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Transform your research into commercial biomedical products with this revised and updated second edition. Covering drugs, devices and diagnostics, this book provides a step-by-step introduction to the process of commercialization, and will allow you to create a realistic business plan to develop your ideas into approved biomedical technologies. This new edition includes: Over 25% new material, including practical tips on startup creation from experienced entrepreneurs. Tools for starting, growing and managing a new venture, including business planning and commercial strategy, pitching investors, and managing operations.Global real-world case studies, including emerging technologies such as regulated medical software and Artificial Intelligence (AI), offer insights into key challenges and help illustrate complex points. Tips and operational tools from established industry insiders, suitable for graduate students and new biomedical entrepreneurs.
Drug discovery and development is a long and arduous process and is particularly challenging for Alzheimer’s disease given the incomplete understanding of molecular mechanisms, variability in clinical presentation, relatively slow disease progression, and heterogeneous patient population. The lack of predictive preclinical models combined with the long and expensive clinical trials raise additional barriers to therapeutic development. Tens of thousands of academic publications identify potential biomarkers, molecular mechanisms, preclinical models, and interventions, yet very few have led to industry-sponsored drug development programs. In this chapter, we will describe one academic program’s approach to bridging the “valley of death.” The Stanford University SPARK Program helps academics advance their projects through the applied science stage of development, reducing the risk to potential industry partners. SPARK uses simple and easily replicated principles to ensure that more academic discoveries find their way to impact patients and to benefit society. Approximately 60% of SPARK projects advance to industry partnerships or directly into university-sponsored clinical trials.
This conclusion reviews changing practices and habits of gambling in Britain in the long eighteenth century, among different groups in society, and among women and men. The rise in female gambling of different kinds was one of the most striking developments of this period, attracting significant comment from the contemporary press and writers, as well as anxiety from authors of the myriad conduct books of the period. The implications of these changes and of the prevalence of different forms of gambling for our understanding of Britain in this period is examined, in particular in relation to debates among historians about the impact and influence of polite values and culture. The final section of the conclusion looks briefly ahead to the new worlds of gambling as they began to develop in the opening decades of the nineteenth century.
This chapter goes in search of the gambling habits and propensities of the bulk of the population, but does so by focusing in the first place on the gambling of the lower orders and many among the middling sorts in the giant British capital. Through examination of a range of activities, including cricket and lottery insurance, and different gambling locales, it seeks to map the sheer extent and diversity of gambling at this level of society in eighteenth-century London. If London in this period was a ‘gambler’s paradise’, as one historian has claimed, then this was about much more than its exclusive gambling clubs. The final section of the chapter focuses on one activity which became very closely identified with betting in the later Georgian era, and across Britain – pedestrianism, or foot-racing. Through exploring the development and appeal of this sport, it seeks to plot a path forwards from the eighteenth century into the world of early to mid nineteenth century popular sport and betting, in which the centre of gravity moved decisively away from London and to the rapidly growing industrial regions and towns of north and midlands, as well as the manufacturing regions of lowland Scotland.
For over two millennia, China has sustained the largest single human society on the planet through the development of one of the most sophisticated agrarian systems in history. Even until quite recent, agriculture occupied a central place in the Chinese economy, commanding a dominant 60 to 70 percent of the total economy throughout. Agricultural institutions define the Chinese economic system and agricultural production drove long-run economic change or growth in China. Agriculture was at the center of the Great Divergence debate. Agricultural harvest or failures sometimes spelled the rise and fall of dynasties throughout history. Moving to the modern era, Chinese agriculture became the scapegoat for China’s modernization failure and was regarded as the incubator for Communist revolution. However, given its overriding importance, research on modern Chinese agriculture has been surprisingly understudied for the last few decades.
