Journal: 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
Journal Volumes
Collection
50 results
Search Results
Now showing 1 - 10 of 50
Publication Intellectual Property Protection for Biologics(2019-09-27) Brewster, Megan; Singh, PallabFor latest version: please go to https://academicentrepreneurship.pubpub.org/pub/d8ruzeq0/release/4 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.Publication Negotiation Strategies(2019-09-30) Martin, Anthony; Max, EricFor latest version: please go to https://academicentrepreneurship.pubpub.org/pub/d3er22l7/release/2 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.Publication FDA Device Regulation: 510(k), PMA(2019-09-25) Van Batavia, Jason; Goldenberg, SethFor latest version: please go to https://academicentrepreneurship.pubpub.org/pub/gxp74m44/release/4 In the U.S., medical devices are classified into one of three groups based on potential risk to patients and this plays an important role in determining the appropriate FDA regulatory pathway. The three most common regulatory pathways through which the FDA clears or approves devices are: 1) exemption status, 2) 510(k), and 3) premarket approval (PMA). Early understanding of likely pathways is essential for planning device design and research strategy. All devices with more than a low or non-significant risk potential must be granted clearance, approval, or an Investigational Device Exemption (IDE) from the FDA prior to use in human subjects. Pre-submission, or Q-sub meetings, allow innovators and device companies to meet with the FDA for free and obtain feedback on the potential pathway and research protocols in an effort to have higher success with a future formal application. Early involvement of a regulatory expert or consultant can lead to a reduction in time to market and important cost savings.Publication Understanding Conflict of Interest for Academic Entrepreneurs(2019-09-26) Alapati, Deepthi; Egan, Patrick; Holcombe, JanetFor 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.Publication Laws and Ethics in relation to Medical Entrepreneurship(2020-01-05) Iyer, Ramesh; Solomon, JeremyFor 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 SBIR/STTR Grants: Introduction and Overview(2019-09-27) Lee, David; Stein, Elliot; Gooneratne, NalakaFor 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 Nonprofit and Foundation Sponsored Research: Developing New Models of Collaboration for Research and Development(2019-09-27) Esparza, ErinFor 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 Strategic Planning and Costs of FDA Regulation(2019-09-30) Van Batavia, Jason; Goldenberg, Seth JFor 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 Marketing in an Academic Institution(2019-09-27) Patel, Neil; Gooneratne, NalakaFor 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 Intellectual Property: Commercializing in a University Setting(2019-09-26) Dahl, CynthiaFor latest version: please go to https://academicentrepreneurship.pubpub.org/pub/av7544wl/release/4 An academic entrepreneur must clarify ownership of their invention and establish an intellectual property protection plan before commercializing. In most cases, a university employer will own the invention created by its researchers and faculty in conjunction with their employment, and will make intellectual property protection decisions. A university may either license out the entrepreneur’s invention to a third-party company to further develop and commercialize, or may license the invention back to the entrepreneur so that they may commercialize it themselves through a start-up. Such license agreements will assign responsibility for paying for patent coverage to protect the invention, set a fee or royalty schedule, and clarify ownership of further improvements or developments. Should the entrepreneur decide to commercialize the invention themselves, besides licensing the invention from the university, they should also be mindful of disclosure issues, contract clearly with founders and other interested parties to clarify issues of equity and intellectual property ownership, and consider whether they need to establish freedom to operate.