Program

All sessions are taking place at the Minneapolis Renaissance Hotel, The Depot unless otherwise noted. All times are in Central Daylight Time (CDT)*

Bioanalytical Track

Pharmaceutical Analysis Track

Monday, July 10

Registration Open  (2:00 PM – 8:00 PM)

Exhibitor Move-In (3:00 PM – 6:00 PM)

Welcome Reception (6:00 PM – 8:00 PM)

Sponsored by:

Tuesday, July 11

Continental Breakfast (7:30 AM – 8:00 AM)

 

Morning Plenary: Old Platform, New Tricks Part 1 (8:00 AM – 11:30 AM)

• Enzyme Analysis by LC-MS/MS
Matthew Schultz, Ph.D., Mayo Clinc
• LCMA; Distinguish Endrogenous vs Drug Product
Ines Santos, Ph.D., Bristol-Myers Squibb
• Transgene Expression – LCMS
Jason M. Walsh Ph.D., Pfizer
• Mass Spectrometry Provides Insights into ADC Drug Development: Case Studies in PK, ADME, and Biotransformations
Violet Lee, Ph.D., Genentech
• Use of LCMS for ADA Isotyping
Li Sun, Ph.D., Merck

Morning Plenary: Lab of the Future (8:00 AM – 11:30 AM)

• Industry-Academia Collaborations to Build the 'Lab of the Future' for Pharmaceutical Analysis
Chris Welch, Ph.D., Indiana Consortium for Analytical Science & Engineering
• Data Integrity Considerations for the Lab of the Future
Meg Gallwitz, BA, The Henrici Group
• Pharmaceutical Applications of Compact Capillary Liquid Chromatography
James P. Grinias, Ph.D., Rowan University
• Greening Pharmaceutical Analysis: Reducing Waste Stream From A Common Test
Adam Socia, Ph.D., Organon
• AI and Automation in the CRO Lab
Sawani Talekar, Ph.D., Crystal Pharmatech

Thought Leadership Presentation (11:30 AM - 12:00 PM)

Challenges and Strategies in Developing Hybrid LCMS Methods for Proteins 
Ben Nie, Ph.D., BioAgilytix

Sponsored By:

Thought Leadership Presentation  (11:30 AM - 12:00 PM)

Analysis and Removal of Procoagulant Contaminants from Your Plasma-derived Therapy
Matt Whelihan, Ph.D., Prolytix

Sponsored By:

Thought Leadership Presentation (12:00 PM - 12:30 PM)

Setting the First Human Dose: Minimizing Variables Across Species
Shane Needham, Ph.D., Veloxity Labs LLC
Sponsored By:

Thought Leadership Presentation  (12:00 AM - 12:30 PM)

Applying Bioinformatics/AI in Mining Public Data to Boost the Lab of the Future
Rohita Sinha, Ph.D., Eurofins Viracor

Sponsored By:

Lunch (12:30 PM – 1:30 PM)

Afternoon Plenary: Old Platform, New Tricks Part 2 (1:30 PM – 3:00 PM)

• Increasing Complexity in Single-Cell Analysis: Challenges and Opportunities for High Parameter Flow Cytometry in Clinical Trials
Enrique Gomez-Alcaide, Ph.D., Roche
• Bioanalysis of Novel Protein Modalities
Alexander Kozhich, Ph.D., Bristol-Myers Squibb
• Application of Mass Spectrometry in Uncovering New Biology of Therapeutic Targets
Eugene Zhen, Ph.D., Lilly

Afternoon Plenary: Analytical Tools to Enable Continuous Manufacturing (1:30 PM – 3:00 PM)

• API Continuous Manufacturing
Bradley Greiner, MS., AbbVie
• High-speed Quality Inspection During Tablet Production by Embedded PAT
Marten Klukkert, Ph.D., Fette Compacting GmbH
• FDA Perspective
David Acevedo, Ph.D., U.S. Food and Drug Administration

Thought Leadership Presentation (3:30 PM - 4:00 PM)

Choosing HRMS vs. LBA for Bioanalysis 
Adriane Spytko, Q2 Solutions

Sponsored By: 

