• by Jeff Trotter , September 16, 2014

Clinical Development and Product Marketing teams within pharmaceutical companies seem so distant from one another sometimes it’s hard to recognize that they are working for the same company. 

We know that there are very good reasons why commercial influence shouldn’t find its way into clinical research, but at the same time, most people would agree that “good science is good marketing” and vice versa. Still, far too many clinical research initiatives are undertaken without sound strategy that articulates how the company sponsor intends to leverage the research (for commercial benefit). And there’s nothing wrong with this as a goal, given the for-profit status of most pharmaceutical and device companies, and within the context of appropriate regulatory guidelines. “Good science” need not compromise “good strategy.”

But the reality is that clinical researchers and product marketers are from different worlds and speak different languages. Nowhere is this disconnect more illustrated than in the peri-approval (immediately pre- and post- product approval and launch) phase when compelling evidence is required to establish a product’s safety and clinical / economic / humanistic value in actual practice settings. Sound, yet strategic and practical research initiatives — often undertaken in connection with key payer stakeholders — are essential in demonstrating a product’s promise and accelerating commercial acceptance.

However, in many cases, important projects are tabled due to a fundamental disconnect. A key problem is that Clinical Development teams are often given the responsibility for executing later-stage research without having the perspectives necessary to “operationalize” studies more for discretionary, commercial aims than for regulatory approval. This doesn’t mean taking short-cuts or employing inappropriate designs. But just as a sports car is not designed to fit the purposes of an 18-wheel truck, a peri-approval study is typically intended for a far different purpose than a randomized clinical trial.

So what can be done? 

While many companies have organized functions that operate on the “bridge” between Clinical and Commercial — multi-disciplinary “Late-Stage” organizations that facilitate an elegant and efficient exchange of the baton from Clinical Development to Product Management — the latest paradigm is to outsource this role in a truly meaningful and strategic way. Indeed, in view of the need for organizational harmony and effective communication between disparate parts of an organization, an outsourced vendor (or even an arbitrator of sorts) can represent a viable approach. That said, neither traditional CROs (on one side) nor communications agencies (on the other) may have the necessary balance and skill-sets to credibly meet these needs.

Whatever the approach, critical success factors begin at the highest levels of the organization, to ensure that appropriate support is given for this role. Beyond that, there must be an understanding of both strategic marketing goals and clinical research operational realities: the truth, however, is that these attributes and skill-sets rarely exist in the same organization. But for the critical transition from development to commercialization to be optimized, these components must be brought together in a balanced, scientific, and strategic manner.

And when it works, the divide is bridged.