Background
At the height of the market for a major pharmaceutical brand, I assumed responsibility for a Washington, D.C. market that included major academic and military healthcare institutions.
The product had extraordinary national awareness and substantial patient demand. Yet within an important military institution, access had effectively disappeared following a senior leadership decision to remove the product from formulary.
This was not a product-awareness problem.
It was not an efficacy problem.
And increasing traditional sales activity was unlikely to solve it.
The Commercial Challenge
The immediate stakeholders surrounding product utilization had little ability—or incentive—to reverse the institutional decision.
My assessment also uncovered valuable expertise and knowledge within the organization that had not been incorporated into the existing commercial approach.
The real question became broader:
What was preventing a clinically established, highly recognized product with significant patient demand from reaching appropriate patients?
Answering that required looking beyond traditional selling activity and understanding the environment surrounding the access decision.
Strategic Approach
I reassessed the situation as an institutional commercialization problem rather than a physician-targeting problem.
That changed both the stakeholders considered and the level at which the access barrier was addressed.
A broader strategy was developed to establish the importance of the patient-access issue, engage the appropriate institutional stakeholders and ultimately bring the issue before senior leadership.
The objective was not simply to generate additional prescriptions.
It was to change the conditions preventing appropriate product access.
Outcome
The institutional decision was reconsidered and formulary access was restored.
More importantly, the experience demonstrated something that has influenced how I evaluate commercialization opportunities throughout my career:
Strong clinical value and patient demand do not ensure product adoption when the environment required to deliver the therapy has not been adequately addressed.
Why This Matters to Biotechnology Today
The same principle is increasingly important for emerging biotechnology companies.
An organization can successfully develop an innovative therapy, achieve compelling clinical results and prepare for regulatory approval—yet still discover that important barriers stand between approval and adoption.
Some of those barriers can be anticipated well before launch.
Others become visible only when commercial development is examined from a perspective broader than traditional forecasting, market research or sales-force planning.
For companies investing substantial capital to bring a therapy through development, discovering those vulnerabilities after approval can be an expensive mistake.
PharmaKonsult Perspective
Commercialization risk begins before commercialization.
Evaluating an asset therefore requires more than determining whether the science is compelling and the market opportunity is large.
The objective is to understand whether the conditions necessary for successful adoption are developing alongside the asset—and to identify vulnerabilities while management still has the opportunity to address them.
About Joseph McCoy
Joseph McCoy is Founder and Principal Consultant of PharmaKonsult and an executive commercial strategy advisor with more than three decades of pharmaceutical and biotechnology commercial leadership experience across neuroscience, rare disease, endocrinology, institutional healthcare and specialty pharmaceuticals.
