What are the critical next steps as the Life Sciences industry embraces a future that is data rather than document driven in its management of information, knowledge and essential business processes? In December 2022, thought leaders from BioNTech, Bayer, Iperion – a Deloitte business, and Beczek.COM came together for a live video discussion on the topic. Generis COO Max Kelleher chaired the proceedings. Here’s what came up.
Where are companies now?
The panel began by reflecting on the current state of data management, particularly around regulatory data, in Life Sciences – and where this is all moving in the future.
Frits Stulp of Iperion – a Deloitte business, noted that the visibility of the Life Sciences industry has been elevated tremendously over the last three years, due to COVID and the direct and immediate value of emerging medicine to quality of life for many people. However, the pandemic also shone a light on archaic registration processes which today still involve the exchange of PDFs. Stakeholders across the industry have begun to see that there is a better way to manage this, he said.
Who’s driving the data-first agenda?
As processes become more data driven, some organisational concerns are emerging around who will drive all of the necessary rigour around data quality? Will that, and should that, be the regulators -via compliance?
Frits suggested that a joint innovation initiative would be most productive. Regulators are not necessarily there to drive innovation, but do need to pave the way for new ways of working, he proposed. Despite a great deal of drive by the industry, there can be paralysis when new initiatives centre around a legal mandate, so it makes sense for both parties to work together.
Vada Perkins of Bayer said that, looked at from an industry perspective, the regulator’s role is more about fostering opportunities. Take the progress of the pharmaceutical industry with investments in AI, to support novel ways of doing things and advance the pipeline. There’s a lot of momentum in the industry already, he noted. What is required from the authorities is an openness to this kind of innovation.
BioNTech’s Melanie Ruppel pointed to the need for greater coordination, too. Despite the available expertise and guidance, this isn’t currently focused into Centres of Excellence. Data governance expectations and advice are too fluid currently, too, she said. Until more is set down and made clear, the industry will struggle to make progress.
Master data management: Structure & ownership
Chairing the discussion, Max Kelleher of Generis highlighted a recent Gens & Associates report on Life Sciences companies’ innovation priorities, which found that one of top responses was master data management and how companies can improve that. The missing link is how this data is structured, and how applications can be connected in to allow different areas of the business to own or manage it.
Preeya Beczek of Beczek.COM emphasised the importance of the patient in all considerations. Ultimately, all planned advances are with a view of improving the speed of patient access to the treatments they need. From this perspective, the conversation about data becomes more meaningful – right across the value chain, she said. Although today’s processes are outdated, they are standardised and driven by current regulations. “So, we need to get better at managing those processes – whether that’s transitioning from phase one to phase two, or on to phase three then registration and delivery,” she suggested.
Certainly, there’s a real opportunity to think about having fewer data handoffs. Other issues relate to who owns the data, Preeya added. Usually it’s seen as ‘Regulatory’ data because those teams are the ones who submit to the health authority. However that’s not where the data originated; there’s a data supply chain – spanning CMC, Quality, Clinical, etc. The function that generates the data owns it, she proposed.
Ultimately, data needs to be correct and consistent wherever and however it appears. That starts with a culture of making sure that data is right first time, every time; a sense of commitment to the quality, completeness and consistency of that data; and an appreciation of what that means for the patient.
Data science as a discipline & the future of RegOps
There was general agreement that things are moving beyond data being a Regulatory Affairs preoccupation, towards more of a general ‘informatics’ concern for companies. “It isn’t necessarily a new role, but additional tasks and abilities may need to be developed now,” BioNTech’s Melanie said.
For Preeya, the ideal would be someone from Regulatory Operations becoming part of a cross-functional data governance or data committee, alongside representatives of the functions that are the sources of the data. Some organisations are hiring Chief Data Officers – someone who sits at the level of the CFO – which feels the right way to go, she said.
Frits said he saw the Regulatory function acting almost as the editor of a newspaper: ensuring that the people submitting content have done their research properly and checked their work.
The panel discussed the example of a medium-sized company known to have renamed its Reg Ops function ‘Regulatory Informatics’. To be effective, though, such teams would need to work closely with other groups, the debaters concurred. As Bayer’s Vada put it, “What an opportunity for those experts to augment their skill set in this data space, complementing the technology being deployed for tomorrow.”
The panel wrapped up the debate with a sense of optimism, agreeing that there are many positives to look forward to as the Life Science industry actively embraces a data-first future, even with some practical challenges still to be ironed out.
A fuller report of this life sciences future debate is available to download from Generis’s web site at https://www.caralifesciences.generiscorp.com/post/the-big-debate-the-future-will-be-data-driven-white-paper
