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  • Tuesday, Jul 14th
    7:00 AM - 8:00 AM East Coast USA Time
    Networking Breakfast
    Location: Kojo Kamau BC
    Bioanalytical TrackPharmaceutical Analysis Track
  • Tuesday, Jul 14th
    8:00 AM - 12:30 PM East Coast USA Time
    Morning Plenary
    Location: Gina Knee
    Moderator: Landon Greene, PhD (he/him/his) – Vertex Pharmaceuticals
    Pharmaceutical Analysis Track
  • Tuesday, Jul 14th
    8:05 AM - 8:45 AM East Coast USA Time
    Accelerated Stability for Shelf Life of Small Molecules and Biologics
    Location: Gina Knee
    Speaker: Kenneth C. Waterman, PhD, FAAPS (he/him/his) – FreeThink Technologies Inc
    Pharmaceutical Analysis Track
  • Tuesday, Jul 14th
    8:45 AM - 9:25 AM East Coast USA Time
    Harmonization of a Physicochemical Profiling Platform of Therapeutic Oligonucleotides
    Location: Gina Knee
    Speaker: Kohsaku Kawakami, PhD (he/him/his) – National Institute for Materials Science
    Pharmaceutical Analysis Track
  • Tuesday, Jul 14th
    9:25 AM - 10:05 AM East Coast USA Time
    Accelerating Drug Product Analytical Research and Development Through Digital-First Science
    Location: Gina Knee
    Speaker: Saisi Xue, PhD – BMS
    Pharmaceutical Analysis Track
  • Tuesday, Jul 14th
    10:30 AM - 11:10 AM East Coast USA Time
    Molecular Dynamics for Prediction of RTs
    Location: Gina Knee
    Speaker: Fabrice G. Gritti, PhD (he/him/his) – Waters Corporation
    Pharmaceutical Analysis Track
  • Tuesday, Jul 14th
    11:10 AM - 11:50 AM East Coast USA Time
    Comprehensive Assessment of Microchip Zone Electrophoresis to Study Large Molecule Therapeutics
    Location: Gina Knee
    Pharmaceutical Analysis Track
  • Tuesday, Jul 14th
    11:50 AM - 12:30 PM East Coast USA Time
    Panel Discussion
    Location: Gina Knee
    Panelist: Kenneth C. Waterman, PhD, FAAPS (he/him/his) – FreeThink Technologies Inc
    Panelist: Kohsaku Kawakami, PhD (he/him/his) – National Institute for Materials Science
    Panelist: Fabrice G. Gritti, PhD (he/him/his) – Waters Corporation
    Panelist: Saisi Xue, PhD – BMS
    Panelist: Anton Kozyryev, PhD (he/him/his) – Merck
    Pharmaceutical Analysis Track
  • Tuesday, Jul 14th
    10:05 AM - 10:30 AM East Coast USA Time
    Morning Break
    Location: Kojo Kamau Prefunction
    Bioanalytical TrackPharmaceutical Analysis Track
  • Tuesday, Jul 14th
    12:30 PM - 1:30 PM East Coast USA Time
    Networking Lunch
    Location: Kojo Kamau BC
    Bioanalytical TrackPharmaceutical Analysis Track
  • Tuesday, Jul 14th
    1:30 PM - 4:00 PM East Coast USA Time
    Afternoon Plenary
    Location: Gina Knee
    Moderator: Eric J. Munson, PhD, FAAPS – Purdue University
    Pharmaceutical Analysis Track
  • Tuesday, Jul 14th
    1:30 PM - 1:35 PM East Coast USA Time
    Afternoon Session Introduction
    Location: Gina Knee
    Pharmaceutical Analysis Track
  • Tuesday, Jul 14th
    1:35 PM - 2:05 PM East Coast USA Time
    N-Nitrosamine Quantitation in Pharmaceticals by Tandem Mass Spectrometry
    Location: Gina Knee
    Speaker: Mousumi Saha (she/her/hers) – Purdue University
    Pharmaceutical Analysis Track
  • Tuesday, Jul 14th
    2:05 PM - 2:35 PM East Coast USA Time
    Development of an Improved Size Exclusion Chromatography Method for Antibody-RNA Conjugates
    Location: Gina Knee
    Speaker: Sean Crowe, PhD – Eli Lilly and Company
    Pharmaceutical Analysis Track
  • Tuesday, Jul 14th
    2:35 PM - 3:05 PM East Coast USA Time
    Application of Benchtop NMR for API Quantification in Modern Drug Product Development and Supply
    Location: Gina Knee
    Pharmaceutical Analysis Track
  • Tuesday, Jul 14th
    3:30 PM - 4:00 PM East Coast USA Time
    Panel Discussion
    Panelist: Mousumi Saha (she/her/hers) – Purdue University
    Panelist: Sean Crowe, PhD – Eli Lilly and Company
    Panelist: Meredith Dinges, PhD (she/her/hers) – Organon
    Pharmaceutical Analysis Track
  • Tuesday, Jul 14th
    3:05 PM - 3:30 PM East Coast USA Time
    Afternoon Break
    Location: Kojo Kamau Prefunction
    Bioanalytical TrackPharmaceutical Analysis Track
  • Tuesday, Jul 14th
    4:00 PM - 5:00 PM East Coast USA Time
    Rapid Fires
    Location: Gina Knee
    Pharmaceutical Analysis Track
  • Tuesday, Jul 14th
    4:00 PM - 4:15 PM East Coast USA Time
    Isolation and Structural Elucidation of Novel Degradants of Edaravone.
