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Advanced Therapies Xchange - San Francisco - 2025

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  1. Commercializing Gene Therapy in 2025
    • Commercializing Gene Therapy in 2025
    Integrating Market Access Strategy in Preclinical Gene Therapy Development
    The importance of aligning early stage development, CMC perspective to pave a path to win market acc ...
    Shengjiang Shawn Liu
    Shengjiang Shawn Liu, President, CSO & CEO - Avirmax
  2. Gene Therapy CMC & Process Development
    • Gene Therapy CMC & Process Development
    Advancing Purity in AAV Gene Therapy: Strategies for Minimizing and Clearing Empty Capsids
     Challenges posed by product-related impurities like empty capsids on safety, efficacy, and regulato ...
    James Warren
    James Warren, SVP, Global CMC Development - Ultragenyx
  3. Commercializing Gene Therapy in 2025
    • Commercializing Gene Therapy in 2025
    Poster Presentation: Payer education and reimbursement models (outcomes-based pricing, annuity models), launch strategies in rare disease markets, real-world evidence and patient registries, cross-border market access and global strategy, regulatory policy shifts impacting commercialization, manufacturing to support commercial supply
  4. Gene Therapy CMC & Process Development
    • Gene Therapy CMC & Process Development
    Poster Presentation:
    Cytiva
  5. Commercializing Gene Therapy in 2025
    • Commercializing Gene Therapy in 2025
    Reflecting the translational journey from scientific development to patient impact - covering pricing, reimbursement, health economics, and stakeholder engagement in a complex market environment
  6. Gene Therapy CMC & Process Development
    • Gene Therapy CMC & Process Development
    Working to move gene therapies from lab-scale to commercial readiness. Focusing on key aspects such as: Upstream/downstream process intensification, scalable plasmid, AAV, and LNP production, analytical method development and validation, comparability and bridging studies, regulatory expectations and global alignment, facility design and tech transfer challenges.
    Focusing on key aspects such as: Upstream/downstream process intensification, scalable plasmid, AAV, and LNP production, analytical method development and validation, comparability and bridging studies, regulatory expectations and global alignment, facility design and tech transfer challenges.
     
  7. Commercializing Gene Therapy in 2025
    • Commercializing Gene Therapy in 2025
    Gene Therapy Launch Readiness: Charting a Clear Path to U.S. Commercial Success
    Prepare the Market: Strategically mapping and engaging key stakeholders—clinicians, payers, patient ...
    Judy Lucas
    Judy Lucas, Vice President, Global Commercial Lead - Gene Therapy - Ultragenyx Pharmaceutical Inc.
  8. Gene Therapy CMC & Process Development
    • Gene Therapy CMC & Process Development
    Strategic CMC Frameworks for Gene Therapy: Regulatory Readiness from Development to Commercialization
    Building Robust CMC Strategies for Complex Modalities Insights into proactive agency interactions an ...
    Rashi Srivastava
    Rashi Srivastava, Head of CMC Regulatory Affairs, Cell & Gene Therapies - Astra Zeneca
  9. Next Gen Vector Engineering & Delivery
    • Next Gen Vector Engineering & Delivery
    Dose Less, Do More: Redefining Specificity in Gene Therapy
    Optimizing tissue tropism, transduction efficiency, and cell-type specificity to lower dosing requir ...
    An Song
    An Song, Chief Research & Translational Development Officer - 4DMT
  10. Next Gen Vector Engineering & Delivery
    • Next Gen Vector Engineering & Delivery
    Poster Presentation: Highlighting the sophisticated engineering driving the next wave of gene delivery technologies, whether viral or non-viral, to improve targeting, efficiency, and safety
  11. Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    • Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    Poster Presentation:
    Excellos
  12. Allogeneic Access: Engineering the Future of Cell Therapy
    • Allogeneic Access: Engineering the Future of Cell Therapy
    Capturing the value proposition of allogeneic therapies—scalability and accessibility. Focussing on solving engineering, persistence, and immunogenicity challenges that hinder widespread clinical adoption
  13. Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    • Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    Sponsor Roundtable

    SK pharmteco

  14. Autologous Therapies in Solid Tumors and Beyond
    • Autologous Therapies in Solid Tumors and Beyond
    Optimizing Autologous Therapies: Commercial & CMC Learnings, Smarter Trials, and Strategic Indication Expansion
    Commercial Lessons from the Front Line: Real-world insights from autologous therapy launches to refi ...
    John Knighton
    John Knighton, Vice President, Cell & Gene Therapy API Development - Johnson & Johnson
  15. Allogeneic Access: Engineering the Future of Cell Therapy
    • Allogeneic Access: Engineering the Future of Cell Therapy
    Proof in the Patient: What CR Outcomes Reveal About T and NK Cell Platform
    Key differences in process design, scalability, and consistency between T cell and NK cell platforms ...
    Faraz Siddiqui
    Faraz Siddiqui, Senior Vice President, Technical Operations - Senti Bio
  16. Allogeneic Access: Engineering the Future of Cell Therapy
    • Allogeneic Access: Engineering the Future of Cell Therapy
    Off-the-Shelf Realities – Where Are We Now? Featuring OmnImmune® and the Evolving Landscape of Allogeneic Cell Therapy
    Exploring lessons from OmnImmune®’s transition from fresh to cryopreserved gamma-delta T cells in re ...
    Bryan Kobel
    Bryan Kobel, Cheif Executive Officer - TC Biopharm
  17. Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    • Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    Implementing Potency and NG Release Assays for γδ T Cell Therapies
    Assay design must reflect γδ T cell-specific mechanisms of action (e.g., cytotoxicity, cytokine rele ...
    Christopher Rold
    Christopher Rold, Vice President Vector Development, Analytical Development & Quality Control - Adicet Bio
  18. Next Gen Vector Engineering & Delivery
    • Next Gen Vector Engineering & Delivery
    Sponsor Roundtable:

