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 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) Substrate Measurement Using LCMS 2 Matthew Schultz, Ph.D. LCMA; Endrogenous vs Drug Product Ines Santos, Ph.D., Bristol-Myers Squibb Transgene Expression – LCMS Jason Walsh Ph.D., Pfizer ADC; Combine LCMS and LBA 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 Digitalization/Data Integration Meg Gallwitz, Ph.D., The Henrici Group Pharmaceutical Applications of Compact Capillary Liquid Chromatography James Grinias, Ph.D., Rowan University Greening Pharmaceutical Analysis: Reducing Waste Stream From A Common Test Adam Socia, Organon AI and Automation in the CRO Lab Rob Wenslow, Ph.D., Crystal Pharmatech Inc. Sponsored Presentations (11:30 AM – 12:30 PM) Partner opportunities available! Learn more Thought Leadership Presentation (11:30 AM - 12:00 PM) Sponsored By: Thought Leadership Presentation (11:30 AM - 12:00 PM) Sponsored By: Thought Leadership Presentation (12:00 PM - 12:30 PM) 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, Ph.D., AbbVie Biologic Continuous Manufacturing Regulatory Perspective David Acevedo, Ph.D., FDA Sponsored Presentations (3:30 PM – 4:00 PM) Partner opportunities available! Learn more Rapid Fire Presentations (4:00 PM – 5:00 PM) Rapid Fire Presentations (4:00 PM – 5:00 PM) Evening Reception at Union Rooftop (6:15 PM – 8:15 PM)
Wednesday, July 12 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 Anolyte is Compromised Iris Xie, Ph.D., Merck HRMS in Regulated Bioanalysis – Ace in the Hole or Jack of All Trades? Barry Jones, Ph.D., Crinetics Considerations in Selecting Quantitative vs. Digital PCR Platforms for Bioanalysis Russell Soon, Ph.D., 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, Ph.D., Merck Morning Plenary: Analytical Challenges in Developing Novel Modalities (8:00 AM – 11:30 AM) Gene Therapy Potency Assay Development 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 Brittney Mills, Ph.D., AbbVie Novel Modalities/Oligonucleotides Claus Rental, Ph.D., Ionis Pharmaceuticals Novel Synthetic Modalities Oligos, Lipids Mirlanda 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) 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 Christian Vetterman, Ph.D., Biomarin Pharmaceutical, Inc. Sample Logistics and Analytical Considerations for Development of a Cellular Immunogenicity Assays for CART Therapies Spencer Hebert, Ph.D., Pharmaceutical Product Development, Inc. (PPD) Analytical Strategy for Oligo and mRNA Afternoon Plenary: Analytical Clinically Relevant Specifications Manufacturing (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., Health Canada Sponsored Presentations (3:30 PM – 4:00 PM) Partner opportunities available! Learn more Rapid Fire Presentations (4:00 PM – 5:00 PM) Rapid Fire Presentations (4:00 PM – 5:00 PM) Closing Reception (5:00 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: Emerging Platforms and New Challenges Part 1 (8:00 AM – 10:30 AM) Differential Immune Responses to Deamidated Adeno-Associated Virus Vector Ronit Mazor, Ph.D., FDA Immunogenicity Safety Monitoring for Systemic Administration of AAV Vectored Gene Therapies Brian Long, Ph.D., Biomarin Pharmaceutical, Inc. Pharma’s Experience on Implementing M10 Chris James, Ph.D., Amgen Morning Plenary: Analytical Challenges in Developing Novel Modalities (8:00 AM – 10:30 AM) Q12 Experiences Hasmukh Patel, Ph.D., FDA Lifecycle Management of Analytical Procedures – an Example of Pharmaceutical Counter Ion Analysis Qinggang Wang, Ph.D., Bristol-Myers Squibb Established Conditions of Analytical Procedures Brian Castle, Ph.D., Eli Lilly Post- Approval Analytical Method Performance Monitoring: A Case Study Maria Cruanes, Ph.D., Organon Closing Session and Moderator Readout (11:00 AM – 11:30 AM) * Agenda as of May 9, 2023.