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The landscape for the life sciences industry is changing. The COVID-19 pandemic, Brexit and the increasingly volatile geopolitical situation relating to the war in Ukraine are influencing the ability to develop, manufacture and distribute therapeutics.
The science is changing too. An improved understanding of disease mechanisms at the molecular level is shifting therapeutic focus from symptoms to underlying causes, moving from treatment to prevention and cure.
At the same time, the digital transformation of healthcare is encouraging new kinds of innovation and attracting technology companies.
All these factors have created numerous challenges for life sciences companies in the risks they face, in managing regulatory affairs, securing supply chains and demonstrating the value of their therapeutics.
But periods of great change bring opportunities too as new products and approaches emerge and markets evolve. A recent New Scientist Debate on The Future of the Life Sciences sponsored by KPMG discussed the forces buffeting the pharmaceutical and biotech industries as well as the challenges and opportunities arising.
One lessons from the pandemic is that, given the right conditions, the development and delivery of healthcare solutions can be dramatically accelerated. “The pandemic has shown the industry’s amazing resilience in its ability to bring both vaccines and covid-19 therapeutics to the market very quickly,” said Alan Morrison, Vice President of International Regulatory Affairs at MSD. “That has been a partnership with regulators and researchers and shows society at its best.”
But, he adds, it brings a challenge: can people and organisations continue to perform at that level? Expectations should be tempered, Morrison reckons: COVID-19 was a unique problem with the entire industry operating on an emergency footing. Today, the systems to bring other innovations through so quickly are not in place.
The panellists (clockwise from top left): Anusha Foy, KPMG; Richard Torbett, Association of the British Pharmaceutical Industry; Alan Morrison, MSD; Nigel Blackburn, Cancer Research UK
The panellists (clockwise from top left): Anusha Foy, KPMG; Richard Torbett, Association of the British Pharmaceutical Industry; Alan Morrison, MSD; Nigel Blackburn, Cancer Research UK
Indeed, some side effects of tackling the pandemic are dragging the industry, For example, clinical trials are a crucial part of drug development and require significant cooperation with Britain’s National Health But various hangovers from the pandemic mean this process is now painfully slow and unable to cope with the sheer volume of clinical trials that need to be done, said Nigel Blackburn, Director of Drug Development at Cancer Research UK.
That said, one emerging benefit is increased global partnerships. “There were so many great examples of collaboration and there are some good signals coming through as global regulators and governments coordinate their activities now,” said Anusha Foy, Head of Life Sciences Biotech Regulatory Solutions Practice at KPMG. She cites Project Orbis, which aims to allow patients all over the world access to emerging cancer treatment options, as a good example.
Another accelerated success is in the use of digital technology. It happened in a wide range of contexts during the pandemic: access to GPs via online platforms such as Zoom; “virtual” clinical trials, where use of digital technologies meant that subjects could enrol for programmes that were centred far from their own geographical location; sharing of trial data and even use of artificial intelligence-based technologies for diagnosis.
Indeed, AI is playing an increasingly important role in diagnosis, drug discovery and management of treatment. It is already having an impact in cancer research, said Blackburn. “I believe AI will help us bring down the cost of drug discovery,” he says. He points to the Galleri trial running in the UK, in which AI-based algorithms analyse blood samples to potentially provide early diagnosis of up to 50 different kinds of cancer.
The growing sources of healthcare data provide other opportunities. “We’re living through incredibly exciting times on this,” said Richard Torbett, Chief Executive of the Association of the British Pharmaceutical Industry. But, he pointed out, there are challenges, such as issues concerning data-protection and transparency. “The challenge for the regulators is to stay on top of the developments in science while creating the right regulatory framework. That way, innovation is still able to flourish but society is still able to have confidence and trust in the work people do,” Torbett said.
A similar challenge is emerging in the era of “omics” technologies—genomics, proteomics metabolomics and so on—that analyse biological samples at the molecular level looking for associations between those molecules and disease pathways. These technologies are already leading to personalised therapies such as gene therapy — interventions that replace a faulty or absent gene with a working copy — or cell therapy, where diseased or damaged cells are replaced by healthy ones. While exciting, this too requires careful regulation and data protection innovations.
They are also expensive and healthcare providers must solve the problem of making sure innovations are available to everyone, not just to wealthy individuals or those living in rich countries (see box).
But in general the future looks promising. “The pace of change in development of new biotherapeutics puts us in an exciting period of time for the life sciences sector,” Morrison said.
Torbett agrees. “We’re in a golden era right now,” he said. “From discovery science to the way we do clinical development and even the way we manage affordability and access: these things really have been accelerated through the pandemic and I think they can help us bring through the next generation of biotherapeutics.”
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Access for all
In an age of expensive medical solutions, how do we ensure that everyone can benefit, regardless of income and geography?
It’s an important question, according to Anusha Foy. “Access to medicines is one of the greatest challenges that the life sciences industry is facing,” she said. “Even in the western world it’s not possible to pay for a treatment that costs £1.8 million for every patient. Governments will need to balance the risk benefits and the costs.”
Richard Torbett agrees but believes there are reasons to be optimistic — especially when it comes to vaccines. “I’m yet to meet anyone in the pharmaceutical industry who isn’t dedicated to making vaccines available to patients that need them,” he said. But he pointed out that many challenges are beyond the remit of the pharmaceutical industry alone. For example, in some areas of the world, the infrastructure for storing and delivering vaccines efficiently and effectively is lacking.
When it comes to expensive drug treatments, or cell therapy and gene therapy, there are few easy answers. “We want to make sure that the prices of these therapies are reflective of the value they are delivering to patients,” Torbett said. This value can be challenging to calculate. There’s no way, for instance, to prove that a new treatment will add 50 years to a child’s life until those 50 years have passed. “We have to develop novel payment mechanisms,” Torbett said.