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Mathematical Sciences

Improved drug development through statistically designed experiments

Research by statisticians in the Southampton Statistical Sciences Research Institute and Mathematical Sciences at the University of Southampton has been pivotal in helping scientists in product development at global healthcare company GlaxoSmithKline (GSK) obtain new knowledge and scientific understanding to ensure quality processes in drug development.

Research challenge

Developing a new drug is a lengthy procedure that costs pharmaceutical companies millions of pounds. A large number of tests and experiments need to be carried out before any new drug can be submitted for approval by the regulatory authorities. The development of chemical processes on which new drugs depend is an inherently multi-factor problem requiring the study of many chemical properties and process features. Designed experiments are required to collect high quality data in order to identify and understand the key factors driving the performance of the system. Careful choice of experimental settings can increase the clarity and scope of results, and reduce the size of the experiment, the time and the resource needed to investigate a large numbers of factors.

Context

Southampton has a strong and long-standing track record of collaboration with industry of developing and applying novel statistical methods which tackle substantive problems and enhance industrial processes. Past industrial partnerships include Ford, Jaguar, Goodrich and Lubrizol. Statisticians from Southampton have a well-established relationship with GSK, stretching back over a decade.

Our solution

Research by David Woods and Susan Lewis, Professors of Statistics, has produced new methods to help pharmaceutical companies find cost-effective and reliable methods of developing chemical processes underpinning the development of new drugs. They addressed the challenge of how best to investigate a large number of factors, or features, that potentially influence a chemical process when experimentation can be time consuming and expensive. Their research enabled the key factors that drive the process to be detected as efficiently as possible so that the outputs from the process can be controlled. Their results have helped industry professionals improve their experiments for both the screening and robustness stages of chemical development to maximise yield and minimise impurities.

What was the impact?

GSK have applied Southampton’s methodology to experiments included in submissions to the US Food and Drug Administration (FDA) for the approval of new drugs. The new statistical design of experiments approach provides a much more economical alternative to the standard statistical tools currently used in the pharmaceutical industry to assess robustness of chemical products, whilst maintaining or enhancing the quality of the scientific decisions.

An important application of the new methodology was in the development of two new skin cancer drugs. GSK’s submissions to the FDA included results from experiments using the Southampton methodology which allowed scientific understanding to be gained on 16 factors with a two-thirds saving in cost and time compared with use of the standard statistical tools.

Helping scientists develop products

Southampton has a strong and long-standing track record of collaboration with industry of developing and applying novel statistical methods which tackle substantive problems and enhance industrial processes.

Dave Woods - Professor of Statistics

Key Publications

List of all staff members in
Staff MemberPrimary Position
Dave WoodsProfessor of Statistics, Head of Statistics
Sue LewisEmeritus Professor
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