Plans for a network of Therapeutic Capability Clusters serving as “one-stop shops” for cutting-edge research mark a concrete step towards the formation of a UK Life Sciences Super Cluster aimed at establishing a world-leading presence in translational research.

A call will go out this spring for a pilot Capability Cluster targeting research in the field of immunology and inflammation, with a focus on diseases such as asthma and rheumatoid arthritis. The pilot, which will be managed by the the UK government's Office for Strategic Co-ordination of Health Research, is expected to be operational by summer this year, with a review of the pilot set-up earmarked for late 2010.

The pilot Therapeutic Capability Cluster will get direct government support in the form of £1 million in funding from the Strategic Investment Fund, to be administered by the Technology Strategy Board (TSB), for the strategic co-ordination and evaluation of the initiative.

The clinical research infrastructure for the Capability Clusters will come mainly from the £160 million per year of support provided by the National Institute for Health Research (NIHR). This is channelled through the existing Biomedical Research Centres (BRCs), Biomedical Research Units (BRUs) and Clinical Research Facilities (CRFs) established by the NIHR through partnerships between the National Health Service and academia.

An update on the Life Sciences Blueprint published by the government’s Office for Life Sciences (OLS) last July also mentions efforts by the TSB and the Medical Research Council to develop co-ordinated approaches to stratified medicine – ie, optimising therapy by identifying shared biological characteristics.

In addition, the MRC and the Association of the British Pharmaceutical Industry (ABPI) are working together on a research initiative focused on inflammation and immunity.

“All of these activities and investment will complement the Capability Cluster pilot activities as well as increase capabilities in other relevant therapeutic areas, which will support the initiative in the longer term,” comments the OLS in its just-published report, Life Sciences 2010: Delivering the Blueprint.

Kick-start

The Capability Cluster pilot will “kick start” moves to realise a UK Life Sciences Super Cluster, a concept unveiled last year in the Life Sciences Blueprint, the OLS said. The idea is to co-ordinate joint research and development across industry, Higher Education and the NHS, with the broader aim of boosting international recognition of the UK life sciences sector.

As the Blueprint noted, in a number of areas in the UK (such as the North West, Scotland and the greater South East), industry, Higher Education, the NHS and medical research charities “are already working closely together. They are building on existing architecture, such as Academic Health Science Centres, with the aim of achieving the same international recognition as overseas clusters such as Boston, USA”.

The government will seek to consolidate these efforts, transforming regional centres of excellence into a UK Life Sciences Super Cluster with the capacity both to compete with equivalent clusters overseas and form strategic alliances with them.

The Capability Clusters, the Blueprint update explains, will constitute “a small number of selected academic and NHS centres of excellence that will collectively provide a single point of contact and focus for industry collaboration in critical therapeutic areas”. They will “harness UK capabilities in these areas by bringing the centres of excellence together with industry to work on early-stage clinical development and experimental medicine”.

Therapeutic Capability Clusters will be formed in areas where:

- There is strong, existing scientific expertise in the UK research community
- Industry has significant research interests and pipeline activity in areas of unmet medical need
- There is already significant infrastructure in place – for example, to provide well-characterised patient cohorts for clinical trials

Co-ordination function

According to the OLS, the Capability Clusters will “provide a vital co-ordination function to facilitate world-class academic-NHS-industry collaborative research. They will enable researchers to better understand the effectiveness and efficacy of potential new medicines or interventions in humans, and to ensure the UK leads in translating these findings into successful products”.

The initiative will also raise awareness of the UK’s capabilities in the field, contribute to the development of a UK communications strategy for Life Sciences research, and improve the UK’s attractiveness as an investment location, the OLS noted.

Targets needed

The move was welcomed by the trade associations for life sciences in the UK, which said the Capability Clusters would “strengthen collaborative efforts between academia, the NHS and industry, ensuring a holistic approach to the development of new therapies”.

However, the associations warned, the longer-term impact of the planned Life Sciences Super Cluster would be contingent on a more aggressive push behind clinical research in the NHS.

“The embedding of clinical trials into core NHS activity in the recently published NHS Operating Framework is a step forward; what we need now are specific performance targets,” they commented.

As Life Sciences 2010: Delivering the Blueprint points out, the Operating Framework for 2010/11 “reinforced the clear expectation to all NHS providers that they will increase their participation and performance in hosting research from both commercial and non-commercial funders”.

In its response last year to Review and Refresh of Bioscience 2015, the progress report issued in January 2009 by the Bioscience Innovation and Growth team headed by Sir David Cooksey, the government said it would work with the NHS to ensure that healthcare providers included in their Quality Accounts the number of patients recruited for clinical research during the previous year.

However, it balked at the Cooksey report’s recommendation that the NHS Operating Framework should include “a specific objective of doubling the number of patients recruited to clinical trials in NHS Trusts over the next three years”.

The government insisted the objective set in the NHS Operating Framework for 2009/10 – to double the number of patients taking part in clinical trials and other well-designed research studies within five years – was “more realistic”.

Recent indications are that the number of clinical trials conducted in the UK fell significantly in 2009 versus the previous year.