May 23, 2022
Luc Gagnon, PhD, vice president of vaccine sciences, leads scientific and operations at Nexelis to support vaccines and biologics throughout the different phases of clinical trials. Luc brings more than 20 years of experience in several biotech, CRO, and pharmaceutical companies to his role, including extensive expertise in ligand binding and microbiology/virology functional assay development, qualification, and validation.
Assay libraries can save time, money, and resources
The COVID-19 pandemic has captured the world’s attention. During the past two years, we have seen unprecedented collaboration and acceleration in vaccine development. Many companies pivoted their research and development efforts, investing in new technologies and platforms in the race to find an effective vaccine or treatment. But with so much focus on the next potential pandemic or “disease X,” is the industry shifting away from existing infectious diseases of regional origin and those uncommon in major markets?
Infectious diseases beyond COVID-19 continue to be a growing public health concern, including dengue, with approximately 100–400 million infections annually, and Ebola virus disease (EVD), which although rare has a case fatality rate of approximately 50 percent.
Strategies to tackle infectious diseases
The pandemic has resulted in a paradigm shift, showing us how clinical research organizations (CROs) can work together. Key nongovernmental organization partnerships, such as the Coalition for Epidemic Preparedness Innovations (CEPI), established a global network of laboratories transferring viral functional methods and reagents worldwide to several different laboratories for rapid vaccine development. A few years ago, this would have been unthinkable.
The Bill & Melinda Gates Foundation is replicating this approach by creating a centralized laboratory network to transfer assays from a leading provider to other CROs worldwide, so that all of the laboratories tackling the next threat are aligned from the research stage to late-stage development. Central to this approach is the need for assay standardization.
An assay library for infectious diseases vaccine efficacy beyond COVID-19 can help accelerate vaccine development. Ideally, a single assay would be used worldwide for ease of comparison; however, challenges exist with delays in deployment of aligned assays.
Assay standardization offers clarity for comparing “apples with apples” when examining candidates. A CRO with the right expertise can be instrumental to streamline and optimize the development of new vaccines. There is no need to reinvent the wheel, only a need to build on the past to work faster in the future. A well-established CRO has the flexibility to execute validation programs and adapt assays to study not only the initial disease but also any variants that may develop.
Partnerships are key
Partnerships drive success and can support industry’s renewed interest in vaccine development. By leveraging the expertise of those at the forefront of assay development, stakeholders can access agile solutions that can accelerate development.
Industry, CROs, and academic laboratories must work together for a faster response, leveraging knowledge from academia before deploying assays into industry and ensuring these can be scaled up. Compromises between parties to adopt new ways of working, and tools to establish harmonized networks that allow for breadth of laboratory coverage, are needed. A highly focused CRO with specialized workstreams can act as an extension of sponsor laboratories, providing expertise and challenging sponsors to pressure test plans in alignment with their end goals. This would ensure they are providing the most effective and efficient solutions from the outset.
Ultimately, collaboration enables quicker assay deployment and better surveillance of the next pandemic. Diseases such as EVD and Zika fever may feel like distant threats, but they are very real—and as the COVID-19 pandemic has highlighted, no one is safe until everyone is safe.