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Full Schedule

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Full Schedule

  • Tuesday, October 27, 2026
  • 9:00 AM - 10:00 AM CT
    Hot Topic: Immunogenicity Expectations: Are They Fact or Fear?
    Hot Topic Speaker: Susan Kirshner – Former FDA OPQ
    Hot Topic Speaker: Yow-Ming C. Wang, PhD – FDA OCP
    Hot Topic Speaker: Jeannine Bussiere – Amgen
    Bioanalytics
  • 9:00 AM - 11:00 AM CT
    Symposium: Advanced Structural and Biophysical Characterization of Lipid Nanoparticle Systems and Biosimilars
    Moderator: Phillip Ramsey, M.S., M.B.A., R.A.C. (he/him/his) – Sangamo Therapeutics
    Manufacturing and Analytical Characterization
  • 9:00 AM - 11:00 AM CT
    Symposium: Enabling High Drug Load and High‑Viscosity Drug Products: From ASDs to Delivery Systems
    Moderator: Jayachandra Ramapuram, Ph.D. – Auburn University
    Formulation and Delivery
  • 9:00 AM - 11:00 AM CT
    Symposium: Innovating Cancer Therapy: Translational Approaches Across New Modalities
    Moderator: Otilia M. Koo, PhD, FAAPS (she/her/hers) – Novo Nordisk
    Preclinical, Clinical, and Translational Sciences
  • 9:00 AM - 11:00 AM CT
    Symposium: Measuring the Unmeasurable: Bioanalytical Innovation for Emerging Modalities
    Moderator: Jennifer Grant, PhD – Beam Therapeutics
    Bioanalytics
  • 9:00 AM - 11:00 AM CT
    Symposium: Model-Informed Innovation: Integrating NAMs Across Translational Workflows
    Moderator: Kent Grindstaff, PhD – BioIVT
    Preclinical, Clinical, and Translational Sciences
  • 9:00 AM - 11:00 AM CT
    Symposium: Modern Analytical Strategies for Impurity Characterization and Lifecycle Management
    Moderator: Wenshan W. Zhuang, PhD – AbbVie, Inc.
    Manufacturing and Analytical Characterization
  • 9:00 AM - 11:00 AM CT
    Symposium: Oligonucleotide Bioanalysis: Ring Trial and Emerging Conjugate Modalities
    Moderator: Karan Agrawal, PhD (he/him/his) – Johnson & Johnson Innovative Medicine
    Bioanalytics
  • 9:00 AM - 11:00 AM CT
    Symposium: Precision Delivery Frontiers: Redefining RNA and Advanced Therapeutics
    Moderator: Annette Bak, PhD, MBA, FAAPS – AstraZeneca
    Formulation and Delivery
  • 10:00 AM - 11:00 AM CT
    Hot Topic: Hot Melt Extrusion 2.0-From Enabling Solubility to Smart Continuous Platforms
    Hot Topic Moderator: Gavin P. Andrews, PhD (he/him/his) – Queen's University Belfast
    Manufacturing and Analytical Characterization
  • 1:30 PM - 2:30 PM CT
    Keynote: A Journey Navigating Drug-Drug Interaction in Discovery and Development
    Keynote Speaker: Xinning Yang, PhD (he/him/his) – Food and Drug Administration
    Moderator: Fenglei Huang, Ph.D. (he/him/his) – Boehringer Ingelheim
    Preclinical, Clinical, and Translational Sciences
  • 1:30 PM - 2:30 PM CT
    Keynote: Converging Platforms and Expanding Biological Insight
    Keynote Speaker: Karan Agrawal, PhD (he/him/his) – Johnson & Johnson Innovative Medicine
    Bioanalytics
  • 1:30 PM - 2:30 PM CT
    Keynote: Enabling Oral Delivery of Next-Generation Drugs: Expanding the Role of Amorphous Solid Dispersions
    Keynote Speaker: Lynne S. Taylor, Ph.D. – Purdue University
    Moderator: Sandip Tiwari, PhD (he/him/his) – BASF Corporation
    Formulation and Delivery
  • 1:30 PM - 2:30 PM CT
    Keynote: From Mechanism to Market: Transforming Biotherapeutic Delivery — Insights from Two Case Studies
    Keynote Speaker: Mayank Patel, Ph.D. – AstraZeneca
    Moderator: Manmohan Singh, PhD – Beam Tx
    Formulation and Delivery
  • 1:30 PM - 2:30 PM CT
    Keynote: Leveraging Advances in Analytical Technologies for Supporting Biosimilar Development/Characterization
    Keynote Speaker: Maria Guiterrez Lugo, PhD – U.S. Food & Drug Administration
    Moderator: Tian Li, Ph.D. – US Food and Drug Administration
    Manufacturing and Analytical Characterization
  • 1:30 PM - 2:30 PM CT
    Keynote: Measuring the Unmeasurable
    Keynote Speaker: Jim X. Shen, Ph.D. (he/him/his) – Bristol-Myers Squibb Company
    Moderator: Jennifer Grant, PhD – Beam Therapeutics
    Bioanalytics
  • 1:30 PM - 2:30 PM CT
    Keynote: Nanomedicine in Translation: From Design to Therapeutic Outcome
    Keynote Speaker: Annette Bak, PhD, MBA, FAAPS – AstraZeneca
    Moderator: Seeprarani Rath, PhD (she/her/hers) – Rutgers, the State University of New Jersey
    Preclinical, Clinical, and Translational Sciences
  • 1:30 PM - 2:30 PM CT
    Keynote: Seeing is Believing: Importance of Detailed Characterization in Understanding Complex Parenteral Drug Products
    Keynote Speaker: Diane J. Burgess, Ph.D. (she/her/hers) – University of Connecticut
    Moderator: Tian Li, Ph.D. – US Food and Drug Administration
    Manufacturing and Analytical Characterization
  • 2:30 PM - 3:30 PM CT
    Hot Topic: GLP-1 Agonists and Drug Absorption: Gastric Emptying DDI Risks
    Hot Topic Speaker: Maria Posada – Eli Lilly and Company
    Hot Topic Speaker: Niloufar Salehi, PhD – Eli Lilly and Company
    Hot Topic Moderator: Niloufar Salehi, PhD – Eli Lilly and Company
    Hot Topic Speaker: Jessica Atieh, MD (she/her/hers) – Mayo Clinic
    Preclinical, Clinical, and Translational Sciences