To discuss the trends shaping the contract research organization (CRO) market, Jim McNally, PhD, CSO at BioAgilytix, made time to talk with GEN. He also responded to questions about how these trends are playing out at his company.


GEN: How do you see the CRO market and services changing in the next five years?

McNally: First, I think we will continue to see growth in the footprint of CROs to better serve global clinical studies. Being present in all major geographies will be essential going forward. Second, continued consolidation of CROs seems to suggest that we are moving toward one-stop shops that are capable of providing all-encompassing services to their clients.

For a period of time, the trend seemed to favor not putting all of your eggs in one basket. However, the pendulum appears to have swung in the other direction, supporting the thought that it is easier to manage fewer vendors; therefore, CROs with the broadest array of services are in favor.

Third, as biotherapeutics become more complex—for example, cell and gene therapies—the methods used to perform regulated bioanalysis are becoming more complex, too. As I mentioned, new platforms not previously used in regulated settings will require industry and regulators to align on guidance for their use and validation of these assays for use.

Finally, I hope we continue to see an expansion of digital services to better connect sponsors with their data and progress on their projects. Specialized applications and digital portals that enable on-demand access to program updates will more closely align CROs with a world where you have a wealth of data at your fingertips just by using the smartphone you carry with you every day.


GEN: What are the top trends going on in your CRO services and why?

McNally: A significant upward trend in outsourcing has occurred over the past year and a half. Some of this is likely due to the COVID-19 lockdowns, where laboratories were not able to bring their people back in, but we were able to adapt our facilities and working schedule—going to shift work—to stay up and running with no known cases of workplace spread of COVID-19 in any of our three locations.

From a scientific standpoint, there is major growth in the cell and gene therapy space that requires the utilization of new tools that were not typically used in the regulated space. Platforms like flow cytometry and quantitative PCR are now leveraged for regulated bioanalysis to support these programs. BioAgilytix proactively invested approximately $6 million to expand our capacity for both platforms in anticipation of the work to come.


GEN: What are BioAgilytix’s key CRO services?

McNally: BioAgilytix focuses primarily on large-molecule bioanalysis—pharmacokinetics and immunogenicity—and biomarker support for both large and small molecules. In addition to those areas of focus, we provide GMP potency assays to support programs at all stages of the drug development process. We have broad expertise with immunoassays, cell-based assays, and molecular assays and can provide global support via our three locations: Durham, NC; Boston, MA; and Hamburg, Germany.

However, the true secret to all of those services are the scientists and people of BioAgilytix. Prior to joining BioAgilytix, I was a customer of BioAgilytix. I was obviously interested in the services we provide, but what made me a repeat customer and then eventually led me to join the company was the amazing scientific team. At every site and on every platform, we have dedicated scientists that have deep expertise in delivering quality assays and data for our customers. They are truly our key service.

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