As 2022 drew to a close, Amplexor asked some of its closest industry partners and regular event speakers for their views on the most pivotal developments in Life Sciences regulatory operations over the last 12 months, and to predict the most prominent themes and priorities for 2023.
Those contributing their views included:
- Steve Gens, Managing Partner, Gens & Associates, a boutique Life Science benchmarking and advisory firmspecializing in operational performance improvement, benchmarking, World Class RIM℠, and organizational transition for the regulatory domain and how it connects with clinical, commercial, safety, quality, and health authorities. Their mission is to help the regulatory eco-system improve their performance through there recognized research platform that bring precision to the most effective changes and investments.
- 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 recognized industry leader in Regulatory Information Management and IDMP, Kelly is an active participant in the EMA SPOR Task Force, a member of the ISO working group responsible for the IDMP standards, and serves as President/CEO of the IRISS Forum.
- Tris Nockles, Labeling Networks Lead at Navitas Life Sciences, a technology-backed global clinical research organization.
Renato Rjavec of Amplexor Life Sciences reports.
The issues currently preoccupying Life Sciences organizations
Of the most prominent issues facing Regulatory functions at the current time, 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 digitization 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.
Kelly Hnat observed that the current advance toward structured data and new submission paradigms would have benefits for Regulatory, and across the enterprise, as the value of clear, accurate and complete data representations of registered medicinal products is tapped.
Access to talent
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 organizations in assembling the right resources to meet increasingly condensed timeframes for submissions.
“Finding people with the right skills to work in life sciences 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.
Organizational change
Other considerations as companies extend their ambitions are the need for more formal organizational change, as the growing flow of standardized data paves the way for new process fluidity across functional boundaries.
As Steve Gens put it, “Companies that are modernizing RIM now are focused on evolving the regulatory operation organization – 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 visualization, and advanced technology will play out. “What we’re witnessing is the birth of the data science era,” he summarized.
Dynamism & agility
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 organizations, and to adapt complex processes and transform the content from large volumes of legacy documents into more dynamic, reusable data,” he said.
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.
Facilitators of change
To get to where they want to be, companies now need to develop a clear digitization strategy in conjunction with other functions such as R&D and Manufacturing, Steve said. That’s in addition to improved information exchange at a local affiliate or “last mile” level, where further innovation is required. These two factors, if addressed appropriately, promise to greatly enhance both the efficiency and effectiveness of the life sciences Regulatory organization.
Specific 2023 priorities
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.
In 2023, companies need to become better at central, regional, and local affiliate collaboration and information management, Steve Gens said. “Lost opportunities persist when it comes to improving how real-time life sciences regulatory information is available globally, to support day-to-day operational tasks across different markets,” he warned.
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 going forward.
More generally, organizations should be careful not to rely too heavily on technology and tools to solve their problems, Kelly said, noting that the key to success will ultimately always be manifested through business process and organizational culture.
“Top-performing organizations excel at the process and organizational work, along with strong implementation execution,” she concluded. “These strengths can overcome the weaknesses with almost any software platform… but the opposite is never true.”
About the author
Renato Rjavec is Director of Product Management at Amplexor Life Sciences. Amplexor helps organizations that are developing pharmaceutical drugs, medical devices, and biotechnology to launch products and break into new markets quickly using innovative end-to-end regulatory and quality management solutions. Its solutions and services expedite the management of highly-structured data and the creation and delivery of consistent, compliant global content. Amplexor’s services include technology consultancy, implementation, and management services.
