The development model for biopharmaceutical companies must shift from two divergent paths based on clinical-medical and commercial information, to one convergent path that combines clinical and commercial resources with market access strategy, information and capabilities.
This according to a new white paper from Quintiles authored by John Doyle, vice president and practice leader of its Consulting Solutions team.
In “A Blueprint for Clinical/Commercial Convergence” Doyle writes that, 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 (Quintiles’ description of the fast-morphing world of biopharma, where companies are under relentless pressure to drive innovation and add value to drug development while continuing to enhance safety, ethics and stewardship), 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, Doyle says, 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 life cycle.
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.
Click here to download a copy of the paper.
Monday, December 20, 2010
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