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Full Schedule

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Full Schedule

  • Monday, May 11, 2026
  • 7:30 AM - 6:00 PM PT
    Registration Hours
  • 8:00 AM - 3:00 PM PT
    Exhibitor Move-In
  • 12:00 PM - 3:00 PM PT
    Speaker Ready Room
  • 3:00 PM - 4:30 PM PT
    Navigating the AI Frontier in Toxicology: Trends, Trust, and Transformation

    Plenary Speaker: Thomas Hartung, MD, PhD – Johns Hopkins University

  • 4:30 PM - 6:00 PM PT
    Welcome Reception in the Solution Center
  • Tuesday, May 12, 2026
  • 7:30 AM - 3:30 PM PT
    Registration Hours
  • 8:00 AM - 9:00 AM PT
    AAPS Regulatory Science, Pharmaceutical Quality, and Global Health Communities

    Community Leader: Allison Elizabeth Radwick, PhD – USP

  • 8:00 AM - 9:00 AM PT
    AAPS Translational and Clinical Science Community

    Community Leader: Alok Pandey, PhD – PBL Assay Science

  • 8:00 AM - 9:30 AM PT
    Charting Your Path: Strategic Career Direction for Mid-Career Biotech Professionals in a Dynamic Market

    Career Center Speaker: Katrina Rogers, ASQ Certified Manager of Quality/Operational Excellence and ASQ Certified Pharmaceutical GMP Professional – KATRINA ROGERS CONSULTING LLC

  • 8:30 AM - 3:30 PM PT
    Speaker Ready Room
  • 9:00 AM - 4:30 PM PT
    Solution Center Hours & Poster Presentations
  • 9:30 AM - 11:00 AM PT
    Symposium: Advancing Precision Therapeutics through AI Innovation and Global Regulatory Harmonization
    Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
  • 9:30 AM - 11:00 AM PT
    Symposium: Bridging from Therapeutic Concept to First in Human
    Moderator: Preeyam Patel, PhD (she/her/hers) – Spyre Therapeutics
    Applying Translational Principles Across the Development Lifecycle
  • 10:00 AM - 11:00 AM PT
    Coffee Break in the Solution Center
  • 10:00 AM - 11:00 AM PT
    Hot Topic: Advances in Predictive Modeling and Machine Learning to Optimize Process Development and Formulation Design of Biologics

    Hot Topic Speaker: Stephen T. Buckley, PhD – Novo Nordisk A/S

    Hot Topic Moderator: Robert Dodge, PhD – Dodge

    Hot Topic Speaker: Pauric Bannigan, PhD – Intrepid Labs

    Hot Topic Speaker: Jeremy Shaver, PhD – Pfizer

    Hot Topic Speaker: Kenan Pandza, PhD – Persist AI

  • 10:15 AM - 11:00 AM PT
    From Antibodies to Bioconjugates: Scalable Multi-Attribute Methods for Emerging Therapeutic Modalities
  • 11:00 AM - 1:00 PM PT
    Dedicated Solution Center Hours
  • 11:15 AM - 12:00 PM PT
    Linking Shear-Dependent Viscosity to Cluster Size and Injection Force in High-Concentration Monoclonal Antibody Formulations
  • 11:30 AM - 12:30 PM PT
    Special Poster Collection
  • 11:30 AM - 1:00 PM PT
    Lunch in the Solution Center
  • 12:15 PM - 1:00 PM PT
    Efficiency Unlocked: The Case for Single-Well Assessment in Bioanalysis
  • 1:00 PM - 2:00 PM PT
    Keynote: Implementation of Generative AI for Drug Discovery and Safety

    Moderator: Jason Pennucci – Moderna Therapeutics

    Keynote Speaker: Weida Tong, PhD – National Center for Toxicological Research, FDA

  • 1:00 PM - 2:00 PM PT
    Keynote: New Approach Methods – From Ugly Ducklings to Beautiful Swans

    Keynote Speaker: Thomas Hartung, MD, PhD – Johns Hopkins University

    Moderator: Babak Basiri, PhD – Dyne Therapeutics

  • 1:30 PM - 2:15 PM PT
    Integrated Bioanalysis: LC MS/MS, Hybrid, and LBA Case Studies
  • 2:30 PM - 3:15 PM PT
    Advancing Bioanalysis with HRMS-based Quantitation
  • 2:30 PM - 3:30 PM PT
    Hot Topic: Because Ellie Can’t Wait: Breaking Barriers in Advanced Therapy Development

    Hot Topic Moderator: Timothy P. Hickling, PhD

    Hot Topic Speaker: Vibha Jawa, PhD, FAAPS – EpiVax, Inc.

