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 TherapyMatt Whelihan, Ph.D., Prolytix Sponsored By: Thought Leadership Presentation (12:00 PM - 12:30 PM) Setting the First Human Dose: Minimizing Variables Across SpeciesShane Needham, Ph.D., Veloxity Labs LLCSponsored By: Thought Leadership Presentation (12:00 AM - 12:30 PM) Applying Bioinformatics/AI in Mining Public Data to Boost the Lab of the FutureRohita 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.