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Mon, Jul 13
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Monday, July 13, 2026
2:00 PM - 6:00 PM
East Coast USA Time
Registration
2:00 PM - 6:00 PM
East Coast USA Time
Registration
Location: Kojo Kamau Prefunction
3:00 PM - 6:00 PM
East Coast USA Time
Exhibitor Move-In
3:00 PM - 6:00 PM
East Coast USA Time
Exhibitor Move-In
Location: Kojo Kamau BC
6:00 PM - 8:00 PM
East Coast USA Time
Welcome Reception
6:00 PM - 8:00 PM
East Coast USA Time
Welcome Reception
Location: Kojo Kamau BC
Tuesday, July 14, 2026
8:00 AM - 11:30 AM
East Coast USA Time
Morning Plenary
Pharmaceutical Analysis Track
8:00 AM - 11:30 AM
East Coast USA Time
Morning Plenary
Location: Gina Knee
Pharmaceutical Analysis Track
8:00 AM - 11:30 AM
East Coast USA Time
Morning Plenary
Location: Kojo Kamau A
Bioanalytical Track
8:00 AM - 8:05 AM
East Coast USA Time
Introduction and Welcome
Location: Kojo Kamau A
Moderator:
Landon Greene, PhD (he/him/his)
– Vertex Pharmaceuticals
Bioanalytical Track
8:05 AM - 8:35 AM
East Coast USA Time
Accelerated Stability for Shelf Life of Small Molecules and Biologics
Location: Gina Knee
Speaker:
Kenneth C. Waterman, Ph.D., FAAPS
– FreeThink Technologies Inc
Pharmaceutical Analysis Track
8:35 AM - 9:05 AM
East Coast USA Time
From Artifacts to Insight: Antidrug Antibody Assays for Antibody-drug Conjugates
Location: Kojo Kamau A
Speaker:
Lin Yang, PhD (she/her/hers)
– AstraZeneca
Bioanalytical Track
8:35 AM - 9:05 AM
East Coast USA Time
Harmonization of a Physicochemical Profiling Platform of Therapeutic Oligonucleotides
Location: Gina Knee
Speaker:
Kohsaku Kawakami, PhD (he/him/his)
– National Institute for Materials Science
Pharmaceutical Analysis Track
9:05 AM - 9:35 AM
East Coast USA Time
High-Sensitivity Immunoassay Platform Evaluation for Pharmacokinetic Analysis of T-Cell Engagers
Location: Kojo Kamau A
Speaker:
Josh T. Albert, BSc
– GlaxoSmithKline
Bioanalytical Track
9:35 AM - 10:05 AM
East Coast USA Time
Two Assays, One mRNA-Derived Protein: Cross-Platform Concordance Between Studies
Location: Kojo Kamau A
Speaker:
Quentin Burke (he/him/his)
– Moderna Inc.
Bioanalytical Track
10:30 AM - 11:00 AM
East Coast USA Time
Improved Sensitivity in IBD Bioanalysis by Addressing Matrix Interference Challenges
Location: Kojo Kamau A
Speaker:
Harpinder Saini
– Genentech, Inc.
Bioanalytical Track
11:00 AM - 11:30 AM
East Coast USA Time
Panel Discussion
Location: Kojo Kamau A
Speaker:
Josh T. Albert, BSc
– GlaxoSmithKline
Speaker:
Quentin Burke (he/him/his)
– Moderna Inc.
Speaker:
Harpinder Saini
– Genentech, Inc.
