According to a poll conducted among pharma regulatory professionals during Generis’s virtual Generate conference for Life Sciences in June 2021, over three-quarters (79 per cent) of companies now have a global capability for managing regulatory submissions. A further 16 per cent have this goal in their sights, leaving just 5 per cent of organisations that don’t see centralised submissions coordination as a priority.
In this context, US/Japanese holistic healthcare group Otsuka Pharmaceutical Co (OPC) charted its experiences of evolving towards a central global submissions management repository - underpinned by the CARA Life Sciences platform from Generis.
The road to harmonisation: reversing global submissions complexity
Otsuka makes both traditional pharmaceutical products and nutraceuticals. Speaking at the event, Bill Hannon, global lead for regulatory technology and operations at Otsuka in Rockville, Maryland in the US, painted a picture of a highly distributed global organisation which has had to ‘learn and grow together’. Before the business could move towards a global submissions capability, it needed to establish a baseline of understanding of what was needed, the practical changes that would be involved, and how these might vary in impact by country/operation/local ways of working.
“We needed to understand the best-fit solution, and we spent a lot of time assessing different software vendors,” he said. “We chose CARA due to its flexibility and support for creativity – that we could shape it to fit our exact requirements.”
Some operational harmonisation was inevitable though. “As a global organisation we needed to commit to the outcome, together. Everyone had to give a little, as it would have been impossible to please everyone. The thing about change is that, while everyone wants it, no one really wants to do it. But our challenges became our opportunities.”
With a whole spectrum of international partners, operating in numerous languages and time zones, Otsuka counted more than 100 different operating procedures (SOPs) for managing and processing regulatory submissions and content around the world. In some countries/companies within the group, the Quality/Regulatory/Safety remit was combined in one role or team. In other areas, the roles were split out, for instance.
“There was a multiplicity of different approaches, a variety of business models, and a whole range of technologies in use – at an infrastructure level down to use of individual tools,” Bill said. Across the global group, numerous different document management systems had been in play, for instance.
“Once we’d baselined what we had, we needed to streamline, standardise and simplify. That’s easy to talk about but not as easy in practice. We were looking to reduce 100+ SOPs to around five, then create individual job aids or quick reference guides to take care of any nuances.”
Sashi Godavarty, Otsuka’s associate director for regulatory technology, picked up the story. “We needed to establish the best approach, and select a single vendor for global implementation.”
Preparing for change
Otsuka formed a team, reflecting the different regions and partner companies that would be affected by the changes - to endorse the new set-up and ensure local buy-in. Next steps included defining the operating framework, and appointing IT and business team members who would define and be responsible for governance. It was important to commit to scheduling and outcomes, too, and create clarity around the scope of the project.
CARA Life Sciences platform provider Generis emerged as a strong contender. “We needed a vendor that could meet all our different language needs, while their provision for sandboxing [the ability to test new software safely in a real environment] really helped,” Sashi explained (see this blog from Generis COO Max Kelleher about how customers should insist on sandboxes from vendors during selection).
Otsuka established function or company-based subject matter experts (SMEs) to define needs at a local user level, and held global meetings with them. It created a strong e-learning strategy, designing a course for the global leads, and created a common knowledge portal for sharing contacts and key data internationally.
The important thing was to remove rather than add complexity, and to manage and communicate change effectively and consistently.
“We needed to develop an architecture that would accommodate everyone’s need, and be able to scale this as we built it out,” Bill explained. The ability to pull data into dashboards, and create robust user support, were among the specific priorities.
The pay-off of upfront planning
All of this investment in upfront planning paid dividends. “Our content management journey was actually quite simple,” Bill noted.
“We went live in key regions in March 2018 with our initial deployment, before globalising further over the next eight months. By early 2019, we had expanded the system’s reach into Asia-Pacific and other countries, expanding and targeting the e-learning and user toolkits. We created standardised SOPs, conducted user surveys and expanded our communications, before final expansion of the CARA system to the remaining countries.”
The benefits have been widespread and tangible. As well as enhanced, proactive compliance with regulatory demands around the world, Otsuka has been able to reduce its overheads through its streamlined and simplified global submissions capability, while enhancing data integration and information sharing, and empowering users around the world with real-time access to support global submission activity.
Best practice: lessons learnt
Keen to pass on what they had learnt from this very positive experience of standardising on the CARA central submissions system, Bill and Sashi ended their session with some practical takeaways and tips for other companies keen to progress their migration to a globalised submission management capability:
1. Expect to put in some long hours to get this right.
2. Engage the project sponsors throughout, to avoid any surprises.
3. Work in parallel, rather than sequentially, to maintain momentum.
4. Innovate and think laterally – leveraging and building on what’s there.
5. Ensure there is a clear change management strategy.
6. Trust but verify: execute effective testing against clear specifications.
7. Maximise adoption with an effective onboarding approach. If e-learning is inadequate, or support is lacking, it could affect acceptance of the new system or new ways of working.
8. Think globally, but consider a phased approach allowing each function/company to consider its own specific needs.