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Sbir/Sttr Grants: Application Guidance, Elliot Stein, David Lee, Nalaka Gooneratne 2019 Pennsylvania Hospital, University of Pennsylvania

Sbir/Sttr Grants: Application Guidance, Elliot Stein, David Lee, Nalaka Gooneratne

Academic Entrepreneurship for Medical and Health Scientists

  • Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) grants provide a valuable opportunity to receive non-diluting capital.

  • The process of applying for an SBIR/STTR grant has several steps and can take months to complete.

  • SBIR/STTR proposals take the form of typical grant proposals, except the former are shorter and have a lower requirement for preliminary data.

  • An academic entrepreneur should not expect to receive SBIR/STTR funding on their first attempt at a proposal.

  • There are several common pitfalls during the application process, and careful consideration of these issues can substantially improve an application.


Conducting Insightful Market Research, Michael Sosnowski 2019 Insights & Research Consultant

Conducting Insightful Market Research, Michael Sosnowski

Academic Entrepreneurship for Medical and Health Scientists

  • 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 ...


Human-Centered Design: Understanding Customers’ Needs Through Discovery And Interviewing, Helge Hartung, Sarah Rottenberg 2019 Children's Hospital of Philadelphia; Perelman School of Medicine, University of Pennsylvania"

Human-Centered Design: Understanding Customers’ Needs Through Discovery And Interviewing, Helge Hartung, Sarah Rottenberg

Academic Entrepreneurship for Medical and Health Scientists

  • 90% of new products fail as a result of a disconnect between what the customer wants and what the company thinks the customer wants.

  • Human-centered design aims to narrow the gap between customer and company through a deeper understanding of customers and their needs, motivations, and desires.

  • Human-centered design is an iterative process: investigate, ideate, iterate, and implement.

  • Design research focuses on the deep story—to understand the many, deeply understand a few.

  • Human-centered design is a team sport and is learned in the field, with an emphasis on qualitative data collection.


I-Corps As A Training Tool For New Technology Development, Annette Krysiewicz, Tomas Isakowitz 2019 Merck, Inc.

I-Corps As A Training Tool For New Technology Development, Annette Krysiewicz, Tomas Isakowitz

Academic Entrepreneurship for Medical and Health Scientists

  • Innovation Corps is a program developed by the National Science Foundation where university scientists and students learn entrepreneurial skills that enable them to take their research be­yond the laboratory and discover the commercial potential of their innovation.
  • I-Corps Sites, located at several universities, offer shortened curricula to qualify teams for participation in the national I-Corps program (NSF I-Corps Teams).

  • The core topics covered in I-Corps Sites’ curricula teach teams about the importance of cus­tomer discovery; the teams are expected to leave the lab and personally interview 20+ potential customers to determine their product-market fit.


A Seat At The Table: Special Considerations For Women And Underrepresented Groups In Academic Entrepreneurship, Linda Fleisher, Alexandra Marquez 2019 Fox Chase Cancer Center

A Seat At The Table: Special Considerations For Women And Underrepresented Groups In Academic Entrepreneurship, Linda Fleisher, Alexandra Marquez

Academic Entrepreneurship for Medical and Health Scientists

  • Women and marginalized groups are underrepresented in STEM-related and entrepreneurial fields

  • These populations face many challenges in these fields, including:

    ○ Finding funding sources for their project and/or lacking knowledge of where to obtain funding

    ○ Risking their academic standing if their project is not based on incentives deemed as academic

    ○ Conscious and unconscious bias

    ○ Lack of diverse groups in review and decision-making roles

    ○ Limited access to experienced mentors


Negotiation Strategies, Anthony Martin, Eric Max 2019 Miller School of Medicine, University of Miami

Negotiation Strategies, Anthony Martin, Eric Max

Academic Entrepreneurship for Medical and Health Scientists

  • 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 ...


Surgical Device Development, Nicolette Driscoll, Mohit Prajapati, Ari Brooks 2019 Department of Bioengineering, University of Pennsylvania

Surgical Device Development, Nicolette Driscoll, Mohit Prajapati, Ari Brooks

Academic Entrepreneurship for Medical and Health Scientists

  • 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 ...


Digital Health: Software As A Medical Device, Mauricio Novelo, Nalaka Gooneratne, James Weimer 2019 Perelman School of Medicine, University of Pennsylvania

Digital Health: Software As A Medical Device, Mauricio Novelo, Nalaka Gooneratne, James Weimer

Academic Entrepreneurship for Medical and Health Scientists

  • 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.


Overview Of Device Development, Anupam Kumar, Nalaka Gooneratne 2019 Vanderbilt University Medical Center

Overview Of Device Development, Anupam Kumar, Nalaka Gooneratne

Academic Entrepreneurship for Medical and Health Scientists

  • 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.


Development Of Radiographic Contrast Agents For Diagnostic Imaging, Ryne Didier, David Mankoff 2019 Perelman School of Medicine, University of Pennsylvania

Development Of Radiographic Contrast Agents For Diagnostic Imaging, Ryne Didier, David Mankoff

Academic Entrepreneurship for Medical and Health Scientists

  • Imaging contrast agents, administered intravenously, are diverse, can be used for diagnostic and therapeutic purposes, and have specific regulatory requirements and development considerations.

  • Collaborative relationships between industry and academia may provide the best approach for the development of these agents.

  • Additional opportunities for development and commercialization include software specific for the analysis of contrast-enhanced examinations.

