Bridging the translation gap

Posted on August 8, 2012 by

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The UK has for decades been a world-leader in medicines discovery and research, and this has brought economic benefits as well as improving the healthcare of millions. But medical research in the UK, particularly the development of new medicines, is changing. The number of new medicines has plateaued over the past decade despite increased investment in research & development (R&D). This, alongside significant revenue losses as important drugs are no longer protected by patent, is putting the industry under considerable pressure, leading to a scaling-back of pharmaceutical R&D.

The Royal Society of Chemistry (RSC) has joined with partner learned societies to recommend a new model of medical research to ensure the UK can foster the development of new medicines, the Healthcare Innovation plan. This plan aims to contribute to the well-being of patients and help drive our future economic prosperity.  We are now looking to work with partners across medical research, including medical research charities, to drive these proposals forward and help bridge the gap between fundamental biology and clinical research.

Background – how is medical research changing?

In 2009, the pharmaceutical and biotechnology sectors invested £4.4bn in R&D, employed some 72,000 skilled staff, including 27,000 highly-trained scientists and doctors, contributed around £8bn to GDP and generated almost £7bn in terms of trade surplus.

Large pharmaceutical companies owned the research and development process from start to finish – identifying new clinical entitities with the potential to become medicines ,  developing and then trialling them with patients. The UK was particularly successful in this field with at least 10 of the top-selling drugs worldwide (>$1bn annual sales at peak) having had UK-trained PhD organic chemists as named inventors.

But in recent years, the number of new clinical entities being discovered has plateaued and, combined with high failure rates (>90%) and escalating R&D costs, this model has become unsustainable.

Much of this failure is due to lack of efficacy in Phase 2 trials. In other words, more often than not we have been working on the wrong targets and we have been testing potential new medicines in the wrong patient groups.

What is being proposed?

In response to these problems there is now a greater focus on developing benefits for defined patient groups, with academia, biotech, contract research organisations, the NHS, charities and the pharmaceutical industry working in collaboration to select targets for drug discovery programmes.

This collaboration requires a mix of disciplines, skills and expertise. Ensuring we have the right mix will be particularly important if the translational aspirations of major biomedical investments such as the Crick Institute and the NIHR’s Biomedical Research Centres and Units are going to deliver the next wave of new drugs demanded by an ageing population.

The Healthcare Innovation plan proposes how to ensure this mix – establishing a network of therapeutic centres of excellence to support drug discovery in the UK. Drug discovery scientists with industry experience would be embedded in the centres to work alongside academic researchers and clinicians. This would introduce a drug discovery perspective respected by industry partners – so bringing together biology and disease expertise, excellent clinical research and the world-leading drug discovery know-how that currently exists. The RSC believes this model would help to drive excellent science and training and share a passion for, and commitment to, discovering medicines that have the quality to make a real difference to patients’ lives.

There is no single blueprint for such a centre, although it is expected that some may be based in academic institutions where there is already a will to bring together fundamental research and clinical research (in particular NIHR Biomedical Research Centres and Units) in a more systematic and coherent approach  With a moderate degree of investment (or at least re-alignment of existing funding streams), these centres have the potential to unlock the vast opportunity for new medicines presented by current research efforts.

What next?

The RSC has teamed up with The British Pharmacological Society, The Society of Biology and the Biochemical Society to advance these proposals. These learned societies combined represent a membership of over 100,000 chemists, pharmacologists, biologists and biochemists in the UK and over 130,000 worldwide. A clear and coherent message from the medical research community on the need to support and invest in healthcare innovation and drug discovery is needed to drive this plan forward. We have started to engage the Academy of Medical Sciences as well as a much wider base of learned societies and professional bodies, particularly around skills development for researchers in the life sciences.

We also want to work with medical research charities. Medical research charities play a key role in funding health research and in establishing therapeutic centres in the UK. These centres offer opportunities to begin embedding and supporting drug discovery expertise to bridge the gap between fundamental biology and clinical research.

We are keen to hear your thoughts on these proposals and how we can work with you – please contact me at foxd@rsc.org.

Posted in: Policy