Peter Taylor of the NIHR Translational Research Collaboration explains how the body is making the most of the industry’s pressing need for more joint working
From reducing time spent on progressing drug development ‘from bench to bedside’, to early identification of the drugs which will genuinely succeed and so prevent unnecessary expense, collaboration is key.
We are in incredibly exciting times in medicine for both potential and actual therapeutic advances, which have come about for two main reasons: firstly, research to date has resulted in a great expansion in the knowledge of pathology of rheumatic disease; secondly, we now have the ability to create targeted therapies – both biologic and small chemical entities that can act at a molecular level – which give rise to a range of new treatments that would not have been possible two generations ago.
The NIHR Translational Research Collaboration’s (TRC) expert investigators are embedded in NIHR Biomedical Research Centres which are partnerships between UK universities and NHS hospitals. As a collective of leading experts in the field, the TRC provides advice on study design and access to patient cohorts, and as a result can fast-track early phase trials, and increase the speed of drug development in order for patients to reap the potential benefits earlier. This highly skilled and unique collaboration model brings together the nation’s leading rheumatology and related inflammatory disease experts to work in partnership with industry. Together we carry out translational research and tackle experimental medicine challenges focusing on a variety of conditions including rheumatoid arthritis, Sjögren’s syndrome and a range of other inflammatory diseases, both common and rare.
While pharmaceutical companies continue to invest heavily in traditional drug development programmes, these can take up to 25 years to achieve a licence – and only then do they conduct research to gain further insight into the mechanisms of action and their full implications on the clinical potential of the drug. In collaboration with industry, the TRC aims to turn this approach on its head.
We are great believers that you can influence the success of drug development through introducing experimental medicine research at an earlier stage. Our experts can bring this research forward and work to obtain early proof of concept together with a better understanding of biological effects. This will help demonstrate whether the drug is a viable treatment option with the potential for further development that will result in meaningful health outcomes.
We can help to identify clinical benefits, potential risks, and most suitable disease indication for a given drug – and whether or not it is different from, or better than, the existing treatments available. This helps to provide an early indication as to whether a drug may be commercially viable and worthy of further investment to avoid wasting millions of pounds on unnecessary clinical research into drugs that fail in the long-run.
In the best-case scenario, the trial shows breakthrough findings that generate the confidence that a drug has the potential to deliver benefits to the clinic. It’s a win–win for patients, industry and society as we only progress the drugs which are going to be beneficial.
But even if an experimental study shows a drug is unlikely to work, we can still learn from it by understanding the biology – we may discover alternative targets which are more advantageous. Furthermore, we can make an informed decision to stop expensive, unnecessary future trials.
Phase III research programmes can cost hundreds of millions of pounds, yet 50-80 percent of those drugs will fail, depending on the research area. In rheumatology, over 80 percent of drugs fail and the rate is even higher for oncology. By investing in experimental medicine upfront, the industry can avoid the huge, and incredibly expensive, failure in late phase trials.
Case study: rheumatic conditions
One of the TRC priorities is to continue to improve treatment for rheumatic conditions. For example, 690,000 people in the UK have rheumatoid arthritis and while there are treatments available, clinicians are not satisfied that enough people go into remission and stay in remission.
Despite significant advances over the last generation, much unmet need remains. There is a shortage of drug options for many rheumatic diseases that allow the majority of patients to achieve and sustain a remission. There was a major breakthrough in rheumatoid arthritis with anti-TNF drugs, but 50 percent of patients come off the drug after two years. Now more needs to be done to enhance the numbers of patients attaining long-term remission.
The TRC is working with patients with established arthritis and analysing samples to understand how the next generation of drugs may give better ongoing treatments.
The NIHR Translational Research Collaborations are managed by NOCRI, the NIHR Office for Clinical Research Infrastructure.
My colleague, Dr Matthew Hallsworth, head of external relations at NOCRI, explains: “Through this TRC, pharmaceutical companies in the UK and abroad have access to experimental medicine of an outstanding level – for biopsies, cutting-edge ultrasound and other novel experimental techniques, the science here in our research centres is second-to-none and we are excited about the medical advances in this field.
“We are always aiming for the next breakthrough approach – for example what would give us a high remission rate for rheumatoid arthritis – that could be a quantum leap forward!”
NOCRI brings world-leading investigators, life science industries and research facilities together, acting as a catalyst to make vital research happen. By brokering crucial relationships, it helps deliver pioneering health breakthroughs, bringing drugs, devices and diagnostics to patients faster.