John Q. Kamerud, Ph.D., is scientific director at Eurofins Pharma Bioanalytical Services, where he serves as scientific and technical advisor for both clients and internal teams for development, validation, and application of assays to comply with scientific goals and regulatory requirements. He has over 20 years of experience in the development, validation, and implementation of immunoassay methods.
The past few years have seen a tremendous amount of restructuring, integration, and “right-sizing” within our industry. According to Forbes, pharma companies have laid off more than 300,000 workers since 2000. A substantial proportion of these were in research and development (R&D) functions. Does that mean that drug development has come to a standstill? Hardly. According to FiercePharma, global R&D spending in the pharma industry increased approximately 228% in the decade 2000–2010. Much of that slack is being taken up by CROs (contract research organizations), which saw a doubling in employment during the same decade, according to the Center for the Study of Drug Development at Tufts University.
CROs provide a variety of services that span the entire drug development process. Clinical CROs manage clinical trials, including patient recruitment, sample collection, and coordination of data flow. Preclinical CROs carry out live-phase toxicology studies. Bioanalytical CROs provide pharmacokinetic, immunogenicity, and biomarker data for both clinical and nonclinical studies. Other CROs are engaged in formulation development, genomic analysis, and in vitro pharmacology. As more and more functions are outsourced to CROs, we come closer to realizing the vision of a FIPNET, a fully integrated pharmaceutical network.
For sponsors, the decision to outsource has two main drivers: capacity and capability. Large companies that once carried out all of the above functions internally may find that they no longer wish to maintain the headcount required to perform all of this work. The CRO then becomes sort of an extension of their own labs. For smaller companies, capability as well as capacity may be limiting. It may be impractical to develop internal capability for every function, and so they rely on the expertise of the CRO to perform the various development functions according to industry best practices.
As someone who has had the pleasure of working in both big pharma and a CRO environment, I am sometimes asked to compare the two experiences. Although the actual job duties might be similar, there are definitely some differences. The CRO employee obviously needs to have a more customer-service orientation. With 50 to 100 clients at any given time, each with aggressive timelines, meeting all of their needs is a challenge, with never a dull moment. Scientifically, one might say the difference is one of depth versus breadth. A pharma company employee might work on one or a few molecules at a time, serving on multi-functional teams that shepherd the molecule through the many stages of development. Successfully meeting a milestone such as product registration gives satisfaction that is shared by the entire team. At a CRO, one typically focuses on one narrow aspect of the project–bioanalytical, for example–and usually does not have insight into the background and progress of the molecule. But he or she may work on literally hundreds of different molecules from dozens of different sponsors, in a variety of therapeutic areas. To experience this variety of projects is rewarding in its own right.
The companies that are most successful in outsourcing work to CROs are those that consider carefully the when, how, and why of outsourcing, and approach this as a collaborative effort. As the pharmaceutical industry continues to change to meet the challenges of the 21st century, the outsourcing business model will no doubt also continue to evolve. It will be interesting to see if this leads to greater convergence, as CROs take on more roles traditionally held by pharma, or greater divergence, as companies specialize in their contributions to the FIPNET.