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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:
JC Chen
– 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
– 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, Ph.D., 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
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, Ph.D.
– 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, Ph.D. (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
1:35 PM - 2:05 PM
East Coast USA Time
Mechanistic, Multi-Modal Characterization of Protein Aggregation to Inform Control strategies
Location: Gina Knee
Speaker:
Hanmi Xi, PhD (she/her/hers)
– Merck and Co Inc
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, Ph.D., 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, n/a
– 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
– Case Western Reserve University
Bioanalytical Track
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 Fire
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, n/a
– 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. (he/him/his)
– Agilent Technologies Inc
Pharmaceutical Analysis 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
Pharmaceutical Analysis Track
