Outsourcing has gradually become a keystone of the drug development process, and all indicators are pointing to increased use of CROs as expert outsourcing partners well into the future. Much of this trend is due to the fact that pharmaceutical and biotechnology companies across the industry are investing more in the discovery and development of large molecule drugs. To date in 2018, 18 biologics have been approved for use in the US market, and the success of these drugs and their precursors have fueled demand for biotherapeutics that address some of the most impactful modern diseases like diabetes, rheumatoid arthritis, and cancer.
Due to the complexity inherent in large molecule bioanalysis, sponsors are increasingly seeking out partners that have the specialized expertise and capacity to handle these often challenging studies. By outsourcing they can gain immediate access to the highly skilled and focused resources they need, in a much more efficient timeframe than trying to build such a level of expertise in-house.
While there are many benefits to bioanalytical outsourcing, sponsors must still be aware of the potential pitfalls that come with putting their study in the wrong CRO’s hands. Below are some of the questions that you need to consider when selecting an outsourced partner to set your large molecule study up for success from the very start:
What is the CRO’s project management methodology?
As competition grows, drug development timelines continue to shrink. Sponsors need to obtain data faster to make effective ‘go’ / ‘no-go’ decisions about how to proceed with their studies, to ensure time and efforts remain focused on the most promising drug candidates in their pipelines. CROs, in turn, are under more pressure to deliver rapid results, but sponsors still – rightfully – expect the science and quality to remain top quality. It is critical that your CRO partner have a formalized approach for study management, which they can clearly articulate and that has parameters built-in to address potential issues like slipping timelines without sacrificing scientific quality.
For example, do they have a communication plan in place with frequent touchpoints to keep you informed of project status? Are they able to work collaboratively with your internal team to identify and head off potential issues before they derail the time-to-results? And most importantly, do they have a process to ensure no corners are cut during bioanalysis, so that output is both timely and high quality?
Continuous and transparent communication between CRO and sponsor, backed by structured, well-defined bioanalytical processes, will help preempt assay problems and keep valuable studies on track.
Does the CRO have the resources required to successfully advance my project?
It is important to note that while communication is critically important, it still cannot make up for lack of expertise in large molecule bioanalysis. Unlike their small molecule counterparts, biologics are quite structurally complex. Even the slightest manufacturing changes can have significant impact on the drug’s efficacy and/or immunogenicity, and deep bioanalytical testing experience is required to ensure the drug candidate can uphold both clinical efficacy and safety.
Therefore, it is critical that your CRO’s team has the necessary scientific expertise as well as intimate knowledge of the complex regulatory landscape. Do they have a track record of compliance? Have they worked on projects similar to yours, and with what results? And can they apply learnings from other innovative large molecule studies they’ve supported to make your own project more successful?
To multiply the productivity of a talented team, the CRO should also have access to bioanalytical technologies that will help their scientists deliver robust, accurate, and timely results. There are a number of platforms that can be leveraged to increase capacity, automate assay procedures, and speed time-to-results. It will also be necessary to evaluate how these platforms can be used as the study progresses; will the CRO have the tools needed to maintain consistent, reliable results over time?
Can the CRO be a true partner?
Even the most expert scientists will inevitably run up against various bioanalytical hurdles, and this is where having a strategic, rather than tactical, partnership with your CRO becomes essential. Aligning with an outsourced partner that is committed to proactively and creatively navigating scientific and regulatory challenges as they arise will ultimately give you an advantage. Are they flexible and skilled enough to apply their knowledge and proven techniques to solve problems in new and innovative ways? It is important for your CRO to be both agile and collaborative, providing a level of ingenuity commensurate with the level of complexity associated with novel large molecule innovations today.
Hopefully these questions will help guide you in the successful selection of an outsourced partner so you can avoid the pitfalls of expanding timelines and insufficient assay results altogether. But, what if you are already outsourcing a project that has stalled out? In our next blog, we’ll discuss why it may not be your assay that needs to change.
At BioAgilytix, we recognize the need for value-add partnerships between sponsors and CROs, which is why we do large molecule bioanalysis differently. Learn more about our proven approach to project management and how we combine a deep bench of large molecule experts with state-of-the-art platforms to advance your study – efficiently and with the highest quality possible.