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The Precompetitive Space for Drug or Vaccine Development: What Does it Look Like Now and What Could it Look Like in the Future?
The pharmaceutical industry including small and large organizations and biotech as well as other stakeholders in the health arena are increasingly aware of the benefits of working together in the precompetitive phase to address common problems. While they rightly remain focused on developing their own independent products and services in healthy competition, there is an increased awareness of the need to improve precompetitive efficiency by identifying and addressing common issues.
A major challenge is defining the domain of precompetitive research. The basic biology, the understanding of disease, biomarkers of prognosis, and even drug responses all can be areas of precompetitive research and development (R&D). Precompetitive collaboration allows a group of competing companies to come together to develop a solution for a problem that they all share, and from which none of them would gain a competitive advantage. Although the primary goal is often cited as the development of that solution, the process of conversing and collaborating is in itself of great value, and a project that enables colleagues from across the industry to develop closer working relationships with each other can be beneficial, even if the deliverables do not live up to expectations.
Precompetitive emphasis and stakeholders. NGOs, non-governmental organizations; PIs, Principle Investigators; SMEs, Subject Matter Experts.
When certain facilitating factors are present, intended collaborators can overcome competitive market dynamics and competing institutional priorities to align financial incentives, quality measurement, and data feedback to support practice transformation. Lessons from multistakeholder initiatives may be helpful to promote more and better collaborations (precompetitive or not) in the future.
While regulatory authorities have suggested that precompetitive research offers the highly competitive pharmaceutical and medical device industries a way to reduce ballooning development costs, it will be up to sponsors to develop and sustain these efforts in conjunction with a diverse stakeholder community so that all benefit in some way.
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