The UK's Life Sciences Strategy: opportunities for clinical pharmacology

Abstract

The UK's Life Sciences Strategy provides UK clinical pharmacologists with a unique opportunity to enhance the impact of their discipline on patients and the NHS as well as the pharmaceutical industry. The full benefits of electronic prescribing systems, supported by artificial intelligence, will require clinical pharmacological expertise. Similarly, the Strategy's support for ‘healthy ageing’ will only be realized if clinical pharmacologists are able to use their expertise in promoting the safe and effective use of medicines in older people. Furthermore, their needs to be an active – and continuing – collaboration between clinical pharmacologists in the NHS and the pharmaceutical industry in general as well as with the discipline of pharmaceutical medicine.

In January 2017, the UK Government, in a Green Paper , announced that it was proposing to develop a new industrial strategy for the UK 1. As part of this programme, a representative group developed a cross‐sector strategy, designed specifically for the life sciences industry. The membership included not only senior individuals from the UK's pharmaceutical and medical technology industries but also the National Health Service, academia, medical research charities and the National Health Service. Under the chairmanship of Professor Sir John Bell, the report of Life Sciences Industry Strategy Board published its recommendations in August 2017 2.

Summary of the reports findings

The report covers seven domains:

• The establishment of a Health Advanced Research Programme (HARP) based in the principles underpinning highly successful the US Defence Advanced Research Projects Agency (DARPA) ;

• Reinforcing of the UK's Science offer;

• Maintaining growing the UK's life sciences infrastructure;

• Collaboration with the UK's National Health Service;

• Recognition of the significance of data;

• The skills necessary for the UK to ‘punch above its weight’ and

• The relevance of proportionate regulation.

Although the term ‘clinical pharmacology’ only appears in the Key Skills section of the Life Sciences report, the significance for the discipline stretches across all seven domains of which the HARP and the Key Skills components are the most significant.

Health Advanced Research Programme

In the domain introducing HARP – the Health Advanced Research Programme – the primary focus is concerned with genomics, digital diagnostics, artificial intelligence (AI) and healthy ageing. For genomics, HARP proposes the extension of whole genomic sequencing of the cancer genome pathway. Though not specifically mentioned, this could also encompass the range of potential pharmacogenetic techniques including both markers influencing pharmacokinetics as well as those with a significant impact on pharmacodynamics response.

For digital diagnostics and AI, the report describes their likely impact in radiology and pathology. But AI could have an even greater influence on prescribing especially when linked to pharmacogenomics. AI has already had some – albeit relatively modest – impact on prescribing in primary care. But the significance of fully developed prescribing using AI could be immense not only in primary care but also in secondary and tertiary cares once all sectors have comprehensive and interoperable electronic prescribing systems. But the full potential of AI in electronic prescribing will only be realized if clinical pharmacologists play a central role.

Similarly, the promotion of healthy ageing also offers massive opportunities for clinical pharmacologists. The crucial importance of ensuring that older people have access to safe and effective medicines is obvious and another activity that clinical pharmacologists should embrace.

Skills

In the section on Skills, the Report states:

In order for the skills base to be developed in line with the needs of the sector, the life sciences sector should come together to develop and deliver a reinforced skills action plan across the NHS, commercial and academic sectors, based on a gap analysis which identifies the key skill areas for future focus. This is expected to include clinical pharmacology, clinical trials, manufacturing, data science, clinical science, engineering and biosciences. Underpinning the advancement of the sector is also a need for people with regulatory skills – across industry, the health service and academia as well as regulators – not only to do the core work of medicines development, regulation and delivery to patients – but to be resourced to develop standards for emerging technologies and methodologies.

This quote has provide the stimulus for the development of a BPS's Action Plan for a Clinical Pharmacology Skills Alliance with the active co‐operation of the Faculty of Pharmaceutical Medicine, Health Education England and the Association of the British Pharmaceutical Industry which is further discussed later.

Responses to the report

The findings and conclusions of the Life Sciences Industrial Strategy Report were endorsed in their entirety by the Government in December 2017 3 and are already having traction.

Industry responses

At the same time as the Government response to the Report was published, MSD announced that it would establish a new UK life sciences research facility focusing on bioscience discovery and entrepreneurial innovation. MSD's new Discovery Centre is expected to accommodate 950 staff. On the same day, QIAGEN announced that it will partner with Health Innovation Manchester to develop a genomics and diagnostics campus with the potential to create 800 skilled jobs.

NHS England's response

Of equal significance has been the recent publication of NHS England's own commitment to research 4 in order to make the NHS in England a more attractive base for research which includes four commitments.

First, NHS England proposes (subject to consultation) to simplify the management of Excess Treatment Costs (ECTs). These are the additional costs (such as the costs of additional imaging or other diagnostic tests) that are necessary for the conduct of a specific clinical trial but which would not be incurred in routine care. ECTs that individual NHS providers seek have become a point of friction with commissioners of healthcare in England. Under the proposed plan, the National Institute of Health Research's 15 clinical research networks would manage Excess Treatment Costs by putting in place a standardized process under which providers would pay them.

Second, NHS England seeks to introduce measures that would reduce delays in establishing multicentre clinical trials. Currently, sponsors of such studies face frequent uncertainties and delays in setting up trial sites because they have to wait for each provider to confirm their participation individually. Worse still, different providers often try to negotiate different terms and prices for the same study; and NHS England claims that there may be differences of up to 9 months for the fastest and slowest sites to be set up.

Thirdly, NHS England aims to standardize the process for assessing contract research. It will require providers to use a standard research contract and publish performance data on their research. This, NHS England believes, would cut costs for NHS providers, industry and research charities.

Finally, NHS England propose other plans to promote clinical research including an NHS genomics service and increasing general practitioners' participation in the Clinical Practice Research Datalink. The latter is a database of primary healthcare records funded jointly by the National Institute of Health Research and the Medicines and Healthcare products Regulatory Agency.

British Pharmacological Society's response

In its own response 5, the British Pharmacological Society recognizes that the UK health and research sectors have, for some time, been suffering from a shortfall in skilled clinical pharmacologists. This has led to the Society developing an Action Plan for a Clinical Pharmacology Skills Alliance discussed earlier.

The implications for clinical pharmacology

Investing in clinical pharmacology and focusing on the future will be essential if the Life Sciences Strategy is to have the impact that the UK needs. Moreover, if clinical pharmacologists are to make a real impact in delivering HARP – and I think we must – then the training needs to be better integrated with the needs of industry. I therefore believe that during their education and training, all clinical pharmacologists should spend a period of time attached to a pharmaceutical company to gain experience and expertise in the drug development process. Similarly, trainees in pharmaceutical medicine should spend some period of time in the NHS and/or academia.

Moreover, in the future, consultant clinical pharmacologists should commit to spending time collaborating with the pharmaceutical industry. Precisely how this is to be accomplished will vary – but we need to be prepared to be flexible. Similarly, both the industry and the NHS would benefit very substantially if fully fledged pharmaceutical physicians were to spend time in the NHS and/or academia. Again, some flexibility would be necessary but the benefits to all parties would be very substantial.

Conclusions

Clinical pharmacology has much to offer not only to the National Health Service but also to the Life Sciences Industry Sector. In doing so, clinical pharmacologists must embrace the opportunities offered by the Life Sciences Industry Strategy Report for the wider benefit of patients, the public and the economy.

Competing Interests

There are no competing interests to declare.

Rawlins, M. D. (2018) The UK's Life Sciences Strategy: opportunities for clinical pharmacology. Br J Clin Pharmacol, 84: 2175–2177. 10.1111/bcp.13629.