The last 50 years have seen an increasing dependence on academic institutions to develop and commercialize new biomedical innovations, a responsibility for which many universities are ill-equipped. To address this need, we created LEAP, an asset development and gap fund program at Washington University in St. Louis (WUSTL). Beyond awarding funds to promising projects, this program aimed to promote a culture of academic entrepreneurship, and thus improve WUSTL technology transfer, by providing university inventors with individualized consulting and industry expert feedback. The purpose of this work is to document the structure of the LEAP program and evaluate its impact on the WUSTL entrepreneurial ecosystem. Our analysis utilizes program data, participant surveys, and WUSTL technology transfer office records to demonstrate that LEAP consistently attracted new investigators and that the training provided by the program was both impactful and highly valued by participants. We also show that an increase in annual WUSTL start-up formation during the years after LEAP was established and implicate the program in this increase. Taken together, our results illustrate that programs like LEAP could serve as a model for other institutions that seek to support academic entrepreneurship initiatives.
The National Institutes of Health launched the NIH Centers for Accelerated Innovation and the Research Evaluation and Commercialization Hubs programs to develop approaches and strategies to promote academic entrepreneurship and translate research discoveries into products and tools to help patients. The two programs collectively funded 11 sites at individual research institutions or consortia of institutions around the United States. Sites provided funding, project management, and coaching to funded investigators and commercialization education programs open to their research communities.
We implemented an evaluation program that included longitudinal tracking of funded technology development projects and commercialization outcomes; interviews with site teams, funded investigators, and relevant institutional and innovation ecosystem stakeholders and analysis and review of administrative data.
As of May 2021, interim results for 366 funded projects show that technologies have received nearly $1.7 billion in follow-on funding to-date. There were 88 start-ups formed, a 40% Small Business Innovation Research/Small Business Technology Transfer application success rate, and 17 licenses with small and large businesses. Twelve technologies are currently in clinical testing and three are on the market.
Best practices used by the sites included leadership teams using milestone-based project management, external advisory boards that evaluated funding applications for commercial merit as well as scientific, sustained engagement with the academic community about commercialization in an effort to shift attitudes about commercialization, application processes synced with education programs, and the provision of project managers with private-sector product development expertise to coach funded investigators.
In 1700 the Mughals controlled much of the Indian subcontinent. By 1858 the British Crown ruled. Why did this transition occur? How did the relationship between the state and economic activity change? And how did the economy perform? This chapter provides an overview, discussing competing perspectives on the breakdown of the Mughal Empire, the rise of the East India Company, the increasing commercialization of the economy, and changes in the economic structure. The literature suggests that the East India Company’s political and military success partly came from more successful fiscal administration compared to its Indian rivals. After consolidating its rule, British policy favoured the export of Indian primary products and the import of manufactured goods, contributing to deindustrialization. In agriculture, the area cultivated increased with population, but technology stagnated. Per capita income, which was already low, may have fallen slightly. Conflicts between the state and local users of forests and other resources emerged, especially in conjunction with the introduction of a major technological innovation, the railways. Our period ends with the Mutiny, a formidable challenge to British rule, following which British policy became conservative, seeking to preserve the existing social order.
Although most research universities offer investigators help in obtaining patents for inventions, investigators generally have few resources for scaling up non-patentable innovations, such as health behavior change interventions. In 2017, the dissemination and implementation (D & I) team at the University of Wisconsin’s Clinical and Translational Science Award (CTSA) created the Evidence-to-Implementation (E2I) award to encourage the scale-up of proven, non-patentable health interventions. The award was intended to give investigators financial support and business expertise to prepare evidence-based interventions for scale-up.
The D & I team adapted a set of criteria named Critical Factors Assessment, which has proven effective in predicting the success of entrepreneurial ventures outside the health care environment, to use as review criteria for the program. In March 2018 and February 2020, multidisciplinary panels assessed proposals using a review process loosely based on the one used by the NIH for grant proposals, replacing the traditional NIH scoring criteria with the eight predictive factors included in Critical Factors Assessment.
two applications in 2018 and three applications in 2020 earned awards. Funding has ended for the first two awardees, and both innovations have advanced successfully.
Late-stage translation, though often overlooked by the academic community, is essential to maximizing the overall impact of the science generated by CTSAs. The Evidence-to-implementation award provides a working model for supporting late-stage translation within a CTSA environment.
