Beyond prescription: pandemic sparks push for precision medicine

Sweeping changes in technology are giving even tiny biomedical start-ups the chance to punch way above their weight in the race to transform healthcare.

On June 25, 2020, PrecisionLife, a computational biology start-up employing just 20 people, revealed that it had discovered 68 genes that could be responsible for some of the more severe symptoms experienced by some people infected by the SARS-CoV-2 virus¹.

Better still, the Oxford-based SME found that some of the effects of those genes might be treatable with drugs currently in trials for other medical conditions.

But how could such a small firm run an analysis, based on data from just over 900 COVID-19 patients, and still contribute a cluster of suspect genes for scientists to begin investigating? It’s testament to the power of two technologies that could be on the verge of fulfilling their promise to change the face of medicine.

The first is ultra-low-cost DNA sequencing technology, which can now affordably read and store all 100 gigabytes of the 3 billion base pairs of genetic code that describes how to build each and every one of us.

The second technology is the one that makes sense of all that data: artificial intelligence-based computer analytics platforms. These draw correlations between our DNA and our health, allowing researchers to infer which genes – or mutations within them – might be responsible for our physiological fate.

Rising expectations

Genomics and analytics are now being used worldwide in the 100-plus attempts to develop a SARS-CoV-2 vaccine and, as a result of all these efforts, some healthcare experts now believe expectations of medicine are set to change dramatically.

Why? Because extensive media coverage of the battle against COVID-19 is offering a tantalising glimpse of a future in which medicine shifts from today's one-size-fits-all treatments to a more personalised proposition. Currently, no matter what a person's genetics, lifestyle or environment, they are likely to be prescribed the same drug as other sufferers of the same broad medical condition.

But by taking into account the variability in our genetic makeup, and how that affects our response to various medications, doctors can better predict which drugs will best suit different groups of people. This approach, called precision medicine, aims to give the right drug to the right patient at the right time².

"Expectations have changed,” says Dr Steve Gardner, CEO of PrecisionLife³. “The public at large is now starting to realise that being able to be much more specific about who's going to benefit, or not, from a treatment is fundamental. And I think it's going to drive an expectation that precision medicine across all sorts of diseases, not specifically infectious diseases, is going to be the way to go."

At the University of Glasgow, Dame Anna Dominiczak, Regius Professor of Medicine and a specialist in cardiovascular genomics, hypertension and precision medicine, takes a similar view.

"Many now agree that there will be higher expectations for precision medicine, because with COVID-19 people have become familiar with the idea that you can quickly sequence the virus, and the human genome, and use this clinically to help people.”³

The potential breakthrough from PrecisionLife is far from the only example of these technologies being used in the fight against COVID-19. In a much broader project, for example, Genomics England, part of the UK Department of Health, is to sequence the DNA of 35,000 COVID-19 patients in a £28 million research programme to find out whether our genetics influences our susceptibility to the virus⁴.

Market expectations for precision medicine are high, too. Research from industry analyst Global Market Insights projects that the global precision medicine market will grow 11% per annum* between 2020 and 2026 – with revenues estimated to jump from $57 billion in 2019 to $119 billion by 2026⁵.

Growing accessibility

This growth is partly being driven by the relentless improvements made in sequencing technology since the first human genome was published in April 2003.

"The first human genome cost $2.7 billion to sequence but now a human genome only costs $1,000. So there's been a massive difference in the capacity that we have to do this sort of work," says Dr Emma Thomson, professor of infectious diseases at the Centre for Virus Research at the University of Glasgow³.

Using today's technology, she says, scientists can take a sample and run 100 million sequences in 24 to 48 hours. "So it's become very, very high scale, high throughput work," she says.

Another advantage, Dr Thomson says, is that sequencing technology has become portable, allowing scientists to sequence genes in non-lab situations. These have included sequencing the Ebola virus in West Africa during its outbreak there between 2013 and 2016, and the more recent outbreak in the Democratic Republic of Congo – a war zone – as well as sequencing Zika virus outbreaks in South America.

Pharmacogenomics goes mainstream

While genomics technology could be crucial in the fight against infectious diseases like COVID-19, it is in the treatment of cancers, and the prevention of adverse drug reactions, that one of the most dominant forms of DNA-related precision medicine – called pharmacogenomics – is having major health impacts.

For instance, patients today can have tumour cells sequenced. This is then compared with DNA from healthy cells, so that mutations that may be driving the growth of the tumour can be identified. Drugs are then prescribed in doses that precisely target those mutations, or their effects.

"Ideally this means you can treat cancer cells and not kill a huge number of healthy cells as this is the major drawback of chemotherapy and radiotherapy type approaches," says Dr Gordon Sanghera, CEO of Oxford Nanopore, a UK company behind many of the enabling technologies fuelling today's low-cost genome sequencing programs³.

Patient genetics.

In addition, pharmacogeneticists can explore why a patient might have an adverse reaction to a drug by sequencing their genome and looking for genes and/or mutations that might reveal why the drug antagonises them physiologically.

However, this does not mean that drugs will be designed, developed and produced specifically for an individual patient's genetic needs. Instead, Dr Gardner says that precision medicine is focused on identifying large groups of patients with similar underlying genetic (and other) issues.

