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Patient support

Joint working between pharma, healthcare and academia benefits patients and innovation

Patient atop a healthcare related house of cardsThe key themes emerging from the joint ABPI/BIA R&D Conference held in October said much: between the pharmaceutical industry, academia and the health service in the UK, we have everything we need to develop innovative medicines cost effectively. Our goals and motivations are also very much aligned in most respects: better patient care, new treatments, the satisfaction of stakeholders and secured funding for renewed innovation.

So the message from the pharmaceutical industry to our colleagues within academic institutions and the NHS is very simple. It is that we are actively seeking more of the kinds of partnerships that have already successfully raised the standards of patient care in key parts of UK healthcare.

We want potential partners to know that pharmaceutical companies are committed to working with them, that the tenets of Joint Working have already been laid down in formal ABPI guidelines and that many outstanding examples of collaboration already exist. Furthermore, progress is being made on initiatives such as the UK Life Sciences Super Cluster and the Industry and Higher Education Forum, both stipulated in the Office for Life Sciences Blueprint.

We're not there yet, but there's progress
However, as we reach out in this way, we must also observe that within the UK's framework for delivering health innovation there are a number of improvements that can be made. These include the need for a culture of research to be embedded within the NHS, and for greater incentives and fewer of the bureaucratic hurdles that currently hinder the adoption and successful delivery of clinical trials in the UK.

Before elaborating on these issues further, it's important to consider some of the great work already being done. The Manchester Cancer Research Centre has come about as the result of a 'deep alliance', involving the pharmaceutical industry (AstraZeneca), the NHS (The Christie NHS Foundation Trust), key faculties and schools at the University of Manchester, and the Paterson Institute for Cancer Research.

The focus has so far been in biomarker-driven research through to clinical trials, and the programme has been expanded to include training in translational medicine. AstraZeneca is funding the work of 17 research fellows at Manchester, and performance measurement of phase I clinical trials showed that the Centre was significantly outperforming other institutions both for the numbers of patients recruited and for cost effectiveness.

The most important aspect is that it gives patients in Manchester access to clinical trials and new drugs and AstraZeneca is able to do a great deal of work there very quickly and very cost effectively. It's a tremendous success story, a unique relationship and should be used as a model for further interactions around the UK and other parts of the world.

Other examples highlight the significance of real world data in projects involving partnership between the pharmaceutical industry and our health service and academic colleagues. Pfizer has two initiatives in the area of CHD, one located in Barnsley and one in Birmingham. In Barnsley, Pfizer has assisted the local PCT to screen hard-to-reach patients identified as being potentially at risk. In Birmingham, a telephone out-reach project to empower people to look after their own health is starting to show real results. Pfizer and many other companies can make a difference in the quality of care. But we can only do this if it's a two-way street. The NHS and industry have to talk and have to listen, and between us we can make a difference.

Boosting collaboration
As already mentioned, the requirement to establish a UK Life Science Super Cluster was set out in the OLS Blueprint (see bis.gov.uk/ols). This is intended to boost collaboration and leadership in translational research by harnessing UK capabilities in areas of unmet clinical need. The first Therapeutic Capability Clusters were announced at the ABPI /BIA R&D Conference by Universities and Science Minister David Willetts and Health Minister Earl Howe, focusing on research in immunology and inflammation for diseases such as asthma and rheumatoid arthritis. Already, the research centres that will take part in the Cluster have been identified, with work currently ongoing to formalise their collaborative and operational model, the class of molecules that will be tested and the scientific questions that will be addressed. A pilot scheme on this important pillar of ABPI activity will then begin.

The Industry and Higher Education Forum has also been successfully established, designed to ensure that university graduates have the skills and knowledge necessary for a career in Life Sciences. We urge the new Government to continue the work of this Forum. Clinical pharmacology, in vivo sciences and academic pathology have been pinpointed as areas of focus. Other measures described in the OLS Blueprint will also help innovation in the UK: the Patent Box, which will apply a 10 per cent rate of corporation tax on patent income from April 2013, will strengthen incentives for companies to undertake clinical innovation in the UK.
But for the UK to continue to be viewed as a world class location for clinical research, we believe that changes need to be made to the culture and the framework that surrounds such research. To this end, the ABPI made a number of observations and recommendations in response to the recent Academy of Medical Sciences review of regulation and governance in medical research.

ABPI's recommendations for the future
The ABPI's observations and recommendations include the fundamental need for a culture of research to become embedded within the NHS and its supporting clinicians. This culture needs to be championed by Trust CEOs and supported by a communication strategy to bring about positive change in the way that all NHS staff view research and its benefit to patients. There must also be additional resources earmarked for Trusts that engage in research, and a suitably incentivising remuneration scheme for investigators.

It also needs to be quicker and easier for potential sponsors of clinical trials to gain NHS approval to conduct research. All UK trials should be managed by a single entity with responsibility for making the UK the world leader in innovative health research — in the view of the ABPI, this role could be performed by NIHR Clinical Research Networks, with an expanded remit. Better incentives should be offered to commercial sponsors, such as the abolition of overhead costs for phase III trials and the removal of charges for CTA submissions to the regulatory agency, as has been implemented in France.

Super Cluster research will be aided by the provision of streamlined sign off procedures, and by the introduction in common practice of a single agreement overseen by a single lead party to reduce the administrative burden.

Where a clinical trial is held across several EU countries, the provision of an optional single EU clinical trial authorisation would remove much complexity and delay from the process, and this should be negotiated within the current review of the EU-CTD (2001/20/EC).

Lastly, with healthcare informatics set to play such a pivotal role in the future of health provision and clinical research, ABPI believes that UK healthcare databases should be co-ordinated under the Health Research Support Service (HRSS). The development of a link between primary and secondary care databases and disease registries would be extremely positive, and the HRSS could be used to identify participants for recruitment to clinical trials. This in itself would revolutionise the conduct of clinical trials.

Everything I have mentioned is intended to help foster a positive environment for experimental medicine and early clinical research here in the UK. We have the talent pool and the aptitude for innovation already, yet it's in the delivery of clinical trials and patients where the UK has fallen down.

That trend can be reversed, and to do so there must be collective and decisive action from the pharmaceutical industry, academic institutions and the health service.

Given such a commitment, the UK will continue to lead the world in clinical innovation.

The Author
Dr Allison Jeynes-Ellis
is medical and innovation director at the Association of the British Pharmaceutical Industry (ABPI).

To comment on this article, email pm@pmlive.com

15th November 2010

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