CTSA Program Commercialization Efforts

CTSA Program institutions have supported innovations that have resulted in numerous patents. From 2006 to 2023, the CTSA Program developed more than 350 patents across 52 CTSA institutions. Many of the patents related to diagnostics, treatments, medical devices, biotechnology and therapeutic methods. These patents reflect ongoing innovations in health care designed to improve human health.

1. I-Corps@NCATS at The University of Alabama at Birmingham (UAB): The I-Corps@NCATS program at UAB (and at additional CTSA Program institutions) trains biomedical scientists to understand the commercial potential of research. This training aims to speed the path from scientific discovery to commercial products. First developed through a CTSA supplement, the program offers a five-week course aimed at academic medical center scientists. I-Corps@NCATS expanded from nine Mentor Nodes to 22 CTSA Program sites, creating a national innovation network. Using a Train-the-Trainer model, the program helped scientists engage in commercialization, compete for funding and connect with collaborators. The pilot phase of the program helped train 150 academic researchers who were sorted into 62 teams. Nine of these teams formed companies to make their discoveries available to customers. To date, 500 teams and 800 individuals have completed the program. Their efforts have made it easier to bring biomedical innovations to market.

   Highlight from the I-Corps@NCATS Program

   The Center for Clinical and Translational Science, the CTSA Program institution and Partner Network based at UAB, worked closely with Allan David, Ph.D. Dr. David is the John W. Brown Professor of Chemical Engineering and Associate Dean for Research at the Auburn University Samuel Ginn College of Engineering. He worked with the center through early phases of its Innovation Corps (I-Corps™) and I-Corps@NCATS programs. Dr. David used market discovery methods to refine the design of contrast agents used in magnetic resonance imaging (MRI). The U.S. National Science Foundation then selected his team for its I-Corps™ national program and subsequent two-year, $1 million SBIR Phase II grant. Dr. David’s team founded a company, Nonoxort, LLC, to provide an iron oxide MRI contrast agent that is more effective and easier on the body.

2. Pitt Challenge: The University of Pittsburgh Clinical and Translational Science Institute sponsors the annual Pitt Challenge. The event is a pharmacy-centered, 36-hour student hackathon to develop solutions to serious health challenges. The event also teaches the fundamentals of design to students across the university and region.
3. The New York University Langone Health (NYULH) Prompt-A-Thon: The NYULH Clinical and Translational Science Institute (CTSI), a CTSA Program institution, helped support the NYULH Prompt-a-thon. The Prompt-A-Thon is a health care crowdsourcing event focused on generative artificial intelligence (GenAI). GenAI creates text in response to detailed prompts and has the potential to make health care organizations more efficient. The Prompt-A-Thon aimed to inspire and build AI fluency within the NYULH community and foster collaboration and innovation. The CTSI also analyzed how participants’ experiences were shaped by prior GenAI exposure and whether they received sample prompts. The event educated and inspired hundreds of in-person and virtual participants on the responsible use of GenAI in a low-cost and technologically practical manner. The event was organized by CTSI Predictive Analytics Lead Yin Aphinyanaphongs and his team.
4. The Ohio State University (OSU) CTSA: The OSU CTSA Program institution played a key role in fostering innovation by joining together various initiatives. Such initiatives included those on mentorship, entrepreneurship training, business incubator support and product commercialization. Additionally, educational initiatives improved participants’ understanding of user-centered design, commercialization strategies, and intellectual property protection. These initiatives included design thinking bootcamps and expert-led lectures. Seed funding programs provided additional support for early-stage product development, enabling proof-of-concept and feasibility testing. By promoting collaboration across various fields and addressing commercialization challenges, the OSU CTSA Program created a successful ecosystem for medical technology advancement. These efforts sped up health care innovation, enhanced patient care and strengthened translational research at OSU and Nationwide Children’s Hospital.
5. Implementation Science Mentorship Program at The University of Chicago: The Implementation Science Mentorship program provides mentorship to quickly expand evidence-based interventions and health policies across the Institute for Translational Medicine (ITM) Chicagoland community. These efforts improve health equity. The Implementation Science Mentorship program is a 12-month directed mentorship that includes a $25,000 Implementation Seed Award for work in three translational science areas. The three areas are hospital-based clinical care, ambulatory care, and community-based programs and public health. The award aims to drive the next phase of implementation translation for projects that include an evidence-based health innovation (e.g., intervention, program). Program mentors will provide high-level strategy and guidance to research teams as they turn their innovations into practice and deliver them. Mentors also will support the team’s health equity goals. The award may be used to develop and pilot distribution and implementation materials. It may also be used to gather further evidence (e.g., feasibility assessment, intervention adaptation, economic analysis) to support implementation goals. This award mechanism is linked to the I-Corps@NCATS training program. ITM I-Corps@NCATS teams that complete the program are eligible to apply.
6. America’s Got Regulatory Science Talent: The University of Rochester’s annual America’s Got Regulatory Science Talent competition lets students compete for a chance to present their regulatory science ideas to the U.S. Food and Drug Administration.
7. Dissemination & Implementation (D&I) Launchpad: The University of Wisconsin–Madison Institute for Clinical and Translational Research Dissemination & Implementation (D&I) Launchpad offers an innovative Design for Equitable Dissemination award. The D&I Launchpad engages various groups — end users, implementers and adopters, including from historically underrepresented communities — early in the intervention design process. By engaging these groups early, the D&I Launchpad aims to improve how feasible, acceptable and adoptable the intervention is. The award is offered in partnership with faculty and researchers from the University of Wisconsin–Madison School of Human Ecology. Outcomes include an intervention model designed with partners that is ready for pilot testing. Other resources from the D&I Launchpad include intellectual property education and an Evidence-to-Implementation award.
8. UMass Chan Medical School Entrepreneurship, Biomedical Innovation and Design Pathway: New educational pathways to train physicians to practice health care in the 21st century were designed. The UMass Chan Medical School put into effect a redesigned M.D. program in fall 2022. The updated program included seven educational pathways, including Entrepreneurship, Biomedical Innovation and Design. This pathway is modeled after the I-Corps™ curriculum, with added material about engineering design. This manuscript describes the pathway curriculum and shares initial evaluation data and learning outcomes.
9. Academic Entrepreneurship E-Book: The University of Pennsylvania Institute for Translational Medicine and Therapeutics partnered with the Children’s Hospital of Philadelphia Research Institute to design a central repository to collect information and experiences about health innovation. It is a place to house and explore the evolving knowledge base around translating evidence into impact. The free Academic Entrepreneurship e-book includes more than 600 pages of content that gives a thorough introduction to biomedical entrepreneurship. It has been downloaded more than 400,000 times worldwide and is a leading textbook in the field.
10. Academic Entrepreneurs Program (AEP): The South Carolina Clinical and Translational Research Institute at the Medical University of South Carolina (MUSC) has established the Academic Entrepreneurs Program (AEP). The AEP allows MUSC inventors and researchers to take short sabbaticals at the Baruch S. Blumberg Institute and its Pennsylvania Biotechnology Center (PABC). The PABC is a nationally recognized leader in life science technology development. The goal of this program is to address the very early stages of discovery development and later handoff into seed investment stages. The broader goal after the AEP has properly positioned candidate discoveries is the development of useful products and new startups. Success in this partnership between an academic center and a private, nonprofit center focused on translating discoveries can be a model of innovation for other CTSAs. To date, 15 technologies from MUSC faculty have been reviewed for collaborative assistance, and one was selected for support of intellectual property evaluation and business and product development.

