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Techniques & Tools Pharma & Biopharma, Technology

Bioanalysis 2.0

Twenty years ago, mass spectrometry swept into the field of bioanalysis and rapidly replaced existing detection methods, such as UV. As a result, pharma was able to scale-up pharmacokinetic (PK) and toxicokinetic measurements in drug discovery and development like never before, allowing portfolio decisions to be based on circulating in vivo concentrations rather than merely the dose administered. Nowadays, bioanalytical measurements extend far beyond drug concentrations in plasma, and support a more translational medicine-centric mind set within the pharmaceutical industry. Increasingly, data-rich preclinical and clinical trials demand much more from limited R&D budgets, and to keep costs manageable, the pharma industry often looks to develop partnerships with contract research organizations (CROs). Indeed, the majority of regulated bioanalytical work is conducted at CROs.

The pharma-CRO partnership should be mutually beneficial but, in reality, innovation in bioanalysis has faltered – caused in no small part by the evolutionary course of the arrangement. Given the current high level of outsourcing, CROs have become the majority shareholder, while pharma has seen a concomitant contraction of internal capital expenditure and bioanalytical staff. In parallel, today’s marketplace for novel medicines means that pharma procurement groups must maximize return on investment (ROI) for any externalized activities, with the goal of getting medicines to market at a price tolerable to payers, shareholders and healthcare providers alike. In turn, CROs are under pressure to keep costs low.

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About the Author

Scott Summerfield and Eric Yang

Scott Summerfield is Head of Bioanalysis at GlaxoSmithKline, Ware, UK. Eric Yang is Vice President, Bioanalysis Immunogenicity and Biomarkers, GlaxoSmithKline, Philadelphia, USA.

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