As the fast-spreading COVID-19 pandemic shuttered businesses in a wave that rapidly circled the globe, Matteo di Tommaso, vice president for Medical and R&D ITS at French global pharmaceutical company Sanofi, guided the IT team responsible for keeping the company’s systems for R&D and medical teams up and running.
“Our crisis plan kicked in very quickly,” di Tommaso said. “Within a short period of time we had a jump to nearly 70,000 people – that’s 70% of our workforce – working simultaneously from home."
How did the team manage the transition? The first priority was to ensure that Sanofi’s work-from-home infrastructure and remote support were scaled up to meet the expanded demand.
“In parallel,” di Tommaso said, “we worked with our partners to ensure that we were openly and proactively addressing any risk areas. This was a significant test of our cloud infrastructure. Our recent investments in Software as a Service [SaaS] solutions, and the simplification of our telecommunications systems, paid off as we were able to transition and scale up our remote operations quickly.”
Sanofi’s fast, smooth transition to a global work-from-home model is testament to the benefits of its digital transformation. It also demonstrates why the world’s leading industry analyst firms point to the pandemic as the moment when transformation stopped being a nice-to-have initiative for the industry and became an imperative for survival.
“The saying that ‘necessity is the mother of invention’ is particularly pertinent here,” said Daniel R. Matlis, president of US-based life sciences analyst firm Axendia. “In fact, I’d take this to the next level and say that ‘disruption is the matriarch of transformation.’ We see the current disruption as a watershed moment for modernization and digital transformation in life sciences.”
Adapting fast
The hasty adoption of telehealth is another compelling example of how digital services delivered via the cloud helped the life sciences industry overcome some of the shutdown’s biggest challenges.
“We’re basically witnessing 10 years of change in one week,” London-based doctor Sam Wessely said in an interview with The New York Times. “It used to be that 95% of patient contact was face-to-face: You go to see your doctor, as it has been for decades, centuries. But that has changed completely.”
Indeed, video consultation appointments on the UK’s National Health Service-approved myGP healthcare app rose by a staggering 1,451% in March alone. In the US, meanwhile, Forrester Research reports that virtual healthcare interactions are on pace to exceed 1 billion in 2020, including 900 million COVID-related visits.
“This was a significant test of our cloud infrastructure. Our recent investments in Software as a Service solutions, and the simplification of our telecommunications systems, paid off.”
Matteo di Tomasso
Vice President for Medical and R&D ITS, Sanofi
Sanofi, for example, switched to direct-to-patient shipping of investigational products, facilitation of in-home infusions of IV drugs to avoid visits to healthcare centers, telemedicine for patient assessments and virtual site visits using video conferencing and digital data collection.
“Virtual access to data, teamed with scalable capabilities for remote interactions, was fundamental to our success here,” di Tommaso said. “We usually have a large number of clinical trials going on at any one time, and we were able to keep most of these on track. What’s more, we were able to initiate new COVID-19 trials very quickly. Our teams demonstrated speed and agility, and IT support and data management capabilities are a critical component for success.”
Meanwhile, Massachusetts-based biotechnology company Moderna, an early leader in the race to develop a COVID-19 vaccine, launched third-stage clinical trials of its mRNA-1273 in July using a scalable cloud platform for clinical development. The trial, which was expected to enroll 30,000 participants, is believed to be one of the largest ever to incorporate data capture directly from participants, decreasing the need for office visits. Moderna’s virtualized data collection allows participants to use their own devices if they wish, easing the burden of having to carry a separate, provisioned device.
“[Our] unified platform is helping us put participants at the center of our efforts to develop a safe and effective vaccine against COVID-19,” said Marcello Damiani, chief digital and operational excellence officer for Moderna. Among the technologies Moderna is using to help support and accelerate its clinical development: electronic data capture, electronic clinical outcomes assessment and centralized statistical monitoring.
Fail to prepare, prepare to fail
Many organizations, however, were not so advanced in their digital transformations when the pandemic struck.
“The science fiction author William Gibson famously said that ‘the future is already here, it’s just not evenly distributed,’” Matlis said. “This is exactly what we are seeing across the life sciences industry. While many innovative companies and sites are leveraging advanced digital technologies to help them rapidly adapt to these changing operating conditions, the industry as a whole is way behind.”