Speaker:
Lin Yang, PhD (she/her/hers)
– AstraZeneca
Bioanalytical Track
8:00 AM - 12:00 PM
East Coast USA Time
Morning Plenary
11:30 AM - 12:00 PM
East Coast USA Time
Panel Discussion
Location: Gina Knee
Speaker:
Kenneth C. Waterman, Ph.D., FAAPS
– FreeThink Technologies Inc
Speaker:
Kohsaku Kawakami, PhD (he/him/his)
– National Institute for Materials Science
Speaker:
Fabrice G. Gritti, PhD (he/him/his)
– Waters Corporation
Pharmaceutical Analysis Track
8:05 AM - 8:35 AM
East Coast USA Time
Morning Plenary
8:05 AM - 8:35 AM
East Coast USA Time
Immunogenicity and AAV Gene Therapies
Speaker:
Jim McNally, PhD
– Sword Bio
Bioanalytical Track
9:05 AM - 9:35 AM
East Coast USA Time
Morning Plenary
9:05 AM - 9:35 AM
East Coast USA Time
Accelerating Drug Product Analytical Research and Development Through Digital-First Science
Location: Gina Knee
Speaker:
Saisi Xue, PhD
– BMS
Pharmaceutical Analysis Track
9:35 AM - 10:05 AM
East Coast USA Time
Morning Plenary
9:35 AM - 10:05 AM
East Coast USA Time
Development of an Improved Size Exclusion Chromatography Method for Antibody-RNA Conjugates
Speaker:
Sean Crowe, PhD
– Eli Lilly and Company
Pharmaceutical Analysis Track
10:30 AM - 11:00 AM
East Coast USA Time
Morning Plenary
10:30 AM - 11:00 AM
East Coast USA Time
Molecular Dynamics for Prediction of RTs
Location: Gina Knee
Speaker:
Fabrice G. Gritti, PhD (he/him/his)
– Waters Corporation
Pharmaceutical Analysis Track
11:00 AM - 11:30 AM
East Coast USA Time
Morning Plenary
11:00 AM - 11:30 AM
East Coast USA Time
Comprehensive Assessment of Microchip Zone Electrophoresis to Study Large Molecule Therapeutics
Speaker:
Anton Kozyryev, PhD (he/him/his)
– Merck
Pharmaceutical Analysis Track
11:30 AM - 12:00 PM
East Coast USA Time
The Nitrate Anion: A Biomarker Assay Subject to Environmental Influence
11:30 AM - 12:00 PM
East Coast USA Time
The Nitrate Anion: A Biomarker Assay Subject to Environmental Influence
Location: Kojo Kamau A
Partner Presentation Speaker:
Nicholas Ingram, BS (he/him/his)
– IQVIA Laboratories
Bioanalytical Track
Sponsored By
12:00 PM - 12:30 PM
East Coast USA Time
Balancing Sensitivity and Robustness in Molecular Bioanalysis
12:00 PM - 12:30 PM
East Coast USA Time
Balancing Sensitivity and Robustness in Molecular Bioanalysis
Location: Kojo Kamau A
Partner Presentation Speaker:
Agostinho Rocha, arocha@smithers.com
– Smithers - Pharmaceutical Development Services
Bioanalytical Track
Sponsored By
1:30 PM - 3:00 PM
East Coast USA Time
Afternoon Plenary
Bioanalytical Track
1:30 PM - 3:00 PM
East Coast USA Time
Afternoon Plenary
Location: Kojo Kamau A
Bioanalytical Track
1:30 PM - 3:00 PM
East Coast USA Time
Afternoon Plenary
Location: Gina Knee
Pharmaceutical Analysis Track
1:30 PM - 1:35 PM
East Coast USA Time
Session Introduction
1:35 PM - 2:05 PM
East Coast USA Time
Clinical ADA Method: Universal vs In Study Cut Point?
Location: Kojo Kamau A
Speaker:
Tong-Yuan Yang, PhD (he/him/his)
– Johnson & Johnson Innovative Medicine
Bioanalytical Track
1:35 PM - 2:05 PM
East Coast USA Time
N-Nitrosamine Quantitation in Pharmaceticals by Tandem Mass Spectrometry
Location: Gina Knee
Speaker:
Mousumi Saha (she/her/hers)
– Purdue University
Pharmaceutical Analysis Track
2:05 PM - 2:35 PM
East Coast USA Time
Advanced Chromatographic Method Development to Enable Comprehensive Control Strategies for Complex Drug Modalities
Location: Gina Knee
Speaker:
Hongyue Guo, PhD
– AbbVie
Pharmaceutical Analysis Track
2:05 PM - 2:35 PM
East Coast USA Time
Comparing Assay Strategies Across Bioanalytical, Biomarker, and Pharmaceutical Testing Frameworks
Location: Kojo Kamau A
Speaker:
Enrique A. Dalmasso, Ph.D.
