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Full Schedule

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Full Schedule

  • Pre-Recorded
  • Prologue: Advancements in Immuno-Oncology : mAbs to Novel Modalities
    Prologue Speaker: Ankit D. Kanthe, PhD – Bristol Myers Squibb
    Advances in Discovery, Formulation, and Delivery of New Modalities
  • Prologue: AI/ML in Drug Manufacturing: Use Cases and Areas of Consideration
    Prologue Speaker: Thomas O'Connor, PhD (he/him/his) – US Food and Drug Administration
    Advances in Discovery, Formulation, and Delivery of New Modalities
  • Prologue: Opportunities and Challenges for Lipid-Based Drug Delivery Systems for Biopharmaceuticals
    Prologue Speaker: Rajiv Nayar, PhD – HTD Biosystems Inc.
    Advances in Discovery, Formulation, and Delivery of New Modalities
  • Prologue: Opportunities and Implications for Using AI/ML in Bioanalytical Assay Development
    Prologue Speaker: Joe Rajarao, PhD (he/him/his) – Accenture
    Novel Strategies to Advance Biotherapeutic Development
  • Prologue: Patient Centric Sampling for Clinical Drug Development
    Prologue Speaker: Melanie Anderson, MS (she/her/hers) – Merck & Co., Inc.
    Novel Strategies to Advance Biotherapeutic Development
  • Prologue: Technology Advances in Vaccine Research
    Novel Strategies to Advance Biotherapeutic Development
  • Monday, May 13, 2024
  • 7:30 AM – 6:00 PM PT
    Registration Hours
  • 8:00 AM – 3:00 PM PT
    Exhibitor Move-In
  • 12:00 PM – 4:00 PM PT
    Speaker Ready Room
  • 3:00 PM – 4:30 PM PT
    Opening Plenary with Hari Pujar, Ph.D.

    Plenary Speaker: Hari Pujar, Ph.D. – Operating Partner at Flagship Pioneering and Chief Operating Officer of Tessera Therapeutics

