Interdisciplinary Centers, Units, and Projects

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  • Publication
    Laws and Ethics in relation to Medical Entrepreneurship
    (2020-01-05) Iyer, Ramesh; Solomon, Jeremy
    For latest version: please go to Some healthcare laws affect academic entrepreneurs who may also be practicing healthcare providers. Understanding the regulatory agencies and relevant laws is essential to avoiding legal entanglement with regulatory authorities and creating a successful health business venture. It is important to follow ethical standards in starting and managing a company. Ethical shortcuts may yield short-term benefits but pose substantial risk in the long run, including the potential for ethical and financial malfeasance.
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    Girls in Gansu, China: Expectations and aspirations for secondary schooling
    (2008-10-27) Adams, Jennifer; Hannum, Emily C.
    Gender stratification in education is declining in China, but some recent research suggests that girls' schooling is still vulnerable in poor rural areas. This chapter investigates girls' educational vulnerability in Gansu, one of China's poorest provinces. Specifically, it analyzes the Gansu Survey of Children and Families, a multisite survey that interviewed 2,000 rural children, along with their families, teachers, principals, and community leaders, in 2000 (when children were 9–12) and 2004 (when children were 13–16). Drawing on comparative and China-specific literature on gender and exclusion, we investigate several questions. First, do gender gaps favoring boys exist in enrollment, children's educational aspirations, and parental expectations? Second, are gender gaps in enrollment, aspirations, and parental expectations worse among the poorest children and families? Third, are girls' educational outcomes more sensitive to prior performance? Fourth, do characteristics of early homeroom teachers and early classroom experiences have different effects on outcomes for girls and boys? Our findings suggest that girls do not face substantially greater access barriers to basic education than do boys in much of rural Gansu.
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    Negotiation Strategies
    (2019-09-30) Martin, Anthony; Max, Eric
    For latest version: please go to Preparation is key for a successful negotiation. Be sure to create a prioritized list of the objectives and try to predict the other side’s prioritized list of objectives. Which objectives align on both sides, and which do not? Research industry standards to serve as a reference point. Determine what your strongest leverage factors are and try to predict the other side’s leverage. Who has more freedom to walk away from the deal? Negotiating with startup cofounders is important for determining the fair distribution of equity and any intellectual property (IP) rights based on product conceptualization, expertise, responsibilities, commitment, and risk. Physician-scientists may negotiate with industry for sponsored research agreements, joint development agreements, or a position on the scientific advisory board. Physician-scientists may negotiate with hiring institutions for objectives like startup package funding, protected research time, start date, salary, and title.
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    Intellectual Property Protection for Biologics
    (2019-09-27) Brewster, Megan; Singh, Pallab
    For latest version: please go to Biologics are a rapidly evolving area within biotechnology, and having the proper intellectual property (IP) protection is crucial to safeguarding inventions. IP protection of genetic material can be traced back to the early 1900s, though biologics themselves are fairly new. All forms of IP, including trademarks, copyrights, trade secrets, and patents can protect biologics, though most current issues have to do with patent protection. The U.S. government grants two types of protection against competition: patents through the U.S. Patent and Trademark Office (USPTO), and regulatory exclusivity through the U.S. Food and Drug Administration (FDA). There are many challenges related to obtaining IP protection of biologics, including cost, difficulties in characterization, and the uncertain nature of laws currently in place. Patent attorneys with experience in biotechnology and the university technology transfer office TTO) can work with the inventors to ensure that the biologic is properly protected.
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    Neuroethics, An Introduction with Readings
    (2010-01-01) Farah, Martha J.
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    Good, better, best?
    (2008-12-01) Caplan, Arthur
  • Publication
    Strategic Planning and Costs of FDA Regulation
    (2019-09-30) Van Batavia, Jason; Goldenberg, Seth J
    For latest version: please go to The regulatory burden for medical device innovation varies based on the specific Food and Drug Administration (FDA) pathway required, and early strategic planning for this regulatory burden is critical. The regulatory strategy and milestones must be integrated with other key components of the innovation process and informed by an understanding of and/or direct communication with all the stakeholders involved, including the customer, engineering/manufacturing team, research and development team, safety/regulatory bodies, the potential payers, and investors. While it is almost never too early to initiate contact with the FDA, inquiries through 513(g) petitions or pre-submission meetings should be focused on specific questions and goals to make the most of these engagements. Regulatory assessments and consultation with experts require upfront costs, but saving time and money in the long term by designing an efficient regulatory strategy can be the difference between success and failure for the academic entrepreneur. Fundraising (private and public) must be considered in the regulatory strategy, as approximately 90% of fundraising is based on claims tied to regulatory milestones.
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    Conducting Insightful Market Research
    (2019-09-30) Sosnowski, Michael
    For latest version: please go to Market research can complement early design work, assist with fine-tuning features and pricing, help attract investors, and suggest new directions to explore. It is critical to know where a startup is in the design process, from whom it wants feedback, and what it intends to do with the data gathered. As a general framework, it is useful to think in terms of three main blocks of the product development life cycle—early stage, middle stage, and late stage. Consider seeking help from research professionals whenever possible. There are many measurement-oriented and other practical considerations to account for, and a number of good resources a startup can turn to for help. Good research answers key objectives, and is customized to fit within a startup’s very real time and budget constraints. Addressing key questions up front will lead to more actionable results.