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  • Tuesday, Jul 14th
    8:00 AM - 11:30 AM East Coast USA Time
    Morning Plenary
    Location: Kojo Kamau A
    Bioanalytical Track
  • Tuesday, Jul 14th
    8:00 AM - 8:05 AM East Coast USA Time
    Introduction and Welcome
    Location: Kojo Kamau A
    Moderator: Landon Greene, PhD (he/him/his) – Vertex Pharmaceuticals
    Bioanalytical Track
  • Tuesday, Jul 14th
    8:35 AM - 9:05 AM East Coast USA Time
    From Artifacts to Insight: Antidrug Antibody Assays for Antibody-drug Conjugates
    Location: Kojo Kamau A
    Speaker: Lin Yang, PhD (she/her/hers) – AstraZeneca
    Bioanalytical Track
  • Tuesday, Jul 14th
    9:05 AM - 9:35 AM East Coast USA Time
    High-Sensitivity Immunoassay Platform Evaluation for Pharmacokinetic Analysis of T-Cell Engagers
    Location: Kojo Kamau A
    Speaker: Josh T. Albert, BSc – GlaxoSmithKline
    Bioanalytical Track
  • Tuesday, Jul 14th
    9:35 AM - 10:05 AM East Coast USA Time
    Two Assays, One mRNA-Derived Protein: Cross-Platform Concordance Between Studies
    Location: Kojo Kamau A
    Speaker: Quentin Burke (he/him/his) – Moderna Inc.
    Bioanalytical Track
  • Tuesday, Jul 14th
    10:30 AM - 11:00 AM East Coast USA Time
    Improved Sensitivity in IBD Bioanalysis by Addressing Matrix Interference Challenges
    Location: Kojo Kamau A
    Speaker: Harpinder Saini – Genentech, Inc.
    Bioanalytical Track
  • Tuesday, Jul 14th
    11:00 AM - 11:30 AM East Coast USA Time
    Panel Discussion
    Location: Kojo Kamau A
    Speaker: Josh T. Albert, BSc – GlaxoSmithKline
    Speaker: Quentin Burke (he/him/his) – Moderna Inc.
    Speaker: Harpinder Saini – Genentech, Inc.
    Speaker: Lin Yang, PhD (she/her/hers) – AstraZeneca
    Bioanalytical Track
  • Tuesday, Jul 14th
    8:05 AM - 8:35 AM East Coast USA Time
    Immunogenicity and AAV Gene Therapies
    Speaker: Jim McNally, PhD – Sword Bio
    Bioanalytical Track
  • Tuesday, Jul 14th
    11:30 AM - 12:00 PM East Coast USA Time
    The Nitrate Anion: A Biomarker Assay Subject to Environmental Influence
    Location: Kojo Kamau A
    Partner Presentation Speaker: Nicholas Ingram, BS (he/him/his) – IQVIA Laboratories
    Bioanalytical Track
    Sponsored By 
  • Tuesday, Jul 14th
    12:00 PM - 12:30 PM East Coast USA Time
    Balancing Sensitivity and Robustness in Molecular Bioanalysis
    Location: Kojo Kamau A
    Partner Presentation Speaker: Agostinho Rocha, arocha@smithers.com – Smithers - Pharmaceutical Development Services
    Bioanalytical Track
    Sponsored By 
  • Tuesday, Jul 14th
    1:30 PM - 3:00 PM East Coast USA Time
    Afternoon Plenary
    Location: Kojo Kamau A
    Bioanalytical Track
  • Tuesday, Jul 14th
    1:35 PM - 2:05 PM East Coast USA Time
    Clinical ADA Method: Universal vs In Study Cut Point?
