Mackay says she sees a role for the government in providing “clear and sustainable funding” for biotechs.
“In the life sciences sector there’s a particular issue around the lack of patient capital and the funds needed to advance a therapy into the clinic through a rigorous programme of multi-site clinical trials.
“There’s a role for both the public and the private sector to support that sustainable investment. In the current model, if companies miss a milestone or a milestone is delayed, valuation rapidly decreases. That is very detrimental to a company. There’s a need for long-term patient investment that isn’t quite resolved yet.”
Oncology biotechs face additional challenges on top of this thanks to the complex nature of the disease area.
“The oncology market remains huge,” says Mackay. “It’s attractive for businesses to go into this area, but it’s also an unbelievably competitive field.
“The failure rate in oncology remains extremely high. We still need better approaches, and better pre-clinical models for every aspect of the process.”
Luckily, she says, the situation is improving.
“There are many great organisations working closely with their clients to develop new models and approaches, not just to get drugs to the clinic faster, but to do so with an increased chance of delivering patient benefit.
Allan Jordan, director of oncology drug discovery at Sygnature Discovery (who help their clients discover novel oncology medicines from their sites at Alderley Park and BioCity in Nottingham), says that supporting companies to think holistically about a drug candidate’s future as early as possible in the development process is key to mitigating the chance of failure.
“Education is still needed in some areas, but we are seeing more and more companies realise that early planning and engagement with stakeholders is the most sensible, commercially relevant and patient-meaningful way to do what we do,” he says.
“The risks of failure are high enough as it is – I’ve seen compounds get all the way through pre-clinical development and start to move towards the clinic before people realise that either the patient population doesn’t exist or they’re so heavily pre-treated that they won’t respond – thankfully I think that is happening less and less. We’re becoming much more astute in that area, much more aware of patient selection, patient stratification, and using that knowledge to drive our drug discovery programmes to enable success, not just in the preclinical stage but also further down the line.”
Jordan says that one thing the COVID-19 pandemic has taught the industry is that access to clinical trials can be much more responsive than it has been in the past.
“We’ve seen with COVID trials that regulatory approval, ethics approval, access to patients and entry into the clinic for novel vaccines, biologics, small molecules, or repurposed agents can be done much faster and more efficiently than it has been done in the past.
Steve McConchie, CEO of Aptus Clinical, a full service clinical CRO based at Alderley Park that specialises in the design, conduct and delivery of clinical trials, adds that this ‘efficiency’ partly involves getting science into the clinic as “quickly and cost effectively” as possible – but it’s important to note that there’s a difference between ‘speed’ and ‘haste’.
“Sometimes just taking a little bit of time to understand what you’re doing and why you’re trying to do it is time well spent,” he says, “because you can charge into a first-in-human study and waste time and money there if it doesn’t recruit or doesn’t get the right results.”
Meanwhile, ‘cost effective’ can mean understanding the best use of the resources the biotech has, and where the limits are.
“By ‘cost effective’ we mean doing the right experiments at the right time to get the right science to the right patient in an optimal way. If you do that then you use your cash in the most efficient manner.”
McConchie adds that, ultimately, early hurdles with patient recruitment, ethics committees and regulatory agencies can often be solved by “following the science and putting the patient at the centre of everything you do”.
“If you focus on the patient, and the strategic/scientific reason of why there’s value to the patient, the ethics committee will be happy with it, the regulatory authorities will be happy with it, and your investigators will agree to it and will be passionate about trying to recruit participants.
“You can sit in an ivory tower and come up with a scientifically amazing trial in melanoma, but if it doesn’t fundamentally engage the early-phase clinician who has got the patients in front of them it’s not going to go anywhere fast.”
Medical conferences like ASCO (which, for the time being, are mostly virtual) remain key opportunities for biotechs to find partners and garner interest – although the larger events can be daunting for the smaller companies asked to present alongside some of the biggest players in the industry. So how can biotechs stand out?
McConchie says that this is another area where focusing on science can be extremely helpful.
“The biggest asset a biotech has is its science – that’s what we are all passionate about, and it’s what investigators are passionate about.