– U.S. Pharmacopeia
Bioanalytical Track
1:30 PM - 3:05 PM
East Coast USA Time
Afternoon Plenary
2:35 PM - 3:05 PM
East Coast USA Time
Title TBD (Bioanalytics)
Location: Kojo Kamau A
Speaker:
Fabrice G. Gritti, PhD (he/him/his)
– Waters Corporation
Bioanalytical Track
1:30 PM - 3:10 PM
East Coast USA Time
Afternoon Plenary
2:35 PM - 3:05 PM
East Coast USA Time
Application of Benchtop NMR for API Quantification in Modern Drug Product Development and Supply
Location: Gina Knee
Speaker:
Meredith Dinges, PhD (she/her/hers)
– Organon
Pharmaceutical Analysis Track
3:30 PM - 4:00 PM
East Coast USA Time
A CROs Prospective on Biomarker Fit for Purpose Validation Tiers for Multiple Bioanalytical Platforms (LBA, PCR, LC-MS/MS)
3:30 PM - 4:00 PM
East Coast USA Time
A CROs Prospective on Biomarker Fit for Purpose Validation Tiers for Multiple Bioanalytical Platforms (LBA, PCR, LC-MS/MS)
Location: Kojo Kamau A
Partner Presentation Speaker:
Dominic Warrino, PhD
– KCAS Bio
Partner Presentation Speaker:
Dawn Dufield, PhD
– KCAS Bio
Bioanalytical Track
Sponsored By
4:00 PM - 4:15 PM
East Coast USA Time
Rapid Fires
4:00 PM - 4:15 PM
East Coast USA Time
Development, Validation, & Implementation of a Shedding/Biodistribution qPCR Assay to Support Development of DB-OTO
Rapid Fire Presenter:
Sasha Fraser, PhD
– Regeneron Pharmaceuticals
Bioanalytical Track
4:00 PM - 4:15 PM
East Coast USA Time
Isolation and Structural Elucidation of Novel Degradants of Edaravone.
Location: Gina Knee
Rapid Fire Presenter:
Kishore Raju Vatsavai, M. Pharm (he/him/his)
– Veranova
Pharmaceutical Analysis Track
4:00 PM - 5:00 PM
East Coast USA Time
Rapid Fires
4:00 PM - 5:00 PM
East Coast USA Time
Rapid Fires
Location: Gina Knee
Pharmaceutical Analysis Track
4:15 PM - 4:30 PM
East Coast USA Time
Managing Biosafety in Nasal Spray Live Vaccine Testing
Location: Gina Knee
Rapid Fire Presenter:
Yannick Baschung, PhD (he/him/his)
– Solvias, Inc
Pharmaceutical Analysis Track
4:30 PM - 4:45 PM
East Coast USA Time
Modern NIR for Biotherapeutics: Comparative Component Identification and Quantitation
Location: Gina Knee
Rapid Fire Presenter:
Joey P. Campbell, PhD (he/him/his)
– Prolytix
Pharmaceutical Analysis Track
4:15 PM - 4:30 PM
East Coast USA Time
Rapid Fires
4:15 PM - 4:30 PM
East Coast USA Time
Navigating the Evolving ADC Landscape: Bioanalytical Challenges, Strategies, and Operational Considerations
Location: Kojo Kamau A
Rapid Fire Presenter:
Drupadkumar Acharya, MS
– Johnson & Johnson Innovative Medicine
Bioanalytical Track
4:30 PM - 4:45 PM
East Coast USA Time
Rapid Fires
4:30 PM - 4:45 PM
East Coast USA Time
Application of ICH M10 Bioanalytical Method Validation Guidelines to Emerging Analytical Technologies
Rapid Fire Presenter:
Tim Lochmann, PhD
– PPD
Bioanalytical Track
Wednesday, July 15, 2026
8:00 AM - 11:15 AM
East Coast USA Time
Morning Plenary
Pharmaceutical Analysis Track
8:00 AM - 11:15 AM
East Coast USA Time
Morning Plenary
Location: Gina Knee
Pharmaceutical Analysis Track
8:00 AM - 11:30 AM
East Coast USA Time
Morning Plenary
Bioanalytical Track