    Location: Kojo Kamau A
    Speaker: Tong-Yuan Yang, PhD (he/him/his) – Johnson & Johnson Innovative Medicine
    Bioanalytical Track
  • Tuesday, Jul 14th
    2:05 PM - 2:35 PM East Coast USA Time
    Comparing Assay Strategies Across Bioanalytical, Biomarker, and Pharmaceutical Testing Frameworks
    Location: Kojo Kamau A
    Speaker: Enrique A. Dalmasso, Ph.D. – U.S. Pharmacopeia
    Bioanalytical Track
  • Tuesday, Jul 14th
    2:35 PM - 3:05 PM East Coast USA Time
    Title TBD (Bioanalytics)
    Location: Kojo Kamau A
    Speaker: Fabrice G. Gritti, PhD (he/him/his) – Waters Corporation
    Bioanalytical Track
  • Tuesday, Jul 14th
    3:30 PM - 4:00 PM East Coast USA Time
    A CROs Prospective on Biomarker Fit for Purpose Validation Tiers for Multiple Bioanalytical Platforms (LBA, PCR, LC-MS/MS)
    Location: Kojo Kamau A
    Partner Presentation Speaker: Dominic Warrino, PhD – KCAS Bio
    Partner Presentation Speaker: Dawn Dufield, PhD – KCAS Bio
    Bioanalytical Track
    Sponsored By 
  • Tuesday, Jul 14th
    4:00 PM - 4:15 PM East Coast USA Time
    Development, Validation, & Implementation of a Shedding/Biodistribution qPCR Assay to Support Development of DB-OTO
    Rapid Fire Presenter: Sasha Fraser, PhD – Regeneron Pharmaceuticals
    Bioanalytical Track
  • Tuesday, Jul 14th
    4:15 PM - 4:30 PM East Coast USA Time
    Navigating the Evolving ADC Landscape: Bioanalytical Challenges, Strategies, and Operational Considerations
    Location: Kojo Kamau A
    Rapid Fire Presenter: Drupadkumar Acharya, MS – Johnson & Johnson Innovative Medicine
    Bioanalytical Track
  • Tuesday, Jul 14th
    4:30 PM - 4:45 PM East Coast USA Time
    Application of ICH M10 Bioanalytical Method Validation Guidelines to Emerging Analytical Technologies
    Rapid Fire Presenter: Tim Lochmann, PhD – PPD
    Bioanalytical Track
  • Wednesday, Jul 15th
    8:00 AM - 11:30 AM East Coast USA Time
    Morning Plenary
    Location: Kojo Kamau A
    Bioanalytical Track
  • Wednesday, Jul 15th
    8:00 AM - 8:05 AM East Coast USA Time
    Session Introduction
    Location: Kojo Kamau A
    Bioanalytical Track
  • Wednesday, Jul 15th
    8:05 AM - 8:35 AM East Coast USA Time
    Bioanalysis for Emerging Modalities: From Exploratory Innovation to Regulatory-Ready Strategies
    Location: Kojo Kamau A
    Speaker: Nan Zhao, PhD – WuXi AppTec
    Bioanalytical Track
  • Wednesday, Jul 15th
    8:35 AM - 9:05 AM East Coast USA Time
    Development Considerations for Tirzepatide: Drug Disposition Package for Registration
    Location: Kojo Kamau A
    Speaker: Jennifer A. Martin, MS (she/her/hers) – Eli Lilly and Company
    Bioanalytical Track
  • Wednesday, Jul 15th
    9:05 AM - 9:35 AM East Coast USA Time
    Delivering Trustworthy Data: The Art of Fit-for-Purpose ELISpot & FluoroSpot Assays
    Location: Kojo Kamau A
    Speaker: Sylvia Janetzki, MD (she/her/hers) – ZellNet Consulting, Inc.
