Up for discussion: Who’s driving Life Sciences’ data-driven future?

On the panel were:

• Dr. Melanie Ruppel, Senior Director Global Regulatory Affairs Regulatory Operations, BioNTech
• Vada A. Perkins, Executive Director, Regulatory Policy & Intelligence and Head of Regulatory Intelligence, Bayer Pharmaceuticals
• Frits Stulp, Managing Director, Iperion - a Deloitte business
• Preeya Beczek, Director & Independent Regulatory Affairs Expert, Beczek.COM

Frits Stulp of Iperion – a Deloitte business, began by noting 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. Yet the pandemic also shone a light on archaic registration processes which today still involve the exchange of PDFs.

Who’s responsible for the data?

As processes become more data driven, questions arise about who will drive all of the necessary rigour around data quality. Should that be the regulators - via compliance?

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 debate ended with a note of optimism, concurring that there are many positives to look forward to with a data-first future, albeit that there remain some practical challenges to be addressed.

• A fuller report of the 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