For those working in the Life Sciences industry, cloud adoption can be a nebulous concept. Cloud technology is bringing about a digital revolution that experts say will transform the way Life Science companies operate and do business, so why does the industry feel hesitant?
Life Sciences companies seem apprehensive of the idea and subsequently slow to adopt, due in no small part to concerns around moving away from legacy systems and on-prem methods. For one, where do you start when it comes to understanding the expectations of regulatory and guidance bodies around this relatively new technology? What are the initial steps and considerations that can set you up for success in migrating to cloud? What are the actual benefits?
Untangling cloud adoption for Life Sciences has been a primary goal of our 2022 webinar series “Possibilities & Practicalities of Cloud Adoption in Life Sciences”, and with the insights shared in the three sessions so far, common threads reappeared throughout that shed some light on the issue.
One point to remember is that market forces and macro drivers alike are all pointing towards digital tools. There are numerous push and pull factors driving the adoption of next generation digital tools, such as the shifting of power to the consumer, the transformation of industry structure, and, of course, regulatory uncertainty. Gartner projects that spending on public cloud services will exceed $591 billion in 2023 and estimates that over 95% of digital workloads will be deployed on cloud-native platforms. This is up from 30% in 2021, a startling statistic that points to a typically hesitant-to-adapt industry recognising that the journey to cloud and adopting next generation digital tools is an imperative.
Perhaps this is partly because the regulators themselves are encouraging cloud adoption and adapting accordingly. In fact, guidance is already adapting to cater for it; GAMP already touches on Agile and iterative testing, and the 2nd edition published this year acknowledges evolving approaches to software development and an expanding arsenal of digital tools. Odyssey VC Head of Business Solutions Fionnán Friel acknowledged the very simple reason why in Part 1 of our webinar series; “It’s much easier for them to audit companies if the data is there in digital format,” he said.
This is one key to success for Software and Connected Health companies attempting to cater to the Life Science industry; you need to ensure that your business and product is audit ready. Aligning with the regulatory needs of Life Sciences companies is a “market opportunity”, as put by CEO Oisín Curran, but also a must. He pointed to EMA (European Medicines Agency) and their stance on XaaS; “Use of XaaS without the possibility to audit or ensure Annex 11 is fulfilled should not be accepted”. “You cannot accept a service unless you can demonstrate that Annex 11 has been fulfilled,” Oisín said.
Conversely, partnering with competent vendors and designing for regulatory uncertainty is the key for Life Science companies. “You know that regulatory uncertainty is part of the business,” Oisín noted in Part 1 of the series. “Looking to partner with competent vendors who are looking to solve these problems at the edge to help you get more agile, faster-to-market products … I think that’s going to be a critical part of success.”
But how can you build a stable relationship with your cloud provider, especially with all the new considerations brought on by operating in a highly regulated industry? Quality Agreements are the main tool to establish a working relationship between cloud providers and regulated companies, as mentioned by Fionnán in Part 2 of the series. Quality Agreements allow both parties – the cloud provider and the regulated company – to “acknowledge and accept their responsibilities in order to accomplish quality objectives which can be measured via agreed-upon quality metrics and KPIs”, according to Fionnán.
As for who is responsible for what when a Quality Agreement is involved, both parties are responsible – in different ways. The cloud provider is responsible for delivering a quality solution following industry and good engineering best practices “to make sure they’re delivering the right system that falls in line with the quality agreement as agreed between them”, as per Fionnán. Meanwhile, GxP requirements accountability resides with the regulated company. “This will never change,” said Fionnán, “for good reason – companies need to recognize and acknowledge this. You can outsource jobs, but the ultimate responsibility can never be outsourced.”
Reflecting the constant growth and change inherent in adopting next generation digital tools, the relationship between regulated company and cloud provider can further develop as you progress with your digital transformation objectives. “You can also include commitments to improve processes as you move forward in the relationship, to allow for even greater trust and even greater confidence and maybe even outsource further aspects of your quality obligations to your supplier – if you find that right supplier,” said Fionnán. “From your supplier assessment, you should know how much you can trust your supplier and how much you can outsource to that supplier”.
With all that said, one last point to remember is that, although you may be hesitant to make the change, the digital revolution is not hesitating. Cloud and digital-first initiatives are increasingly becoming the name of the game, with the transition gathering pace as companies realise the benefits, and as they become aware of the urgency around digital transformation in general. Whether this urgency has been partly driven by the new need for speed and efficiency brought about by the Covid-19 pandemic is debatable, but what’s definite is that, according to Forbes, only 44% of companies are prepared for potential digital disruption.
Oisín underlined this urgency in Part 3 of the series; “Every conversation we go into around digital solutions – whether that be pure automation in the manufacturing space, or whether it’s more business-focused in the R&D and clinical trials space – everybody’s first position is ‘we’re looking for a cloud deployment model,’” he said.
“What that’s driving is the underlying software vendors have to adapt to that, but it also means that the traditional on-prem deployment models for software are slowly being eroded. It may be the case that, in the very near future, you won’t be able to purchase software in that traditional way, even if that’s your preferable model.”
Although this may sound ominous and companies may fear being left behind, the flip side is that 60% of companies that have undergone a digital transformation have created new business models. Minimising supply chain disruptions, driving business efficiencies by doing away with archaic paper-based practices, delivering medicines to the market faster; the benefits of cloud adoption in the Life Sciences industry far outweigh the pitfalls, and as long as you put a strategy in place from the start and remain aware of your compliance obligations, there’s no reason why your business can’t start reaping the benefits of cloud immediately.
Odyssey VC have helped some of the world’s leading Life Sciences and SaaS organisations grow and excel by offering an expert hand for their compliance needs, giving them a unique advantage in the market and ultimately allowing them to focus on their core business. If you would like to find out more about this or any other services we provide, get in touch and speak to one of our experts today.
To register for the fourth and final part of our 2022 webinar series “Possibilities & Practicalities of Cloud Adoption in Life Sciences”, click here.