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Full Schedule

Full Schedule

  • Monday, April 24, 2023
  • 8:00 AM – 4:00 PM ET
    Speaker Ready Room
  • 8:00 AM – 5:00 PM ET
    Registration Hours
  • 9:00 AM – 9:30 AM ET
    Prologue: Overcoming Critical Challenges of Evolving Biologics
  • 9:00 AM – 9:30 AM ET
    Prologue: Overview of Biomarker and Bioanalytical Readouts for Safety and Efficacy Evaluation of AAV Gene Therapy
  • 9:30 AM – 11:00 AM ET
    IP and Patents for Pharmaceutical Scientists & Entrepreneurs
  • 9:30 AM – 11:00 AM ET
    Symposium: Innovation Based on Non-Traditional Platforms

    Moderator: Haichen Nie, PhD – Teva Pharmaceuticals

    Turbocharging Innovation in CMC: Driving Back to Rational Drug Design

  • 9:30 AM – 11:00 AM ET
    Symposium: Recent Advances in Gene Therapy

    Moderator: Catherine Vrentas, PhD – PPD, A ThermoFisher Company

    Advances in Therapeutic Development Across Modalities

  • 10:00 AM – 11:00 AM ET
    Coffee Break in the Solution Center
  • 10:00 AM – 11:00 AM ET
    Hot Topic: Translational Intelligence in Omics: Exploring Advances in Genomics and Metabolomics

    Hot Topic Moderator: Sanjeev Bhardwaj, PhD – Janssen BioTherapeutics

    Hot Topic Speaker: Timothy J. Garrett, PhD – University of Florida, Department of Pathology

    Hot Topic Speaker: Anup Madan, PhD – PPD

    Advances in Therapeutic Development Across Modalities

  • 10:00 AM – 4:30 PM ET
    Solution Center Hours & Poster Presentations
  • 10:15 AM – 11:00 AM ET
    Easy Automated Sample Prep for Regulated and Nonregulated Labs
  • 11:00 AM – 12:30 PM ET
    Light Lunch in the Solution Center
  • 11:00 AM – 1:00 PM ET
    Dedicated Solution Center Hours
  • 11:15 AM – 12:00 PM ET
    LNP Characterization Using Field Flow Fractionation with Light Scattering Detection
  • 11:30 AM – 12:30 PM ET
    Career Conversation Hosted By NIH/NINDS
  • 12:15 PM – 1:00 PM ET
    Chromatographic Methods for the Analysis of RNA Therapeutics
  • 12:30 PM – 1:30 PM ET
    Special Poster Collection
  • 1:00 PM – 2:00 PM ET
    Keynote: Bioanalytical and Biomarker Strategies for Sickle Blood Cell Gene Editing Therapies
  • 1:00 PM – 2:00 PM ET
    Keynote: Translation of Microneedle Patch Technology into the Clinic
  • 1:30 PM – 2:15 PM ET
    Lipids, Learnings and Future Opportunities
  • 2:00 PM – 2:30 PM ET
    Coffee Break in the Solution Center
  • 2:30 PM – 3:15 PM ET
    Panel Discussion: Common Challenges in Bioanalytical Assay Validation/Development in CGTP
  • 2:30 PM – 3:30 PM ET
    Rapid Fire: Innovation Based on Non-Traditional Platforms

    Rapid Fire Moderator: Jing Ling, PhD – Merck & Co., Inc.

    Turbocharging Innovation in CMC: Driving Back to Rational Drug Design

  • 2:30 PM – 3:30 PM ET
    Rapid Fire: Recent Advances in Gene Therapy

    Rapid Fire Moderator: Robert Dodge, PhD – Novartis Institutes for BioMedical Research, Inc.

    Advances in Therapeutic Development Across Modalities

  • 3:00 PM – 4:00 PM ET
    Hot Topic: Turbocharging Innovation in CMC - Driving Back to Rational Drug Design

    Hot Topic Moderator: Wei Xu, Ph.D. – Merck & Co., Inc.

    Turbocharging Innovation in CMC: Driving Back to Rational Drug Design

  • 3:00 PM – 4:30 PM ET
    Happy Hour Sponsored by B2S Life Sciences and Veloxity Labs
  • 3:00 PM – 4:30 PM ET
    Happy Hour Sponsored by Certara
  • 3:30 PM – 4:15 PM ET
    AAPS Gene and Cell Therapy Products Community Membership Meeting
  • 3:30 PM – 4:30 PM ET
    Special Poster Collection
  • 5:00 PM – 6:30 PM ET
    Sustaining Partner Reception (by invitation only)