The Evolution of the Contract Research Organization
Jeff is a neuropharmacologist by training with 20 years of experience in the drug discovery divisions of top-tier Pharma organizations. In the last 4 years he has shifted his efforts to consulting and presently counts both biotechs and CROs as clients. In part, Jeff works to identify project team needs and helps to determine whether outsourcing is the sensible option. As the “interface” between Pharma and CROs he has a unique view of their working relationship, both from an historical perspective and in terms of future directions. So, in this article, Jeff shares his experience with CROs, in particular, how they have evolved in recent years.
Years ago, let’s say as many as 10-15 years ago, CROs (or Contract Research Organizations) first caught our attention as part of a new wave of management initiatives intended to curb the rising costs of drug discovery projects. The idea was this new thing called “outsourcing”, in which we, the drug discovery scientists, were being asked to give up part of our role and place it into the hands of an organization outside of our group. Rather than having that lab resource “down the hall” as it had always been, it was now to be spread across the country and, in some cases, around the world. Studies would be run by people we didn’t know and who we feared had little idea what it was we were trying to achieve. It was the new paradigm and we were sadly stuck with it, all for the sake of driving down cost.
And in those early days, our fears were generally realized. Yes, there were those instances in which it was indeed magical: send a compound to a CRO hundreds of miles away and receive data in spreadsheet form within weeks. But like sending your exposed film to a photo processing company and getting the prints back in the return mail – yes, it was that long ago – the utility of the data were largely a function of how lucky you were to pick the right experimental design from the packages listed in the CRO’s brochure. More often the results were useful, but not as useful as those that your colleague might have generated after a quick discussion over coffee. And sometimes they were not useful at all and your only recourse was to avoid that CRO in the future.
Quickly advance to the present day and you find a much different situation. Yes, the CROs are still here, more now than ever, all under the still bright banner of outsourcing. And, yes, the driver is often economics as the cost of developing and maintaining an assay is borne by the CRO and a range of these assays is at your disposal whenever one or another might be needed. But the dynamics have changed and so have the CROs. Slowing disappearing are the ones that offer only study execution and data distribution, ones that only fulfill requests from a limited selection of packaged assays from their web-based catalog. Today – happily – a growing number of CROs have as their primary mission the forging of a direct relationship with the client drug discovery team. A partnering takes place in which the client and the CRO brainstorm study design options in response to given project needs. Following the execution of the work, the results are discussed jointly with the CRO fully prepared to suggest next steps based on the study outcomes.
This evolution from simple “service provider” to “on-demand laboratory” has been the result of a conscious effort to respond to drug discovery team needs. Many CROs can be responsible and reliable vendors, their business heads surmised, but which ones can become team-focused partners? The answer was simple, those CROs that hoped to survive. Further evolution is possible (and necessary) as the line between an FTE (Full-Time Equivalent) at the Pharma company and an FTE at the CRO blurs. As before, this change will be spurred by client feedback – both partners in the relationship need to ask, what does the CRO of 2015 need to be?