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Cell & Gene Therapy Manufacturing & Commercialization US
Mark Your Calendar for This Year's Event!
September 27-30, 2022Boston Convention and Exhibition Center
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CONFERENCE DAY TWO - EST/EDT (Eastern Daylight, GMT-4)

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CONFERENCE DAY TWO - EST/EDT (Eastern Daylight, GMT-4)

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8:00am - 8:20am20 mins
Coffee & Registration
    8:20am - 8:30am10 mins
    Chairperson’s Opening remarks
    • Ali Mohamed - VP, CMC, Immatics
    Allogeneic CAR & T Cell Therapies – iPSc, NK, Gene Editing & Universal Cells
    8:30am - 9:00am30 mins
    Joint Plenary Session
    Azzur Cleanrooms on Demand – Addressing the Buy vs Build Conundrum for Cell and Gene Therapy Manufacturing
    • Ravi Samavedam - President & COO of Azzur Cleanrooms on Demand™, Azzur Group, USA
    9:00am - 9:30am30 mins
    Joint Plenary Session
    Charting a new path. Reimagining Automation in Cell Therapy Manufacturing.
    • Fabian Gerlinghaus - Co-Founder & CEO, Cellares
    9:30am - 10:25am55 mins
    Morning Coffee and Networking
      10:25am - 10:30am5 mins
      Cell Therapy/ Gene Edited Ex Vivo Cell Therapy
      Chairperson's Opening Remarks
      • Marinna Madrid - Co-Founder, Cellino
      10:25am - 10:30am5 mins
      In Vivo Gene Therapy
      Chairperson's Opening Remarks
      • Jorge Santiago-Ortiz, Ph.D. - Director, Process Development, BioCentriq, USA
      10:30am - 10:50am20 mins
      Cell Therapy/ Gene Edited Ex Vivo Cell Therapy
      Building an Analytical Toolbox for Potency Testing for Next Generation CARs
      • Daniel Hui - Associate Director – Product Characterization/Clinical Assay Development, Tmunity Therapeutics
      10:30am - 11:00am30 mins
      In Vivo Gene Therapy
      Measuring the DNA cargo of Adeno-Associated Viruses using nanofluidic resonators
      • Georgios Katsikis - Postdoctoral Associate, Massachusetts Institute of Technology, USA
      10:50am - 11:10am20 mins
      Cell Therapy/ Gene Edited Ex Vivo Cell Therapy
      An Introduction to Cell and Gene Therapy Validation Challenges
      • Sharif Ahmed - Senior Product Supply Product Lead for rFVIII Products, Bayer Pharmaceuticals, USA
      11:00am - 11:30am30 mins
      In Vivo Gene Therapy
      Developing a Fed-Batch process to increase productivity of the Bac/Sf9 Platform
      • Krishanu Mathur - CMC, Early & Late Stage Gene Therapy, Voyager Therapeutics, USA
      11:10am - 11:30am20 mins
      Cell Therapy/ Gene Edited Ex Vivo Cell Therapy
      Potency Assay Development for Commercialization
      • Knut Niss - Chief Technology Officer, Mustang Bio
      11:30am - 12:00pm30 mins
      Cell Therapy/ Gene Edited Ex Vivo Cell Therapy
      High Throughput Characterization of Antibody, AAV and Cell Therapy Aggregates and Particulate Impurities Using the Aura
      • Bernardo Cordovez - Chief Science Officer and Founder, Halo Labs, USA
      11:30am - 12:00pm30 mins
      In Vivo Gene Therapy
      Platform Manufacturing Approach for Adeno Associated Virus: Accelerated Time and Cost Saving
      • Elie Hanania - Director of Upstream Process Development, FUJIFILM Diosynth Biotechnologies
      12:00pm - 1:25pm85 mins
      Lunch & Networking
        1:25pm - 1:30pm5 mins
        Cell Therapy
        Chairperson's Opening Remarks
          1:25pm - 1:30pm5 mins
          Gene Edited Ex Vivo Cell Therapy
          Chairperson's Opening Remarks
          • Knut Niss - Chief Technology Officer, Mustang Bio
          1:25pm - 1:30pm5 mins
          In Vivo Gene Therapy
          Chairperson's Opening Remarks
          • David Dobnik - Senior Research Associate, National Institute of Biology, Slovenia
          1:30pm - 2:00pm30 mins
          Cell Therapy
          Please move to another track
            1:30pm - 2:00pm30 mins
            Gene Edited Ex Vivo Cell Therapy
            Is Gene Editing a Gene Therapy or Cell Therapy or both? Where does it fit?
            • Devyn Smith - Chief Executive Officer, Arbor Biotechnologies, Inc.
