Clinical research in the UK must build on industry collaboration, says NIHR director

Last month, the Labour government came into power in the UK after almost two decades, with a plan to “kickstart economic growth” and reform the British economy.

A key part of the UK economy is the healthcare sector and in his first week in power, UK’s new health secretary Wes Streeting addressed a popular concern of delayed medical care by announcing plans to tackle the backlog of patients awaiting hospital treatments. Now, the pharma and biotech sector is looking to see how the new government will address other issues facing the UK healthcare ecosystem.

“Four weeks into this new government now, I think they’re slowly getting to understand health research and its impact,” says Michael Lewis, director of the Invention for Innovation (i4i) Programme and the Small Business Research Initiative (SBRI) at the National Institute for Health and Care Research (NIHR). Lewis is also.

In Lewis’s work as the NIHR scientific director for innovation, he is accountable for some of the organisation’s industry investment programs. He is also one of the for scientific directors who advise the Department of Health and Social Care, and is a professor of Life Science Innovation at the University of Birmingham.

In an exclusive interview with Pharmaceutical Technology, he discusses the key areas for change for the NIHR and ways to improve the UK’s standing within the global clinical research space.

This interview has been edited for length and clarity.

Michael Lewis: ​​​​​​​We also need the NHS to do commercial clinical trials, working in partnership with the pharma and biotech industries. The more commercial clinical trials you can do, the better it’s going to be for the NHS in terms of cost saving, and you’re going to be able to provide newer therapies to people in the country.

We have seen a trend in clinical studies getting longer. Having a longer period for long-term studies would allow you to make commitments to the people working in these organisations. You can say “You are going to have a job. There is going to be some career building as well, so you feel much more secure.”

The government has previously talked about doing more long-term planning for research, proposing a 10-year plan related to UK Research and Innovation (UKRI). I have not heard that mentioned specifically in terms of health research, but that would be a good thing to do.

We are putting in place some of O’Shaugnessy’s list of 28 recommendations… but I think we need to continue to do more of those and push ahead. We are opening new patient recruitment centres so people can enlist in trials, and enabling people to participate in clinical studies using the NHS app. We need to enhance those areas, push forward to emphasise that industry is a good actor in this and that we can work together.

Michael Lewis: The NIHR can be a complex organisation for people to work with. If we make ourselves approachable and simple to work with, so industry comes to us first, we can help them find the best places to run trials, help with study design, and improve their methodologies and statistics so they get the right outcomes.

If we can foster more relationships between the NIHR researchers and researchers from pharma and biotech companies, we can start building those bridges. We see the benefits in these deals, like the deal that we signed with Moderna, where Moderna agreed to build a manufacturing site in the UK. We also helped them set up expert groups, so they could tap into academic expertise. We would love to do that with more companies.

We have also done something with BioNTech, and we’d love to do [similar partnerships] with the medium-sized biotech companies. There are probably another eight to 10 major pharmaceutical companies that we would love to bring into that sort of arrangement.

Michael Lewis: ​​​​​​​We have set up things like the email address [industry@nihr.ac.uk] where people can ask those questions. Medium-sized biotech companies usually have a single asset, and they have raised quite a lot of money to back it, but they lack the expertise to run, set up, and manage clinical trials. They outsource that part of the business, but we can help them find sites and determine eligible patients with the great data we have within the NHS and NIHR. Each person has a single record that is tied to their NHS number, which follows them from pre-birth until they die… So, for medium-sized biotech, they should reach out if they want help understanding how to design trials to get regulatory approval.

Having worked with a few of the medium-sized biotechs, you soon realise that their needs are totally different from big pharma companies who have regulatory and manufacturing departments. We have to help them bring products or modified therapies from overseas, and ensure they have the right Medicines and Healthcare products Regulatory Agency (MHRA) approvals in place. As O’Shaughnessy pointed out, we’ve fallen from fourth in the world for Phase III clinical studies to 10^th, and we are putting in place a lot of measures, so we can get back up there.

Michael Lewis: Engineering biology is going to be really important for cancer vaccines, novel therapies and rare diseases. The Labour Party highlighted that 27 out of 28 [engineered biology] companies had originated in the US, and that we [the UK] were behind the curve in terms of engineered biology, which is probably one of the game-changing technologies we’re looking at; like with gene silencing and base pair editing.

There are also so many disease areas to look at. Sometimes you find things out when you are looking at rare diseases that have implications beyond rare diseases.

We need to make sure that we are educating the right people, and putting the building capacity behind engineered biology, because if we just put money behind it and build a nice structure and a school of engineered biology without people who have the right education, it will fail, and programs won’t get done. You have to build a place, you have to build programs, and you have to have people.