When it comes to bioanalysis, the platform used can have a significant impact on a study’s resulting data quality. As such, contract research organizations (CROs) as well as large pharma and biotech companies are eager to invest in the latest platforms that claim more rapid, precise, and reproducible results. However, to truly drive study success, the focus should really be on implementing the right new technology: investing in the platform because it is flexible, robust, and needed to achieve the required results, and not just because it is the flashiest new “toy” available on the market. How a CRO approaches technology investment is an excellent way to evaluate its priorities and commitment to strategic innovation.
Reverse Engineering Technology Requirements
I see bioanalytical technology as a way to solve a problem, and believe that new technology should only be needed when there is a gap between the analysis required and the capabilities of an organization’s existing instruments. This gap can often be closed by making improvements to current technologies. However, if that is not possible, then it is time to consider adding an entirely new platform to address the need. This approach to bringing on new technologies is often driven by a pharma or biotech partner whose study requires specific capabilities, but it can also be driven by an overall need that a CRO sees in the market. In either situation, it is important to start with the problem and work your way back to determine if you have access to the most appropriate technology solution, or need to acquire it.
Focusing on the Bioanalytical Data’s End-Use
When I am evaluating the need for new bioanalytical platforms for a specific project, I always ask my clients what the data will be used for, as well as what is an absolute requirement and what is a “nice to have” in a technology solution. Those wants and needs will depend entirely on what a client is trying to solve and will help determine if we have an existing technology that will get the job done, or if more out-of-the-box methods and new supporting technologies are needed. Additionally, many of the more modern and innovative platforms have yet to be proven to the regulatory agencies, potentially introducing new roadblocks to already complicated studies. Understanding the end use of the data will help you make a more informed decision about what technologies to use.
Evolving the Use of Bioanalytical Platforms
For those looking to get the most out of the technologies they already have, there is good news. Platforms that were originally built only to be used in research and discovery projects are now being pushed for use in the later stages of drug development. This shift is taking place all thanks to proactive, forward-thinking platform vendors who are making efforts to produce technologies that are more robust and ready to be used in a regulated environment in the later stages of development. As this change takes place over time, it can still be challenging for CROs to make a certain platform work through the phases of drug development. It sometimes means doing some creative software validation or adding automation to make it useful for the later stages of the process. An ideal technology provider will be planning for the future; if they are not, it can cause headaches for CROs and the pharma and biotech companies they serve.
While having robust, innovative platforms is essential, there is an inherent risk in implementing in new technologies. It is important to evaluate the study’s requirements and your existing instruments to make the right investment decisions for your organization.
Learn more about BioAgilytix’s approach to technology and gain more insight into the demand for new bioanalytical technologies in the full-length Business of Bioanalysis panel discussion from WRIB 2018, featuring BioAgilytix’s Founder & Global CSO, Afshin Safavi, Ph.D.