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  • 1.  Pharm/Tox Phase 1 Vaccine IND - 1 species?

    This message was posted by a user wishing to remain anonymous
    Posted 30-Mar-2023 07:35
    This message was posted by a user wishing to remain anonymous

    Dear Colleagues, Have you received agreement from FDA for Safety Pharmacology and/or Tox data package for Phase 1 Vaccine IND with 1 animal species (instead of 2)?

    If yes, please could you share a few points on how it was justified?  - for e.g. Only animal/species A is relevant because...

    Or if no, what was the pushback from CBER?

    Thanks in advance



  • 2.  RE: Pharm/Tox Phase 1 Vaccine IND - 1 species?

    This message was posted by a user wishing to remain anonymous
    Posted 30-Mar-2023 11:37
    This message was posted by a user wishing to remain anonymous

    We were able to get CBER/OVRR approval to conduct only 1 animal species tox study (repeat-dose) since there are no appropriate animal models for the disease in question. However, we did do a 2nd species biodistribution study. Neither of the 2 species were truly appropriate, but we had to do something to proceed with our FIH study.


    Original Message


  • 3.  RE: Pharm/Tox Phase 1 Vaccine IND - 1 species?

    This message was posted by a user wishing to remain anonymous
    Posted 31-Mar-2023 08:25
    This message was posted by a user wishing to remain anonymous

    Thank you! Did you do a  Safety Pharmacology study ((1 or 2 species) ? --  [i.e., in addition to Tox (1 animal species) + 2nd species biodistribution]
    Also, did you include the tox study summary/results - or -  just the design in the pre-IND meeting package?
    Thanks  in advance.


    Original Message


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