8:00 AM - 11:30 AM
East Coast USA Time
Morning Plenary
Location: Kojo Kamau A
Bioanalytical Track
8:00 AM - 8:05 AM
East Coast USA Time
Session Introduction
Location: Kojo Kamau A
Bioanalytical Track
8:05 AM - 8:35 AM
East Coast USA Time
Bioanalysis for Emerging Modalities: From Exploratory Innovation to Regulatory-Ready Strategies
Location: Kojo Kamau A
Speaker:
Nan Zhao, PhD
– WuXi AppTec
Bioanalytical Track
8:05 AM - 8:35 AM
East Coast USA Time
Regulatory and Compendial Expectations for Analytical Method Lifecycle Management
Location: Gina Knee
Speaker:
Kim Huynh-Ba, MS, PMP, FAAPS (she/her/hers)
– Pharmalytik
Pharmaceutical Analysis Track
8:35 AM - 9:05 AM
East Coast USA Time
Analytical Method Standardization- An Initiative for Quality, Efficiency, and Harmonization
Location: Gina Knee
Speaker:
Wendy Yang, MSc (she/her/hers)
– Eli Lilly and Company
Pharmaceutical Analysis Track
8:35 AM - 9:05 AM
East Coast USA Time
Development Considerations for Tirzepatide: Drug Disposition Package for Registration
Location: Kojo Kamau A
Speaker:
Jennifer A. Martin, MS (she/her/hers)
– Eli Lilly and Company
Bioanalytical Track
9:05 AM - 9:35 AM
East Coast USA Time
Delivering Trustworthy Data: The Art of Fit-for-Purpose ELISpot & FluoroSpot Assays
Location: Kojo Kamau A
Speaker:
Sylvia Janetzki, MD (she/her/hers)
– ZellNet Consulting, Inc.
Bioanalytical Track
9:05 AM - 9:35 AM
East Coast USA Time
Method Lifecycle Management: From Development Through Commercial Manufacturing
Location: Gina Knee
Speaker:
Kimberly A. Lupo, M.S., M.B.A.
– PORTRETT PHARMACEUTICALS LLC
Pharmaceutical Analysis Track
9:35 AM - 10:05 AM
East Coast USA Time
Beyond the Template: Flexible Neutralizing Antibody (nAb) Assessment in the Era of Emerging Modalities and Complex Mechanisms of Action
Location: Kojo Kamau A
Speaker:
Gurleen Saini, MS
– Boehringer Ingelheim
Bioanalytical Track
10:30 AM - 11:00 AM
East Coast USA Time
PBBM in Drug Development - Case Studies and Regulatory Applications
Location: Kojo Kamau A
Speaker:
Tycho H. Heimbach, PhD, FAAPS (he/him/his)
– Tycho Heimbach
Bioanalytical Track
11:00 AM - 11:30 AM
East Coast USA Time
Panel Discussion
Location: Kojo Kamau A
Bioanalytical Track
9:35 AM - 10:05 AM
East Coast USA Time
Morning Plenary
9:35 AM - 10:05 AM
East Coast USA Time
A Comparative Analytical Framework for NDA and ANDA Submissions
Speaker:
Rachna Chaddha, Masters in Analytical Chemistry (she/her/hers)
– Eli Lilly and Company
Pharmaceutical Analysis Track
10:30 AM - 11:00 AM
East Coast USA Time
Morning Plenary
10:30 AM - 11:00 AM
East Coast USA Time
From ATP to QC: A Risk-Based Assessment Workflow to Enables Robust Commercial Analytical Methods
Speaker:
Peter I. Tattersall, PhD (he/him/his)
– Bristol Myers Squibb Company
Pharmaceutical Analysis Track
11:00 AM - 11:30 AM
East Coast USA Time
Morning Plenary
11:00 AM - 11:30 AM
East Coast USA Time
Characterization of Product Variants and Product-Related Impurities Detected by Capillary Electrophoresis
Speaker:
Timothy Blanc
– Biopharm Control Strategy
Pharmaceutical Analysis Track
