The Evolution of Bioanalytical Outsourcing Partnerships
By Jim Datin, President and CEO, BioAgilytix
Bioanalytical outsourcing has changed dramatically in the past 30 years, which isn’t surprising when you consider how our economy, the healthcare market, technology, and drugs themselves have changed in that same period. In order to keep up with external market pressures and the complexity of emerging large molecule drugs, pharmaceutical and biotechnology companies have had to reevaluate when it is appropriate to outsource projects, and to what kind of partner. Today, they are finding that access to the right external specialty expertise can be a strategic advantage, and are looking to establish true partnerships with their outsourced providers. To fully understand how we have arrived, as an industry, at a place where outsourcing is vital to our collective success, it is helpful to look back at where we started.
The Beginning: Outsourcing as a Commodity
Contract research organizations (CROs) first started to become prevalent in the 1980s, but at that time the outsourcing market was much smaller and offered less value to partners. CRO teams were generally seen as an extra set of hands by the industry, not as equal partners. In fact, most bioanalytical work was not outsourced at all, but was instead conducted within the major pharmaceutical and biotechnology companies by their heavily resourced internal laboratories. Having robust scientific and bioanalytical talent in-house, these teams were able to perform all the planning behind assay and drug development methods. Only after these methods were established would pharma and biotech companies transfer projects to CROs to be run in a regulated environment. There was a distinct lack of meaningful, scientifically collaborative partnerships between sponsor companies and CROs.
Additionally, the type of work that was conducted by CROs at this time was less complex. In the 90s the focus of drug development and outsourcing was largely centered on small molecule drugs. Because of the advances in LC-MS technology, the workflows related to small molecule analysis were relatively standardized, and therefore this work was generally seen as a commodity. It was easy to trust an outsourced resource with moderate expertise to run these assays and generate the required data.
A Changing Pharmaceutical Industry Impacts Outsourcing Practices
In response to the global financial crisis in 2008, many large pharmaceutical companies had to cut internal resources and the industry saw mass layoffs of highly skilled scientists. A large pool of quality scientific talent had to look for alternative career opportunities, and many of them ended up moving to CROs or other pharmaceutical partner organizations like technology vendors. Concurrently, pharmaceutical companies no longer had the workforce needed to carry out all of their bioanalytical testing in-house, and so they began to outsource more and more work to make up for lack of internal resources and talent – which had now moved to the CROs.
During this time there was also an increase in the rate at which new bioanalytical technologies were being developed. Improvements to technology increased their capacity, enabling CROs to take on more work and grow efficiently. These technical advancements also increased the robustness and reliability of bioanalytical platforms, which helped sponsor companies to begin to trust outsourced partners with more complex projects. And the timing was right, because the industry as a whole was beginning to focus more heavily on large molecule drug development and the opportunities they held to to create more specific, effective therapies. Large molecule drugs, unlike their simple small molecule counterparts, are very structurally complex and therefore their bioanalysis requires a high degree of scientific expertise.
Throughout this period of transition, more and more pharmaceutical and biotechnology companies realized that they could drive greater efficiency through outsourced relationships, rather than building out all the capabilities needed to address the quickly evolving demands of bioanalysis in-house. Working with a CRO partner could give them immediate access to a wide variety of specialized expertise without the significant time and cost investments needed to hire the right talent and maintain the appropriate resources in-house.
The State of Modern Outsourcing
Today, most regulated bioanalysis is outsourced and has also broadened in scope, as large molecule drugs have become an even more significant part of many organizations’ drug development pipelines. CROs are being asked to get involved in the earlier phases of biologic development as well, and pharmaceutical and biotechnology companies are increasingly adopting outsourcing as a strategy to contain costs, reduce timelines, and access targeted expertise in this highly complicated area.
The change in mindset about what a CRO can offer in turn demands more from contract laboratories today. Sponsor companies rightfully have higher expectations for the level of work produced, and it is imperative for CROs to maintain focus on quality in order to keep up with increasing sponsor pressures and ever-evolving bioanalytical challenges. The projects being outsourced are more complex than ever, and often require more interaction between the CRO and the sponsor’s internal scientific team. And because both pharmaceutical companies and CROs are now comprised of scientists with deep expertise, the approach to bioanalytical outsourcing is no longer transactional but instead about building meaningful, collaborative partnerships, where the CRO’s expertise adds real value and plays a prominent role in the sponsor’s drug development successes.
Looking to the Future of Bioanalytical Outsourcing
As the trends indicate, bioanalytical outsourcing will continue to be a significant part of the regulated bioanalysis strategy of pharmaceutical and biotechnology companies globally. Sponsor companies have seen the many benefits that outsourcing can offer if done through a trustworthy, reliable, and highly skilled CRO team. For sponsors that are focused on biotherapeutics development, having a CRO partner that is equipped with the expertise and the latest technologies needed for innovative bioanalysis will be essential, especially as large molecule drugs continue to become a more significant part of the overall industry’s drug development pipeline.
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