Innovation in the Pharmaceutical Industry¶
DiMasi, J. A., Grabowski, H. G., & Hansen, R. W. (2016). Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs. Journal of Health Economics, 47, 20-33.
Cited by¶
2 citations across 2 artifacts.
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Primes¶
- Stage Gate Process
- A single worked instance shows the substance: an oncology drug advancing through microdosing, single-arm safety, mid-stage efficacy, and large-scale efficacy gates, each producing evidence that licenses the next-stage commitment, each with explicit go and kill criteria, the total commitment sliced rather than committed up front, and roughly one in ten Phase-I candidates reaching approval — by design, not by failure.
This sourceDocuments the cost-staging and roughly one-in-ten Phase-I-to-approval attrition of oncology and other drug development.
- A single worked instance shows the substance: an oncology drug advancing through microdosing, single-arm safety, mid-stage efficacy, and large-scale efficacy gates, each producing evidence that licenses the next-stage commitment, each with explicit go and kill criteria, the total commitment sliced rather than committed up front, and roughly one in ten Phase-I candidates reaching approval — by design, not by failure.
- Time
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