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Activity Number:
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509
- Biopharmaceutical Section P.M. Roundtable Discussion
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Type:
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Roundtables
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Date/Time:
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Thursday, August 6, 2020 : 12:00 PM to 1:00 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #312600
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Title:
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Making Drug Development More Quantitative: Applying Bayesian Decision-Making to Stage-Gate the Risk of Development
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Author(s):
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Gengqian Cai* and Timothy Montague and Inna Perevozskaya
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Companies:
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GlaxoSmithKline and GlaxoSmithKline and GlaxoSmithKline
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Keywords:
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Bayesian;
quantitative decision making;
stage-gate;
drug development
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Abstract:
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We live in the day and age of abundance of data: traditional randomized controlled clinical trials, observational studies, patient registries and expert opinions. Not surprisingly, there is growing desire to utilize all available data in drug development decisions to benefit patients and public. But having access to large amounts of multiply-sourced data can be overwhelming as not all data may be relevant to the problem at hand. One of the common reactions is to engage with information selectively. Bayesian decision making framework helps to avoid this pitfall by creating a structured approach incorporating information based on data and other relevant knowledge into the prior. The prior reflects what we DO know and what we DO NOT know, which feeds into study design and decision-making and helps to quantify the uncertainty/risks. The authors will briefly highlight GSK’s journey to transform its clinical development by applying award-winning Quantitative-Decision-Making framework. Attendees will then be asked to share their experiences.
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Authors who are presenting talks have a * after their name.