  • 4:30 PM – 6:00 PM PT
    Welcome Reception in the Solution Center
  • Tuesday, May 14, 2024
  • 8:30 AM – 9:30 AM PT
    AAPS Bioanalytical Community Membership Meeting
  • 8:30 AM – 3:30 PM PT
    Registration Hours
  • 8:30 AM – 3:30 PM PT
    Speaker Ready Room
  • 9:30 AM – 11:00 AM PT
    Executive Track - Cell and Gene Therapies at the Intersection of Business
  • 9:30 AM – 11:00 AM PT
    Symposium: Development Strategy for Novel Targeted Therapeutic Delivery
    Moderator: Lynn Kamen, PhD – BioAgilytix Labs
    Novel Strategies to Advance Biotherapeutic Development
  • 9:30 AM – 11:00 AM PT
    Symposium: Preformulation and Formulation Approaches for Biologics and New Modalities
    Moderator: Haichen Nie, PhD – Teva Pharmaceuticals
    Advances in Discovery, Formulation, and Delivery of New Modalities
  • 10:00 AM – 11:00 AM PT
    Coffee Break in the Solution Center
  • 10:00 AM – 11:00 AM PT
    Hot Topic: Particle Safety and Size Threshold for Particle Visibility Revisited
    Hot Topic Moderator: Nazila Miller, PhD (she/her/hers) – Takeda
    Advances in Discovery, Formulation, and Delivery of New Modalities
  • 10:00 AM – 4:30 PM PT
    Solution Center Hours & Poster Presentations
  • 10:15 AM – 11:00 AM PT
    High Resolution Accurate Mass Analysis: Addressing Sensitivity and Specificity
  • 11:00 AM – 1:00 PM PT
    Dedicated Solution Center Hours
  • 11:15 AM – 12:00 PM PT
    High-Speed Microdroplet Reactions for Faster Therapeutic Protein Analysis
  • 11:30 AM – 12:30 PM PT
    Special Poster Collection
  • 11:30 AM – 1:00 PM PT
    Light Lunch in the Solution Center
  • 12:15 PM – 1:00 PM PT
    Mass Photometry – an Analytical Technology for Biomolecular Characterization
  • 1:00 PM – 2:00 PM PT
    Keynote: Crafting Complex Biologics: A Fusion of Art and Science?
    Keynote Speaker: Yongchao Su, PhD – Merck & Co, Inc.
    Moderator: Elizabeth Thoryk – Merck & Co., Inc.
    Advances in Discovery, Formulation, and Delivery of New Modalities
  • 1:00 PM – 2:00 PM PT
    Keynote: Using Biomarkers to Accelerate Development of Disease Modifying Therapies for Rare Disease
    Keynote Speaker: Emil Kakkis, MD, PhD (he/him/his) – Ultragenyx
    Moderator: Karen J. Quadrini, PhD – Prothena Biosciences
    Novel Strategies to Advance Biotherapeutic Development
  • 1:30 PM – 2:15 PM PT
    Advances in Accelerated Quantification of Oligonucleotides with Automated, Microfluidic Methods
  • 2:00 PM – 2:30 PM PT
    Coffee Break in the Solution Center
  • 2:30 PM – 3:15 PM PT
    Formulation Development of sa-RNA Lipid Nanoparticles and Adjuvants for Regulating Immune Response
  • 2:30 PM – 3:30 PM PT
    Hot Topic: Biomarkers and Accelerated Approval for Advanced Therapy
  • 2:30 PM – 3:30 PM PT
    Rapid Fire: Development Strategy for Novel Targeted Therapeutic Delivery
    Rapid Fire Moderator: Wei Wei, PhD (she/her/hers) – Boehringer Ingelheim
    Novel Strategies to Advance Biotherapeutic Development
  • 2:30 PM – 3:30 PM PT
    Rapid Fire: Preformulation and Formulation Approaches for Biologics and New Modalities
    Rapid Fire Moderator: Scott Rudge, PhD (he/him/his) – SynerG Biopharma Group
    Advances in Discovery, Formulation, and Delivery of New Modalities
  • 3:30 PM – 4:15 PM PT
    Immunogenicity Assessment and Target Binding Reagents Beyond Antibodies
  • 3:30 PM – 4:30 PM PT
    Happy Hour Sponsored by Aragen Lifesciences Ltd
  • 3:30 PM – 4:30 PM PT
    Special Poster Collection
  • 5:00 PM – 6:30 PM PT
    Sustaining Partner Reception (by invitation only)
  • Wednesday, May 15, 2024
  • 8:30 AM – 9:30 AM PT
    AAPS Biomarkers and Precision Medicine Community Membership Meeting
  • 8:30 AM – 3:30 PM PT
    Registration Hours
  • 8:30 AM – 3:30 PM PT
    Speaker Ready Room
  • 9:30 AM – 11:00 AM PT
    Symposium: Advances in Analytical and Bioanalytical Platform Technology
    Moderator: Shoshana Oberstein (she/her/hers) – PPD, part of Thermo Fisher Scientific
    Novel Strategies to Advance Biotherapeutic Development
  • 9:30 AM – 11:00 AM PT
    Symposium: Drug Delivery for New Modalities and Therapies
    Moderator: Asmita Khanolkar, MS – SMC Ltd.
    Advances in Discovery, Formulation, and Delivery of New Modalities
  • 10:00 AM – 11:00 AM PT
    Coffee Break in the Solution Center
  • 10:00 AM – 11:00 AM PT
    Hot Topic: Applications of qPCR/dPCR in Cell and Gene Therapies; Case Studies