"The basic, fundamental capability at the heart of precision medicine is the ability to do high-resolution patient stratification. In other words, understand, for a complex disease, which patients are going to have which form of the disease and which treatment is most likely to be relevant to them," he says.

NHS approach.

It's an approach that is gaining traction: the NHS, for instance, aims to integrate genomic medicine into routine care by 2025⁶. And this approach is about to get a broad, real-world test, after the University of Glasgow won a UK Research & Innovation grant to open a ‘Living Lab’ focused on translating cutting-edge science and innovation into a real-world clinical setting, addressing everything from cancer to general medicine⁷.

"The idea is that we will incorporate pharmacogenomics into normal clinical care and look at all diseases. We will have a way to measure common adverse drug reactions before we prescribe, and we will do it in people who are on multiple drugs who have multiple conditions," says Dr Dominiczak.

A major aim of the lab will be to begin to prove in practice what projections show: that in preventing the suffering caused by adverse drug reactions, an enormous amount of NHS cash can be saved on unnecessary hospital admissions and treatment. How enormous? Over 50 years, the NHS in Scotland could save £70 billion by adopting precision medicine techniques, according to an analysis by the University of Glasgow's Health Economics and Health Technology Assessment unit⁸.

Building dependable data sources

A critically important factor in precision medicine – and one that the COVID-19 pandemic has really highlighted – says Dr Patrick Short, CEO of Sano Genetics, a Cambridge, UK, start-up, is having systems in place to quickly generate actionable data in medical emergencies³. “Systems for collecting and analysing data need to be more adaptive and responsive,” he says.

And that data has to be highly dependable, says Dr Stephanie Kuku, a former NHS surgeon and now a Senior Consultant in Health Tech and Clinical AI at Hardian Health in London and at the WHO³.

"Trust is key. Right now, much advanced healthcare AI is in clinical trials. The systems which gain trust from the medical community will ultimately be most likely to be accepted by patients," she says.

One application of such quickly generated data is to train new, predictive AI models. For example, medical images are aiding precision medicine's AI-based fight against COVID-19, says Dominic Cushnan, Head of AI Imaging at the NHS Artificial Intelligence Lab – part of NHSX, the service's digital transformation arm³.

Just weeks after the pandemic broke out, Mr Cushnan and his colleagues stood up the National COVID Chest Imaging Database, which hosts anonymized imagery of 5000 patients’ lungs – many damaged to various degrees by COVID-19 infections. This is now being used to help predict outcomes.

"Previously, there was no repository for such data that would allow us to understand the disease from an image perspective. But for us to train algorithms, and test whether a predictive model actually works, we needed that large dataset," he says.

The AI skills barrier

Getting enough people who can write those intelligent algorithms and test those machine learning models, however, is proving one of the barriers to precision medicine taking off, says Dr Dominiczak.

"We need lots of very clever computer scientists to get interested in biomedicine. That's been the most difficult thing for us. Because if you're a computer scientist, if you're an AI expert, it's much easier for you to go into fintech and deal with numbers in financial services, or in other parts of the economy.”

Dr Kuku says that another barrier is that healthtech innovators have to build systems with clinicians, nurses, workflow and contextual challenges in mind. But such constraints could lead to big opportunities for smart precision medicine start-ups – and those who invest in them.

The reason? It’s still a very young industry, and companies that are willing to take the time to get it right, and invest in expertise and technology, can prosper in this space. After all, hospitals want to offer better value by avoiding ineffective and/or painful treatments, and optimising patient outcomes is key to any sustainable healthcare system.

And opportunities abound: "Research both in the academic sphere, from spin-outs and within start-ups is vast – and ranges from rare diseases, to cancer, anti-ageing and diagnostics," says Dr Kuku.

That's why Barclays, University College London's Medical Genetics unit, and Capital Enterprise have launched the UK's first precision medicine incubator and accelerator⁹. Called the P4 Precision Medicine Accelerator Programme, the venture allows start-ups to partner with Barclays and UCL to road test their ideas, and means the efficacy of their healthcare technologies and services can be objectively assessed.

However, identifying the winners in this space will be challenging and will depend on a proper evaluation of the underlying technology, says Michael Topley, Head of Sustainable Portfolio Management at Barclays Private Bank. “While precision medicine is an incredibly attractive area to invest in, bringing together a range of exciting technologies to help address global challenges, it is uncertain who the winners will be,” Topley suggests.

“Therefore, rather than focusing on the area from a top-down thematic perspective, we look at it from the bottom-up, trying to identify which specific companies in the supply chain have the best prospects for maximising risk-adjusted return.”

Mr Topley’s sustainable strategy therefore holds several names at different points in the supply chain, from the tools used to sequence a person’s DNA, to the artificial intelligence systems that help to determine how a particular protein could be made.

That notion of bottom-up fundamental, rather than top-down thematic, precision medicine investment is echoed by Dr Kuku. "Healthcare is now seen as an opportunity area for investors post-pandemic. However, we must still be cautious about hype," she warns.

"As long as healthcare remains under-funded, we must ensure only technology that proves it can do what it claims to do is implemented. Technology is the tool, not the goal, and it must help healthcare teams provide significant clinical and public health impact."

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