Resurrecting academic translational research amidst COVID-19: An opportunity to shift the paradigm
I have had the opportunity to speak with several friends, colleagues and research partners in academic labs over the last few months about how the COVID-19 pandemic and the shutting down of their academic lab has affected their work and how they expect to return to “normal,” or should I say “a new normal.” The comments I received were very consistent, and don’t paint a pretty picture. To cut to the quick – it’s a mess out there!
Universities are finding their budgets stretched to the max and face massive budget deficits. State funding, where it is (rather, was) available is being focused on direct patient care. Endowments can only be tapped for limited amounts and specific purposes, such as providing for endowed professorships, scholarship support, etc. (not for operating costs). The rapid shutdown resulted in the permanent loss of key assets. Perhaps more important is the forfeiture of momentum for the research project that will inevitably delay publication, grant submissions and protection of intellectual property.
Closing up shop certainly had its challenges but ramping up is proving to be even more difficult. My contacts tell me that they are looking at a staged return to the lab that will take some time, and with that comes a host of additional issues. Who determines the “pecking order” as to which labs and vivariums will open first? Which gets priority if an investigator holds joint appointments with a department and a university venture? How will social distancing be maintained in labs that are often crowded? Will shift work be implemented? And the question that is foremost on everyone’s mind: How long will this take? That issue takes on particular significance given the necessary coordination of state and local governments, public health officials, students, faculty and staff.
So, how did we come to this? No one saw this coming, and no one had a plan in place to handle it. As the saying goes, failure to plan is planning to fail! That’s easy to say at this point because hindsight is 20/20. What will happen if, instead of coming out of the pandemic we find ourselves back to square one? What if there is a second event (whatever that might be)?
A sage advisor once told me to not let a good crisis go to waste, and I feel that there is an opening in the academic research community to reset and revise their strategy. An opportunity to obtain an insurance policy. I pose the question: What if your insurance policy was your research partner?
Contract research organizations (CROs) have been carrying on work throughout the pandemic, largely without missing a beat. These organizations have developed robust business continuity plans that are standing up to the pressures of COVID-19. Physical, engineering and administrative contingency plans are keeping their engines turning. Larger organizations have multiple sites across the globe and can shift projects and resources to accommodate local challenges. Many CROs perform customized translational research studies to answer mechanistic questions for their clients. Some can generate transgenic animals, breed colonies and cryopreserve these precious resources. The real strength of these organizations is their ability to provide extensive bandwidth for the more routine, “industrialized” assays and tasks. These include iterative in vitro testing, structural and synthetic chemistry support, ADME and PK assessments, and in vitro and in vivo biology and pharmacology work.
Working with a CRO has many advantages, and Big Pharma has already figured that out. A great deal of what we might call “turn the crank” assays and activities are being outsourced so that their in-house staff can concentrate on the real value add to the portfolio. They also request specific, customized work to tap into the intellectual resources of the CROs so that they don’t have to reinvent what has already been validated. This approach generates a partnership between the sponsor and the CRO wherein each side has some skin in the game. If the biopharmaceutical industry has adopted this paradigm, why should academic labs not follow suit? I posed this question to my friends and colleagues in academia, and they agreed that asking the hard questions such as why we are doing this, or better yet, why are we doing something this way need to be addressed directly.
Working with a CRO can be approached in several ways. Those rote, repetitive procedures and tests are an obvious choice. Many academic investigators are shifting the focus of their work to attacking COVID-19 in some very imaginative ways. That often involves finding experts to complement the brainpower that exists in the host lab. CROs can help with that. There are other, creative tactics that might also be applied. Recently I was part of a group of Charles River investigators that was invited to review several proposals from a university’s tech transfer office. That office was offering competitive, specific dollar amount grants that would bring a translational project to its next go/no go decision point. We met with the investigators, brought their data to a larger group of Charles River scientists and developed research plans, budgets and timelines to meet the grant criteria. This consultation was provided gratis with the understanding that the funded work would be placed with our labs. Several proposals were approved, and joint project teams were set up to drive those projects to the decision point.
Science Magazine recently published a Policy Forum article on the very topic of ramping up academic research during COVID-19. When I read the article, I was struck by what I perceive as a “go it alone” approach to ramp up within the academic community with some help from the government. There was no mention of the use of CROs even as a stop gap measure to accelerate return of the research.
There are certainly challenges to using CROs. Fit is, perhaps, most important. Finding the right CRO with the expertise and capabilities that can either replicate or balance an investigator’s is a paramount concern. There will likely also be logistical issues. The biggest hurdle that I see is the cost to do the work and who will supply those funds. Most CROs are sensitive to academic budgets and will do their best to work with their partners. Projects involving third party sponsors may have some recourse.
If the COVID-19 pandemic has taught us anything it is that our academic institutions need reliable platforms and partners in place to mitigate risk and weather the next storm. The challenges we are facing from the pandemic are an opportunity to reset the research strategy and think about things differently. A solid, reliable CRO can fill that need. This kind of thinking would be a major paradigm shift and a significant departure from the status quo, but as the saying goes – if you always do what you always did, you’ll always get what you always got!