Intellectual Property-Regulatory

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  • 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
    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.
  • Publication
    Overview of Device Development
    (2019-09-30) Kumar, Anupam; Gooneratne, Nalaka
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/d3v70grd/release/2 Device development can be summarized by the Three I’s: Identification, Invention, and Implementation. The current era of “first to file” requires early patenting. There are a number of public and private sources for seed investment. Determining the appropriate pathway for regular approval requires accurate risk classification.
  • Publication
    Working with the University Technology Transfer Office
    (2019-09-26) Fauzan, Ryan; Gooneratne, Nalaka
    For latest version, please go to https://academicentrepreneurship.pubpub.org/pub/gn0c2t4w/release/4 Academic technology transfer is a rigorous process that involves many different constituencies within the university with different perspectives and interests. Aligning those interests is crucial to a successful transfer of inventions that ultimately result in commercialization of value-added products and services. Individuals within universities should leverage the technology transfer office’s (TTO) resources and advice as early as when the idea was originally conceived. TTOs can help move the innovation process forward and keep track of progress to guide the next point of inflection. In building relationships throughout the technology transfer process, inventor(s) must understand the terms and policies involved. Starting with the TTO, they must pay careful attention to the university’s intellectual property (IP) policies. When dealing with outside companies, investors must negotiate the terms carefully to make sure that every party has their interests aligned. The TTO would be of valuable help in conducting negotiations to achieve this. In addition, they can be a link to other internal and external resources, including investment capital and mentoring that can help the academic entrepreneur commercialize their innovation.
  • Publication
    Surgical Device Development
    (2019-09-30) Driscoll, Nicolette; Prajapati, Mohit; Brooks, Ari
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/ix4cdtm1/release/5 The pre-development phase takes an idea to a concept with a business case for developing the device. Key elements include defining user needs, generating different concepts and their respective regulatory pathway, intellectual protection strategy, reimbursement model and overall commercialization strategy. The development phase is an iterative process that converts the concept into a product that is tested and evaluated through the verification and validation process, and ready for regulatory submission. Design Transfer is a set of procedures that are required to ensure that the device’s design is correctly translated into production specifications and performing a market preference evaluation prior to a full scale product launch. Following product launch, the product enters the post-market activities phase, in which operations are scaled up to reach sales targets, the product is maintained and improved if possible, and strategies for product refresh, product extensions, seeking new markets.
  • Publication
    Orphan Drugs: Understanding the FDA Approval Process
    (2019-09-27) Srivastava, Gauri; Winslow, Ashley
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/einr3b30/release/2 In the U.S., a rare disease is one that affects fewer than 200,000 patients. There are more than 7,000 rare diseases today but relatively few specific therapies for them, mainly because the manufacturers cannot recoup their drug development costs. Orphan drug status allows sponsors to apply for incentives such as the Orphan Drug Tax Credit (ODTC), marketing exclusivity for seven years for the first orphan drug for a given rare disease, and an attractive drug-pricing scheme, amongst other benefits. Orphan drug trials are generally single arm (no placebo arm), nonrandomized, and open label. Safety Phase 1 trials are not usually required, and Phases 2 and 3 can be combined when the patient population is very low. Sponsors of an orphan drug can make use of expedited Food and Drug Administration (FDA) programs such as the Fast Track, Breakthrough Therapy, and Priority Review designations, as well as the Accelerated Approval pathway and unique grant funding opportunities, such as the Orphan Products Clinical Trials Grant program. The FDA facilitates patient-focused drug development (PFDD) meetings, wherein they collect patient experience data from the patients, their family members, their caregivers, and disease foundations. These data can help the orphan drug developers for a given rare disease in determining clinical endpoints and the route of therapy administration for their clinical trials.
  • Publication
    Overview of Drug Development
    (2019-10-09) Gooneratne, Nalaka
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/8a05fz36/release/4 Drug development costs range from $2 to $3 billion and may span from 7 to 12 years. Beginning with drug discovery, key steps in the process include preclinical testing, Phase 1–3 clinical trials, FDA New Drug Application (NDA) approval, and subsequent Phase 4 clinical research. Academic entrepreneurs should understand the unique needs of each phase and their potential role in the process, as well as the services their academic medical center can provide.
  • Publication
    Preclinical Animal Models
    (2019-10-07) Park, Sunghee E; Schaer, Thomas P
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/tzu9lgys/release/4 Animal models can support and develop medical product development during the nonclinical phase. Well-designed animal models can address regulatory safety concerns and can provide further de-risking during product validation. Assessing minimum viable products and prototypes in animal models can improve quality assurance and compliance structure. Developing a roadmap for product innovation strategies (regulatory, reimbursement) is essential in order to avoid unnecessary preclinical testing. Involving end users in product development is critical for the success of the medical device in the market. Animal studies can provide insight and value in the preparation of the regulatory submission.
  • Publication
    Digital Health: Software as a Medical Device
    (2019-09-30) Novelo, Mauricio; Gooneratne, Nalaka; Weimer, James
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/software-as-a-medical-device/release/3 Software, such as mobile device apps or telemedicine, creates exciting new opportunities for patient engagement and for improving healthcare. There are three main types of mobile apps: native, web, and hybrid. The wireless technologies in smartphones and wearable sensors, such as smartwatches, offer the potential for additional biometric data collection. HIPAA compliance requires multiple levels of oversight and auditing. The software development costs for healthcare are considerably higher than for consumer-oriented products due to FDA regulatory requirements; testing out proof-of-concept through low-cost alternatives is an important development strategy.