  • 2:30 PM - 3:30 PM PT
    Rapid Fires: Advancing Precision Therapeutics through AI Innovation and Global Regulatory Harmonization
    Rapid Fire Moderator: Soumya Sundaram, MS – Celerion
    Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
  • 2:30 PM - 3:30 PM PT
    Rapid Fires: Bridging from Therapeutic Concept to First in Human
    Rapid Fire Moderator: Pankajini Mallick, PhD (she/her/hers) – Neurocrine Biosciences
    Applying Translational Principles Across the Development Lifecycle
  • 3:30 PM - 4:15 PM PT
    Enabling Translational Decisions Through Quantitative Target Biology
  • 5:00 PM - 6:30 PM PT
    Sustaining Partner Reception (by invitation only)
  • Wednesday, May 13, 2026
  • 7:30 AM - 3:30 PM PT
    Registration Hours
  • 8:00 AM - 9:00 AM PT
    AAPS Bioanalytical Community Membership Meeting

    Community Leader: Robert Dodge, PhD – Dodge

    Community Leader: Xinyuan Li, PhD – Johnson & Johnson

  • 8:00 AM - 9:30 AM PT
    Executive Track: Guiding Good Science to Patients Through Evolving Markets and an Uncertain Regulatory Environment

    Moderator: Jef Akst, MS – BioSpace

    Executive Education Speaker: Thomas Hartung, MD, PhD – Johns Hopkins University

    Executive Education Speaker: Amit Rakhit, MD, MBA – BlueRock Therapeutics

    Executive Education Speaker: Court Turner, JD – LYZZ Capital Advisors

  • 8:30 AM - 3:30 PM PT
    Speaker Ready Room
  • 9:00 AM - 4:30 PM PT
    Solution Center Hours & Poster Presentations
  • 9:30 AM - 10:30 AM PT
    Symposium: Advancing Precision Manufacturing and Delivery for Complex Modalities
    Moderator: Weiping Shao, PhD – Astrazeneca
    Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
  • 9:30 AM - 11:00 AM PT
    Symposium: Bridging from First-in-Human to Registrational Trials
    Moderator: Anup Zutshi, PhD (he/him/his) – Chinar Pharmaceutical Sciences LLC
    Applying Translational Principles Across the Development Lifecycle
  • 10:00 AM - 11:00 AM PT
    Coffee Break in the Solution Center
  • 10:00 AM - 11:00 AM PT
    Hot Topic: Advancing Precision Manufacturing and Delivery for Complex Modalities

    Hot Topic Moderator: Jo Goodman, BSc – Celerion

  • 10:15 AM - 11:00 AM PT
    Immunogenicity Assessment for Biotherapeutics and Target Binding Reagents Beyond Antibodies
  • 11:00 AM - 1:00 PM PT
    Dedicated Solution Center Hours
  • 11:15 AM - 12:00 PM PT
    Development of a Quantitative Assay in Whole Blood using Microsampling
  • 11:30 AM - 12:30 PM PT
    Special Poster Collection
  • 11:30 AM - 1:00 PM PT
    Lunch in the Solution Center
  • 12:15 PM - 1:00 PM PT
    Longitudinal and Lifecycle Management of Potency Release Assays
  • 1:00 PM - 2:00 PM PT
    Keynote: Advancing the Design Logic of mRNA Nanomedicines

    Keynote Speaker: Owen Fenton

    Moderator: Weiping Shao, PhD – AstraZeneca

  • 1:00 PM - 2:00 PM PT
    Keynote: Beyond Translation: Accelerating Development to Bring Breakthroughs to Patients Faster

    Keynote Speaker: Amit Rakhit, MD, MBA – BlueRock Therapeutics

    Moderator: Amrit Chakravarty, PhD – KCAS Bio

  • 1:30 PM - 2:15 PM PT
    Automated Immunoassays Address Analytical Bottlenecks in ADC Drug Development
  • 2:00 PM - 2:30 PM PT
    Coffee Break in the Solution Center
  • 2:30 PM - 3:15 PM PT
    Advancing GLP-1 Development with Next-Generation Analytical Tools
  • 2:30 PM - 3:30 PM PT
    Hot Topic: Transparency to Predictive Insights: Lessons from Complete Response Letters

    Hot Topic Moderator: Allison Elizabeth Radwick, PhD – USP

    Hot Topic Speaker: Grace McNally – ELIQUENT Life Sciences, Inc.