    Invetech

    • Autologous Therapies in Solid Tumors and Beyond
    • Allogeneic Access: Engineering the Future of Cell Therapy
    • Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    • Next Gen Vector Engineering & Delivery
    • Gene Therapy CMC & Process Development
    • Commercializing Gene Therapy in 2025
    Afternoon Refreshments
    • Autologous Therapies in Solid Tumors and Beyond
    • Allogeneic Access: Engineering the Future of Cell Therapy
    • Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    • Next Gen Vector Engineering & Delivery
    • Gene Therapy CMC & Process Development
    • Commercializing Gene Therapy in 2025
    Morning Refreshments
  21. Next Gen Vector Engineering & Delivery
    • Next Gen Vector Engineering & Delivery
    Innovations in AAV Design and Emerging Alternatives for Gene Delivery
    Engineering capsids with enhanced tissue specificity, immune evasion, and payload capacity. Explorin ...
    Robert Lin
    Robert Lin, Chief Executive Officer - Avista Therapeutics
    • Autologous Therapies in Solid Tumors and Beyond
    • Allogeneic Access: Engineering the Future of Cell Therapy
    • Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    • Next Gen Vector Engineering & Delivery
    • Gene Therapy CMC & Process Development
    • Commercializing Gene Therapy in 2025
    Evening Drinks Reception
  23. Allogeneic Access: Engineering the Future of Cell Therapy
    • Allogeneic Access: Engineering the Future of Cell Therapy
    Poster Presentation:
    Terumo
  24. Autologous Therapies in Solid Tumors and Beyond
    • Autologous Therapies in Solid Tumors and Beyond
    Poster Presentation
    Lonza
    • Autologous Therapies in Solid Tumors and Beyond
    • Allogeneic Access: Engineering the Future of Cell Therapy
    • Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    • Next Gen Vector Engineering & Delivery
    • Gene Therapy CMC & Process Development
    • Commercializing Gene Therapy in 2025
    1-2-1 Meetings / Networking Break
    • Autologous Therapies in Solid Tumors and Beyond
    • Allogeneic Access: Engineering the Future of Cell Therapy
    • Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    • Next Gen Vector Engineering & Delivery
    • Gene Therapy CMC & Process Development
    • Commercializing Gene Therapy in 2025
    1-2-1 Meetings / Networking Break
    • Autologous Therapies in Solid Tumors and Beyond
    • Allogeneic Access: Engineering the Future of Cell Therapy
    • Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    • Next Gen Vector Engineering & Delivery
    • Gene Therapy CMC & Process Development
    • Commercializing Gene Therapy in 2025
    Spotlight Presentation: Minaris Advanced Therapies
    Spotlight Presentation: Minaris Advanced Therapies
    • Autologous Therapies in Solid Tumors and Beyond
    • Allogeneic Access: Engineering the Future of Cell Therapy
    • Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    • Next Gen Vector Engineering & Delivery
    • Gene Therapy CMC & Process Development
    • Commercializing Gene Therapy in 2025
    Networking Lunch
  29. Autologous Therapies in Solid Tumors and Beyond
    • Autologous Therapies in Solid Tumors and Beyond
    Emphasizing the personalized nature of autologous therapies while expanding beyond hematologic malignancies into solid tumors and new indications
    • Autologous Therapies in Solid Tumors and Beyond
    • Allogeneic Access: Engineering the Future of Cell Therapy
    • Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    • Next Gen Vector Engineering & Delivery
    • Gene Therapy CMC & Process Development
    • Commercializing Gene Therapy in 2025
    1-2-1 Meetings / Networking Break
    • Autologous Therapies in Solid Tumors and Beyond
    • Allogeneic Access: Engineering the Future of Cell Therapy
    • Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    • Next Gen Vector Engineering & Delivery
    • Gene Therapy CMC & Process Development
    • Commercializing Gene Therapy in 2025
    1-2-1 Meetings / Networking Break
  32. Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    • Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    Advancing CMC for Autologous Cell Therapies: Building Robust, Scalable Platforms
    Streamlining upstream and downstream workflows to support consistent and scalable autologous product ...
    Heike Abeck
    Heike Abeck, Senior Director, BioPartnering & Development Program Lead - Bayer
  33. Autologous Therapies in Solid Tumors and Beyond
    • Autologous Therapies in Solid Tumors and Beyond
    Next-Gen Personalised Cell Therapy Engineering Innovations
    Proprietary tools enhancing potency, precision, and control in autologous cell therapies. Manufactur ...
    Brian Garrison
    Brian Garrison, Vice President of Research - Senti Bio
    • Autologous Therapies in Solid Tumors and Beyond
    • Allogeneic Access: Engineering the Future of Cell Therapy
    • Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    • Next Gen Vector Engineering & Delivery
    • Gene Therapy CMC & Process Development
    • Commercializing Gene Therapy in 2025
    Opening Address & Keynote Presentation:
    • Autologous Therapies in Solid Tumors and Beyond
    • Allogeneic Access: Engineering the Future of Cell Therapy
    • Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
    • Next Gen Vector Engineering & Delivery
    • Gene Therapy CMC & Process Development
    • Commercializing Gene Therapy in 2025
    Registration
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