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Tuesday, July 14, 2026
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 - 11:30 AM East Coast USA Time

Morning Plenary

Location: Gina Knee

Pharmaceutical Analysis 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