological Samples
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Cody Fullenwider, PhD Associate Director, DMPK @ Vividion Therapeutics, Inc. GSH Conjugation in a Covalent Drug Discovery Paradigm: The Untold GST Story |
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Dr. Andreas Luippold, Director Discovery Sciences Technologies @ Boehringer Ingelheim Pharma GmBH & Co KG, Germany Intelligent BioAnalysis (iBA) System: Pioneering the Future of Bioanalysis |
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SCIEX USER MEETING & Reception (Oct. 6th; 5:00PM - 6:00 PM) Tatjana Talamantes, PhD Senior Product Manager, High Resolution Accurate Mass @ Sciex Unlocking Sensitivity and Selectivity:ZenoTOF 8600 for BioA, DMPK, and Beyond |
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Benjamin Wei, PhD Vice President of DMPK & Bioanalysis @ Medicilon USA Corp
Leveraging Orthogonal Platforms to Address the Bioanalysis Needs of New Modalities in Drug R&D
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Paige Vinson, PhD Director of High-Throughput Screening @ Southern Research Talk title - TBA
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Matthew Stone, PhD Sr. Advanced Workflow Specialist @ Sciex Build Resilience and Maintain Unparalleled Sensitivity for Long-term Bioanalysis
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APA 2025 Sessions
Regulated Bioanalysis Workshop
Session I: Regulated BA - Precision Strategies in Regulated BA & Biomarker Validation
Session II: Analytical Innovations in Emerging Modalities & Nucleic Acid-Based Therapies
Session III: Immunogenicity Matters: Advances in ADA Assay Development and Monitoring
Session IV: Beyond Buzzwords: Real-World AI and ML Applications in Bioanalysis
Session V: Rapid Fire Poster Presentations
Discovery Bioanalysis and New Technologies Workshop
Session I: Bioanalytical Challenges and Approaches for Oligonucleotides in Therapeutic Development
Session II: Immunogenicity & ADA Assessment
Session III: AI & Machine Learning in Bioanalysis and Drug Discovery
Session IV: Complex Biologics, Bioanalytical Strategies & Biomarker Analysis and Applications in Drug Development
Mechanistic ADME Workshop
Session I: PROTACs and Molecular Glues with respect to ADME challenges and human PK/dose projection; Early dose prediction strategies
Session II: Use of AI & ML for Early Dose Prediction and ADME Properties
Session III: New Insights on the Discovery and Chanracterization of Covalent Inhibitors
Session IV: Recent Progress on Understanding Mechanisms of Hepatotoxicity
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