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11 June 2020

Mike Smith, Jacquie Christie

Mike Smith (Pfizer) talks on innovation, play and failing. What is innovation? How do I innovate? Is it a skill that I can learn or improve on? In this presentation I will attempt to define what I mean by innovation and break down what I consider to be drivers of innovation. Some of these are things that you CAN definitely work on. It is true that some are environmental or cultural but even these are things that you can influence or change. I will illustrate how these elements have come together to help me and my colleagues deliver on projects, innovate and break out of “tried and tested” methods, including those cited in my RSS/PSI Statistical Excellence in the Pharmaceutical Industry award.

Jacquie Christie (GSK) talks about Quantitative Decision-Making for Clinical Development. Low productivity and late-stage attrition are well-known pharmaceutical R&D problems; one cause is poor decision-making at key milestones. Failure to consider the impact of current design choices on future investment options increases uncertainty when the decision-point arrives, and consequently increases the risk of a wrong decision. This talk will outline an approach to quantitative decision-making in a completely Bayesian setting. Prior distributions are used to evaluate proposed study designs and decision rules against not only the probability of success of the current study, but that of the subsequent study or set of studies. Termination and progression criteria and associated risks are then clear, allowing more informed decision-making. The approach is applicable to all phases of R&D.

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