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9 Mar 2021

Clinical Development Success Rates and Contributing Factors 2011-2020: New Report from Informa Pharma Intelligence

Biologic products advance through clinical development with a higher success rate than traditional small molecules, this new analysis of clinical development success from Informa Pharma Intelligence, the Biotechnology Industry Organization and the Quantitative Life Sciences shows.

Biologics have 9.1% likelihood of making it through the clinic to US Food and Drug Administration approval, compared to 5.7% for new molecular entities (conventional small molecules), according to the study, which is based on an analysis of ten years of Informa's Biomedtracker drug development data.

"Biological complexity in drug modalities generally leads to higher LOA,” or likelihood of approval, the analysis concludes.

Vaccines – with 10 times fewer candidates than other biologics – clocked in with a 9.7% chance of a Phase I candidate eventually gaining approval.

Informa and BIO analyzed a decade of data, identifying 12,728 clinical phase transitions, which mark a program’s movement out of a clinical phase, commonly by advancement or suspension. QLS Advisors applied machine learning to “uncover underlying drivers of success” in the 9,704 clinical drug development programs included in the study, “Clinical Development Success Rates and Contributing Factors, 2011-2020,” published 17 February 2021.

Overall, for all modalities, the LOA from Phase I was 7.9% for the 2011-2020 period.

Click here to download the report.

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