Applied Pharmaceutical Analysis 2025
In-Person Event
October 6 - 8, 2025
Sanofi, Cambridge, MA
Regulated Bioanalysis Workshop - Monday, October 6, 2025
Discovery Bioanalysis and New Technologies Workshop - Tuesday, October 7, 2025
Mechanistic ADME Workshop - Wednesday, October 8, 2025
APA 2025 Program
 |
PLENARY LECTURE Chandra Prakash, PhD Senior Research Fellow @ Agios Pharmaceuticals Human Mass Balance and Metabolite Profiling Studies: Regulatory Guidance, Technical Approaches and Clinical Implications |
 |
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 |
 |
PLENARY LECTURE Gary Jenkins, PhD Senior Director @ AbbVie AI/ML in bioanalysis and drug discovery - talk title TBA |
 |
Kaushik Mitra, PhD Distinguished Scientist, DMPK & Safety Assessment, Therapeutic Lead Ophtalmology, Cardiovascular & Metabolic Diseases @ Johnson & Johnson, Adjunct Professor, Med. Chem @ University of Missouri Talk title TBA |
 |
Patrick Breslin Principal Scientist @ Johnson & Johnson Innovative Medicine Recommendations on cross-validation experiment design from bioanalytical and clinical pharmacology perspective - Title TBA |
 |
Wenkui Li, PhD Director Bioanalytics @ Novartis Institutes for BioMedical Research (NIBR) Metabolite bioanalysis on behalf of IQ consortium - Title TBA |
 |
Brad Roadcap, PhD Director @ Merck Title TBA |
 |
Lindsay King, PhD Executive Director, Head Clinical and Translational Biomarkers, Translational Clinical Science @ Pfizer Biomarker validation strategies in drug development - Title TBA |
 |
Krisna Duong-Ly, PhD Associate Principal Scientist @ Merck Identification of Critical Reagents for Novel Biotherapeutic Modalities: Considerations and Case Studies |
 |
Rosemary Lawrence-Henderson Principal Scientist @ Pfizer Characterization of Critical Reagents with Different New Modalities |
 |
Amy Li, PhD Principal Scientist @ Genentech Using S/N for ADA assays - Title TBA |
 |
Kiyoto Aramis Tanemura, PhD Research Investigator, Quantitative Systems Pharmacology @ BMS ML Guided Chiral Chromatography Conditions Selection |
 |
Stephanie Pasas Farmer, PhD President and Founder @ BioData Solutions Consulting and Software Leveraging AI in Bioanalysis: Real-World Applications of Large Language Models |
 |
Jan Elias, PhD Principal Scientist @ Boehringer Ingelheim Mathematical Modeling for Human Dose Prediction of Degraders |
 |
Diana Cha, PhD Principal Scientist @ Alnylam Pharmaceuticals LBA approaches and innovations - Title TBA |
 |
John Chen, PhD Senior Vice President @ NovaBioAssays work on LC-MS analysis of the oligonucleotides - Title TBA |
 |
Yunlin Fu, PhD Senior Principal Scientist @ Novartis Bridging HELISA and LC-MS for Quantification of siRNA and Its Metabolite in Preclinical Studies |
 |
Emilee Knowlton, PhD Immunology Sales Specialist @ ProImmune, Inc. immunopeptidomics for immunogenicity - Title TBA |
 |
Xiaobin Zhang, PhD Associate Director @ Takeda Immunogenicity Risk Assessment at the pre-IND Stage: Integrated Immunogenicity Risk Assessment in Protein-based Biotherapeutic Drug Development |
 |
Mark Niosi Principal Scientist @ Pfizer Title TBA |
 |
Jesse Yu, PhD DMPK Scientist @ Relay Therapeutics Title TBA |
 |
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 |
 |
Aimee Mattei, PhD Director of Immunoinformatics @ EpiVax In Silico Immunogenicity Risk Assessment: AI-Enhanced Prediction of Clinical Immunogenicity Outcomes with EpiVax's ISPRI Toolkit |
 |
Fabio Broccatelli, PhD Head of DMPK and Computational Chemistry @ Altos Labs Early dose prediction and ADME properties - Title TBA |
 |
Yipei Zhang, PhD Senior Scientist @ Takeda A Two -cycle Immunoaffinity Enrichment Strategy with Acid Treatment to Enhance Biotherapeutics Assay Sensitivity in Tissues |
 |
Maria Jadhav, PhD Director, GCP Team Lead, Bioanalysis @ Novartis Unraveling xRNA Immunogenicity: Insights and Future Horizons |
 |
Brittany Youngs, Senior Scientist, Translational DMPK & Clinical Pharmacology @ Stoke Therapeutics Overcomig Challenges Associated with ADA Assay Development for ASO's |
 |
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 |
 |
Afsana Trini, PhD Principal Scientist, Clinical Pharmacology, Pharmacometrics & Bioanalysis @ BMS Immunogenicity AI/ML - talk title TBA |
 |
Reilly Eason, PhD Senior Scientist @ Merck AI/ML applications in drug discovery - talk title TBA |
 |
Wei Liang, PhD Senior Scientist @ AbbVie Leveraging AI in Computational Toxicology |
 |
Qinying Yu, PhD Senior Scientist @ Genentech New DILI mechanism - talk title TBA |
|
Douglas Donaldson, PhD Senior Scientist @ Moderna ADA's assay singlicate vs duplicate sample testing - talk title TBA |
|||
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: Oligonucleotide Bioanalysis & Therapeutic Nucleic Acids
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: Building reliable screening funnels for Targeted Covalent Binders
Session IV: Recent progress on understanding mechanisms of hepatotoxicity
Join our Linkedin Group:
