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Cell & Gene Therapy Manufacturing & Commercialization US

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Delivered as a Hybrid Event
September 27-30, 2022Boston Convention and Exhibition Center
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Day 1 - EST/EDT (Eastern Daylight, GMT-4)

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8:00am - 9:00am60 mins
Coffee and Registration
    9:00am - 11:00am120 mins
    Principles and Practices of CMC Analytics for Cell and Gene Therapy
    Principles and Practices of CMC Analytics for Cell and Gene Therapy
    • Nadine Ritter - President and Analytical Advisor, Global Biotech Experts, LLC.
    9:00am - 11:00am120 mins
    CDMO Partnerships- Selection, Negotiation, Tech Transfer, Life Cycle Management
    CDMO Partnerships- Selection, Negotiation, Tech Transfer, Life Cycle Management
    • James Blackwell - President and Principal Consultant, The Windshire Group, LLC
    9:00am - 11:00am120 mins
    Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding
    Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding
    • Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
    9:00am - 11:00am120 mins
    Analytical Technologies and CMC Comparability of Biotechnology Products
    Analytical Technologies and CMC Comparability of Biotechnology Products
    • Kevin Zen, PhD - Executive Director, Chemistry Manufacturing and Control, AnaptysBio, AnaptysBio
    9:00am - 9:30am30 mins
    Pre-Conference Symposia: Cell Line Development & Engineering
    Cell Line Case Study: Amgen
    • Geneva Alok - Postdoctoral Fellow, Amgen
    9:00am - 11:00am120 mins
    Pre-Conference Symposia Drug Product Formulation & Fill/Finish
    Drug Product Formulations & Fill-finish
    • Marc Taraban - Assistant Professor, University of Maryland
    • Sisi Zhang, Msc. - Lead Research Specialist, Analytical Chemistry, Regeneron
    9:30am - 10:00am30 mins
    Pre-Conference Symposia: Cell Line Development & Engineering
    Cell Bank Characterization and Retrospective Assessment of Clonality
    • Benson Li - Associate Principal Scientist, Merck
    10:00am - 10:30am30 mins
    Pre-Conference Symposia: Cell Line Development & Engineering
    Use of Transposase-Mediated Integration to Reduce Screening and Shorten Cell Line Development Timelines
    • Hillary Warrington - Scientist, Janssen
    10:30am - 11:00am30 mins
    Pre-Conference Symposia: Cell Line Development & Engineering
    Perkin Elmer Presentation
      11:00am - 11:30am30 mins
      Networking Break
        11:30am - 1:00pm90 mins
        Principles and Practices of CMC Analytics for Cell and Gene Therapy
        Principles and Practices of CMC Analytics for Cell and Gene Therapy
        • Nadine Ritter - President and Analytical Advisor, Global Biotech Experts, LLC.
        11:30am - 1:00pm90 mins
        CDMO Partnerships- Selection, Negotiation, Tech Transfer, Life Cycle Management
        CDMO Partnerships- Selection, Negotiation, Tech Transfer, Life Cycle Management
        • James Blackwell - President and Principal Consultant, The Windshire Group, LLC
        11:30am - 1:00pm90 mins
        Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding
        Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding
        • Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
        11:30am - 1:00pm90 mins
        Analytical Technologies and CMC Comparability of Biotechnology Products
        Analytical Technologies and CMC Comparability of Biotechnology Products
        • Kevin Zen, PhD - Executive Director, Chemistry Manufacturing and Control, AnaptysBio, AnaptysBio
        11:30am - 12:00pm30 mins
        Pre-Conference Symposia: Cell Line Development & Engineering
        Growing Pains: The Ups and Downs of Building a CLD Platform Process from Scratch
        • Allyn Spear - Principal Research Scientist, Elanco Animal Health
        11:30am - 1:00pm90 mins
        Pre-Conference Symposia Drug Product Formulation & Fill/Finish
        Drug Product Formulations & Fill-finish
        • Marc Taraban - Assistant Professor, University of Maryland
        • Sisi Zhang, Msc. - Lead Research Specialist, Analytical Chemistry, Regeneron
        12:00pm - 12:30pm30 mins
        Pre-Conference Symposia: Cell Line Development & Engineering
        Accelerating Cell Line Development Process Through Automation Platform Integration
        • Woo Chi - Principal Scientist, Just Evotec Biologics
        12:30pm - 1:00pm30 mins
        Pre-Conference Symposia: Cell Line Development & Engineering
        Spotlight Session
          1:00pm - 2:00pm60 mins
          Networking Luncheon
            2:00pm - 3:30pm90 mins
            Principles and Practices of CMC Analytics for Cell and Gene Therapy
            Principles and Practices of CMC Analytics for Cell and Gene Therapy
            • Nadine Ritter - President and Analytical Advisor, Global Biotech Experts, LLC.
