Outsourcing complex bioanalysis has not always been a common course of action for pharmaceutical research and development divisions. In the past, companies generally only outsourced more routine projects, often for cost cutting reasons. But today organizations have begun to view outsourcing of more complicated assays in a different light, as a way to not only cut costs, but to take advantage of specialized expertise that drives efficiency in drug development processes, and frees up internal R&D functions to focus on the company’s core competencies.
Clinical biomarkers have come into focus as one such complex area of pharmaceutical R&D that requires specialized scientific expertise. The increase in use of clinical biomarkers has been spurred by several factors such as companies need to know the mechanism of action of their drug, assess pharmacodynamics of their drug, patient stratification and these biomarkers have the potential to help pharmaceutical companies to make decisions faster, thus accelerating the drug development process. However, it is important to keep in mind that outsourcing clinical biomarker studies is not as straightforward as traditional outsourcing projects. As this industry grows, there will be challenges that pharmaceutical companies and CROs will need to address in order to produce successful outcomes.
Regulations, or Lack Thereof
Clinical biomarkers can be separated into biomarkers that are meant to contribute to internal decision-making and those that will actually go on to support regulatory decisions and drug label information. In theory, regulations for these different types of biomarkers should vary based on the study’s intended use. But because biomarkers are part of a developing industry, as of today, there are no specific health authority guidelines yet to address the regulatory parameters for biomarkers used in support of “drug development”; most of the industry guidance came from the PK bioanalysis world with the exception of some white papers. Because of the lack of official clinical biomarker guidance for drug development, actual studies using clinical biomarkers tend to rely on a combination of GLP, GCP, fit-for-purpose, and general quality considerations. In order to ensure the highest quality result, pharmaceutical companies must outsource to a CRO with a high level of expertise to account for the lack of regulation in the industry.
Partnership Based on Communication
Because regulations surrounding clinical biomarkers are still so ambiguous, it is absolutely vital to work with a trustworthy and competent outsourcing partner. The exploratory nature of most biomarkers studies necessitates strong collaboration between the sponsor and CRO laboratory personnel. This partnership should include a great deal of communication between laboratory bioanalysts from both parties to outline the appropriate fit-for-purpose assay requirements and acceptance criteria based on the study’s needs and the intended use of the resulting data. A lack of effective partner communication and mutual understanding can lead to increased complexity, and ultimately negatively impact the quality of work produced or increase the final cost of the study.
Oversight for Continued Quality
Even after choosing the best CRO for your project, it is still important to maintain oversight and monitoring as a part of your outsourcing model. To ensure consistent follow through, it can be helpful to include a plan for oversight in the project’s bioanalytical plan. I would suggest using a risk-based tiered level of monitoring, individualized for each study. You can base the ideal level of oversight and monitoring on the level of experience you have with the vendor as well as the status of your biomarker’s validation. For example, if you are working with a preferred vendor on a previously validated biomarker assay, oversight can be significantly reduced.
As you can see, outsourcing can be an effective route for pharmaceutical companies even when dealing with more complex projects such as those involving clinical biomarkers – as long as both they and their CRO partner’s expectations are fully aligned. The right combination of expertise, communication, and planning will enable your outsourced biomarker study to produce high-quality results, efficiently.
If you’re interested in learning more about how BioAgilytix partners with pharmaceutical innovators to support complex studies, speak to one of our scientists today.