  • There are special considerations for each class of imaging contrast agents with regards to market growth and potential avenues for future development.


Building A Successful Startup Team, Maura Weber, Zev Sunleaf 2019 ETHOS Health Communications

Building A Successful Startup Team, Maura Weber, Zev Sunleaf

Academic Entrepreneurship for Medical and Health Scientists

  • The startup team built in the early phases of commercialization can be a critical determinant in a company’s future success.

  • A primary technological and/or scientific founder should be established, along with a CEO who can assist with business planning.

  • Secondary team members such as marketing and regulatory personnel, should be brought on, if applicable.

  • Tertiary team members and consultants can include entrepreneurs in residence, human re­sources, business lawyers, software engineers and scientific advisory boards.

  • Creative employee compensation strategies should be considered in order to maximize limited financial resources.


Marketing In An Academic Institution, Neil Patel, Nalaka Gooneratne 2019 University of California San Francisco

Marketing In An Academic Institution, Neil Patel, Nalaka Gooneratne

Academic Entrepreneurship for Medical and Health Scientists

  • 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.


Handling Disruptive Innovation In Clinical And Research Settings, Prima Pisuttisarun, Nalaka Gooneratne 2019 IQVIA, Inc

Handling Disruptive Innovation In Clinical And Research Settings, Prima Pisuttisarun, Nalaka Gooneratne

Academic Entrepreneurship for Medical and Health Scientists

  • The process of disruptive innovation is a driving force in making healthcare more afforda­ble and effective.

  • Building resilience through diversification of financial resources, networking, and focusing time/effort can help an academic entrepreneur tolerate setbacks and minimize risks.

  • The sleep medicine case study highlights how fast a disruptive innovation can impact organizations on a micro and macro level.


Sbir/Sttr Grants: Introduction And Overview, David Lee, Elliot Stein, Nalaka Gooneratne 2019 Perelman School of Medicine, University of Pennsylvania

Sbir/Sttr Grants: Introduction And Overview, David Lee, Elliot Stein, Nalaka Gooneratne

Academic Entrepreneurship for Medical and Health Scientists

  • 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.


Intellectual Property Protection For Biologics, Megan Brewster, Pallab Singh 2019 Perelman School of Medicine, University of Pennsylvania

Intellectual Property Protection For Biologics, Megan Brewster, Pallab Singh

Academic Entrepreneurship for Medical and Health Scientists

  • 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 ...


Orphan Drugs: Understanding The Fda Approval Process, Gauri Srivastava, Ashley Winslow 2019 IQVIA, Inc.

Orphan Drugs: Understanding The Fda Approval Process, Gauri Srivastava, Ashley Winslow

Academic Entrepreneurship for Medical and Health Scientists

  • 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 ...


Does My Invention Already Exist? Conducting A Patent / Prior Art Search, Toshitha Kannan, Elliot Stein, Mark Maloney 2019 The Wistar Institute

Does My Invention Already Exist? Conducting A Patent / Prior Art Search, Toshitha Kannan, Elliot Stein, Mark Maloney

Academic Entrepreneurship for Medical and Health Scientists

  • 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 ...


Writing Business Plans For A Life Science Startup Or Clinical Program, Maire Conrad, Vanessa Chan, Linda Miller 2019 Children’s Hospital of Philadelphia; Perelman School of Medicine, University of Pennsylvania

Writing Business Plans For A Life Science Startup Or Clinical Program, Maire Conrad, Vanessa Chan, Linda Miller

Academic Entrepreneurship for Medical and Health Scientists

  • The business plan is an important tool for raising capital, finding strategic partners, recruit­ing, and providing an internal guide on how to drive a company’s growth.

  • The plan should include an executive overview, introduction to the management team, market and competitive analyses, value proposition, operating plan, financial projections, and potential risks.

  • The plan should be concise, well written, and dynamic. Details behind key assumptions should be included.

  • Common business plan pitfalls include focusing only on the product without framing it in the context of the consumers/patients, the market dynamics, and the ecosystem in which it will be ...


Equity Allocation In Startups, Neil Patel, Adam Dakin 2019 University of California San Francisco

Equity Allocation In Startups, Neil Patel, Adam Dakin

Academic Entrepreneurship for Medical and Health Scientists

  • Founders should not necessarily split equity evenly among cofounders; unequal splits can help prevent team dissonance and renegotiations as the company develops.

  • The timing of equity splits is critical, with most experts favoring early discussions of own­ership.

  • Companies should strive for capitalization tables that are simple in structure and easy to understand.

  • Capitalization tables should have equity pools set aside to anticipate non-founder compen­sation of new hires.

  • Equity dilution from future investors should be viewed in terms of the business’s overall financial strategy.


Seeking Venture Capital Investment, Elliot Stein, Brett Topche 2019 Pennsylvania Hospital, University of Pennsylvania

Seeking Venture Capital Investment, Elliot Stein, Brett Topche

Academic Entrepreneurship for Medical and Health Scientists

  • Venture capital (VC) firms exchange cash for equity or equity-like securities.

  • Venture capital funding most often occurs in the early to middle stages of a company, be­fore an acquisition or an initial public offering. Typically, VC firms make a relatively large investment, ranging from 1 to 30 million dollars, though in more recent years, “micro-VCs” that write smaller checks have become more common. Often, a company will raise money from several venture capital firms, either simultaneously or in subsequent transac­tions.

  • Investors expect a 3–10x+ return on investment for any given investment, depending on the stage of the ...


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