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Off-target screening in regulatory submissions – industry survey results

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Although we are regularly informed that our target specificity screening data have been successfully used in regulatory submissions, it is difficult to share much of this information due to the confidential nature of individual projects. In order to help with understanding the wider impact of Retrogenix specificity assessment, and to quantify the extent to which it is replacing methods such as tissue cross reactivity (TCR) screening, we undertook a survey to find out how recently screened biotherapeutics are progressing.

Pharma, biotech and non-profit sponsors who have undertaken at least one project in the past two years were surveyed. Key results:

  • 50% of respondents had used Retrogenix data in a total of 70 recent/ongoing submissions
  • Data were used in both INDs & BLAs globally, including submissions to: US FDA, EMA (Europe), PMDA (Japan) & NMPA (China)
  • Over a third of submissions that included Retrogenix results relied solely on these data for specificity assessment, with no TCR studies (38%)
  • 90% of submissions using Retrogenix data have been approved to date.

We are grateful to all the sponsors that took part in the survey. More details on these results can be viewed here:

See survey results

A deeper analysis of the stats for individual regions and for different types of biotherapeutics is available on request. Please contact a member of our team.

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