Ushering in the data science era: the view from Steve Gens

As 2022 wraps up, we asked some of our revered industry partners and popular BE THE EXPERT event speakers for their views on the biggest developments in the Life Sciences Regulatory sphere over the last 12 months – and to predict the most prominent themes and priorities for 2023.
Here’s what Steve Gens, managing partner of Gens and Associates, had to say.

What, for you, is the single biggest issue of importance in relation to the Regulatory function right now, and why?

Improving global ways of working, to decrease the time for market approvals (that is, the time from first to last market submission), has been the biggest area of focus and progress.

Biopharmaceutical companies with Covid19 products (vaccine or therapy) were able develop and gain regulatory approval in records time. Never in our history has getting products to patients been so critical, and there were new approaches developed to accomplish this (as measured in Gens & Associates’ 2020 and 2022 Covid19 Regulatory Impact studies).

This has led to new ways of working, increased application of modern technology and digitization, and good old-fashioned process enhancement (change control, label management, regulatory intelligence, etc) at an end-to-end level.

How do you see all of this playing out over the next year – and beyond (eg. 3-5 years ahead) – and what do companies need to watch out for?

Companies that are modernizing their regulatory information management program now are focused on evolving the regulatory operation organization driven by the data sciences, and also the application of advanced technology. This includes robotic process automation, structured content generation, and connectivity to other critical functions such as Quality, Manufacturing, Safety, and Clinical.

What do you see as being the main facilitators? In other words, where do companies need to focus their efforts now, and what decisions/actions in particular will be important in determining how well they do?

Companies need a clear digitization strategy, in conjunction with other functions (e.g. R&D, Manufacturing), as well as improved information exchange at a local affiliate or “last mile” level where further innovation is required.

These two factors will greatly enhance both the efficiency and effectiveness of the Regulatory organization.

As soon as we look beyond the immediacy of the Regulatory function, the picture shifts for data management and its potential. What excites you the most in terms of what could be possible and how far this could go – and what might that look like?

We are in the early stages of the “data connectivity” period, where critical data from various functions (Regulatory, Quality, Manufacturing, Safety, Clinical, etc) are gradually being connected.

This requires a clear focus and excellence around cross-functional data governance, and on ensuring all data from all these various systems is at the same high level. The goal is to achieve sufficient confidence in data quality to directly impact productivity and facilitate more effective decision-making.

This is where the promise of cross-functional business analytics, real-time information visualization, and advanced technology will play out. What we’re witnessing is the birth of the data science era.

When you look across your surveys, including the most recent findings, what frustrates you most in terms of what companies still haven’t realized, or still aren’t doing – and what should they do differently in 2023?

This one is simple: companies need to become better at central, regional, and local affiliate collaboration and information management. Lost opportunities persist when it comes to improving how real-time regulatory information is available globally, to support day-to-day operational tasks across different markets. On top of that there is substantial untapped scope to strategically improve the “time to patient” for new products – especially in the smaller markets around the globe.

Improved regulatory intelligence sharing; global dossier management excellence; and the central organization working more seamlessly with the local affiliate will be critical success factors.

About the author

Steve Gens (MSOD) is the Managing Partner of Gens & Associates Inc., A Life Science benchmarking and advisory firm specializing in performance improvement, strategy, regulatory information management, and organizational transition. His early career was spent at Johnson and Johnson in a variety of management positions and then transitioned to consulting where he led global Life Science consulting practices for First Consulting Group and Booz Allen Hamilton.

 His organization is well known for their insightful industry benchmarks, World Class RIM industry performance standard, and thought leadership. Steve has a Bachelor of Science in Business Computer Science and a Master in Organizational Development. He is a frequent speaker, has many publications, and was named to the 2017 PharmaVoice 100 and as an innovator in the 2021 Innovations in Pharmaceutical Development™ for his contributions to industry.