    Hot Topic Speaker: Alison Sathe – Redica Systems

    Hot Topic Speaker: Matthew Vankoski, MBA, MS Reg Sci – USP

  • 2:30 PM - 3:30 PM PT
    Rapid Fires: Advancing Precision Manufacturing and Delivery for Complex Modalities
    Rapid Fire Moderator: Sanjeev Bhardwaj, PhD (he/him/his) – Moderna Therapeutics
    Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
  • 2:30 PM - 3:30 PM PT
    Rapid Fires: Bridging from First-in-Human to Registrational Trials
    Rapid Fire Moderator: Bill Nowatzke, PhD – Immunovant
    Applying Translational Principles Across the Development Lifecycle
  • 3:30 PM - 4:15 PM PT
    Development and Qualification of a Multiplexed Immunoassay to Assess the Immunogenicity of Shigella Vaccines
  • 3:30 PM - 4:30 PM PT
    Happy Hour Sponsored by BioSpace
  • 4:30 PM - 8:00 PM PT
    Exhibitor Move-Out
  • 5:00 PM - 6:30 PM PT
    Women in Biotech Reception
  • Thursday, May 14, 2026
  • 8:30 AM - 2:00 PM PT
    Registration Hours
  • 8:30 AM - 2:00 PM PT
    Speaker Ready Room
  • 9:00 AM - 10:30 AM PT
    Symposium: Advancing Cross-Modality Bioanalytics and Translational Biomarkers for Complex and Personalized Therapeutics
    Moderator: Jason Pennucci, MS – Moderna
    Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
  • 9:00 AM - 10:30 AM PT
    Symposium: Bridging from Registrational Trials to Commercialization
    Moderator: Paul Rhyne, NA – Luminex
    Applying Translational Principles Across the Development Lifecycle
  • 9:30 AM - 10:30 AM PT
    Hot Topic: Laboratory AI Literacy: Accelerating Research Through Human-AI Training Parallelization
  • 10:30 AM - 11:00 AM PT
    Coffee Break
  • 11:00 AM - 12:00 PM PT
    Keynote: Finding the Right Patients: Diagnostic-Driven Commercialization for Emerging Therapies

    Keynote Speaker: Hannah Mamuszka, MS – Alva10

    Moderator: Swetha Thiyagarajan – North Dakota State University

  • 11:00 AM - 12:00 PM PT
    Keynote: Strategic Implementation of AI in Regulated Bioanalytical Testing During Clinical Development

    Keynote Speaker: Jean-Claude Marshall, MSc, PhD – Moderna

    Moderator: Darshana Jani, PhD – Moderna

  • 12:00 PM - 1:30 PM PT
    Networking Lunch
  • 12:15 PM - 1:15 PM PT
    Coffee Break
  • 1:30 PM - 2:15 PM PT
    Rapid Fires: Bridging from Registrational Trials to Commercialization
    Rapid Fire Moderator: Charles Theuer, MD PhD – Halozyme Inc
    Applying Translational Principles Across the Development Lifecycle
  • 1:30 PM - 2:30 PM PT
    Hot Topic: Organ Chip Clinical Mimicry and NAMs Applied to the Development of New and Follow‑On Therapeutics

    Hot Topic Moderator: Weiping Shao, PhD – AstraZeneca

  • 1:30 PM - 2:30 PM PT
    Rapid Fires: Advancing Cross-Modality Bioanalytics and Translational Biomarkers for Complex and Personalized Therapeutics
    Rapid Fire Moderator: Jo Goodman, BSc (she/her/hers) – Celerion
    Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
  • 1:30 PM - 2:30 PM PT
    Rapid Fires: Bridging from Registrational Trials to Commercialization

    Rapid Fire Moderator: Charles Theuer, MD PhD – Halozyme Inc

  • 2:45 PM - 4:00 PM PT
    Closing Plenary with Dr. Lingle Wang

    Plenary Speaker: Lingle Wang