Regenerative medicine translation: The UK bioentrepreneur experience.

Regenerative Medicine is an emerging biomedical paradigm promising to radically change healthcare. For this to happen, basic science breakthroughs must be translated into the clinical setting and market. This thesis examines the evolving Regenerative Medicine Translation process from the perspective of UK-based bioentrepreneurs. While much is known about the views of scientists, clinicians and industry stakeholders, an understanding of what it is to be an RM entrepreneur and company founder and often drive the whole process has not been fully explored. Based on interviews with bioentrepreneurs and other secondary sources this thesis explores three main 'areas' of the Regenerative Medicine Translation process: Funding, Regulation, and cross-disciplinary Collaboration. A variety of conceptual tools and social science analytical motifs are employed to explore the broad range of activities and roles undertaken by bioentrepreneurs. The exploration provides an in-depth look at individual experiences (at various stages of the clinical and commercial Translation process of their research) and sheds light on factors that influence the Translation process and the evolving role of bioentrepreneurs in it. A main assumption throughout the thesis is that in the nascent field of Regenerative Medicine therapeutics (including cell-based and tissue-based), RM bioentrepreneurs are acting as crucial mediators of knowledge across the various scientific, institutional and professional domains. Their unique human capital (including scientific, clinical, regulatory and, often, business expertise) in combination with their formal status/position as founders of commercial entities aiming to commercialise new technologies, places them in a unique position between the bench, the clinic, and the industry from where they have the potential to elevate the available resources, facilitate Translation and promote innovation. Findings from this investigation address voids in the understanding of RM Translation in the UK, provide insights not available through other types of stakeholder, and by means of lessons learned, potentially can help facilitate a cadre of more successful entrepreneurs and hence more successful Translation in the future