Feature: Digital Regulations
The Big Debate: The Future of Life Sciences’ Regulation and Processes Will Be Data Driven – But Who Will Steer That Future?
Industry experts joined in a live video discussion about the critical next steps as life sciences embrace a future that is data rather than document driven in its management of information, knowledge and essential business processes. Ultimately, whose responsibility should it be to look after the quality and consistency of the data, and how will they do this?
Max Kelleher (MK): Where are companies now?
Frits Stulp (FS) at Iperion – a Deloitte business: The visibility of the life sciences industry has been elevated tremendously over the last three years, due to COVID-19 and the direct and immediate value of emerging medicine to quality of life for many people. But the pandemic also shone a light on archaic registration processes that today still involve the exchange of PDFs. Stakeholders across the industry have begun to see that there is a better way to manage this.
MK: Who’s driving the data-first agenda? As processes become more data driven, though, who will drive all of the necessary rigour around data quality? The regulators, via compliance?
MK: Who’s driving the data-first agenda? As processes become more data driven, though, who will drive all of the necessary rigour around data quality? The regulators, via compliance?
FS: 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. Despite a great deal of drive by the industry, there can be paralysis when new initiatives centre around a legal mandate. It makes sense for both parties to work together.
Vada Perkins (VP) at Bayer: From an industry perspective, the regulator’s role is more about fostering opportunities. Look at what the pharmaceutical industry is doing with investments in AI to support novel ways of doing things and advance the pipeline. There’s a lot of momentum in the industry; what we require from the authorities is that they are open to this kind of innovation.
Melanie Ruppel (MR) at BioNTech: There needs to be greater coordination too. Although there’s a lot of expertise and guidance, it isn’t currently focused into Centres of Excellence. In terms of data governance, we’re in a very fluid environment too. Creating something more concrete will require both sides setting out where we want to be in terms of exchanging data in the future so that everyone can get started as soon as possible.
MK: A recent Gens & Associates report on life sciences companies’ innovation priorities found that one of the top responses was master data management and how companies can improve that. The missing link is how we structure this data, and bring in applications to allow different areas of the business to own or manage it.
Preeya Beczek (PB) at Beczek.COM: It’s important not to lose sight of the patient in all of this, too. Ultimately, everything we’re trying to advance now is with a view of improving the speed of patient access to the treatments they need. If we keep that in mind, the conversation about data becomes more meaningful – right across the value chain. Today’s processes might be outdated, but they are standardised and driven by the current regulations we have. So, we need to get better at managing those processes – whether that’s transitioning from phase 1 to phase 2, or on to phase 3 then registration and delivery.
“Ultimately, everything we’re trying to advance now is with a view of improving the speed of patient access to the treatments they need”
It’s often at an operational level where companies get lost; where there are disagreements about who owns and leads what process and therefore who owns the data coming out of that process. Certainly, there’s a real opportunity to think about having fewer data handoffs.
Other issues relate to who owns the data. Usually, it’s seen as ‘Regulatory’ data because those teams are the ones who submit to the health authority. But that’s not where the data originated; there’s a data supply chain that spans CMC, Quality, Clinical, etc. The function that generates the data owns it.
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, that there is a sense of commitment to the quality, completeness and consistency of that data, and there is an appreciation of what that means for the patient.
MR: We’re 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.
PB: Really now, someone from Regulatory Operations should be part of a cross-functional data governance or data committee, alongside representatives of the functions that are the sources of the data. Yes, Regulatory will be at the centre of this to an extent, but the burden of responsibility shouldn’t fall to Regulatory Operations.
FS: I see 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.
PB: Some organisations are hiring chief data officers – someone who sits at the level of the CFO – which feels the right way to go.
MR: I see RegOps remaining independent, but I also see the teams working in Regulatory Operations having the opportunity to develop intodata governance/cross-functional roles. And certainly, there needs to be thought about acquiring additional talent and expertise linked to trending topics – systems, data collection and so on. It would certainly be very helpful to have the ‘informatics’ point of view included in Regulatory Operations.
VP: I know of a medium-sized company that has renamed its RegOps function ‘Regulatory Informatics’, which is an interesting move. To be effective, such teams do need to work closely with other groups. But what an opportunity for those experts to augment their skill set in this data space, complementing the technology being deployed for tomorrow.
Conclusion
Conclusion
The panel wrapped up the debate with a sense of optimism, agreeing that there are many positives to look forward to as the life sciences industry actively embraces a data-first future, even with some practical challenges still to be ironed out.
Max Kelleher has worked in the Regulated Data Management space for eight years at Generis, working first in implementation and configuration of the CARA Platform before moving into business development and eventually becoming COO. Along with his father, CEO James Kelleher, Max’s vision is to enable the digital transformation of processes in regulated industries with the CARA Platform. In his own words, his goal is “helping hundreds of thousands of people to not hate their work-life with outrageously good software”.
Dr Melanie Ruppel, senior director of Global Regulatory Affairs Regulatory Operations at BioNTech, graduated from the Technical University Darmstadt in 2003 as a biologist, with her PhD and PostDoc studies, focusing on epigenetics in leukemia, at the German Cancer Research Center in Heidelberg, both in Germany. Melanie’s career in the pharma industry begun at Boehringer Ingelheim (BI) Vetmedica in International Regulatory Affairs. Shortly after, she joined Regulatory Operations within BI’s Human Pharma organisation, focusing on eSubmission topics as well as globally managing several projects in RegOps responsible for initial MAA/NDA submissions. After 12 years at BI, Melanie joined BioNTech in July 2022 to establish and lead its RegOps organisation.
Vada A Perkins is executive director, Regulatory Policy & Intelligence and head of Regulatory Intelligence at Bayer Pharmaceuticals and a former FDA senior advisor for Regulatory Science, with global regulatory policy and intelligence expertise including the application of international standards and technology to regulatory science and informatics/telematics initiatives. As the co-lead/co-editor of the ISO IDMP standards and corresponding technical specifications for ISO 11615/20443 and ISO 11616/20451, Vada collaborated with various international organisations and health authorities to ensure successful publication and remains active to promote its interoperability and extensibility to relevant international regulatory initiatives.
Frits Stulp, managing director at Iperion - aDeloitte business, is a valued strategic advisor to the life sciences industry, relevant regulators and software providers. With a background as programme manager and advisor in Information Management, process design and Regulatory Compliance, specialised in the implementation of both XEVMPD and ISO IDMP requirements, Frits led numerous projects. He worked at a top 20 pharmaceutical for many years and has been co-founder of Iperion Life Sciences Consultancy. Besides his role at Iperion/Deloitte, Frits is chairman of the Board of CTADHL, the IRISS IDMP topic group and a well-known speaker. His specialties are Regulatory Information Management, Substances, programme management, information strategy and process improvements.
Preeya Beczek, director & independent regulatory affairs expert at Beczek.COM. Preeya has 24 years’ experience across the life sciences industry, leading regulatory projects across the entire product life cycle in various therapeutic areas and platforms. Preeya has held roles at PAREXEL, GSK, Pfizer, JNJ, Ipsen, DOW Chemicals and worked with many other organisations as part of her client base and professional network. Preeya holds a Bachelor of Science degree in Chemistry and Management Studies and a Master of Science in Environmental Strategy from the University of Surrey, UK.
Innovations in Pharmaceutical Technology (IPT)
IPT provides a platform for cutting-edge ideas, concepts, and developments shaping the future of pharmaceutical R&D.