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
Tuesday, July 11 Morning Plenary: Old Platform, New Tricks Part 1 (8:00 AM – 11:30 AM) Establishing FVIII Activity as a Reliable Predictor of Hemostatic Efficacy Christian Vetterman, Ph.D., Biomarin Pharmaceutical, Inc. Substrate Measurement Using LCMS 2 Matthew Schultz, Ph.D. LCMA; Endrogenous vs Drug Product Ines Santos, Ph.D., Bristol-Myers Squibb Transgene Expression – LCMS Henrik Neubert, 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 ML to Monitor Bio Processes Sponsored Presentations (11:30 AM – 12:30 PM) Partner opportunities available! Learn more 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 Biologic Continuous Manufacturing Regulatory Perspective Sponsored Presentations (3:00 PM – 3:30 PM) Partner opportunities available! Learn more Rapid Fire Presentations (4:00 PM – 5:00 PM) Submit a Rapid Fire by May 1! Learn more Rapid Fire Presentations (4:00 PM – 5:00 PM) Submit a Rapid Fire by May 1! Learn more Evening Reception (6:00 PM – 8:00 PM)
Wednesday, July 12 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) Novel Synthetic Modalities Oligos, Lipids Mirlanda Biba, Ph.D., Merck 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 Gene Therapy Potency Assay Development Savita Sankar, Ph.D., Pfizer Sponsored Presentations (11:30 AM – 12:30 PM) Partner opportunities available! Learn more Lunch (12:30 PM – 1:30 PM) Afternoon Plenary: Emerging Platforms and New Challenges Part 2 (1:30 PM – 3:00 PM) Integration Risk Assessment in Human Liver following AAV5-Factor VIII Gene Transfer 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 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 Perspective Sponsored Presentations (3:00 PM – 3:30 PM) Partner opportunities available! Learn more Rapid Fire Presentations (4:00 PM – 5:00 PM) Submit a Rapid Fire by May 1! Learn more Rapid Fire Presentations (4:00 PM – 5:00 PM) Submit a Rapid Fire by May 1! Learn more
Thursday, July 13 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. Morning Plenary: Analytical Challenges in Developing Novel Modalities (8:00 AM – 10:30 AM) Q12 Experiences Hasmukh Patel, Ph.D., FDA Morning Plenary: Joint Regulatory Panel (10:30 AM – 11:30 AM) Brian Long, Ph.D., Biomarin Pharmaceutical, Inc. Ronit Mazor, Ph.D., FDA Hasmukh Patel, Ph.D., FDA * Agenda as of March 27, 2023.