Abstract

Academic discovery in biomedicine is a growing enterprise with tens of billions of dollars in research funding available to universities and hospitals. Protecting and optimizing the resultant intellectual property is required in order for the discoveries to have an impact on society. To achieve that, institutions must create a multidisciplinary, collaborative system of review and support, and utilize connections to industry partners. In this study, we outline the efforts of Case Western Reserve University, coordinated through its Clinical and Translational Science Collaborative (CTSC), to promote entrepreneurial culture, and achieve goals of product development and startup formation for biomedical and population health discoveries arising from the academic ecosystem in Cleveland. The CTSC Office of Translation and Innovation, with the university's Technology Transfer Office (TTO), helps identify and derisk promising IP while building interdisciplinary project teams to optimize the assets through key preclinical derisking steps. The benefits of coordinating funding across multiple programs, assuring dedicated project management to oversee optimizing the IP, and ensuring training to help improve proposals and encourage an entrepreneurial culture, are discussed in the context of a case study of therapeutic assets, the Council to Advance Human Health. This case study highlights best practices in academic innovation.

Highlights

  • Academic medical centers and their lead universities in the United States are recipients of tens of billions of dollars in Federal and Foundation funds[1] to study, understand, and alleviate human suffering to prevent, treat and cure disease. In order for these discoveries to have the opportunity to reach the market and have patient impact, patent filings and studies into safety and efficacy of the discovery need to be completed to industry standards

  • Since the advent of the Patent and Trademark Law Amendments Act (e.g. Bayh-Dole act) in 19802 nonprofits and small businesses have had the right to retain ownership in inventions developed under Federal contracts, leading to an increase in academic patent filings in many fields at American research universities.[3,4]

  • Scientists require strong support in terms of respected outside advice and milestone driven pilot funding, attentive project management, continued education around market need, and encouragement to pivot when indicated. Given these kinds of stable, consistentsupport, an entrepreneurial culture of academic discovery can be developed within 10 years, given sustained effort and resources that include access to translational funding, training opportunities for program teams, and broad collaboration and coordination between various translational research stakeholders, university leadership, and regional partners

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Summary

Introduction

Academic medical centers and their lead universities in the United States are recipients of tens of billions of dollars in Federal and Foundation funds[1] to study, understand, and alleviate human suffering to prevent, treat and cure disease. The CTSC, funded by the National Center for Advancing Translational Sciences (NCATS), has as its mission to “catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions”.

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