The development model for bio pharmaceutical companies must shift from two divergent paths to one that combines clinical and commercial resources with market access strategy, information and capabilities.
Traditionally, clinical development of new medicinal products has been driven by the clinical-medical leads in a biopharma development organization. In the New Health landscape, biopharma must converge the clinical-medical foundation with a fact-based understanding of the new constellation of stakeholders who control access to today’s markets – policy-makers, more empowered regulatory entities, payers and provider groups. The post-reform market will demand deep understanding of the root interests, networks and decision drivers of each these stakeholders. And dramatic benefits will be realized by companies who develop a differentiated understanding around the confluence of stakeholder needs early in the development phase and then continuously use this data throughout the lifecycle.
This paper examines the obstacles to achieving the convergence of clinical development and commercialization, and offers suggestions on how to develop and deploy a “Clinical-Commercial Product Blueprint” to compete in the New Health.