Research and development efforts in small and midsized biopharmaceutical companies are characterized by the convergence of multiple scientific, medical, and business-related interests. It’s not just the prospect of the financial returns that might result from the successful introduction of a novel therapeutic intervention targeting a significant unmet need. Nor is it solely the validation of elegant science and the intellectual property that ensues. For many small and midsize biopharmaceutical companies, particularly those working within therapeutic areas characterized by significant unmet need and the absence of effective pharmacotherapy, a cause—a passion—drives discovery, development, and commercialization efforts. Scientific and financial validation are foundational, but the prospect of alleviating disability and possibly premature mortality provides an overarching, highly laudable objective.
Small innovators rarely possess the full repertoire of expertise and operational acumen required to navigate a novel therapy through the process of discovery, development, and commercialization. To complement internal capabilities, innovators turn to contract research organizations (CROs) for additional preclinical and clinical expertise and resources. A strategically effective process requires integration with the corporate team and raises additional challenges regarding process and functional role delineation, particularly when it comes to the extent to which core activities will be delegated to external consultants. While there is a long-established rationale for engaging a CRO on a primarily transactional, ad hoc basis, there is also increasing recognition of the need for more strategic, long-term commitments to optimize achievement of key development milestones.
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