Bridging the Gap: Aligning Clinical R&D with Commercial Goals

Throughout my two decades in Clinical R&D, I've been privileged to receive Outlook invites from my Commercial counterparts. These invitations vary in timing, arriving as early as before a phase 3 study's database lock or as late as the drafting of high-level documents for an NDA. Reflecting on these experiences, I used to joke with my Clinical R&D colleagues about Commercial expecting us to pull a rabbit out of a hat. Yet, upon deeper contemplation, I realized that perhaps we should be capable of such feats after all.

After all, isn't a magic trick essentially a well-thought-out strategy aimed at delivering precisely what the audience desires? In our context, the Commercial team seeks to leverage our scientific inquiry to substantiate key promotional claims and confer commercial legitimacy upon our product to our stakeholders’ desires.

Imagine if our key functional areas convened early, during the preclinical stage, to engage in mutual discourse regarding the promotional claims needed to bolster the commercial and social responsibility needs of the company. Such proactive collaboration would empower Clinical to identify the types of claims pivotal for Commercial's achievements. These product claims could evolve into constructs to be tested throughout the molecule's scientific development. Initiating these critical discussions in the initial phase enables Clinical to either validate or contest the promotional claims intended by Commercial, well in advance of the marketing approval phase.

Contrary to certain opinions found in online blogs, I disagree with attributing these communication gaps solely to a company's cultural disposition (e.g., silos, mistrusts). Instead, I believe that the real obstacle lies in carving out dedicated time for focused discussions and extending the invitation to Medical Affairs and HEOR. As aforementioned, meetings to discuss promotional claims usually have happened late in the clinical development timeline and key functions may not be invited. Adhering to conventional paradigms, not only hampers the effectiveness of key functional areas, but also undermines the vital roles played by complementary functions like Medical Affairs and HEOR. These teams are instrumental in comprehending public health nuances and addressing prescriber needs.

The significance of early dialogue between Clinical R&D and Commercial cannot be overstated in shaping a comprehensive product claims strategy. Encouraging an environment that fosters open dialogue between these teams not only aligns company goals but also cultivates a more coherent product claims strategy resonating across functional areas, ultimately reaching our consumers.