Overview of Drug Development

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

Marketing in an Academic Institution

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

Clinical and Translational Science Awards

Clinical and Translational Science Awards (CTSA) are large federal grants provided to an academic institution that support education and infrastructure relevant to translational science. CTSA site services, training, and pilot grant funding can benefit researchers at any stage of their career, from trainees to faculty. While all CTSA-funded programs offer support for research and training, the focus and services offered vary by institution

Working with the University Technology Transfer Office

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

Resources at Academic Entrepreneurship Centers

Universities harbor numerous resources for academic entrepreneurs. Academic entrepreneurship centers differ: the more comprehensive ones provide an array of services that support innovations at all stages of development. Universities often have educational programs to teach faculty about entrepreneurship; usually offered in business schools, they are increasingly being offered in engineering and medical programs. Entrepreneurship education increasingly involves experiential learning. Other entrepreneurial support at academic institutions includes: incubators, accelerators, mentoring, business plan competitions, and other programs that support the creation and maturation of startups. University seed funds can help early-stage startups breach the funding gap and attract new investors. Technology transfer offices (TTOs) focus on intellectual property (IP) protection for inno­vations stemming from university research, and increasingly provide other services and linkages that support the commercialization of innovations

Overview of Device Development

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

Handling Disruptive Innovation in Clinical and Research Settings

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: Application Guidance

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

Digital Health: Software as a Medical Device

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

SBIR/STTR Grants: Introduction and Overview

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