Analysing Complex Data in the Pharmaceutical Industry: The Case for Multivariate Analysis

02nd May 2019 | 10:00am GMT | Presented by Mike Tobyn, Research Fellow at Bristol-Myers Squibb |WATCH FOR FREE

The Pharmaceutical Industry has a strong need to develop knowledge from data. Although the latter is not at a premium in the Pharmaceutical Industry the former is, as always, at a premium. Multivariate data analysis (MVA) is a set of statistical data analytical methods which has  been widely adopted within the Pharmaceutical Industry, and it has pre-eminence within the discipline.

The ability of MVA to provide validatable solutions within a Regulated Pharmaceutical environment has arisen because of its transparency and reproducibility, across a wide field of data sources. An ecosystem of software providers, allied with hardware solutions, means that the  techniques are becoming widely understood and applied.

Key to this adoption has been the ability of MVA techniques to meet not only direct Regulatory Guidance, but also Industry Standards such as ICH Q8 and initiatives such as Quality by Design.

A wide body of literature is now available which explains how to use the technique appropriately, so that these Guidances can be met, leading to robust solutions

Presented by Mike Tobyn, Research Fellow at Bristol-Myers Squibb


Dr Mike Tobyn is a Research Fellow in Materials Science and Engineering within Bristol-Myers Squibb, Moreton, leading a transatlantic team covering early to late phase Material Properties of drugs and excipients. His team studies API and excipient properties and their interaction with pharmaceutical processes. He has been at BMS for 13 years, following jobs in Academia and working with a company from start-up to IPO. He has published more than 75 papers in the area of formulation and Pharmaceutical Materials Science.

The understanding of the complex interactions in Pharmaceutical Materials Science has led Mike to investigate techniques of data analysis as it pertains to R&D and production, of small and large molecules. 2018 saw the publication of the book he edited with Dr Ana Ferreira and Professor Jose Menezes entitled “Multivariate Analysis in the Pharmaceutical Industry” covering the technical and regulatory aspects of MVA and associated techniques.

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