As with Moderna and Sanofi, cloud-enabled digital transformations have been the dividing factor.
“What is clear to me is that those companies who fall into the ‘cloud-first’ category have been able to very quickly and effectively pivot to support the entire value network,” Matlis said. “However, those firms that still leverage on-premise solutions – firms that we call cloud-averse or cloud-curious – have found it very difficult to manage many aspects of their business. While we are definitely seeing a shift in how comfortable organizations are with the cloud, there are probably only 15%-20% of firms that are cloud-first. That tells us that there’s a lot of room for improvement.”
For most life science companies, Matlis said, supply chain disruption was a particularly difficult challenge.
"Getting hold of raw materials has been a real challenge for the life sciences industry,” he said. “The majority of active pharmaceutical ingredients are manufactured in China and India. Those two countries were heavily affected by the pandemic early on and, as a result, caused significant supply chain disruptions.”
Changing that situation, he said, will require the industry to put less dependence on single sourcing. A richer, more dispersed roster of suppliers, however, can only be managed effectively by implementing powerful digital supply chain planning systems that can execute pre-planned shifts in supply and logistics within minutes.
“The technology exists to provide full visibility and control across your supply network, to quickly identify the optimal schedule for running a process with qualified ingredients and to collaborate even when most of your staff is working from home,” Matlis said. “The limiting factor is not technology, but changing the organizational culture to support changing the processes and adoption of the technology.”
“What is clear to me is that those companies who fall into the ‘cloud-first’ category have been able to very quickly and effectively pivot to support the entire value network.”
Daniel R. Matlis
President, Axendia
Changing for good
As a signal of what’s possible, Matlis points to the digitally enabled collaborations occurring among pharmaceutical, biotech and university researchers to accelerate COVID-19 drug development.
“We’re currently seeing the best of the industry come together using digital technologies to fight this pandemic,” he said. “There’s so much potential for the future.”
Virtual twins – dynamic, scientifically accurate 3D representations of people, products or buildings that can be used to safely test theories and then monitor results in the real world – represent a desired state the industry should work toward, Matlis said.
“Bringing a new bio-pharma product to market, which can currently take up to 15 years, can be shortened massively through the use of digital twins,” he said. “Massive efficiencies can be gained by simulating portions of clinical trials using virtual human models. And think about the time saved on process development. Modeling and simulation technology is already helping pharmaceutical companies to accurately scale up recipes to pinpoint the precise ratio of ingredients for a product to be most effective. This cuts out a large part of the tech-transfer process.”
When combined with innovative medical devices, virtual twins have the potential to redefine the delivery of care.
“It’s possible that you will have a smartwatch, a fitness band, a ring with biometric sensors or another set of devices that are measuring your body temperature, your blood-oxygen saturation levels, your movement and your pulse rate,” Microsoft chief technology officer Kevin Scott said in an interview with consulting firm McKinsey. “And the devices are putting the data into diagnostic models that could tell you when you are sick, or getting sick, way before you would ever notice.
“This would give us the ability to do medicine in a way that we can’t do it right now: if we could treat people when they are less gravely ill, their chance of recovery would be much higher, and it would be cheaper to intervene then than after someone is symptomatic or more seriously ill. It may be something that helps us manage the next pandemic.”
Regulatory relief
Moving toward a more digital future, however, will require significant collaboration among key players in healthcare and life sciences, along with support and acceptance from regulatory bodies.
“The industry as a whole needs to work together to make this possible,” Matlis said. “We’re already seeing movement to break down some of the biggest barriers to digital transformation, such as internal regulatory inertia. The [US] FDA has recognized this and is bringing in guidance to help expedite the approvals process for new software that enables improved agility. This has the potential to remove 70%-80% of the documentation that is currently required when firms look to implement new technology in areas like manufacturing and quality systems.”
That kind of change, Matlis said, will help continue the drive toward digital transformation, far beyond the COVID-19 pandemic.
“COVID-19 has been a window into what’s possible for the life sciences industry,” he said. “Ultimately, what we’ve discovered is that when you give your best people the best tools, they can do amazing things.”