            1:30pm - 2:00pm30 mins
            In Vivo Gene Therapy
            Challenges for Potency Assay Development for Gene Therapies & the Matrix Approach
            • Roland Pach - Project Leader, F.Hoffmann-La Roche, Switzerland
            • Christina Grigoriadou - Associate Director, AstraZeneca
            2:00pm - 2:30pm30 mins
            Cell Therapy
            Process Analytical Technologies for Cell Therapies
            • Ho-Tak Lau - Senior Scientist, Bristol Myers Squibb, USA
            2:00pm - 2:30pm30 mins
            Gene Edited Ex Vivo Cell Therapy
            Novel Modalities to Address CAR-T Challenges - NK Cell Case Study
            • Bruno Marques - Head of Process & Product Development, Century Therapeutics
            2:00pm - 2:30pm30 mins
            In Vivo Gene Therapy
            Developing Functional Potency Assay for Gene Therapy Products
            • Arkadi Manukyan - Scientist, Analytical Development, Sanofi, USA
            2:30pm - 2:45pm15 mins
            Cell Therapy
            Human Liver-Chips: Qualifying a Preclinical Model System for AAV Vector Development
            • S. Jordan Kerns, PhD - Director of Applied Biosciences, Emulate, Inc., USA
            2:30pm - 2:45pm15 mins
            Gene Edited Ex Vivo Cell Therapy
            FectoVIR®-AAV: the next-generation transfection reagent for large-scale AAV manufacturing
            • Ashlee Sun - Field Application Specialist, Polyplus-transfection, USA
            2:30pm - 3:00pm30 mins
            In Vivo Gene Therapy
            Leveraging lessons from the COVID-19 pandemic to accelerate the development and production of adeno-associated virus (AAV)-based gene therapies
            • Yasser Kehail - Single Use & Enterprise Business Development Leader, Cytiva, USA
            2:45pm - 3:00pm15 mins
            Gene Edited Ex Vivo Cell Therapy
            Spotlight Presentation - Asimov
              3:00pm - 4:00pm60 mins
              Cell Therapy
              Refreshment Break in the Poster & Exhibit Hall
                3:00pm - 4:00pm60 mins
                Gene Edited Ex Vivo Cell Therapy
                Refreshment Break in the Poster & Exhibit Hall
                  3:00pm - 4:00pm60 mins
                  In Vivo Gene Therapy
                  Refreshment Break in the Poster & Exhibit Hall
                    3:30pm - 5:00pm90 mins
                    Exhibition Hall Content
                    Emerging and Innovative Technology Session
                    • Jeffrey Baker - Deputy Director, Office of Biotechnology Products, CDER, FDA, CDER, FDA
                    • Lynne Frick - Co-Head, Biologics Franchise, Resilience and Co-Executive Director, The BioInnovation Group
                    • Cheryl Huie - Co-Executive Director, BioInnovation Group
                    4:00pm - 4:30pm30 mins
                    Cell Therapy
                    Manufacturing Tissues at Scale - A Platform that Enables Precise Control Over iPS Cell Fate in their Natural Environment
                    • Marinna Madrid - Co-Founder, Cellino
                    4:00pm - 4:30pm30 mins
                    Gene Edited Ex Vivo Cell Therapy
                    Please move to another track
                      4:00pm - 4:30pm30 mins
                      In Vivo Gene Therapy
                      Rational Design & Development of Vector Genome Assay by ddPCR
                      • Santoshkumar Khatwani - Associate Director, Analytical Development, Sangamo Therapeutics
                      4:30pm - 5:00pm30 mins
                      Cell Therapy
                      Autologous iPS Cell Therapy for Macular Degeneration: From Bench-to-Bedside
                      • Kapil Bharti - Earl Stadtman Tenure-Track Investigator, National Eye Institute, National Institutes of Health
                      4:30pm - 5:00pm30 mins
                      Gene Edited Ex Vivo Cell Therapy
                      Unlocking the Bottlenecks in The Supply Chain of Autologous Therapies: A Patient-Centric Approach
                      • Gabrielle Humphrey - CMC Consultant, VECTAPLUS (formerly Adaptimmune)
                      4:30pm - 5:00pm30 mins
                      In Vivo Gene Therapy
                      New Bioprocess Tools and Designs towards the Continuous Purification of Viral Vectors for Gene Therapy
                      • Stefano Menegatti - Associate Professor, North Carolina State University, USA
                      5:00pm - 5:30pm30 mins
                      Cell Therapy
                      AAV Full Capsid Enrichment for Serotypes 5, 8 & 9
                      • Mark Schofield - Senior Manager, Research and Development, Pall Corporation
                      5:00pm - 5:30pm30 mins
                      Gene Edited Ex Vivo Cell Therapy
                      AAV Full Capsid Enrichment for Serotypes 5, 8 & 9
                      • Mark Schofield - Senior Manager, Research and Development, Pall Corporation
                      5:00pm - 5:30pm30 mins
                      In Vivo Gene Therapy
                      AAV Full Capsid Enrichment for Serotypes 5, 8 & 9
                      • Mark Schofield - Senior Manager, Research and Development, Pall Corporation
                      5:15pm - 6:15pm60 mins
                      Exhibition Hall Content
                      Panel: COVID-19 and The Future of Therapies
                        6:30pm - 8:00pm90 mins
                        BWB Lawn on D Party
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