GlaxoSmithKline Clinical Unit Cambridge
The CUC is a clinical research facility embedded in the heart of Addenbrooke’s Hospital in Cambridge since 1999. The Unit specialises in innovative Phase 1 and early Phase 2 studies across a broad range of therapeutic areas, exemplified by recent studies on atherosclerosis, type 2 diabetes, obesity, cognitive impairment, and various aspects of inflammation.
The majority of the CUC’s work is on asset-related decision-making studies for project teams as well as studies that do not immediately involve a specific asset but are intended to advance drug development in future, by validating new methodology or by improving understanding of major disorders.
Critically, the Unit has also been able to follow through and deliver these newly validated methods to add value to several asset-related studies. From 2007 to 2009 inclusive ‘ the CUC has trebled its activity while keeping costs consistently low throughout this period. This amounts to a substantial improvement in productivity. In 2009 alone, 19 studies were carried out by the 34-strong team, demonstrating the growing importance of the Unit to our business.
The CUC leads on innovation in early clinical development, for example through the use of a new endpoint or lab assay, access to a stratified patient group, or development of a new phase 1 model. This is usually inaccessible by outsourcing to CROs that are operating a traditional, high volume, “feed and bleed” business model.
In addition to the state-of-the-art facilities of the CUC itself, the GSK team also maintains an extensive network of contacts in the Cambridge clinical and academic community. This means that the Unit can offer the benefits of externalising GSK R&D projects, by engaging local academic talent, while maintaining high standards of regulatory compliance and operational efficiency. About half of the Unit’s current portfolio involves experts at The University of Cambridge. One recent example of CUC-based academic-industrial partnership has been a series of projects commissioned by the Academic DPU to develop a new drug for over-eating and obesity. The University of Cambridge has world-class academic leadership in several therapeutic areas and the Clinical School is strategically committed to support closer working with GSK ‘ so this is an aspect of CUC activity where the team hopes to see more growth in future.
Access to patients and healthy volunteers is another critical aspect of CUC operations where the team has invested heavily to improve its service to discovery customers. For example, the Unit maintains a panel of healthy volunteers, many of whom have provided a sample of DNA so that they can be screened for recruitment into genetically stratified phase 1 studies. In 2009, the CUC successfully completed two studies using this resource to investigate the effects of genetic variation in a drug target. This experimental approach can provide compelling early evidence to a project team that their compound is having pharmacodynamic effects by hitting the intended target; the existence of the CUC panel helps to make it logistically easier to access whatever genetically-defined groups the team is interested in. The Unit has also built specialist patient databases for obesity and type 2 diabetes and is open for discussion with partners in discovery about any disease area where they see a long-term requirement for enhanced patient access. For example, teams taking a more mechanistically refined approach to development for a major disorder may want access to a certain segment of the patient population. The CUC can prepare the way by identifying potential patients and pre-screening them to match eligibility criteria for a stratified phase 2 study.
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