Academic Entrepreneurship for Medical and Health Scientists

ISSN
Publisher
Discipline
Entrepreneurial and Small Business Operations
Description
Academic Entrepreneurship is a free Open Education Resource that seeks to support and grow a new academic research community of Boundary Spanners -- those who work in academia and with industry in order to realize the potential of basic discoveries that support the process of translational research through to commercialization and impact. This ebook is a repository of tools, wisdom and best practice that seeks to democratize innovation regardless of where the academic researcher resides. There are more than 50 chapters of material, divided across the five major sections: Academia, People, Ideation, IP/Reg, and Finance. Need Help with Your Idea? https://rebrand.ly/ACEnextsteps Interested in organizing an event at your institution for a free Penn/CHOP webinar on Academic Entrepreneurship? https://rebrand.ly/organize-a-webinar Browse Contents https://repository.upenn.edu/ace/all_issues.html

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Now showing 1 - 10 of 50
  • Publication
    Nonprofit and Foundation Sponsored Research: Developing New Models of Collaboration for Research and Development
    (2019-09-27) Esparza, Erin
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/tz6ti0cb/release/3 In recent years there has been an increasing need for investigators to secure alternative sources of funding, and nonprofit organizations have become integral parts of the research and development process. Venture philanthropy is a relatively new concept of cooperation in which nonprofits not only fund research but also take a businesslike approach to product development, commercialization, and collaboration with industry partners. Potential opportunities that come with nonprofit funding can include better patient access, more early funding for research and development, and increased networking opportunities. Investigators must be prepared for potential pain points such as managing conflicts of interest, managing intellectual property, and ensuring prior art is accounted for during the application process. With proper management and transparency, involvement with a nonprofit foundation has the potential to be greatly beneficial to both the investigator and the foundation.
  • Publication
    SBIR/STTR Grants: Introduction and Overview
    (2019-09-27) Lee, David; Stein, Elliot; Gooneratne, Nalaka
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/1elox915/release/3 The purpose of the Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) grant mechanism is to stimulate technological innovation through facilitating private-sector commercialization of research advances. Small business entities do not need to relinquish equity in exchange for SBIR/STTR funding. A key difference between SBIR and STTR grants is that the STTR requires university participation, which is optional for the SBIR. SBIR/STTR applications can be submitted in conjunction with more traditional R01/R21 grant applications and are ideal for exploring the commercialization potential of research results.
  • Publication
    Careers in Academia and Industry: Transitions and Challenges
    (2019-09-21) Shewale, Swapnil; Winston, Flaura
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/gub9p4a0/release/4 Start the career planning process with self-discovery and feedback from mentors. Understand the setting, culture, organizational structure, and leadership of the organizations under consideration for one’s career. Understand the expectations of potential career paths. For personal development beyond hard knowledge and skills, acquire excellent people skills and a strong network. Careers are dynamic. Maintain flexibility. Moving between environments (academia vs. industry) can be challenging, but those who successfully navigate this do so with extensive planning.
  • Publication
    Conducting Insightful Market Research
    (2019-09-30) Sosnowski, Michael
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/psdorj9y/release/4 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.
  • Publication
    Strategic Planning and Costs of FDA Regulation
    (2019-09-30) Van Batavia, Jason; Goldenberg, Seth J
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/planning-and-costs-of-fda-regulation/release/2 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.
  • Publication
    Innate Biases
    (2019-10-07) Meer, Elana
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/jsarhqw5/release/2 Entrepreneurs face a host of innate biases that inhibit their ability to make optimal and objective decisions under conditions of uncertainty. Biases include overconfidence bias, illusion of control bias, anchoring and adjustment bias, confirmation bias, curse of knowledge bias, and optimism bias. Through awareness, collaboration and inquiry, open discussion, and the deliberate challenging of consensus, entrepreneurs can mitigate these innate biases.
  • Publication
    My Invention Already Exist? Conducting a Patent / Prior Art Search
    (2019-09-27) Kannan, Toshitha; Stein, Elliot; Maloney, Mark
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/dswh4b84/release/2 Patent/prior art searches are an essential step in the process of establishing the novelty of a product or solution. Increasing the comprehensiveness of a prior art search enhances the likelihood of success for a new patent because the inventor becomes more aware of the state of the field, can create and perceive distinctions between their invention and existing inventions, and is able to preempt sources of conflict with prior patent literature. Publicly available resources are the best place to start a prior art search. Follow this mantra—brainstorm, search, retrieve and expand! Documentation of all search results is a necessity and may prove essential in later discussions with a patent professional or when filling patent paperwork to demonstrate that a reasonably extensive search was performed. Resources from the university can offer counsel. There are almost always people who are trained to be experts in prior art searches and will be more than willing to help out.
  • Publication
    Marketing in an Academic Institution
    (2019-09-27) Patel, Neil; Gooneratne, Nalaka
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/7jj52kah/release/4 Mapping out key stakeholders at an institution and how they connect to each other can help strengthen one’s understanding of the ecosystem in which the company will start. Proactive marketing through targeted meetings and participation in on-campus events can help build one’s network. Becoming aware of the various marketing channels at an academic medical institution is critical for promoting one’s startup. Winning small grants can help build traction through an early reputation of success.
  • Publication
    Laws and Ethics in relation to Medical Entrepreneurship
    (2020-01-05) Iyer, Ramesh; Solomon, Jeremy
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/oibkkvvo/release/3 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.
  • Publication
    Understanding Conflict of Interest for Academic Entrepreneurs
    (2019-09-26) Alapati, Deepthi; Egan, Patrick; Holcombe, Janet
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/r71twlze/release/3 A conflict of interest (COI) is defined as the presence of a risk for an undue influence on primary goals due to a secondary goal such as financial gain. Individuals must understand that the mere presence of the risk, and not the actual occurrence of the undue influence, constitutes a potential COI. In biomedical research, COI policies protect human subjects and research integrity while preserving public trust. Damage caused by actual research misconduct is severe and creates wide and long-lasting public mistrust. Thus, individuals should not view COI policies as burdensome and instead should consider them as preventative strategies that protect them from broader repercussions after a concern for research bias has been raised. The disclosure of individual financial relationships is a critical but limited first step in the process of identifying and managing COIs. The presence and severity of a COI in an individual’s disclosure are assessed by the institution’s COI committee to determine appropriate strategies for the management of the COI, such as the need for more specific disclosure information, restriction of the individual’s role in the research, or even, in some circumstances, the elimination of a conflicting relationship.