Commercializing biomedical discoveries is a challenging process for many reasons. However, Academic Medical Centers (AMC) that have teaching, patient care, research, and service engrained in their mission are well poised to host these discoveries. These academic discoveries can lead to improvement in patient health and economic development if supported to cross the “valley of death” through institutional assistance, by providing guidance, gap funding and product development expertise. Colorado has a vibrant local startup ecosystem, state support for commercialization and entrepreneurship as well as critical mass of product development expertise. University of Colorado Anschutz Medical Campus, as a major AMC, is an engine for growth for the region. This article discusses innovation efforts at the University of Colorado Anschutz Medical Campus as a case study, which is built around two major efforts: the CCTSI and CU Innovations. I-Corps at CCTSI and the SPARK|REACH program of CU Innovations have been instrumental in fostering innovation, commercialization, and entrepreneurship on the campus.
Implementation of clinically useful research discoveries in the academic environment is challenged by limited funding for early phase proof-of-concept studies and inadequate expertise in product development and commercialization. To address these limitations, the National Institutes of Health (NIH) established the National Centers for Accelerated Innovations (NCAI) program in 2013. Three centers competed successfully for awards through this mechanism. Here, we present the experience of one such center, the Boston Biomedical Innovation Center (B-BIC), and demonstrate its remarkable success at the translation of innovations to clinical application and commercialization, as well as skills development and education.
Traditional training and funding mechanisms in academic health centers often do not support its faculty, staff, and trainees in evaluating and implementing innovative ideas, necessitating supplemental innovation programming. The University of Michigan (U-M) Frankel Cardiovascular Center partnered with U-M Fast Forward Medical Innovation (FMMI), a biomedical innovation and commercialization unit funded in part by the Clinical and Translational Science Award awarded to the Michigan Institute for Clinical & Health Research, to provide training and resources to advance ideas toward impacting patients. The program recruited faculty, trainees, staff, patients, and family members from multidisciplinary backgrounds. Engaging patients and family members expanded the ideas generated and furthered clinical relevance. Over two years, 11 project teams completed an 11-week, 16-session course on innovation and entrepreneurship concepts that incorporated workshops to progress ideas and develop a pitch for development funding. An increase in knowledge was reported in key innovation topics, such as customer discovery, assessing markets, and intellectual property. Participants reported an increase in project preparation, including obtaining stakeholder support, preparation of a development plan, readiness to apply for funding, and filing invention disclosures. This program can serve as a model for implementing training and funding mechanisms to advance innovative ideas.
Chapter 2 looks in detail at the economics of paper and its value. Starting from the vexed question of cost, it untangles a number of threads regarding other economic concerns relating to the journey of paper to England. England was not at the periphery of paper use, because it was a leading producer of wool. This flourishing market attracted the mercantile community which elected to use paper as the tool of their trade. This chapter also suggests that the great success that paper enjoyed as technology and craft was in direct proportion to its multiple uses, of which book making is only one aspect of that story. This chapter discusses the availability of Italian paper and its distribution from Italy to Europe more widely and thinks more carefully about the quality of paper, different types of paper, and the evidence for its arrival in England. This chapter reconsiders the papermaking process from the point of view of its many products and how these products then circulated within international and English markets. Building on the first chapter, I argue that the spread of paper to England and its use in administrative and book production is not dissimilar from that of other European countries.
The purpose of this study is to assess the impact of participation in the land rental market on smallholder farmers’ commercialization using farm household panel data in Tigrai, Ethiopia. Regression results reveal that 1 hectare increase in area rented in by tenant households leads to a 60% increase in the likelihood of participation in the output market as a crop seller and increases the marketed output sold by tenant households by US$ 200/year. The results appear to indicate that land rental market in the land scarcity economy to some extent contributes positively in the facilitation of transformation toward smallholders’ commercialization.
Chapter 10 takes a broader look at IP protection as an incentive to innovate. Patent protection gaps brought about by 3D printing technology must be viewed in conjunction with how the technology dramatically lowers the costs of innovation (and imitation) for 3D printable goods. Moreover, although patents serve as a primary incentive to innovate, they are not the only incentive. The chapter looks at other IP rights, contracts, and extra-legal appropriability mechanisms, as well as nonmonetary incentives to innovate, to determine how the IP regime should respond to 3D printing technology. I describe the need for a better empirical understanding of 3D printing’s effects on innovation incentives, but I argue that current evidence does not suggest a need for stronger IP incentives for 3D printable goods. Therefore, radical changes to patent law are not necessary even in the face of de facto weakened patents. In addition, because copyright protection is not needed as an extra incentive for utilitarian innovation, copyright law should not protect DMFs of primarily utilitarian objects.