Rapid Fire Presentations (4:00 PM – 5:00 PM)

• Development of Pharmacodynamic Assay to Measure Intracellular Response Biomarkers using Peripheral Blood Mononuclear Cells: Paths and Pitfalls
Eric Cruz, Ph.D., Celerion
• Single PK Method for Active, Mask, and Prodrug using LC/MS
Emily Werth, Ph.D., Boehringer Ingelheim
• Ultra-sensitive Immuno-capture PCR Demonstrates Rapid Plasma Clearance and Minimal Shedding of Intact AAV5 Vector Capsids
Krystal Sandza, BS, BioMarin Pharmaceuticals
• Computational Prediction of Biotherapeutic Immunogenicity Risk
Patrick Wu, MD, Ph.D., Genentech

Rapid Fire Presentations (3:30 PM – 4:15 PM)

• A Modular Automation Approach to High-Throughput Drug Profiling.
Kenneth Gleason, BS, AbbVie
• Predictive dissolution of nanoparticle formulations
Emre Tuereli, Ph.D., MyBiotech GmbH
• Internet of Things in the Laboratory
George Cokenakes, Ph.D., Gnosko Bio

Evening Reception at Union Rooftop (6:15 PM – 8:15 PM)

• Partner opportunities available! Learn more

Wednesday, July 12

Registration Open (7:00 AM – 5:00 PM)

Continental Breakfast (7:30 AM – 8:00 AM)

 

Morning Plenary: Emerging Platforms and New Challenges Part 1 (8:00 AM – 11:30 AM)

• Immune Monitoring Biomarker Strategies for Gene Therapies
Kristen Kahle, Ph.D., Spark Therapeutics
• Capillary vs Venous Blood Draws - Which Analyte is Compromised
Iris Xie, MS, Merck
• HRMS in Regulated Bioanalysis – Ace in the Hole or Jack of All Trades?
Barry Jones, Ph.D., Crinetics Pharmaceuticals
• Considerations in Selecting Quantitative vs. Digital PCR Platforms for Bioanalysis
Russell Soon, Jr., BS, BioMarin Pharmaceutical
• Application of Blood Microsampling in Cynomolgus Monkey and Demonstration of Equivalent mAB PK Parameters Compared to Conventional Sampling
Ying Wang, Ph.D., Pfizer
• Microsampling/Patient-Centric Sampling – Bioanalytically Focused
Melanie Anderson, MS, Merck

Morning Plenary: Analytical Challenges in Developing Novel Modalities (8:00 AM – 11:30 AM)

• Approach to AAV GTx Potency Strategy in the Context of a Comprehensive Control Strategy
Savita Sankar, Ph.D., Pfizer
• Technical and Strategic Considerations for Enabling Co-Formulated Biologics: Venturing Beyond Standard IgGs at Narrow Ratios
Joseph Valente, Ph.D., Bristol-Myers Squibb
• ADC/Drug Linker Structure/Conjugation Site Effect on Phys Chem
Brittney Mills, Ph.D., AbbVie
• Novel Modalities/Oligonucleotides
Claus Rental, Ph.D., Ionis Pharmaceuticals
• Novel Synthetic Modalities Oligos, Lipids
Mirlinda Biba, Ph.D., Merck

Sponsored Presentations (11:30 AM – 12:30 PM)

Partner opportunities available! Learn more

Thought Leadership Presentation (11:30 AM - 12:00 PM)

Accelerating Immunogenicity Analysis From IgG- to AAV-based Therapies 
Manny Lozano, Gyros Protein Technologies

Sponsored By:

Lunch (12:30 PM – 1:30 PM)

 

Afternoon Plenary: Emerging Platforms and New Challenges Part 2 (1:30 PM – 3:00 PM)

• Establishing FVIII Activity as a Reliable Predictor of Hemostatic Efficacy Following AAV5 Gene Therapy in Hemophilia A
Christian Vetterman, Ph.D., Biomarin Pharmaceutical, Inc.
• Sample Logistics and Analytical Considerations for Development of a Cellular Immunogenicity Assays for CART Therapies
Kevin Lang, Ph.D., Pharmaceutical Product Development, Inc. (PPD)
• Analytical Strategy for Oligo and mRNA

