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Key Sessions
Nadine Ritter, Ph.D.
Accelerated CMC Strategies for Biological/Biosimilar Products
Global Biotech Experts, LLC
Janet Lathey, Ph.D.
KEYNOTE: Standardizing Assays Using ZIKV as an Example
DMID/NIAID/NIH
Wei Zhang, Ph.D.
Featured Presentation: Bioassay Strategies for AAV Gene Therapy Products
Biogen
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Main Conference - Day One

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Main Conference - Day One

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9:00am - 9:05am5 mins
PLENARY SESSION
Opening Remarks
    9:10am - 9:35am25 mins
    PLENARY SESSION
    Accelerated CMC Strategies for Biological/Biosimilar Products
    • Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
    9:40am - 10:05am25 mins
    PLENARY SESSION
    KEYNOTE: Standardizing Assays Using ZIKV as an Example
    • Janet Lathey, Ph.D. - Health Science Specialist, DMID/NIAID/NIH
    10:05am - 10:30am25 mins
    PLENARY SESSION
    Live Q&A with Nadine Ritter and Janet Lathey
    • Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
    • Janet Lathey, Ph.D. - Health Science Specialist, DMID/NIAID/NIH
    10:30am - 10:50am20 mins
    WELL CHARACTERIZED BIOLOGICS TRACK
    Quantify Viral Vector Attributes with Light Scattering
    • Andrew Meyer, Ph.D. - Southeast Regional Manager & Senior Applications Scientist, Wyatt Technology
    10:30am - 10:50am20 mins
    BIOLOGICAL ASSAYS TRACK
    Measuring Protein Concentration by Diffusion-filtered Quantitative Nuclear Magnetic Resonance Spectroscopy
    • Scott Bradley - Principal Research Scientist, Eli Lilly
    10:50am - 11:20am30 mins
    Networking Break: View Exhibit Booths & Poster Rooms, Schedule Some Meetings
      11:20am - 11:40am20 mins
      WELL CHARACTERIZED BIOLOGICS TRACK: Analytical and Biophysical Characterization Requirements for Novel Modalities
      High-Resolution Mass Spectrometry as a Tool for Characterization of Post-Translational Modifications (PTMs) and Sequence Extensions in Fc-Fusion Proteins
      • Chris Spahr - Senior Scientist, Discovery Attribute Sciences, Amgen
      11:20am - 11:40am20 mins
      BIOLOGICAL ASSAYS TRACK: Bioassay Development for Non-mAbs
      Development of a Robust Functional Cell-based Assay for Replacing the Rabbit Blood Sugar Bioidentity Test of Insulin Analog
      • Junming Yie - Principal Scientist, Cell Based Assays, Merck
      11:45am - 12:05pm20 mins
      WELL CHARACTERIZED BIOLOGICS TRACK: Analytical and Biophysical Characterization Requirements for Novel Modalities
      International Regulatory Landscape for Cell and Gene Therapy Products (CGTP)
      • Chenghong Wei, Ph.D. - Associate Director, Global Regulatory Affairs CMC, AstraZeneca
      11:45am - 12:05pm20 mins
      BIOLOGICAL ASSAYS TRACK: Bioassay Development for Non-mAbs
      Bioassays for use in measuring the expression and biological activity of therapeutic transgenes within recombinant oncolytic virus genomes
      • Dylan Weil - R & D Associate II, Astrazeneca
      12:10pm - 12:30pm20 mins
      WELL CHARACTERIZED BIOLOGICS TRACK: Analytical and Biophysical Characterization Requirements for Novel Modalities
      Accelerating Assay Execution and Data Analysis with Antha® Auto-programming Software
      • Luke Cach - Scientific Solutions Lead, Synthace
      12:10pm - 12:30pm20 mins
      BIOLOGICAL ASSAYS TRACK: Bioassay Development for Non-mAbs
      Bioassay To Assess Knockdown Efficiency Using mRNA Knockdown rAAV Technology
      • Esteban Carrillo - Research Scientist (Technical Project Manager), PPD Laboratories
      12:30pm - 1:00pm30 mins
      WELL CHARACTERIZED BIOLOGICS TRACK: Analytical and Biophysical Characterization Requirements for Novel Modalities
      Live Q & A Panelists: Andrew Meyer, Chris Spahr, ChengHong Wei, Luke Cach Moderator: Ranjini Ramachander
      • Luke Cach - Scientific Solutions Lead, Synthace
      • Andrew Meyer, Ph.D. - Southeast Regional Manager & Senior Applications Scientist, Wyatt Technology
      • Chris Spahr - Senior Scientist, Discovery Attribute Sciences, Amgen
      • Chenghong Wei, Ph.D. - Associate Director, Global Regulatory Affairs CMC, AstraZeneca
      • Ranjini Ramachander, Ph.D. - President and CEO, NuBioVista LLC Consulting
      12:30pm - 1:00pm30 mins
      BIOLOGICAL ASSAYS TRACK: Bioassay Development for Non-mAbs
      Live Q & A Panellists: Scott Bradley Junming Yie, Dylan Weil, Esteban Carrillo Moderator: Gaurav Agrawal
      • Scott Bradley - Principal Research Scientist, Eli Lilly
      • Esteban Carrillo - Research Scientist (Technical Project Manager), PPD Laboratories
      • Dylan Weil - R & D Associate II, Astrazeneca
      • Junming Yie - Principal Scientist, Cell Based Assays, Merck
      • Gaurav Agrawal, Ph.D. - Scientific Development Manager, Eurofins DiscoverX
      1:00pm - 1:30pm30 mins
      Luncheon Roundtable A
      Analytical and Biophysical Characterization of Novel Modalities – Experiences and Lessons Learned
      • Chris Spahr - Senior Scientist, Discovery Attribute Sciences, Amgen
      • Chenghong Wei, Ph.D. - Associate Director, Global Regulatory Affairs CMC, AstraZeneca
      1:00pm - 1:30pm30 mins
      Luncheon Roundtable B
      Conducting Biological Assays for Cell & Gene Therapies
      • Wei Zhang, Ph.D. - Associate Director, Biogen
      • Rajeev Boregowda - Senior Manager, Sangamo Therapeutics Inc.