11:30 AM - 12:00 PM
East Coast USA Time
Comprehensive Characterization of Biotherapeutics Using Complementary LC-MS Workflows
11:30 AM - 12:00 PM
East Coast USA Time
Comprehensive Characterization of Biotherapeutics Using Complementary LC-MS Workflows
Location: Kojo Kamau A
Partner Presentation Speaker:
Randy Arnold, PhD
– SCIEX
Bioanalytical Track
Sponsored By
12:00 PM - 12:30 PM
East Coast USA Time
From Receipt to Report: Automating the Project Lifecycle
12:00 PM - 12:30 PM
East Coast USA Time
From Receipt to Report: Automating the Project Lifecycle
Location: Kojo Kamau A
Partner Presentation Speaker:
Ely Porter, PhD
– Dash Bio
Bioanalytical Track
Sponsored By
1:30 PM - 3:00 PM
East Coast USA Time
Afternoon Plenary
Bioanalytical Track
1:30 PM - 3:00 PM
East Coast USA Time
Afternoon Plenary
Location: Kojo Kamau A
Bioanalytical Track
1:35 PM - 2:05 PM
East Coast USA Time
Assumed Safe, Proven Risky: Reference Materials and Assay Performance
Location: Kojo Kamau A
Speaker:
Tatiana Mordente Clemente, PhD (she/her/hers)
– Celerion
Bioanalytical Track
2:05 PM - 2:35 PM
East Coast USA Time
Mass Spectrometry Regulated Bioanalytical Advances for Biomarkers
Location: Kojo Kamau A
Speaker:
Hemanth Akkiraju, PhD (he/him/his)
– IQVIA Laboratories
Bioanalytical Track
1:30 PM - 3:10 PM
East Coast USA Time
Afternoon Plenary
Pharmaceutical Analysis Track
1:30 PM - 3:10 PM
East Coast USA Time
Afternoon Plenary
Location: Gina Knee
Pharmaceutical Analysis Track
2:05 PM - 2:35 PM
East Coast USA Time
New Approaches to Nitrosamine Detection and Mitigation
Location: Gina Knee
Speaker:
Eric J. Munson, PhD, FAAPS
– Purdue University
Pharmaceutical Analysis Track
2:35 PM - 3:05 PM
East Coast USA Time
An Excipient-Dependent Surfactant Threshold Governs Aggregation in Monoclonal Antibody Formulations
Location: Gina Knee
Speaker:
Oluwatosin Y. Ibhagui, PhD
– Regeneron Pharmaceuticals
Pharmaceutical Analysis Track
1:30 PM - 3:30 PM
East Coast USA Time
Afternoon Plenary
2:35 PM - 3:05 PM
East Coast USA Time
Pseudo Leukotrienes: Cysteinyl Leukotriene-like Agonists are Upregulated in Severe Asthma
Location: Kojo Kamau A
Speaker:
Siyang Liu (he/him/his)
– Case Western Reserve University
Bioanalytical Track
3:30 PM - 4:00 PM
East Coast USA Time
Automated Immunoassays Address Analytical Bottlenecks in ADC Drug Development
3:30 PM - 4:00 PM
East Coast USA Time
Automated Immunoassays Address Analytical Bottlenecks in ADC Drug Development
Location: Kojo Kamau A
Partner Presentation Speaker:
Eric Plante, PhD
– Gyros Protein Technologies
Bioanalytical Track
Sponsored By
4:00 PM - 5:00 PM
East Coast USA Time
Rapid Fires
Pharmaceutical Analysis Track
4:00 PM - 5:00 PM
East Coast USA Time
Rapid Fires
Location: Gina Knee
Pharmaceutical Analysis Track
4:00 PM - 5:00 PM
East Coast USA Time
Rapid Fires
Location: Kojo Kamau A
Bioanalytical Track
4:00 PM - 4:15 PM
East Coast USA Time
Evaluating Particle Size Distribution in Micronized and Nanosuspension Systems
Location: Gina Knee
Rapid Fire Presenter:
Srinivasulu Kasa
– Hikma Pharmaceuticals Usa Inc.
