The rapid development, approval and deployment of the COVID-19 vaccine surprised people both inside and outside the medical field.
The vaccine was publicly fast-tracked, and the general public got a first-hand view of the development and approval process — something that typically does not make global headlines.
While the vaccines’ accelerated development demonstrated a lot about the capabilities of contemporary clinical research, it could also bring future challenges for research organizations to keep up the pace of production in future projects.
In the same way that the pandemic brought on a new normal for many workers, will the vaccine require changes to the field to meet the demands of shareholders and the general public? What can clinical research organizations (CROs) do to meet these future challenges?
The COVID-19 pandemic and ensuing vaccines gave CROs a very good reason to reevaluate and increase their existing resources.
“COVID-19 has accelerated their transformation timelines for implementing new technologies and approaches,” writes Andrea Bastek, director of innovation at Florence Healthcare. “Former technology infrastructure estimates for sites, sponsors, and clinical research organizations (CROs) for 2025 have now been pulled forward to 2021.”
With access to the right tools, researchers can continue to prove the return on investment of these resources to better meet the demands of healthcare.
Good data can’t guarantee a fast trial or quick product turnaround, but it is increasingly pointed to as an essential tool in guiding CRO operations.
"There's a real opportunity for remote monitoring and technology. Companies are having to adapt, to incorporate more remote technology,” says Jon Meyer, co-founder and principal of Life Sciences Strategy Group.
Data will be essential in leading products and trials moving forward, but also in helping teams regroup from the past year. It can help companies save money, identify high- and low-risk projects, and provide insights into how to keep projects on track.
With CROs reaching optimal capacity again, teams can start clinical trials that were put on hold before the pandemic. Without data and analytical insights, these projects can drive up costs as firms struggle to identify which ones are ready to move forward and which ones need to be adjusted for the post-pandemic world.
It may not always be possible for CROs to meet the the same timelines they did with COVID-19 vaccine development. But it revealed specific resource needs if CROs want to accelerate schedules and develop ways to identify projects that already have a high probability of success.
As the pandemic spread in 2020, a refocus on how global clinical supply chain efficiencies could be enhanced emerged. With factories shut down and borders closed, teams were challenged to get supplies wherever they could.
“[The pandemic] has forced buyers to initiate plans to mitigate risk of buying from overseas suppliers,” says Alan Walker, vice president of marketing and development at Kaneka Americas Inc. “Many Western CDMOs have already shifted operations back to the USA and Europe as intensive business activity in China has driven up labor costs.”
Moving forward, CROs will likely look to build their domestic and local supply chain infrastructures. This will allow teams to keep up the pace of production, as they won’t have to worry about shipping periods, while also allowing for greater quality control and oversight of nearby vendors.
Researchers will also look to remove geographic hurdles in their observations and treatments of participants. This is simply the continuation of a trend that started before, and accelerated during, the pandemic.
Case in point: Kent Leslie, chief scientific officer at Amylyx, shared how his team adjusted an Alzheimer’s trial because of COVID-19. They put a greater emphasis on remote monitoring and virtual check-ins, limiting the need for in-person visits.
“Every six weeks someone would go to [the patient’s] home,” he explains. “A phlebotomist would collect blood when necessary and patients would be called every few weeks to make sure nothing changed with their cognitive symptoms. With the mad scramble for virtual technologies, it took us about four weeks to get that model in place.”
From suppliers all the way to remotely monitored patients, CROs’ value chains are becoming less vulnerable to geographic hurdles. Teams must continue to prioritize this kind of resiliency in both aspects of their operations.
While the speed at which the COVID-19 vaccines were rolled out cannot be guaranteed for future trials, speed should not be the focus but rather ensuring future trials run smoothly, without disruption or error.
“The future focus will be a much stronger shift towards the security of supply and the resiliency of the supply chain,” says Michael Quirmbach, group chief executive officer and president of CordenPharma Group.
“Although the term resilience of the supply chain is becoming a new buzz-phrase which is rather vague and open to interpretation, it generally means that suppliers will face more scrutiny and the need for a deeper understanding about the sourcing behind their partners and suppliers.”
The best way to ensure the resilience of future research is to ensure research organizations are prepared for future challenges. “Contingency planning will be a big part of the future for CROs, and scenario modeling everything from climate change and social unrest to cyber attacks and wars should be a key activity,” says Tonny Dekker, partner at Ernst & Young.
“Going one step further, resilience war games can test and hone the organization’s response to these situations, just like a fire drill.”
CROs can therefore invest in more security and planning, balancing a focus on more the disruption aspect of the COVID-19 pandemic with the need for keeping pace with drug development.
Researchers had been studying coronaviruses and related diseases for years before the COVID-19 pandemic.
“A lot went into the mRNA platform that we have today,” Akiko Iwasaki, immunologist and professor at the Yale School of Medicine, tells Nature. Research on DNA vaccines started 25 years ago and RNA vaccines within the past decade. Iwasaki emphasizes that five years ago, the technology used to develop this vaccine would not have been ready.
What this means is tomorrow’s breakthrough therapy is likely already in development today. The CROs that will be in the best position to lead their fields will already have guidelines and plans in place for whatever happens in the future.
“In calm periods ... processes, rules and procedures may seem unnecessary and too strict, but in times of crisis like COVID-19 pandemic, they turned out to be hugely advantageous,” says Paolo Morelli, CEO at PM Holding. “They have allowed us to provide business as usual approach to our clients and ensure a smooth transition to the home office for our teams.”
The lesson for CROs, then: Focus on internal infrastructures and resilience.
Images by: fizkes/©123RF.com, fizkes/©123RF.com, Belova59