At Breakthrough 2024 this month, Sam Wallis, Head of ICSR Case Processing within the Worldwide Patient Safety Operations at Bristol Myers Squibb, will join a panel discussion on the reality of transitioning Safety/Regulatory systems to the cloud. Here, he provides a glimpse into BMS’s own journey, which he’ll share candidly during the Day 1 debate.

Samuel Wallis Headshot

By the time I sit down to this much-anticipated panel discussion on the journey to the cloud, and specifically LifeSphere MultiVigilance, it will be two years since Bristol Myers Squibb (BMS) made the transition with our worldwide Safety database. I’m looking forward to sharing our expectations and real experiences, and what we’ve learnt along the way – not least the importance of a trusted partnership with ArisGlobal in ensuring the project’s continued success.

With LifeSphere MultiVigilance, we expect to process some 550,000 data points/receipt items this year. I’m keen to share what we’ve achieved, and how we are striking that all-important balance between exquisite individual case safety reports that users can trust – in support of benefit/risk evaluation and the development of assets – while supporting the highly effective and cost-efficient processing of those ICSRs, end to end, through strategic use of automation.

 

Effective Safety data processing drives everything else downstream

Case management – high-quality ICSR generation – is central to any pharmacovigilance and drug safety environment, driving everything else downstream. Ultimately, the integrity and credibility of our Safety database, and efficient associated processes, are paramount to ensure that BMS’s investment in drug development and our post-marketing safety strategy is absolutely focused on bringing medicines through the pipeline and to commercialization, so that we can benefit more patients faster.

Until two years ago, our Safety database was managed entirely on premise. In 2022, we faced trying to integrate Celgene’s PV activities with BMS’s, following the company’s acquisition. This was a very large-scale undertaking. Moving from two ‘heritage’ databases to a multi-tenant cloud environment with LifeSphere MultiVigilance offered a good opportunity to tackle that integration in a sustainable and scalable way via a futureproof platform. (I believe most on-premise Safety databases will be phased out in due course; the cloud is becoming the obvious target for managing these vast data sets.)

Our experiences of moving to LifeSphere MultiVigilance, working in very close partnership with ArisGlobal, have been interesting and I’ll be very transparent about all of this during the Breakthrough2024 panel discussion. That’s because I know others will benefit a lot from hearing about what works well, where the challenges lie, and how to maximize the advantages of a cloud-based global Safety database on the LifeSphere MultiVigilance platform through close collaboration with ArisGlobal.

I’ll be just as interested to hear the first-hand experiences of our peers at this interactive session, which I am confident will be well attended – as moving to the cloud is something most companies will have on their roadmaps now, if not their immediate agenda.

I hope you’ll join us for what promises to be a lively and thought-provoking session.

  • Sam Wallis is Senior Director and Head of ICSR Case Processing, within the World Wide Patient Safety Operations at Bristol Myers Squibb. He joined BMS when the company acquired Celgene in 2022. He is based in London, England.  
  • At Breakthrough 2024, on Day 1 – Tuesday, March 20 – Sam will take part in a panel discussion exploring what’s involved in transitioning to the cloud, covering Bristol Myers Squibb’s own journey with its global Safety database over the last two years, and the associated efficiency gains, hidden benefits, and challenges. Life in The Cloud: Moving from Legacy On-Prem to Cloud