Cell Microarray data in regulatory submissions

Data from Retrogenix’s IND-enabling specificity studies have been included in numerous regulatory applications, often instead of tissue cross reactivity studies. In order to help understand the wider impact of Retrogenix specificity assessment, and to quantify the extent to which it is replacing other IND-enabling methods, such as tissue cross reactivity (TCR) screening, we have initiated a feedback process which allows us to collate and share data on how recently screened biotherapeutics are progressing. We surveyed pharma, biotech and non-profit sponsors who had undertaken at least one specificity screening project with Retrogenix since mid 2018. The results showed that:

  • Retrogenix screening data have been used in at least 75 regulatory IND submissions. Notably, Retrogenix’s specificity screening data were also included in the licensing application for Novartis’ Kymriah (tisagenlecleucel) which, in 2017, was the first CAR T immunotherapy to receive FDA approval.
  • Retrogenix data is accepted globally; with submissions to the US FDA, EMA (Europe), PMDA (Japan) and NMPA (China).
  • No tissue cross reactivity studies had been performed, in over a third of these submissions (38%) . The data for specificity assessment came solely from Retrogenix studies.
  • 90% of submissions using Retrogenix data have been approved to date*.

*last survey mid-2020

Further details of how our IND-enabling specificity data are being accepted by global regulators can be found by following the link below.

See full survey results

Study Design Selection

Retrogenix has a variety of study types for all stages of the drug discovery process (i.e. IND/BLA-enabling, lead selection). Please get in touch to discuss which study type best suits your needs.

Case Studies

Retrogenix’s results are now supporting patent applications, appearing in peer-reviewed publications and being presented at international conferences.

Find out about how the Retrogenix Technology has been used:

Case Studies

 

FAQ: “What data will I receive?”

A full report presenting and interpreting the results of the screens is provided at the end of the study. On request, members of the Retrogenix team can also present and discuss the results via a web meeting.

More FAQs

Talk to us about a project

    I would like to thank you very much for the great and very timely work including this report which will be key data for our submission to the regulatory authorities.
    Marcel Walser, PhD, Senior Director Research, Molecular Partners
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    Aveo Oncology - The Human Response
    Theraclone Sciences
    BioInvent
    AstraZeneca
    Bluebird Bio
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    The Center for Infectious Disease Research
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    The University of Copenhagen
    Lund University
    MedImmune
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    The University of Pennsylvania
    Scripps Florida - The Scripps Research Institute
    Peptinnovate Ltd - Unlocking Nature's Potential
    The University of Sheffield
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