The Institute of Medicine recommended the advance of innovation and entrepreneurship training programs within the Clinical & Translational Science Award (CTSA) program; however, there remains a gap in adoption by CTSA institutes. The University of Michigan’s Michigan Institute for Clinical & Health Research and Fast Forward Medical Innovation (FFMI) partnered to develop a pilot program designed to teach CTSA hubs how to implement innovation and entrepreneurship programs at their home institutions.
Materials and methods
The program provided a 2-day onsite training experience combined with observation of an ongoing course focused on providing biomedical innovation, commercialization and entrepreneurial training to a medical academician audience (FFMI fastPACE).
All 9 participating CTSA institutes reported a greater connection to biomedical research commercialization resources. Six launched their own version of the FFMI fastPACE course or modified existing programs. Two reported greater collaboration with their technology transfer offices.
The FFMI fastPACE course and training program may be suitable for CTSA hubs looking to enhance innovation and entrepreneurship within their institutions and across their innovation ecosystems.
The Institute of Translational Health Sciences (ITHS), a Clinical and Translational Science Award (CTSA)-funded program at the University of Washington (UW), established the Drug and Device Advisory Committee (DDAC) to provide product-specific scientific and regulatory mentoring to investigators seeking to translate their discoveries into medical products. An 8-year retrospective analysis was undertaken to evaluate the impact of the DDAC programs on commercialization metrics.
Tracked metrics included the number of teams who consulted with the DDAC, initiated a clinical trial, formed a startup, or were successful obtaining federal small business innovation awards or venture capital. The review includes historical comparisons of the startup rates for the UW School of Medicine and the Fred Hutchinson Cancer Research Center, two ITHS-affiliated institutions that have had different DDAC utilization rates.
Between 2008 and 2016, the DDAC supported 161 unique project teams, 28% of which went on to form a startup. The commercialization rates for the UW School of Medicine increased significantly following integration of the DDAC into the commercialization programs offered by the UW technology transfer office.
A formalized partnership between preclinical consulting and the technology transfer programs provides an efficient use of limited development funds and a more in-depth vetting of the business opportunity and regulatory path to development.
Organometal trihalide perovskite solar cells (PSCs) have sparked a frantic excitement in the scientific community because they can achieve high power conversion efficiencies (PCEs) even when fabricated by low-cost solution-processing technologies. However, the poor stability of PSCs has seriously hindered their commercialization. Among various kinds of PSCs, carbon-based PSCs without hole transport materials (C-PSCs) seem to be the most promising for addressing the stability issue because carbon materials are stable, inert to ion migration, and inherently water-resistant. Concurrent with the steady rise in PCE of C-PSCs, great progresses have also been attained on the device stability and scaling-up fabrication of C-PSCs, which have well signified the possible commercialization of PSCs in the near future. In this review, we will summarize these progresses with a view of exposing the promising prospect. We start by collating recent stability testing results of C-PSCs with reference to those of HTM-PSCs. Then, we update the research status on large-scale C-PSCs and their associated scalable fabrication technologies. Finally, we identify main issues to be addressed alongside future research directions.
In 2014, the Japanese government amended the laws concerning regenerative medicine. This reform aimed to contribute to the appropriate promotion of regenerative medicine and new drug discovery for intractable diseases using stem cells. It also helped restrict stem cell tourism, that is, provision of stem cell therapy of unclear efficacy and safety to tourists from abroad, and its relaxed regulations may even lead to the resolution of the drug lag problem. Stem cell medicine is positioned as a part of a national growth strategy that requires cooperation among the industry, government, healthcare field, and academia. It can be characterized as a “mesoscopic strategy,” in that it aims to achieve high-level technological developments that would allow results from human-induced pluripotent stem cell and traditional stem cell research to contribute to regenerative medicine and drug development for intractable diseases, while attempting to strike a balance with commercialization and improved access of citizens to cutting-edge medical care.