    Bioanalytical Track
  • Wednesday, Jul 15th
    9:35 AM - 10:05 AM East Coast USA Time
    Beyond the Template: Flexible Neutralizing Antibody (nAb) Assessment in the Era of Emerging Modalities and Complex Mechanisms of Action
    Location: Kojo Kamau A
    Speaker: Gurleen Saini, MS – Boehringer Ingelheim
    Bioanalytical Track
  • Wednesday, Jul 15th
    10:30 AM - 11:00 AM East Coast USA Time
    PBBM in Drug Development - Case Studies and Regulatory Applications
    Location: Kojo Kamau A
    Speaker: Tycho H. Heimbach, PhD, FAAPS (he/him/his) – Tycho Heimbach
    Bioanalytical Track
  • Wednesday, Jul 15th
    11:00 AM - 11:30 AM East Coast USA Time
    Panel Discussion
    Location: Kojo Kamau A
    Bioanalytical Track
  • Wednesday, Jul 15th
    11:30 AM - 12:00 PM East Coast USA Time
    Comprehensive Characterization of Biotherapeutics Using Complementary LC-MS Workflows
    Location: Kojo Kamau A
    Partner Presentation Speaker: Randy Arnold, PhD – SCIEX
    Bioanalytical Track
    Sponsored By 
  • Wednesday, Jul 15th
    12:00 PM - 12:30 PM East Coast USA Time
    From Receipt to Report: Automating the Project Lifecycle
    Location: Kojo Kamau A
    Partner Presentation Speaker: Ely Porter, PhD – Dash Bio
    Bioanalytical Track
    Sponsored By 
  • Wednesday, Jul 15th
    1:30 PM - 3:00 PM East Coast USA Time
    Afternoon Plenary
    Location: Kojo Kamau A
    Bioanalytical Track
  • Wednesday, Jul 15th
    1:35 PM - 2:05 PM East Coast USA Time
    Assumed Safe, Proven Risky: Reference Materials and Assay Performance
    Location: Kojo Kamau A
    Bioanalytical Track
  • Wednesday, Jul 15th
    2:05 PM - 2:35 PM East Coast USA Time
    Mass Spectrometry Regulated Bioanalytical Advances for Biomarkers
    Location: Kojo Kamau A
    Speaker: Hemanth Akkiraju, PhD (he/him/his) – IQVIA Laboratories
    Bioanalytical Track
  • Wednesday, Jul 15th
    2:35 PM - 3:05 PM East Coast USA Time
    Pseudo Leukotrienes: Cysteinyl Leukotriene-like Agonists are Upregulated in Severe Asthma
    Location: Kojo Kamau A
    Speaker: Siyang Liu (he/him/his) – Case Western Reserve University
    Bioanalytical Track
  • Wednesday, Jul 15th
    3:30 PM - 4:00 PM East Coast USA Time
    Automated Immunoassays Address Analytical Bottlenecks in ADC Drug Development
    Location: Kojo Kamau A
    Partner Presentation Speaker: Eric Plante, PhD – Gyros Protein Technologies
    Bioanalytical Track
    Sponsored By 
  • Wednesday, Jul 15th
    4:00 PM - 5:00 PM East Coast USA Time
    Rapid Fires
    Location: Kojo Kamau A
    Bioanalytical Track
  • Wednesday, Jul 15th
    4:00 PM - 4:15 PM East Coast USA Time
    Good Laboratory Practice (GLP) Compliance qPCR-Validation
    Location: Kojo Kamau A
    Rapid Fire Presenter: Hikmat Al-Hashimi – Eurofins Viracor BioPharma
    Bioanalytical Track
  • Wednesday, Jul 15th
    4:15 PM - 4:30 PM East Coast USA Time
    Bioanalytical Divide: Adapting AI Assays for Resource-Limited Ethiopian Settings
    Location: Kojo Kamau A
    Rapid Fire Presenter: Gadisa Tulu, n/a – Haramaya University
    Bioanalytical Track
  • Wednesday, Jul 15th
    4:30 PM - 4:45 PM East Coast USA Time
    One for the Win: Singlicate Analysis for Diverse Therapeutic Modalities
    Rapid Fire Presenter: Deborah Johnson, PhD (she/her/hers) – Regeneron
    Bioanalytical Track
  • Wednesday, Jul 15th
    4:45 PM - 5:00 PM East Coast USA Time
    Integrated Metabolite Identification and Quantitation Strategies for Lipid Nanoparticle in mRNA Vaccines and Therapeutics
    Location: Kojo Kamau A
    Rapid Fire Presenter: Prasad Gobburi, PhD (he/him/his) – Moderna Therapeutics LLC
    Bioanalytical Track
  • Thursday, Jul 16th
    8:00 AM - 10:30 AM East Coast USA Time
    Morning Plenary
    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
    10:30 AM - 10:35 AM East Coast USA Time
    Closing Remarks - 2027 Program Chair
    Location: Kojo Kamau A
    Speaker: Mark Wissel, Ph.D. – Eurofins Scientific
    Bioanalytical TrackPharmaceutical Analysis Track
  • Thursday, Jul 16th
    10:35 AM - 11:00 AM East Coast USA Time
    Grab and Go Break
    Bioanalytical TrackPharmaceutical Analysis Track