    Location: Gina Knee
    Rapid Fire Presenter: Kishore Raju Vatsavai, M. Pharm (he/him/his) – Veranova
    Pharmaceutical Analysis Track
  • Tuesday, Jul 14th
    4:15 PM - 4:30 PM East Coast USA Time
    Managing Biosafety in Nasal Spray Live Vaccine Testing
    Location: Gina Knee
    Rapid Fire Presenter: Yannick Baschung, PhD (he/him/his) – Solvias, Inc
    Pharmaceutical Analysis Track
  • Tuesday, Jul 14th
    4:30 PM - 4:45 PM East Coast USA Time
    Modern NIR for Biotherapeutics: Comparative Component Identification and Quantitation
    Location: Gina Knee
    Rapid Fire Presenter: Joey P. Campbell, PhD (he/him/his) – Prolytix
    Pharmaceutical Analysis Track
  • Wednesday, Jul 15th
    7:00 AM - 8:00 AM East Coast USA Time
    Networking Breakfast
    Location: Kojo Kamau BC
    Bioanalytical TrackPharmaceutical Analysis Track
  • Wednesday, Jul 15th
    8:00 AM - 12:30 PM East Coast USA Time
    Morning Plenary
    Location: Gina Knee
    Moderator: Xiuli Li, PhD (she/her/hers) – Eli Lilly and Company
    Pharmaceutical Analysis Track
  • Wednesday, Jul 15th
    8:05 AM - 8:45 AM East Coast USA Time
    Regulatory and Compendial Expectations for Analytical Method Lifecycle Management
    Location: Gina Knee
    Pharmaceutical Analysis Track
  • Wednesday, Jul 15th
    8:45 AM - 9:25 AM East Coast USA Time
    Analytical Method Standardization- An Initiative for Quality, Efficiency, and Harmonization
    Location: Gina Knee
    Speaker: Wendy Yang, MSc (she/her/hers) – Eli Lilly and Company
    Pharmaceutical Analysis Track
  • Wednesday, Jul 15th
    9:25 AM - 10:05 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
  • Wednesday, Jul 15th
    10:35 AM - 11:15 AM East Coast USA Time
    A Comparative Analytical Framework for NDA and ANDA Submissions
    Location: Gina Knee
    Pharmaceutical Analysis Track
  • Wednesday, Jul 15th
    11:15 AM - 11:55 AM East Coast USA Time
    From ATP to QC: A Risk-Based Assessment Workflow to Enable Robust Commercial Analytical Methods
    Location: Gina Knee
    Speaker: Peter I. Tattersall, PhD (he/him/his) – Bristol Myers Squibb Company
    Pharmaceutical Analysis Track
  • Wednesday, Jul 15th
    11:55 AM - 12:25 PM East Coast USA Time
    Panel Discussion
    Panelist: Kim Huynh-Ba, MSc, PMP, FAAPS (she/her/hers) – Pharmalytik
    Panelist: Wendy Yang, MSc (she/her/hers) – Eli Lilly and Company
    Panelist: Kimberly A. Lupo, M.S., M.B.A. – PORTRETT PHARMACEUTICALS LLC
    Panelist: Rachna Chaddha, Masters in Analytical Chemistry (she/her/hers) – Eli Lilly and Company
    Panelist: Peter I. Tattersall, PhD (he/him/his) – Bristol Myers Squibb Company
    Pharmaceutical Analysis Track
  • Wednesday, Jul 15th
    10:05 AM - 10:30 AM East Coast USA Time
    Morning Break
    Location: Kojo Kamau Prefunction
    Bioanalytical TrackPharmaceutical Analysis Track
  • Wednesday, Jul 15th
    12:30 PM - 1:30 PM East Coast USA Time
    Networking Lunch
    Location: Kojo Kamau BC
    Bioanalytical TrackPharmaceutical Analysis Track
  • Wednesday, Jul 15th
    1:30 PM - 3:10 PM East Coast USA Time
    Afternoon Plenary
    Location: Gina Knee
    Pharmaceutical Analysis Track
  • Wednesday, Jul 15th
    1:35 PM - 2:05 PM East Coast USA Time
    New Approaches to Nitrosamine Detection and Mitigation
    Location: Gina Knee
    Speaker: Eric J. Munson, PhD, FAAPS – Purdue University
    Pharmaceutical Analysis Track
  • Wednesday, Jul 15th
    2:05 PM - 2:35 PM East Coast USA Time
    An Excipient-Dependent Surfactant Threshold Governs Aggregation in Monoclonal Antibody Formulations
    Location: Gina Knee
    Speaker: Oluwatosin Y. Ibhagui, PhD – Regeneron Pharmaceuticals