Afternoon Plenary: Clinically Relevant Specifications (1:30 PM – 3:00 PM)

• Use of PBPK Models for Dissolution Specs/Post Approval Changes
Tycho Heimbach, Ph.D., Merck
• Biologics View on Clinically Relevant Specifications
Marisa Joubert, Ph.D., Amgen
• Regulatory View of Clinically Relevant Specs
Jayda Siggers, Ph.D., Biologic and Radiopharmaceutical Drugs Directorate (BRDD) Health Canada

Rapid Fire Presentations (3:30 PM – 4:30 PM)

• Harnessing Nanoflow LC-MS to maximize sensitivity for analysis of bio-therapeutics in a high-throughput bioanalytical laboratory
Nicholas Saicheck, Ph.D., Labcorp
• Advances in At-Home Microsampling Kits for Liquid Blood Collections
Greg Sommer, Ph.D., Labcorp
• Streamlined Biomarker Assay Qualification in a Rare Matrix on the Ella Platform
Jennifer Getz, Ph.D., Genentech
• Streamlining immunogenicity assay development with binding measurements
Krisna Duong-Ly, Ph.D., Merck and Co., Inc.

Rapid Fire Presentations (3:30 PM – 4:30 PM)

• Enabling Clinically Appropriate Degradation Product Limits through Analytical Characterization of API Epimerization
Nathan Contrella, Ph.D., Merck and Co., Inc.
• Evaluation of Various Spectroscopic Procedures to Calculate Free Thiol Content in Biotherapeutics
Nicole Halaszynsku, Ph.D., Merck and Co., Inc.
• Overcoming Sterilization Challenges with Highly Viscous Pharmaceutical Formulations: Derisking from Development to the Clinic
Mohannad Kadhum, Ph.D., Lifecore Biomedical
• Structural Fingerprinting for Biologic Risk Assessment: Correlating High Resolution NMR to a Functional Outcome
Robert Brinson, Ph.D., National Institute of Standards and Technology

Closing Reception (4:30 PM - 6:00 PM)

Exhibitor Move-Out (6:00 PM - 7:00 PM) 

Thursday, July 13

Continental Breakfast (7:30 AM – 8:00 AM)

Morning Plenary:  Risk Assessment of Next Generation Biologics (8:00 AM – 10:30 AM)

• Differential Immune Responses to Deamidated Adeno-Associated Virus Vector
Ronit Mazor, Ph.D., U.S. Food and Drug Administration
• Immunogenicity Safety Monitoring for Systemic Administration of AAV Vectored Gene Therapies
Brian Long, MS, Ph.D., BioMarin Pharmaceutical, Inc.
• ICH M10 – CRO Perspective
Beth Hyer, BS, Labcorp
• Pharma’s Experience on Implementing M10
Chris James, Ph.D., Amgen
• Process: Challenges and Opportunities for Global Harmonization
Tina Morris, Ph.D., American Association of Pharmaceutical Scientists

Morning Plenary: Life Cycle Management of Analytical Procedures (8:00 AM – 10:30 AM)

• Q12 Experiences
Hasmukh Patel, Ph.D., U.S. Food and Drug Administration
• Lifecycle Management of Analytical Procedures – an Example of Pharmaceutical Counter Ion Analysis
Qinggang Wang, Ph.D., Bristol-Myers Squibb
• ICH Q14: An Enabler for Analytical Procedure Lifecycle Which Ensures Robustness of Analytical Methods During a Drug’s Lifetime
Brian Castle, Ph.D., Eli Lilly
• Post- Approval Analytical Method Performance Monitoring: A Case Study
Maria Cruanes, Ph.D., Organon
• Panel Discussion with above speakers and Jayda Siggers, Ph.D., Biologic and Radiopharmaceutical Drugs Directorate (BRDD) Health Canada

Closing Session and Moderator Readout (11:00 AM – 11:30 AM)

* Agenda as of June 12, 2023.