Supply chains that span the globe. Billions of doses of medicines each year. Those are big enough challenges under normal circumstances, and the novel coronavirus pandemic blew normal to bits.
That's something Novartis and its massive manufacturing network know well. Most employees at its manufacturing plants were sent home in the early weeks of the pandemic. But even with reduced staff, those sites had to keep Novartis' supply chain up and running—and ramp up production of possible COVID-19 therapies at the same time.
Novartis' employees stepped up to the plate, keeping plants running at not only full but expanded capacity and meeting Novartis' ambitious drug donation plans, according to Steffen Lang, Ph.D., global head at Novartis Technical Operations.
"They delivered the output amazingly––this is a testimony to the commitment and the environment that people continued to be focused to deliver," Lang said.
The strength and flexibility of Novartis' manufacturing, Lang argued, allowed the drugmaker to absorb those blows, keep the supply lines running and keep employees safe. Here's how they did it.
'A new normal'
In March, as the novel coronavirus began shutting down communal workplaces around the globe, leadership at Novartis Technical Operations sat down to discuss what to do with their manufacturing site employees.
The team immediately put employee safety at the top of their list, Lang said, but it wasn't clear how to ensure that safety at plants that require on-site employees.
"We typically had all people required to do the job there," Lang said. "Overnight, we developed and introduced plans that reduced the number of people who were really required to be at the site to roughly 50% of the workforce."
Novartis Technical Operations manages manufacturing and supply at 60 global sites, including for its Innovative Medicines and Sandoz generics units. Lang has headed the unit since 2017 and was hired on at Novartis in 1994.
Sidelining half of on-site employees came with added pressure: Novartis still had to supply billions of doses of its drugs at a time when it faced spiking demand for national stockpiles and needed to ramp up possible COVID-19 therapies. Novartis employees had to adjust rapidly to staggered schedules and work-from-home inconveniences to maximize production and keep the chain intact despite a periodic 20% to 30% increase in demand.
With that kind of pressure ever-present, Novartis knew it needed to work to keep employees safe and happy. The drugmaker launched a global task force to discover what was working and what wasn't, Lang said, and then share best practices among its sites worldwide. Its facilities also offered a hotline to medical professionals and established safety measures to reduce the risk of an internal COVID-19 outbreak.
But employees also took it upon themselves to help one another. According to Lang, some employees working in staggered shifts cared for their coworkers' children to help ease the burden of school closures, among other acts of solidarity.
"This gave the confidence and support required for not only our people to feel safe but also to feel supported to continue to deliver," Lang said.
A strong foundation
But employee morale can only go so far––having a contingency plan in place is necessary to keep the ship afloat.
According to Lang, Novartis' business continuity and pandemic response plans included maintaining robust inventory levels and "dual supply points" that allowed Novartis the flexibility to take a hit to operations and keep moving ahead.
"The question is, as a manufacturer, how can you be agile enough to resupply?" Lang said. "What is important and what has helped is the significant inventory levels we have of finished products not only in certain countries but through the entire value chain."
That two-pronged strategy has kept Novartis' supply chain intact and helped it weather an increased demand for antimalarial hydroxychloroquine, JAK inhibitor Jakafi and IL-1beta inhibitor Ilaris amid global clinical trials for COVID-19 and skyrocketing demand.
Moving ahead, Lang said Novartis has not only prioritized keeping that foundation strong, but it's also working actively with its suppliers to keep channels of communication open and maintain "end-to-end" visibility on the chain through greater digital investment.
"The more we optimize this and the more digital we are going to be, the less and less vulnerable we will be," Lang said. "Partnership with our suppliers (will ensure we) will be even better prepared if another pandemic will come."
The HCQ problem
While Novartis has been able to meet its pledges for potential therapies in the COVID-19 fight, will the fate of hydroxychloroquine be a cautionary tale moving ahead?
In late March, Novartis pledged 130 million donated doses of hydroxychloroquine––a cheap generic antimalarial––to global clinical trials and emergency use after President Donald J. Trump expressed confidence in the drug as a treatment for COVID-19 taken with antibiotic azithromycin.
That donation was light years ahead of other drugmakers: Mylan planned to ramp up production at its West Virginia Facility to make 50 million tablets; Teva said it would donate 16 million tablets to hospitals around the U.S.; and Amneal pledged to make 20 million tablets by mid-April.
Bayer, the first to jump in with a donation, pledged 3 million doses of the drug just days before Novartis.
Since then, hydroxychloroquine has taken a beating in limited clinical trials. Following small-scale studies that found limited efficacy in COVID-19, the World Health Organization halted its own clinical trials for the drug in May before deciding to continue this week, and France became the first country to ban the drug's use to treat the disease.
Meanwhile, Novartis in late April announced it would launch a 440-patient phase 3 clinical trial, evaluating hydroxychloroquine alone or in combination with azithromycin against placebo.
Despite waning enthusiasm for hydroxychloroquine, Lang said that Novartis' commitment to providing huge amounts of the drug for free was still the "right approach" given its potential benefit. Novartis was on track to produce 100 million doses of the drug by the end of May, he said.
For Jakafi and Ilaris, neither of which has posted conclusive data in a clinical trial, Lang's team has built enough supply to accommodate a potential approval to treat COVID-19, and it's working with suppliers to establish back-up supply in case of high demand.
"We have a great partnership with our clinical and medical teams, but of course it’s a journey and we are finalizing our plans as we speak," he said.