Intellectual Property-Regulatory

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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.
  • Publication
    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.
  • Publication
    FDA Device Regulation: 510(k), PMA
    (2019-09-25) Van Batavia, Jason; Goldenberg, Seth
    For latest version: please go to 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
    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 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
    Understanding Conflict of Interest for Academic Entrepreneurs
    (2019-09-26) Alapati, Deepthi; Egan, Patrick; Holcombe, Janet
    For latest version: please go to 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 Drug Development
    (2019-10-09) Gooneratne, Nalaka
    For latest version: please go to 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 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 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.
  • Publication
    Orphan Drugs: Understanding the FDA Approval Process
    (2019-09-27) Srivastava, Gauri; Winslow, Ashley
    For latest version: please go to 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
    Intellectual Property: Commercializing in a University Setting
    (2019-09-26) Dahl, Cynthia
    For latest version: please go to 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.