    Pharmaceutical Analysis Track
  • Wednesday, Jul 15th
    2:35 PM - 3:05 PM East Coast USA Time
    Characterization of Product Variants and Product-Related Impurities Detected by Capillary Electrophoresis
    Location: Gina Knee
    Speaker: Timothy Blanc – Biopharm Control Strategy
    Pharmaceutical Analysis Track
  • Wednesday, Jul 15th
    3:30 PM - 4:00 PM East Coast USA Time
    Panel Discussion - Pharm A
    Location: Gina Knee
    Panelist: Eric J. Munson, PhD, FAAPS – Purdue University
    Panelist: Oluwatosin Y. Ibhagui, PhD – Regeneron Pharmaceuticals
    Panelist: Timothy Blanc – Biopharm Control Strategy
    Pharmaceutical Analysis Track
  • Wednesday, Jul 15th
    3:05 PM - 3:30 PM East Coast USA Time
    Afternoon Break
    Location: Kojo Kamau Prefunction
    Bioanalytical TrackPharmaceutical Analysis Track
  • Wednesday, Jul 15th
    4:00 PM - 5:00 PM East Coast USA Time
    Rapid Fires
    Location: Gina Knee
    Moderator: Xiuli Li, PhD (she/her/hers) – Eli Lilly and Company
    Pharmaceutical Analysis Track
  • Wednesday, Jul 15th
    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
  • Wednesday, Jul 15th
    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, MS, MBA (he/him/his) – Agilent Technologies, Inc.
    Pharmaceutical Analysis Track
  • Wednesday, Jul 15th
    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, CSSBB (she/her/hers) – Eli Lilly and Company
    Pharmaceutical Analysis Track
  • Wednesday, Jul 15th
    5:00 PM - 6:00 PM East Coast USA Time
    Closing Reception
    Location: Kojo Kamau BC
    Bioanalytical TrackPharmaceutical Analysis Track
  • Thursday, Jul 16th
    7:00 AM - 8:00 AM East Coast USA Time
    Networking Breakfast
    Location: Kojo Kamau Prefunction
    Bioanalytical TrackPharmaceutical Analysis Track
  • Thursday, Jul 16th
    8:00 AM - 10:30 AM East Coast USA Time
    Morning Plenary - Joint Session
    Location: Kojo Kamau A
    Moderator: Landon Greene, PhD (he/him/his) – Vertex Pharmaceuticals
    Bioanalytical TrackPharmaceutical Analysis Track
  • Thursday, Jul 16th
    8:05 AM - 8:40 AM East Coast USA Time
    Distinguishing AI, Coding, and Automation in Modern Bioanalytical Workflows
    Location: Kojo Kamau A
    Speaker: Jean Custodio, PhD (he/him/his) – IQVIA Laboratories
    Bioanalytical TrackPharmaceutical Analysis Track
  • Thursday, Jul 16th
    8:40 AM - 9:15 AM East Coast USA Time
    Implementing FDA Guidance for Artificial Intelligence in Drug Development Lifecycle
    Location: Kojo Kamau A
    Bioanalytical TrackPharmaceutical Analysis Track
  • Thursday, Jul 16th
    9:15 AM - 9:50 AM East Coast USA Time
    Applying Artificial Intelligence to Accelerate Report Writing
    Location: Kojo Kamau A
    Speaker: Anuj Chadha – Alchemi
    Bioanalytical TrackPharmaceutical Analysis Track
  • Thursday, Jul 16th
    9:50 AM - 10:25 AM East Coast USA Time
    Panel Discussion - Joint Session
    Location: Kojo Kamau A
    Moderator: Landon Greene, PhD (he/him/his) – Vertex Pharmaceuticals
    Panelist: Anuj Chadha – Alchemi
    Panelist: Kishore Raju Vatsavai, M. Pharm (he/him/his) – Veranova
    Panelist: Jean Custodio, PhD (he/him/his) – IQVIA Laboratories
    Bioanalytical TrackPharmaceutical Analysis Track
  • Thursday, Jul 16th
    10:25 AM - 10:30 AM East Coast USA Time
    Closing Remarks - 2027 Program Chair
    Location: Kojo Kamau A
    Speaker: Mark Wissel, Ph.D. – Eurofins Viracor
    Bioanalytical TrackPharmaceutical Analysis Track
  • Thursday, Jul 16th
    10:30 AM East Coast USA Time
    Grab and Go Break
    Location: Kojo Kamau Prefunction
    Bioanalytical TrackPharmaceutical Analysis Track