Author: Lilian Zhang, Jason Brauner, and Marc Herant

Recon takes an analytical look behind select developments in healthcare

A Kaplan-Meier view of oncology development

We refresh a prior analysis of two cohorts of oncology development programs: one with first-in-human (FIH) in 2012, and the other with FIH in 2017H2. We use a Kaplan-Meier approach to track whether programs have reached either of two final outcomes: a first approval from FDA, or a discontinuation of development. We find again that programs from commercial pharma reach final outcomes much faster than those from early-stage biotechs, which likely reflects a mix of a higher operational resourcing and efficiency, and more portfolio prioritization rigor. Beyond other specific findings,

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Trends and strategy in oncology development

PDF: Trends and strategy in oncology development Summary We review a sample of oncology programs from the past decade and arrive at the following key findings: The use of expansion cohorts in first-in-human (FIH) studies has grown significantly in the last decade, with an accompanying decrease in separate phase 2 studies Commercial-stage sponsors and early-stage companies backed by established VCs are much more aggressive in discontinuing programs quickly compared to other early-stage companies For drugs that achieve approval, the time from FIH to approval is much shorter for big pharma

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