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Mark Your Calendar for Next Year's Event!
November 2022Metro Washington DC Area
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Oct 25

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Oct 25

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10:55am - 11:00am5 mins
Conference Opening and Welcome
    11:00am - 11:30am30 mins
    PLENARY SESSION
    KEYNOTE: Structural studies of mRNA vaccines using cryogenic electron microscopy (cryo-EM) and scattering
    • Thomas Cleveland - Physicist, National Institute of Standards and Technology, Biomolecular Measurement Division
    11:35am - 12:05pm30 mins
    Well Characterized Biologics
    Comparative assessment of mAb higher order structure in biopharmaceutical development using novel NMR and chemometric analysis
    • Victor Beaumont - Senior Scientist, Pfizer
    12:10pm - 12:40pm30 mins
    Well Characterized Biologics
    FDA Address: Detection of Stability Change in Frozen Drug Substance and Efficient Stability Monitoring of Drug Product
    • Mikhail Ovanesov, CBER, OTAT, DPPT - Research Biologist, Principal Investigator, FDA CBER
    12:40pm - 1:45pm65 mins
    Networking Break
      1:45pm - 2:15pm30 mins
      Well Characterized Biologics
      Navigating the Analytical CMC Pathway
      • Greg Adams - Senior Director, Global Analytical Strategy & Development, FUJIFILM Diosynth Biotechnologies
      2:20pm - 2:50pm30 mins
      Well Characterized Biologics
      FDA Address: Manufacturing, Quality and Regulatory Considerations for Cell & Gene Therapies
      • Laura Ricles - Cell Therapy Team Lead, FDA
      NextOct 26
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