Pharmaceutical Analysis Track
4:00 PM - 4:15 PM
East Coast USA Time
Good Laboratory Practice (GLP) Compliance qPCR-Validation
Location: Kojo Kamau A
Rapid Fire Presenter:
Hikmat Al-Hashimi
– Eurofins Viracor BioPharma
Bioanalytical Track
4:15 PM - 4:30 PM
East Coast USA Time
Bioanalytical Divide: Adapting AI Assays for Resource-Limited Ethiopian Settings
Location: Kojo Kamau A
Rapid Fire Presenter:
Gadisa Tulu, n/a
– Haramaya University
Bioanalytical Track
4:15 PM - 4:30 PM
East Coast USA Time
Understanding-Implementing ICH Q14 and USP 1220 in Analytical Labs
Location: Gina Knee
Rapid Fire Presenter:
Manu Grover, M.S. MBA (he/him/his)
– Agilent Technologies Inc
Pharmaceutical Analysis Track
4:30 PM - 4:45 PM
East Coast USA Time
One for the Win: Singlicate Analysis for Diverse Therapeutic Modalities
Rapid Fire Presenter:
Deborah Johnson, PhD (she/her/hers)
– Regeneron
Bioanalytical Track
4:30 PM - 4:45 PM
East Coast USA Time
Rapid Fires
4:30 PM - 4:45 PM
East Coast USA Time
Automated Bioassay Sample Preparation Using a Hamilton STAR Liquid Handler in a Regulatory GMP Environment
Location: Gina Knee
Rapid Fire Presenter:
Cindy Heath (she/her/hers)
– Eli Lilly
Pharmaceutical Analysis Track
4:45 PM - 5:00 PM
East Coast USA Time
Rapid Fires
4:45 PM - 5:00 PM
East Coast USA Time
Integrated Metabolite Identification and Quantitation Strategies for Lipid Nanoparticle in mRNA Vaccines and Therapeutics
Location: Kojo Kamau A
Rapid Fire Presenter:
Prasad Gobburi, PhD (he/him/his)
– Moderna Therapeutics LLC
Bioanalytical Track
Thursday, July 16, 2026
8:00 AM - 10:30 AM
East Coast USA Time
Morning Plenary
Moderator:
Landon Greene, PhD (he/him/his)
– Vertex Pharmaceuticals
Bioanalytical Track
Pharmaceutical Analysis Track
8:00 AM - 10:30 AM
East Coast USA Time
Morning Plenary
Location: Kojo Kamau A
Moderator:
Landon Greene, PhD (he/him/his)
– Vertex Pharmaceuticals
Bioanalytical Track
Pharmaceutical Analysis Track
8:05 AM - 8:40 AM
East Coast USA Time
Distinguishing AI, Coding, and Automation in Modern Bioanalytical Workflows
Location: Kojo Kamau A
Speaker:
Jean Custodio, PhD (he/him/his)
– IQVIA Laboratories
Bioanalytical Track
Pharmaceutical Analysis Track
8:40 AM - 9:15 AM
East Coast USA Time
Implementing FDA Guidance for Artificial Intelligence in Drug Development Lifecycle
Location: Kojo Kamau A
Speaker:
Kishore Raju Vatsavai, M. Pharm (he/him/his)
– Veranova
Bioanalytical Track
Pharmaceutical Analysis Track
9:15 AM - 9:50 AM
East Coast USA Time
Applying Artificial Intelligence to Accelerate Report Writing
Location: Kojo Kamau A
Speaker:
Anuj Chadha
– Alchemi
Bioanalytical Track
Pharmaceutical Analysis Track
10:30 AM - 10:35 AM
East Coast USA Time
Closing Remarks - 2027 Program Chair
10:30 AM - 10:35 AM
East Coast USA Time
Closing Remarks - 2027 Program Chair
Location: Kojo Kamau A
Speaker:
Mark Wissel, Ph.D.
– Eurofins Scientific
Bioanalytical Track
Pharmaceutical Analysis Track
10:35 AM - 11:00 AM
East Coast USA Time
Grab and Go Break
10:35 AM - 11:00 AM
East Coast USA Time
Grab and Go Break
Bioanalytical Track
Pharmaceutical Analysis Track
