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Activity Number:
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306
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Type:
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Contributed
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Date/Time:
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Tuesday, August 2, 2016 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #319415
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View Presentation
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Title:
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Value-Driven Decision Making at Late Stage of Drug Development: Statistical Simulation Approach
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Author(s):
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Masanori Ito* and Hideki Hirooka
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Companies:
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Astellas Pharma and Astellas Pharma
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Keywords:
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decision analysis ;
scenario simulations ;
expected net present value ;
probability of success
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Abstract:
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Drug development strategy is often planned by decision tree method with expected net present value (eNPV) based on estimated costs, timeline and pre-defined probability of success (PoS) at each development stage in pharmaceutical firms. The development strategy of confirmatory phase should be reviewed and updated based on any available data and current internal/external situations once we confirm the proof of concept. A good scenario to achieve the regulatory approval with viable commercial value often exists in a trade-off between the risk & PoS and the cost & timeline. It always becomes a complicated problem and therefore statistical scenario simulation would be a great tool as a quantitative decision making approach. Late phase strategy should be evaluated in terms of various factors. Enrichment strategy can be conducted to solve the trade-off problem between PoS and commercial value. We introduce the simulation examples. PoS for meet the target product profile is re-estimated. eNPV in each scenario is calculated based on the study design, re-estimated PoS and estimated cash flow. Uncertainty of each factor is estimated as a variance from the simulation iteration.
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Authors who are presenting talks have a * after their name.
