CROs might be the engine that keeps preclinical research moving during COVID-19
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Contrary to the situation for in-house preclinical research, preclinical CROs are largely open for business, according to a survey conducted by Science Exchange.
The survey, conducted March 17-20, included CROs and academic laboratories that are verified providers on Science Exchange Inc.’s service marketplace. The exchange, co-founded by CEO Elizabeth Iorns and COO Dan Knox in 2011, connects scientists with research service providers, including CROs, academic labs and government providers.
In many regions, the restrictions on movement due to COVID-19 have caused companies to dial down on their internal preclinical activities. That’s despite the fact that pharmaceutical and biotech companies were carved out as essential industries in the San Francisco Bay Area’s “shelter-in-place” order, a standard that is being mimicked by other regions, including Massachussetts’ guidance to municipalities.
The Department of Homeland Security also includes “workers conducting research critical to COVID-19 response” in its essential critical infrastructure workforce.
In many cases, companies are holding back from conducting in-house discovery research in favor of clinical or mission-critical IND-enabling studies. The idea is to restrict campus access to business continuity staff carrying out these and other key operations, such as maintaining drug supply, animal welfare and lab equipment (see “Bay Area Companies Pare Down to Essentials”).
The COVID-19 shutdown might see a large swing to CROs, which allow organizations to minimize the risk to both their workforce and their preclinical pipelines by investing in external R&D.
In a survey run by Science Exchange, only 12 (3%) out of 368 preclinical CROs globally said they had closed and suspended operations. The largest proportion by far, 67%, were open and fully operational, and another 30% were open, but partially staffed and partially operational (see Figure: “Open For Business During COVID-19”).
Figure: Open for business during COVID-19: Preclinical CRO survey
Source: Science Exchange Inc. survey
“For the most part, biotechs are continuing to operate, though they’re sending some scientists home,” Iorns told BioCentury. They’re aiming to meet their goals by outsourcing more projects, she said.
“If they’ve only got strategic relationships with one or two CROs, that doesn’t provide much risk mitigation.”
Iorns said that though the data are a snapshot -- Science Exchange will repeat the survey -- the major CROs are still fully operational for now. Charles River Laboratories International Inc. (NYSE:CRL) said March 12 that its sites “remain fully operational, staffed, stocked, and are supplying clients with products and services.”
Science Exchange’s survey found that 68% of open preclinical CROs are accepting deliveries at all hours. The remainder only accept deliveries if they’ve received a prior request from the researcher (see Figure: “Working Round the Clock During COVID-19”).
Figure: Preclinical CROs open during COVID-19 are Working around the clock
Source: Science Exchange survery
However, even some fully open CROs are experiencing delays, as 177 (48%) sites said they are taking longer than normal to complete a project. At 175 sites, CROs are accepting projects with no change in turnaround time. Sixteen, including the 12 that have closed operations, said they are not accepting new projects (see Figure: “Feeling the Impact of COVID-19”).
Figure: Feeling the impact of COVID-19: PRECLINICAL CRO SURVEY
Source: Science Exchange survey
Iorns told BioCentury that a major shift to outsourcing R&D has happened over the last five to 10 years. That could grow with the pandemic-induced shutdown. “One of the issues that organizations are facing right now is that if they’ve only got strategic relationships with one or two CROs, that doesn’t provide much risk mitigation,” said Iorns.
She said the vast majority of the biotechs using these services are “big, stable companies,” though some smaller companies use the network as well.
Smaller companies without manufacturing have one less set of employees to worry about. On the other hand, for these biotechs any delay in the pipeline could be much more catastrophic than for larger companies.
Using a networked approach can allow biotechs to find alternative CROs if their go-to CRO is affected. For example, Science Exchange’s contracts allow work to be moved to different facilities within the exchange and immediately initiated. The exchange also is helping companies conducting COVID-19 research find CROs quickly through its master service agreements, CDAs and material transfer agreements.
While 60% of the surveyed CROs said they were working on non-COVID-19 projects, almost one-quarter had programs related to the outbreak. The remaining 16% declined to disclose (see Figure: “Working On and Beyond COVID-19).
Figure: Working on and beyond COVID-19: preclinical CROs
Source: Science Exchange survey
CROs are also contributing to the innovation around COVID-19. In a follow-up question to providers on March 22, 57 CROs told Science Exchange they had developed reagents and novel models for COVID-19, and/or were offering discounts.
Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.