On Wednesday the 16th of June Odyssey VC hosted the first part of our 4-part webinar series “Compliant Digital Transformation for Life Sciences”.
Part 1, titled “What does digital transformation mean for Life Sciences and where do you begin?”, featured contributions from Odyssey’s own Oisín Curran, Fionnán Friel and Mag Corduff, as well as industry guest speakers Barry Heavey and Barry Curry. The free event included an engaging panel discussion and presentations on topics such as digital transformation and how to deliver digital compliance, and many fresh insights were shared during the session. Whether you were in attendance or not (you can receive videos of the entire event by registering here, here are five key takeaways from the webinar.
The imperative to transform digitally – and in a compliant way – can reduce costs from “billions to millions”.
Barry Heavey, Managing Director in Accenture’s Life Sciences Division, shared a lot of great insights during his presentation “The Digital Transformation Imperative in Biopharma”, but one of the most eye-catching was this; transforming digitally, and doing so in a compliant way, can reduce costs from “billions to millions”. He said that companies can achieve this by adopting New Sciences and digital tools in process development, changing how we approach clinical trials and how we engage with regulators, driving towards “Digitally Lean” operations, and the virtualisation of the commercial model in the pharma industry.
The shift to cloud and digital is coming – whether you’re ready or not.
There is some comfort and security in continuing to use your tried-and-tested paper-based processes. Historically this analogue approach has worked for you and so why change it?
In Oisín Curran’s presentation, he made a strong case for reconsidering that thinking. Gartner projects that 95% of Life Sciences organisations will be purely cloud-first by 2022, but only 11% of regulated data is currently operating in the cloud. There is a huge gap to close in terms of the amount of regulated data that currently operates in the cloud, for companies that aim to be “cloud-first”.
As Oisín said, you may not think that the shift to cloud is relevant to you or your business, but this is not the case; “the industry is driving you that way”. “If software companies and connected heath companies understand that that shift is happening, and strategically present themselves to take advantage of the digital transformation approach, there’s an opportunity for us to introduce some real disruption to the Life Sciences space, to really accelerate that, to move into real value-generating digital transformation strategy.”
“If you don’t see how that cloud-first strategy and that lack of migration of regulated data into the cloud is presenting an opportunity for you to provide better services, to facilitate that digital transformation, you’re potentially missing out on the strategic direction of the Life Science companies in that space”.
Having a digital compliance plan in place from the outset will greatly facilitate your digital transformation.
In Mag Corduff’s presentation she brought us through the steps of how to demonstrate digital compliance. Following on from Oisín’s point, Mag said that the Gartner projections will guarantee that “regulators will be looking at digital and cloud-first initiatives across 95% of Life Sciences organisations to confirm compliance to regulations”. However, she said that the expectations of regulators will not change “whether you’re operating on glass or on paper”.
“The requirements will stay the same,” she said, “but they will look to see that as part of your transformation you have maintained compliance to those regulations. A digital compliance programme will facilitate the adoption of your digital first / cloud-first strategy.”
You can design for regulatory uncertainty and the impact of audits
… Through partnering with competent vendors. In Odyssey VC CEO Oisín Curran’s presentation on compliance in digital transformation strategies, he said that “regulations don’t change that rapidly; the interpretations of the regulations and areas of focus do. He also pointed to “the quality function and assessing good quality vendors” as the way to avoid the pitfalls that could potentially hamper a company’s digital transformation strategy.
“Whether it’s an IoT company or a software company, if you partner with a company in the delivery of your digital transformation solutions who understand the regulatory impact of what they’re doing on your behalf, that’s huge progress” in achieving your compliant digital transformation goals. That’s why it’s important to, as he said, make sure that your business is “audit-ready”.
“The more open you are, the more audit-ready and structured you are, the more of an opportunity that represents for you to access this change in dynamic, this change in market.”
70% of digital transformations fail – but there are ways to mitigate that failure
During our panel discussion an attendee asked the question; “What do you see as the bigger reason for digital transformation project failures and are there ways to mitigate them?”. System E Founder and Principal Consultant Barry Curry dropped the staggering statistic that 70% of digital transformation projects fail, and that the most pertinent reason for this is not engaging every single department from the beginning.
“If you bring people together and help them craft their own solutions, through facilitated techniques such as design thinking and so on, the projects are definitely much more successful”, he said. It’s really “engagement of all the different disciplines and skills in an organisation” that facilitates successful digital transformation, and it’s easier to make compliant if you have every department’s input from the beginning.
That means that you get a “longer lead-in before you see the first solution”, he went on to say, but when the solution is implemented it’s “more robust, well-rounded and well-received.”
Part 1 of “Compliant Digital Transformation for Life Sciences” took place on the 16th of June 2021. To watch video of each presentation from the webinar and to receive exclusive news about Part 2, click here to register to our webinar series mailing list.
