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. Our previous article featured 5 key takeaways from the webinar, but there were so many tips, hints and fresh insights shared that we decided to share 5 more. Whether you were in attendance or not (you can receive videos of the entire event by registering here), here are five more insights from Part 1 of “Compliant Digital Transformation for Life Sciences”.
Demonstrating digital compliance is not just possible, but also very beneficial … if given the right approach
Assessment of potential IaaS and SaaS suppliers can be a daunting task for organisations as they set out on their digital transformation journeys. However, Odyssey VC’s own Mag Corduff argued that, with the right planning, it is more than possible and can even compliment your existing Risk Management process. Digital Compliance is cyclic; it follows a continuous “Assess, Mitigate & Review” approach and, if done right, it can be a very useful tool for:
• Facilitating digital transformation (including acceptance of change),
• Ensuring product quality & patient safety
• Demonstrating compliance
• Promoting audit readiness at all times
“New Science” is driving the industry’s growth
In his presentation titled “The Digital Transformation Imperative” in Life Sciences”, Managing Director of Accenture’s Life Sciences Division Barry Heavey described “New Science” as “new modalities, new therapeutic approaches and the combination of science [and] technology”.
New Science is projected to contribute to 81% of revenue growth in biopharma and 61% of all revenues between 2021 and 2026. Also, 76% of new deals intended to create new therapies involve New Science treatments. “The net present value of investment in New Science is much higher than in more traditional approaches to treating disease.”
However, New Science comes at a cost
Barry went on to say that although all projections point towards the continuing shift towards New Science approaches, it won’t come without a cost. Between $2.6 billion and $6.7 billion to be precise, the projected cost of bringing a successful New Science treatment to market. “It’s a massive investment by companies”, he said.
Digital Transformation or not, regulator expectations will stay the same
As both CEO Oisín Curran and Mag Corduff pointed out, Gartner projects that 95% of Life Sciences organisations will be purely cloud-first by 2022. This also means that regulators will most likely be looking at digital and cloud first initiatives across 95% of Life Science organisations to confirm compliance to regulations.
However, the expectation from the regulators will not change “regardless of whether you are operating on glass or on paper”, according to Mag. Regardless of whether you’ve implemented digital transformation initiatives or not, she said, “the requirements will stay the same, but they will look to see that, as part of your transformation, you have maintained compliance to those regulations.”
This should make your Digital Transformation less daunting, especially if you take Mag’s advice to incorporate compliance from the outset rather than “trying to test it in at a later stage”.
Applications should be validated, infrastructure should be qualified
Regulatory expectations stay the same, something mirrored in CEO Oisín Curran’s presentation “Compliant Digital Transformation in Life Sciences”. From a digital perspective, regulations can be distilled down to two concepts “regardless of your segment”; applications should be validated and infrastructure should be qualified.
“It has always been a risk-based approach,” he said. “You focus the efforts from a compliance perspective on where you see the risk, but it means you have to assess risks.” He also stressed that you need a “robust quality system to facilitate that”.
News about Part 2 of our webinar series, “How can you satisfy ALCOA+ principles as part of your Compliant Digital Transformation?”, is coming very soon. If you would like to receive exclusive news about Part 2 as well as video of Part 1, click here.