      1:30pm - 2:00pm30 mins
      Luncheon Roundtable C
      Novel Approaches to Accelerating Characterization – Successes and Failures
      • Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
      1:30pm - 2:00pm30 mins
      Luncheon Roundtable D
      Optimizing Bioassay Workflows & Methods To Achieve Better Product Quality
      • David Lansky, Ph.D. - President and Principal Statistician, Precision Bioassay, Inc.
      • Nathan Oien, Ph.D. - Senior Scientist, Zoetis Inc.
      • Luke Cach - Scientific Solutions Lead, Synthace
      2:00pm - 2:20pm20 mins
      WELL CHARACTERIZED BIOLOGICS TRACK: Analytical and Biophysical Characterization Requirements for Biosimilars
      Physicochemical Characterization of Antibodies in Undiluted High-Concentrated Drug Product Solutions and in Concentrations Used in the Clinic – Comparison of the Originator Bevacizumab with a Biosimilar Candidate
      • Tudor Arvinte, Ph.D. - Professor / CEO, University of Geneva Switzerland / Therapeomic Inc.
      2:00pm - 2:20pm20 mins
      BIOLOGICAL ASSAYS TRACK: Bioassay Development for Non-mAbs
      Considerations for Gene Therapy Potency Assay Development
      • Rajeev Boregowda - Senior Manager, Sangamo Therapeutics Inc.
      2:25pm - 2:45pm20 mins
      WELL CHARACTERIZED BIOLOGICS TRACK: Strategies for Accelerated Method Development & Phase Appropriate GMP Work
      Accelerated Analytical Development for Biopharmaceuticals in the 21st Century
      • Drew Kelner, Ph.D. - President, Colorado Biotechnology Consultants
      2:25pm - 2:45pm20 mins
      BIOLOGICAL ASSAYS TRACK: Bioassay Development for Non-mAbs
      Featured Presentation: Bioassay Strategies for AAV Gene Therapy Products
      • Wei Zhang, Ph.D. - Associate Director, Biogen
      2:50pm - 3:10pm20 mins
      WELL CHARACTERIZED BIOLOGICS TRACK: Strategies for Accelerated Method Development & Phase Appropriate GMP Work
      Lean CMC Strategies and Phase Appropriate Stability
      • Ranjini Ramachander, Ph.D. - President and CEO, NuBioVista LLC Consulting
      2:50pm - 3:10pm20 mins
      BIOLOGICAL ASSAYS TRACK: Bioassay Development for Non-mAbs
      Building Quality into a Cell-Based Assay for a Potent Receptor Agonist; a DOE approach
      • Nathan Oien, Ph.D. - Senior Scientist, Zoetis Inc.
      3:10pm - 3:30pm20 mins
      WELL CHARACTERIZED BIOLOGICS TRACK: Strategies for Accelerated Method Development & Phase Appropriate GMP Work
      Live Q&A with Tudor Arvinte, Drew Kelner. Ranjini Ramachande
      • Tudor Arvinte, Ph.D. - Professor / CEO, University of Geneva Switzerland / Therapeomic Inc.
      • Drew Kelner, Ph.D. - President, Colorado Biotechnology Consultants
      • Ranjini Ramachander, Ph.D. - President and CEO, NuBioVista LLC Consulting
      3:10pm - 3:30pm20 mins
      BIOLOGICAL ASSAYS TRACK: Bioassay Development for Non-mAbs
      Live Q & A with Rajeev Boregowda, Wei Zhang, and Nathan Oien
      • Rajeev Boregowda - Senior Manager, Sangamo Therapeutics Inc.
      • Wei Zhang, Ph.D. - Associate Director, Biogen
      • Nathan Oien, Ph.D. - Senior Scientist, Zoetis Inc.
      • David Lansky, Ph.D. - President and Principal Statistician, Precision Bioassay, Inc.
      3:30pm - 4:25pm55 mins
      Networking Break: View Exhibit Booths & Poster Rooms, Schedule Some Meetings
        4:25pm - 4:45pm20 mins
        Next Generation Characterization Approaches
        Structure Characterization of Protein Therapeutics
        • Frank Delaglio, Ph.D. - Principal Investigator, IBBR, National Institute of Standards and Technology and the University of Maryland
        4:45pm - 5:00pm15 mins
        Next Generation Characterization Approaches
        Live Q & A Panellists: Frank Delaglio
        • Frank Delaglio, Ph.D. - Principal Investigator, IBBR, National Institute of Standards and Technology and the University of Maryland
        5:00pm - 6:00pm60 mins
        Networking Activity - More details to come!
          Pre-Conference Workshops
          NextMain Conference - Day Two
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