Technology Transition
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This overreaching goal of this activity is to forge a uniquely transformative, innovative, and integrative academic and industrial home for translational science that has the collective resources to combine the recruitment of entrepreneurial research programs, establishment of core facilities, and fusion with interests of global companies in order to position the McGowan Institute as the ideal partner through which companies can explore, participate in, and then manufacture regenerative medicine products. Specifically, the objectives of the Magnet Program are to:
As more regenerative therapies come close to reaching the market, a new business paradigm for these technologies is emerging. Big Pharma has taken interest in the field and is actively seeking partnerships with academic institutions. McGowan has the unique ability to contribute both human and physical resources and use their basic and clinical research as the basis for new technologies of interest. REGULATORY AFFAIRS This activity was established to set-up a regulatory support system for investigators as they move their technologies from the bench to the bedside. The experts retained in this area are professionals whose job it is to keep track of the ever-changing legislation in all the regions in which the Institute wishes to distribute its technologies. They also advise on the legal and scientific restraints and requirements, and collect, collate, and evaluate the scientific data that their research and development colleagues are generating. They also give strategic and technical advice at the highest level in the Institute, right from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development program and the Institute as a whole. HEALTH ECONOMICS FOR REGENERATIVE MEDICINE Regenerative technologies may yield considerable commercial opportunities, from the sale of products (ranging from engineered tissues to the processes by which those products are manufactured or tissue structure or function is regenerated) to the delivery of services (utilizing the engineered tissues or methods of regeneration) for either therapeutic or diagnostic applications. But belief in the utility of such technologies cannot, by itself, generate the significant capital investment required to bring them to market. At this early stage in the development of the field of regenerative medicine, its commercial potential remains uncertain in the absence of compelling product development and commercialization strategies that reflect a clear-eyed, informed evaluation of clinical need (i.e., market size) and the barriers to market acceptance. There is a clear need for informed, critical re-analysis of available healthcare data to provide a more realistic measure of market size for cell- and tissue-based products. A Regenerative Medicine oriented approach to healthcare data analysis can help quantify relevant unmet need and reveal clinical experience with existing medical products which may establish the criteria for displacing them with regenerative technologies. The initiative will be a multi-disciplinary based program studying the economic issues that impact the development of regenerative medicine technologies. Through a series of interrelated activities the initiative will become the scholarly center of expertise where scientists, investors, business and government leaders, reporters or scholars would turn when seeking an understanding of how to perform research and development of tissue engineered medical products in a way that enables future clinical and commercial delivery of a technology. Tissue engineered medical products are not simple biologics, drugs and devices and the initiative will seek to build a dynamic center of excellence that can strategize about how such combination products translate into viable clinical applications and commercial products. Key issues will be addressed, including:
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