            2:00pm - 3:30pm90 mins
            CDMO Partnerships- Selection, Negotiation, Tech Transfer, Life Cycle Management
            CDMO Partnerships- Selection, Negotiation, Tech Transfer, Life Cycle Management
            • James Blackwell - President and Principal Consultant, The Windshire Group, LLC
            2:00pm - 3:30pm90 mins
            Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding
            Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding
            • Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
            2:00pm - 3:30pm90 mins
            Analytical Technologies and CMC Comparability of Biotechnology Products
            Analytical Technologies and CMC Comparability of Biotechnology Products
            • Kevin Zen, PhD - Executive Director, Chemistry Manufacturing and Control, AnaptysBio, AnaptysBio
            2:00pm - 2:30pm30 mins
            Pre-Conference Symposia: Cell Line Development & Engineering
            Evaluation of Transposase Technology to Generate Highly Productive CHO Cell Lines
            • Eric Lee - Senior Associate Scientist, Biogen
            2:00pm - 3:30pm90 mins
            Pre-Conference Symposia Drug Product Formulation & Fill/Finish
            Drug Product Formulations & Fill-finish
            • Marc Taraban - Assistant Professor, University of Maryland
            • Sisi Zhang, Msc. - Lead Research Specialist, Analytical Chemistry, Regeneron
            2:30pm - 3:00pm30 mins
            Pre-Conference Symposia: Cell Line Development & Engineering
            Epigenetic Comparison Reveals Divergent Methylation and Transcription Patterns across CHO Lineages
            • Meiping Chang - ., Merck
            3:00pm - 3:30pm30 mins
            Pre-Conference Symposia: Cell Line Development & Engineering
            Spotlight Presentation
              3:30pm - 4:00pm30 mins
              Networking Break
                4:00pm - 5:00pm60 mins
                Principles and Practices of CMC Analytics for Cell and Gene Therapy
                Principles and Practices of CMC Analytics for Cell and Gene Therapy
                • Nadine Ritter - President and Analytical Advisor, Global Biotech Experts, LLC.
                4:00pm - 5:00pm60 mins
                CDMO Partnerships- Selection, Negotiation, Tech Transfer, Life Cycle Management
                CDMO Partnerships- Selection, Negotiation, Tech Transfer, Life Cycle Management
                • James Blackwell - President and Principal Consultant, The Windshire Group, LLC
                4:00pm - 5:00pm60 mins
                Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding
                Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding
                • Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
                4:00pm - 5:00pm60 mins
                Analytical Technologies and CMC Comparability of Biotechnology Products
                Analytical Technologies and CMC Comparability of Biotechnology Products
                • Kevin Zen, PhD - Executive Director, Chemistry Manufacturing and Control, AnaptysBio, AnaptysBio
                4:00pm - 4:30pm30 mins
                Pre-Conference Symposia: Cell Line Development & Engineering
                Cell Lines for AAV Gene Therapies
                • Saurabh Sen - Associate Director, Cell Line Development, Sanofi
                4:00pm - 5:00pm60 mins
                Pre-Conference Symposia Drug Product Formulation & Fill/Finish
                Drug Product Formulations & Fill-finish
                • Marc Taraban - Assistant Professor, University of Maryland
                • Sisi Zhang, Msc. - Lead Research Specialist, Analytical Chemistry, Regeneron
                4:30pm - 5:00pm30 mins
                Pre-Conference Symposia: Cell Line Development & Engineering
                Novel Modalities from BMS
                • Jacqualyn Schulman, Ph.D. - Scientist, Cell Line Development & ‘Omics Biologics Development, Bristol-Myers Squibb
                6:30pm - 11:00pm270 mins
                Biotech Week Boston Awards Ceremony
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