Starting an antiviral programme is exciting. Whether you are developing a novel antiviral, validating a new platform technology, testing a disinfectant, or evaluating the neutralising activity of an antibody, the temptation is to jump straight to the experimental details. Which virus? Which cells? Which readout?
Yet the success of a study is often determined long before the first cell is seeded. Asking a few simple questions at the outset can save considerable time and money later.
Here are the five worth asking.
1. Why?
The first question is also the most important: why are you performing the study? Is this an exploratory experiment to determine whether a concept has merit? Is it intended to compare a panel of lead compounds? Is it supporting investor discussions? Preparing for regulatory interactions? Or generating data for an IND package?
The answer changes what the study has to deliver. Work intended for regulatory submission may require compliance with specific quality systems or documentation standards, and the OECD Principles of Good Laboratory Practice set out what that involves, from standard operating procedures and raw data documentation through to archiving and defined study director responsibilities. An IND application must include nonclinical pharmacology and toxicology data supporting the rationale for testing in humans, and the FDA encourages sponsors to discuss the design of those studies at a pre-IND meeting. An early discovery programme, by contrast, may benefit from a more flexible approach that prioritises speed and scientific learning.
Having the end goal in mind helps ensure the study is designed appropriately from the beginning, rather than requiring repeat work later because an important requirement was overlooked.
2. What?
Once the objective is clear, the next question becomes: what is the best assay to answer it?
There is rarely a single “best” antiviral assay. Do you need to determine antiviral potency? Demonstrate neutralising activity? Measure virucidal efficacy? Understand mechanism of action? Compare compounds? Generate a simple yes or no answer before investing further?
The choice of virus strain, cell line, endpoint, and controls should likewise be driven by the scientific question rather than by habit or convenience.
The measure of a good assay is whether its data answer the question being asked.
3. When?
Developing antiviral capability internally can be worthwhile, but virology is a highly specialised discipline. It requires scientific expertise across multiple aspects of virus biology, together with the appropriate containment facilities, permits, health and safety procedures, quality systems, trained personnel, and validated methodologies.
The regulatory burden alone is substantial. In the UK, biological agents are classified into hazard groups by the Advisory Committee on Dangerous Pathogens, and the HSE Approved List of biological agents determines the containment level at which a given virus must be handled, with containment measures set out in COSHH Schedule 3. We have written previously about what working at CL2 and CL3 actually involves. Establishing all of this from scratch can take years.
There are therefore two timelines to consider: when do you need the data? and when can meaningful and reliable data realistically be generated?
If your timeline is driven by investment milestones, funding deadlines, regulatory submissions, or partner expectations, it is worth asking whether building capability internally is really the fastest route. Established CROs often have validated or easily adaptable assays that can be implemented within weeks rather than months.
4. Who?
Once the scientific objectives and timeline are clear, the next decision often becomes obvious: who should perform the work?
There is no universal answer. Some organisations have virology groups with the expertise and infrastructure to perform routine studies internally. Others require antiviral testing only occasionally, making it difficult to justify maintaining specialist facilities and personnel.
The majority find themselves somewhere in between. They possess strong biology, chemistry, or translational expertise, but virology represents only one part of a much broader research programme.
In these situations, outsourcing complements internal expertise rather than replacing it. A good CRO should function as an extension of your scientific team, bringing specialist knowledge that would be difficult, time-consuming, or expensive to develop in-house.
5. Where?
If the decision is made to outsource, one final question is where is the work actually being performed?
Will the study be carried out within the CRO’s own laboratories, or subcontracted elsewhere? Can you speak directly with the scientists running the assay? Would it be easy enough to visit the facility if needed? Are the virologists designing the experiments also involved in discussing the results?
These questions concern transparency as much as geography. Projects tend to run more smoothly when communication is direct and the people performing the work are easily accessible. Small discussions during a project often prevent much larger problems later.
And Finally, How Much?
It would be difficult to discuss antiviral studies without addressing cost.
For many organisations, particularly those without established virology teams, outsourcing can reduce overall spend. Building antiviral capability internally requires much more than purchasing reagents. Facilities, specialist staff, biosafety compliance, quality systems, training, equipment, and ongoing maintenance all represent substantial investments. We have worked with many companies as their external virology team, allowing them to access specialist expertise only when required, without the overhead of maintaining that capability in-house.
Price is naturally an important consideration, but it is rarely the whole story. Comparing quotations on cost per assay alone can be misleading. Two studies that appear similar on paper may differ enormously in the level of scientific support, communication, experimental design, troubleshooting, reporting, and interpretation provided.
The most cost-effective study is the one that answers the scientific question clearly, generates data you can trust, and allows you to make the next decision with confidence. That is not always the cheapest quotation.
The Right Questions Lead to Better Studies
When planning an antiviral programme, it is easy to focus on experimental details. Stepping back to ask why, what, when, who and where (and, inevitably, how much) tends to produce better decisions before the first experiment begins.
How VRS Can Help
We work with clients at every stage, from exploratory screening through to studies supporting regulatory submissions, across antiviral drug screening, neutralisation assays, and virucidal efficacy testing, all performed in our own CL2 and CL3 laboratories. Get in touch to talk through the right approach for your programme.
References
- OECD. Good Laboratory Practice and Compliance Monitoring. Organisation for Economic Co-operation and Development. Available here
- US Food and Drug Administration. IND Application Procedures: Interactions with FDA. Available here
- Health and Safety Executive. The Approved List of Biological Agents (Advisory Committee on Dangerous Pathogens). Available here