“You can’t have a massive stand at ASCO, you can’t do all of the things that some of the larger organisations can do, but what you do have is your science. Again, I think interacting with investigators at a scientific level is really important, because leveraging science for the benefit of patients is what unites us all. That’s how you build those key relationships.”
Despite the many challenges facing biotechs, Mackay and Jordan both stress that the UK has a vibrant ecosystem for oncology.
Jordan says that having the NHS as a fully integrated health service is “the jewel in the crown” of this environment.
“The networks that exist within the NHS – such as the Experimental Cancer Medicine Centres, expert clinicians, and a communications network across the country that can assign patients to clinical trials, even if they’re not necessarily running in that particular centre – are a huge asset. I don’t think anything like that exists to the same extent in many places around the world. There’s a huge opportunity in those networks to make the UK a global leader in clinical trials.
“That gives us a great baseline to work from. From there we need to encourage greater engagement from the biotech community to strengthen and deepen those networks – turning them into a real force for patient benefit – and get companies to place clinical trials in the UK where that support exists, rather than taking them elsewhere, such as the US, which seems to be a common way forward.”
Meanwhile, Mackay highlights the plethora of small businesses and biotechs at Alderley Park working in this area, supported by the wider ecosystem.
She adds that cell and gene therapies are an area of “great strength” for the UK.
“A lot of investment has gone into supporting development of novel CAR-T cell therapies, which are now licensed for use in the UK. There has been a deliberate and sustained investment from the UK government to support the cell therapy field and we’re starting to see returns on that now.”
Mackay notes that biotechs working in these specialist areas often require more targeted support, such as in manufacturing cell therapies.
“If we really want these novel treatments to be scaled, then that support needs to be continued because the manufacturing challenges are very different to those in developing a small molecule drug. A lot of research and funding is needed to facilitate widespread use and commercialisation.
“There needs to be a lot of support for helping these new types of therapies onto the NHS – it will require changes to every aspect of the pathway, from lab to bedside.”
Mackay says that while this support has been good so far, it needs to be “rolled out to the next stage”.
She adds that the UK also needs to encourage more innovation and entrepreneurialism if biotechs are to get more cancer medicines into development and eventually to patients.
McConchie concludes: “At the end of the day, drug development is a team sport. Companies need to engage with scientists, academia and with the service sector to be successful – I think a lot of people don’t realise how amazing the service sector here is. You can get anything you need.
“There are a lot of great individuals and organisations that can help you on the journey. I think we’re very lucky in the UK to have such a vibrant ecosystem that can help anyone at whatever stage of the journey they’re on. You just need to reach out and develop those relationships.”
Dr Kath Mackay is managing director of Alderley Park, home to the UK’s largest single-site life science campus. Her responsibilities include stimulating new business ventures and managing further development of the Park. Mackay joined Alderley Park in 2019 from Innovate UK. In her most recent role there, Mackay was director for ageing society, health and nutrition, and part of the executive management team.
Steve McConchie is CEO of Aptus Clinical. After obtaining a PhD in Biochemistry, McConchie spent 25 years in a variety of clinical development roles with AstraZeneca where he gained valuable global experience in the delivery of numerous oncology and haematology clinical development programmes. Since forming Aptus Clinical with former AZ colleagues, he and his expert teams have continued to support a broad range of life science and biotech clients with the design, conduct and delivery of innovative early phase clinical studies in oncology.
Allan Jordan is director of oncology drug discovery at Sygnature Discovery. His role includes scientific oversight of the oncology projects within Sygnature and the strategic development and enhancement of capabilities and expertise in oncology. Jordan started his career as a medicinal chemist at RiboTargets (now Vernalis). After ten years in the lab, he joined Cancer Research UK (CRUK) as head of chemistry in the Manchester Institute Drug Discovery Unit.
Alderley Park is a place where world leading science, innovation and stylish living come together to create a place like no other.
Part of Bruntwood SciTech, a 50:50 joint venture between leading property company Bruntwood and Legal and General, Alderley Park is currently undergoing a £247 million investment. Home to the internationally recognised Mereside life science campus, the Park offers more than 1m sq ft of high specification lab space, a range of scientific services and an accelerator delivering a comprehensive programme of business support for start-ups and scale-ups. It is also home to a vibrant and fast-growing community of over 60 established and 150 pre start-up companies.