    Hot Topic Moderator: Jacqueline Murphy, MS – Janssen
    Novel Strategies to Advance Biotherapeutic Development
  • 10:00 AM – 4:30 PM PT
    Solution Center Hours & Poster Presentations
  • 10:15 AM – 11:00 AM PT
    The Impact of Polysorbate Quality/Grade on Biopharmaceutical Formulations
  • 11:00 AM – 1:00 PM PT
    Dedicated Solution Center Hours
  • 11:15 AM – 12:00 PM PT
    Recombinant Human Hyaluronidase Facilitated Subcutaneous Drug Delivery Using a 10mL High-Volume Auto-Injector
  • 11:30 AM – 12:30 PM PT
    Special Poster Collection
  • 11:30 AM – 1:00 PM PT
    Light Lunch in the Solution Center
  • 12:15 PM – 1:00 PM PT
    From ASO to mRNA—Oligonucleotide Therapeutics Separation and Characterization Using LC/MS
  • 1:00 PM – 2:00 PM PT
    Keynote: Development of Oligonucleotide Therapeutics
    Keynote Speaker: Raman Bahal
    Moderator: Linzhi Chen, PhD (he/him/his) – Boehringer Ingelheim Pharmaceuticals, Inc.
    Novel Strategies to Advance Biotherapeutic Development
  • 1:00 PM – 2:00 PM PT
    Keynote: In vivo Delivery of mRNAs for Anti-Aging Applications: Potential and Challenges
    Keynote Speaker: Vittorio Sebastiano, PhD (he/him/his) – Stanford University and Turn Biotechnologies
    Moderator: Nitesh Kunda, PhD – St. John's University
    Advances in Discovery, Formulation, and Delivery of New Modalities
  • 1:15 PM – 3:00 PM PT
    PCR Assay Recommendations for Cell and Gene Therapies: Insights from an Industry Panel
  • 2:00 PM – 2:30 PM PT
    Coffee Break in the Solution Center
  • 2:30 PM – 3:30 PM PT
    Hot Topic: Prior Knowledge Integration in Product Development
  • 2:30 PM – 3:30 PM PT
    Rapid Fire: Advances in Analytical and Bioanalytical Platform Technology
    Rapid Fire Moderator: Nancy Yu (she/her/hers) – Genentech, Inc
    Novel Strategies to Advance Biotherapeutic Development
  • 2:30 PM – 3:30 PM PT
    Rapid Fire: Drug Delivery for New Modalities and Therapies
    Rapid Fire Moderator: Karthik Nagapudi, PhD – Genentech, Inc.
    Advances in Discovery, Formulation, and Delivery of New Modalities
  • 3:30 PM – 4:15 PM PT
    Bioanalytical Strategy for Quantitation of GLP-1 Analogs
  • 3:30 PM – 4:30 PM PT
    Happy Hour Sponsored by INTERPHEX
  • 3:30 PM – 4:30 PM PT
    Special Poster Collection
  • 4:00 PM – 5:00 PM PT
    AAPS Gene and Cell Therapy Products Community Membership Meeting
  • 4:30 PM – 8:00 PM PT
    Exhibitor Move-Out
  • 5:00 PM – 6:30 PM PT
    Women in Biotech Reception Sponsored by AstraZeneca
  • Thursday, May 16, 2024
  • 8:30 AM – 2:00 PM PT
    Registration Hours
  • 8:30 AM – 2:30 PM PT
    Speaker Ready Room
  • 9:00 AM – 10:00 AM PT
    Coffee Break
  • 9:30 AM – 11:00 AM PT
    Symposium: AI/ML in Drug Discovery and Development
    Moderator: Maxwell Korang-Yeboah, PhD – FDA/CDER/OPQ/OPQR
    Advances in Discovery, Formulation, and Delivery of New Modalities
  • 9:30 AM – 11:00 AM PT
    Symposium: High Content Bioanalysis
    Moderator: Eric Thomas, PhD – LabCorp
    Novel Strategies to Advance Biotherapeutic Development
  • 10:00 AM – 11:00 AM PT
    Hot Topic: Advances in in-vivo Therapeutic Nucleic Acid Delivery: Ushering New Era
    Hot Topic Moderator: Sandeep Nema, PhD (he/him/his) – Saliogen Therapeutics
    Advances in Discovery, Formulation, and Delivery of New Modalities
  • 11:00 AM – 12:30 PM PT
    Networking Lunch
  • 12:30 PM – 1:30 PM PT
    Keynote: Artificial Intelligence for Drug Discovery (AIDD)-Are We There Yet? How AI is Transforming the Drug Discovery Process
  • 12:30 PM – 1:30 PM PT
    Keynote: Getting Up Close and Personal: Can Understanding the Pharmacogenetic Determinants of Immunogenicity Help in the Design of Safer Biologics?
  • 1:30 PM – 2:00 PM PT
    Coffee Break
  • 2:00 PM – 2:45 PM PT
    Rapid Fire: AI/ML in Drug Discovery and Development
    Rapid Fire Moderator: Swati Gupta, PhD (she/her/hers) – AbbVie
    Advances in Discovery, Formulation, and Delivery of New Modalities
  • 2:00 PM – 3:00 PM PT
    Hot Topic: Navigating the New FDA Immunogenicity Labelling Guidance
  • 2:00 PM – 3:00 PM PT
    Rapid Fire: High Content Bioanalysis
    Rapid Fire Moderator: Devangi Mehta, PhD – Immunologix Laboratories
    Novel Strategies to Advance Biotherapeutic Development
  • 3:15 PM – 4:30 PM PT
    Closing Plenary with Dr. Peter Lee

    Plenary Speaker: Peter Lee, Ph.D.