With the speed of development for the COVID-19 vaccine hailed from all quarters, Michael Nelson looks at the technologies that have been behind this success, and what it means for the future of the industry.
The pharmaceutical industry has often found itself on the receiving end of a lot of criticism, with a 2019 poll by consultancy firm Gallup ranking it last on a list of 25 American industries they test annually. In that poll, Americans were more than twice as likely to rate the industry negatively (58 per cent) as positively (27 per cent).
However, with the onset of the COVID-19 pandemic, ‘Big Pharma’ has become key to preserving our future. It has been able to develop treatments and vaccines to mitigate against the effects of the pandemic, and at a speed which has previously been unheard of.
Rik Van Mol is the senior vice president for Development Cloud at Veeva, who provide cloud computing solutions to pharmaceutical companies. He says he is astounded by the speed at which the industry was able to mobilise and develop a vaccine for COVID-19, and believes that digitisation is playing a key role in accelerating drug discovery and patient treatment.
“Communication is one of the key areas of development in clinical settings – between research sites and clinics, and between them and patients,” he says. “Typically, this takes a long time because it involves lots of paperwork, and there is a lot of back and forth. It is an area which is benefitting massively from new technologies which were not previously available.”
Digital technology and cloud computing in treatment development
In accelerating drug development, Van Mol suggests there are two different areas of consideration; making the internal life science organisation as efficient as possible and understanding the needs of the multiple different stakeholders involved.
“If you look at a pharmaceutical or life sciences company, they have several different departments which are involved in different stages of drug development, whether that be clinical development, regulation, manufacturing, or the supply chain,” he continues. “Before the pandemic, these different departments worked much more independently, but it became obvious that the inefficiencies this created – duplicating information because individual departments’ systems did not interact with each other for example – was slowing the process down.
“When these departments are working from a single platform, it allows connectivity between them and streamlines the information they require.
“Likewise, for clinical trials, you have investigators, doctors, and research sites, as well as the patient themselves, all invested in this process. The collaboration between the research site and the patient is not very efficient, because it is done over paper, and the information flow is much slower as a result. So, the technology available in the industry which streamlines their processes and makes for a better user experience should be available to these stakeholders as well.”
For Veeva, this is a brand new area of development. The Veeva Clinical Network was established at the beginning of 2020, with a view to increasing the ease and speed of access to information between relevant parties. Pharmaceutical companies are already beginning to adopt Veeva Site Connect as a way of automating information sharing, improving site engagement and satisfaction, while allowing them to focus more on patient care.
More recently, Veeva have launched their eConsent software, which is a free solution for sites and patients that aims to transform the current paper-based consent into a digital creation, approval, and exchange process. This can help make patient participation easier in clinical trials, while providing sponsors visibility throughout.
“In the past, much of the technology available was seen as beneficial to sponsors, rather than researchers or patients,” Van Mol concludes. “But there has been in a big shift recently, with more technology aiming to improve the user experience for researchers and patients, and that has been driven by automating information flows and streamlining the environment through digitisation.”
Challenges in implementation and regulation
Despite an understanding that AI can help bring new drugs to market more rapidly and securely, research commissioned by software optimisation firm Aspen Technology shows that as many as 96 per cent of the industry professionals they surveyed face challenges with using advanced digital technology.
Three hundred leading pharmaceutical industry decision makers from the UK, the US, Germany, Spain, and Sweden were surveyed as part of the research. Nearly half (49 per cent) of all respondents said that their company has no overarching strategy for AI, while 31 per cent said that they lack consistent data structures that make implementation easier or have high levels of unstructured data that are more complex to handle.
Of most concern, more than four-in-ten (43 per cent) pharma executives believe that if companies in their industry fail to learn the lessons of AI and ML adoption from other sectors, they will be in severe financial trouble within two years.
“Our research shows pharma companies need to act now to tackle their data challenges and implement AI,” David Leitham, senior vice president and general manager of pharma at Aspen Technology, says. “Advances in AI will relieve the growing pressures on them, built on the ability to break down the barriers between systems and types of data within production processes and supply chains. Organisations must reimagine their digital culture and think more holistically about what data will add across all aspects of drug manufacture.”
The research also revealed that three-in-ten executives (30 per cent) say their companies struggle with data that is held in separate, siloed systems, while more than a quarter (28 per cent) suffer from a lack of digital skills or a risk-averse culture that does not foster innovation. Even the more advanced, data-driven companies in the research have a problem with risk-averse culture.
“There is no shortage of smarter, better ways for pharma companies to use technology,” Leitham adds. “Best of all, these solutions are available now, they are being adopted, and they are helping companies get ahead.”
At no time has this been more apparent than over the last year, with the world paralysed by the Coronavirus pandemic. Van Mol explains that, while the pharmaceuticals industry is still generally hesitant towards change, COVID-19 helped highlight the urgency with which change was needed.
“With the pandemic, there was no other option but to use all the technology available. Things had to be done differently for us to get to the point where we are at now, where people are getting vaccinated all over the world.
“In other circumstances, it would have taken years before we got to this stage. Now, it is about applying what we have learned and deploying it into other disease areas as well.”
He argues that the reason for industry conservatism is to do with compliance. Healthcare regulators such as the US Food and Drug Administration (FDA) have been forced to review their usually rigid set of regulations to respond to the urgency of the Coronavirus pandemic, and Van Mol says dialogue between regulators and the pharmaceutical industry is essential to define a way forward.
“The technology is there; the momentum is now there too,” he adds. “It is just a matter of getting regulators to allow certain things to happen to make the process more efficient. For example, some countries still do not allow the use of e-consent, insisting that everything is still done on paper, which is very time consuming. That is the kind of mindset that needs to change if we really want to see research and development accelerate in finding answers to other diseases.”
A revolution in the pharmaceutical industry
While COVID-19 has had a devastating impact on the globe, it has also led to the realisation of accelerated treatments in a multitude of other departments, such as oncology. Van Mol concludes that the impact this will have on society will be enormous.
“The acceleration of treatments – getting treatments to patients faster – has always been talked about, even from the beginning of my time in the industry almost 25 years ago.
“Back then, people were talking about slashing a few things over a ten-year period. Now, we are talking about accelerating by 25 per cent in just one year. Some pharmaceutical companies are even suggesting they can accelerate by 50 per cent in one year.
“This is not an evolution anymore. This is a revolution.”