We’re all familiar with the ways COVID-19 has impacted our lives over the past year, from the trivial to the life-altering. But how did the people and companies responsible for producing the vaccine – the very thing that would return our lives to normal – cope with the disruption to their own jobs? Last week, five leaders of the top life science companies shared how they pivoted to keep production of the COVID-19 vaccine and other key drugs going in a radically altered world.
Reality of a Global Shutdown
Creating and producing drugs in the life science industry of today requires deep collaboration between professionals spread around the globe. Experts are regularly flown in for physical, on-site interaction to tour a new manufacturing site, troubleshoot an equipment issue, or consult on a new production process as a few examples.
“We were in the middle of a fill/finish line for a vendor in Germany,” recalls Zack Gendron, Associate Director of Automation Information Systems of ElevateBio and formerly of Sanofi. “The vendor was regularly flying in to resolve issues but that was cut off when the pandemic started.”
Similarly, Joe Montano, Director of Customer Experience & Communication Excellence at Catalent, shared that they immediately sent home ~30% of their 16,000 person workforce once the shutdown started. For a company that works so closely with its customers and conducts over 500 site audits a year, this was a radical shift.
As the reality of the long-term nature of the pandemic set in, it quickly became an exercise of identifying who were critical personnel to go on-site, how to support operations for all identified as non-critical, and what additional procedures were needed to protect staff from exposure. “You had to redo everything you know about going to work and reevaluate what’s really critical,” remembered Zack.
The Pandemic Pivot
As shutdowns continued longer than anyone anticipated, the leaders recognized it was time for action.
Douglas Arnold, Director, MSDC Client Service Leader, MMD Information Technology at Merck, began to realize his existing project to more quickly troubleshoot equipment issues through remote collaboration technology was about to get supercharged. Pre-pandemic, his goal was to reduce the time to diagnose an issue down to 1 hour. To do so they had to find a way to get experts that usually travelled 15 – 20 hours to ‘be on-site’ via remote access. Douglas’s plan was to use Apprentice’s Tandem technology, which combines a powerful remote collaboration app with hands-free headsets, to give a first-person view of site equipment to anyone in the world. Still in the pilot phase when COVID hit, Douglas was asked to fast-track the rollout. “We essentially had to go from a 24 month roadmap to ‘do it now’,” he said. Condensing the plan down to an 8-month rollout, Douglas and team deployed 200 Tandem devices to 5,000 Merck users across the globe.
Nobel Vale, Principal Scientist at BristolMeyersSquibb (BMS), echoed Douglas’s story with his own experience. “Luckily, we were in pilots already with Apprentice and had shown the business the extreme benefit of this technology,” he stated. BMS started the pandemic with 30 Tandem headsets for the Product Development team and quickly ballooned to over 100 across Auditing, Biologics, Cell Therapy, Manufacturing, and Science & Technology groups. Nobel shared that once these groups heard about the technology his team was using, they were eager to bring it into their own teams – only adding fuel to Tandem’s rapid adoption.
“At Sanofi what swiftly transpired was word-of-mouth that we had a way to support operations remotely,’ agrees Zack. “And we quickly jumped from 20 to 30 users to well over 200 or 300 users in a 2 – 3 month period.”
Flying in experts across continents for a 2-3 week stay on-site was also the norm for Suelyn Lee, Product Director of Manufacturing Workflow at GSK. Like Douglas and Nobel, she had been overseeing a pilot of Tandem that went from a 6 – 9 month timeline to an immediate rollout of 120+ headsets over 30 locations. “Anything we used to do physically face-to-face we now do remotely through Apprentice. Sure enough, we were able to keep the milestones for some key oncology drugs last year and this year despite the challenges of COVID,” shared Suelyn.
As a major producer of the COVID vaccine, the pressure was on for Catalent to keep to production schedules. In addition to adding 2,000 employees to scale up manufacturing, Catalent had to find a way to maintain close communication with customers who keep a strict eye on the quality of the vaccine creation process. First deployed in 2015, Apprentice had been proven out at their Kansas City site to keep in touch with customers, equipment vendors, and even regulators. Joe led the expansion of Tandem to 35+ sites, 12 countries, and 4 continents to keep production on-track during COVID.
A New Normal
As the world cautiously reopens, a new normal is taking shape in how we live and work and these leaders expect nothing different for the life science industry.
“It’s been a crazy thrill ride during this pandemic to get this technology out there,” noted Nobel, but shared it’s just the beginning. “Remote collaboration was just the first use-case for Apprentice, there is more to come. Now the question is ‘What else can we do with this? How do we think outside the box and apply this technology to our business?’” Nobel and team will be exploring Apprentice’s intelligent manufacturing execution system (MES), which leverages the Tandem headset in concert with a platform to more quickly and accurately execute batch manufacturing procedures.
Suelyn will look to expand remote collaboration to more activities that typically require on-site travel including Factory/Site Acceptance Testing, equipment commissioning, and equipment installation/operational qualification.
With 20 – 25% of the workforce still remote and recently published FDA guidance on remote audits, Joe knows that Tandem collaboration is here to stay at Catalent. Like Nobel, Joe will also begin to pilot Apprentice MES to enable digital batch manufacturing and gather more data and insight on their performance to share with customers.
Next up for Douglas at Merck is similarly exploring Apprentice’s intelligent MES for guided task execution during batches – the first of a host of Pharma 4.0 capabilities he’d like to start driving on the shop floor.
As for Zack: “I’ve been with [ElevateBio] for three weeks and we’re going to launch a pilot with Apprentice immediately because I had such success with the technology at prior companies. This technology is not going away – just because COVID pushed it over the line – it’s going to stay.”