Bridging the divide: How clinical and commercial can (and must) work together

Today’s pharmaceutical, biotech, and medical device companies face a challenging landscape characterised by constraints. To name a couple of big ones: over product pricing and stakeholder communications. These constraints present a direct challenge to corporate revenues and, as such, inspire companies to focus on creative approaches to clinical product development, being more selective about development candidates, and getting the most out of the fewer products that make it past regulatory approval. It’s all about return-on-investment – either through improving cost-efficiency or via revenue enhancement – and accelerating both clinical development and product commercial acceptance.

Increasingly, the answer lies in building a bridge between the two classic “land masses” of Clinical and Commercial: leveraging clinical development as a platform for eventual product marketing, and ensuring future marketing activities are built on a solid foundation of scientific evidence. We believe companies need a multi-dimensional partner to support the elegant baton exchange that ultimately wins the race through a variety of efficient and synergistic activities that balance science and strategy and, in so doing, challenge conventional and often myopic thinking.

For example, a clinical trials patient recruitment campaign can be a critical solution for ensuring accelerated clinical development, but only collaborative thinking would utilize the recruitment activity as a platform for engaging patients and physicians, for establishing the basis for a “real world” observational registry, and for establishing a patient community for future clinical trials.

 “Good science is good marketing”

A serious challenge, however, is that Clinical Development and Product Marketing teams within pharmaceutical companies typically operate in an insular and isolated – if not altogether mistrustful – manner. 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.”

Still, 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 “operationalise” studies more for discretionary, commercial aims than for regulatory approval.

While many companies have organized functions that operate on the “bridge” between Clinical and Commercial – multidisciplinary “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, objectivity and effective communication between disparate parts of an organization, an outsourced vendor (or even an arbitrator of sorts) may represent the most viable approach. That said, neither traditional CROs (on one side) nor traditional advertising agencies (on the other) may have the necessary balance and skill-sets to credibly meet these needs.

We believe the answer lies in a distinct response that embraces the best of both worlds in a nuanced manner: a set of capabilities that includes an understanding of both strategic marketing goals and clinical research operational realities, brought together in a balanced, scientific, and strategic manner.

To this end, Blue Chip recently formed Continuum Clinical, a purpose-built healthcare research and marketing company including a distinct set of services directed toward either Clinical or Commercial, and for those clients ready to capitalise on a collaborative approach, both. Albeit somewhat of a new paradigm, the reality is that traditional approaches aren’t effectively serving as the necessary bridge and may even be perpetuating the divide.



Ken Shore is EVP at Continuum Clinical, USA.

Article taken from thenetworkone’s Health and Life essay collection. To read the full essay collection, click here.