Announcements

  • TPI Community Goals

    By: Vibha Jawa Vibha Jawa , 5 years ago

    AAPS Immunogenicity Risk Assessment and Mitigation Working Group Goals for 2020

    Scientific Focus

      1. Webinar
      2. Ask the Expert Session – 12 pm, April 30th, Thursday "Immunogenicity Risk Assessment Tools and Mitigation"
    2. Manuscript/White Paper Goal
      1. Manuscript on survey of risk assessment tools from the Risk Assessment Community (Assay Survey and Harmonization)
      2. Compendium of manuscripts on how to perform modality based risk assessments
    3. An inter-community collaboration
      1. A topical discussion with one other with one other community ;
        1. TPI community and the Biopharmaceutical Product Attribute and Biological Consequences will work together on this discussion TBD
      2. A broad progress update at least twice a year
        1. Progress update to AAPS community in May scheduled online
        2. October at Pharm Sci 360 as part of community social
      3. At least one student/post-doc/early career scientist development objective.
        1. Reach out to student community for a volunteer on monthly calls
      4. Expand outreach
        1. European Immunogenicity community and collaborate on proposals for workshops and programming for Pharm Sci 360 for AAPS / EIP assay harmonization workshop proposal
      5. Initiate new discussion groups
        1. Novel Modalities Immunogenicity
        2. CMC CQA issues and Immunogenicity of biologics
        3. Residual impurities risk assessment and regulatory requirements