Data-first business process redesign set to drive Life Sciences Regulatory functions

Amplexor partners share insights and predictions for the future of the Life Sciences Regulatory sector, ranging from transitioning to data-first ways of working to tackling resource challenges within condensed timeframes. Renato Rjavec of Amplexor Life Sciences reports.

The following Amplexor partners contributed to this article:

• Steve Gens, Managing Partner, Gens & Associates, a boutique Life Science benchmarking and advisory firm specialising in operational performance improvement, benchmarking, World Class RIM^℠, and organisational transition for the regulatory domain - including closer integration with clinical, commercial, safety, quality, and health authorities.
• Remco Munnik, Associate Director, Iperion - a Deloitte business, a subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP.

• Kelly Hnat, founder and Principal of K2 Consulting (k2rim.com), a Regulatory Information Management and IDMP expert and active participant in the EMA SPOR Task Force.

• Tris Nockles, Labeling Networks Lead at Navitas Life Sciences, a technology-backed global clinical research organisation.

Of the most prominent issues facing Regulatory functions, Steve Gens sensed renewed urgency around improving global ways of working, particularly around reducing the time for market approvals.

Gens & Associates, which has been tracking RIM-related improvement activity closely, has observed increased application of modern technology and digitisation focused on improved ways of working and process enhancement (change control, label management, regulatory intelligence) at an end-to-end level.

There is general agreement now that the shift away from inconsistent manual, document-oriented processes towards agreed use of standards-based data will be pivotal to transforming key processes. Remco Munnik noted that, up to now, Regulatory has always been the “spider in the web” within a pharmaceutical company – collecting all of the relevant information for submission of the registration: Clinical, CMC, administrative data, etc – then compiling a valid eCTD by the submission deadline. In future, all of this will be data driven, he said - requiring a different approach to managing everything and ensuring its quality.

Skills challenges

The potential for transformed processes may be considerable, but the industry faces ongoing challenges in getting to where it would ideally like to be. Tris Nockles highlighted the challenges for organisations in assembling the right resources to meet increasingly condensed timeframes for submissions.

“Finding people with the right skills to work in Regulatory, which has been problematic historically, seems to have become a more difficult and lengthy pursuit in recent years,” she said, noting that it can take 6-12 months to onboard mid-level and senior staff these days. “On top of that, technology is under-delivering in many cases,” she added. “It’s not uncommon for companies to augment their RIM capabilities with more friendly technologies to capture and feed data in, or look to flexible resourcing to enter data on behalf of their Regulatory staff.”

With the twin challenge of speed of delivery in a highly competitive job market, Tris said, companies will need to consider new and innovative ways of filling the staffing void, whether through flexible resourcing (outsourcing/offshoring) and technology and automation to enable routine operational work, or adjusted talent strategies that value technology-savvy newcomers in the workforce.

Embedding process fluidity

Other considerations as companies extend their ambitions are the need for more formal organisational change, as the growing flow of standardised data paves the way for new process fluidity across functional boundaries.

As Steve Gens put it, “Companies that are modernising RIM now are focused on evolving the regulatory operation organisation - driven by the data sciences and advanced technology including robotic process automation, structured content generation, and connectivity to other critical functions such as Quality, Manufacturing, Safety, and Clinical.

“We are in the early stages of the ‘data connectivity’ period, he said. This in turn requires a clear focus and excellence around cross-functional data governance, he explained. It is where the promise of cross-functional business analytics, real-time information visualisation, and advanced technology will play out. “What we’re witnessing is the birth of the data science era,” he summarised.

Develop a clear digitisation strategy

With EMA’s direction toward agile development now, pharmaceutical companies too must become agile - in terms of adapting their own processes and systems, Remco added. “The biggest challenge ahead is for companies to become more data-driven organisations, and to adapt complex processes and transform the content from large volumes of legacy documents into more dynamic, reusable data.”

Ultimately the challenge ahead is a business process one, though. Kelly urged change in the way Regulatory product teams work with technology to facilitate this.

To get to where they want to be, companies now need to develop a clear digitisation strategy in conjunction with other functions such as R&D and Manufacturing. Above all, companies need to reset their strategy now, adapting as they go, so that they can deliver more data-driven ways of working without the scale of the opportunity, and the associated challenge, becoming too daunting.

Technology does not have all the answers

Organisations should be careful not to rely too heavily on technology and tools to solve their problems. Kelley says: ““Top-performing organisations excel at the process and organisational work, along with strong implementation execution. These strengths can overcome the weaknesses with almost any software platform… but the opposite is never true.”

According to Steve. “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.” And there is untapped opportunity to strategically improve the ‘time to patient’ for new products - especially in the smaller markets around the globe.