1. Massachusetts Medical Device Development Center & Biotech Incubator (M2D2): The University of Massachusetts (UMass) Center for Clinical and Translational Science (CCTS) M2D2 is a lifeline for the state’s smaller medical device companies. M2D2 offers inventors and executives easy, affordable and coordinated access to world-class researchers and resources through a partnership between the UMass Lowell and UMass Chan Medical School campuses.
2. North Carolina Translational and Clinical Sciences Institute (NC TraCS): The University of North Carolina (UNC) CTSA: The UNC School of Medicine’s NC TraCS has a strong impact on innovation at UNC and across the region. In 2017, NC TraCS launched FastTraCS, the first MedTech incubator at UNC focused on supporting clinical and health care innovations in partnership with UNC Health. The program has supported more than 30 projects, filed for 10 patents and launched four startup companies.
3. Drug and Device Advisory Committee (DDAC): The University of Washington Institute of Translational Health Sciences (ITHS) Technology Development Center is staffed with clinical, regulatory and commercialization experts. The Technology Development Center helps academic and industry innovators with translation, startup formation, clinical study, regulatory clearance, fundraising and market entry through its Drug and Device Advisory Committee (DDAC) and follow-on project consulting. Between 2008 and 2016, 28% of the teams that consulted DDAC went on to form a startup. Commercialization rates for the UW School of Medicine increased significantly as a result of combining ITHS DDAC services with complimentary commercialization programs offered by the UW technology transfer office.
4. BioLabs@NYULangone: The New York University Clinical and Translational Science Institute (CTSI) works with the New York City Economic Development Corporation (EDC) to develop a biotechnology ecosystem in New York City. This ecosystem helps academic centers translate their research for the benefit of patients into new therapies, medical devices and startup companies. One example of this tight collaboration is the BioLabs@NYULangone incubator. This incubator opened in July 2019. It is managed by and co-programmed with the BioLabs group from Cambridge, Massachusetts, and hosts 37 companies as of Q4 2024. Support for the incubator includes $5 million from NYU Langone Health; $5 million from the EDC; $2 million from the New York Empire Fund; $3.5 million of in-kind donations from equipment and instrument manufacturers; and $3 million in sponsorships from pharmaceutical companies, law firms and others. The latter amount is applied against the operating budget to enable low-cost rents for up to 35 biotech startup companies.
5. Columbia University CTSA: The Irving Institute for Clinical and Translational Research has trained 95 teams in commercialization and awarded $1.4 million to 42 faculty-led teams over eight program cycles. Alumni have raised $84.6 million in follow-on funding. The Institute and its partners hold in-person networking events for all life science accelerator teams. Such events let the teams meet fellow innovators and advisers and hear from successful teams that previously completed the program. The events are often hosted at Alexandria LaunchLabs@Columbia, a partnership between Alexandria Real Estate Equities, Inc., and Columbia University. This partnership offers a unique state-of-the-art facility, shared lab space and move-in-ready office space for fast-growing startups that are part of the Alexandria investment network.
6. The University of Chicago CTSA: The University of Chicago CTSA leverages the NIH Research Evaluation and Commercialization Hubs (REACH) and Chicago Biomedical Consortium Hub for Innovative Technology and Entrepreneurship in the Sciences (CBC-HITES) to help Chicago’s academic inventors partner with biopharmaceutical industry leaders to transform their research into commercial products.
7. ZorroFlow, Inc.: The University of Alabama at Birmingham (UAB) Center for Clinical and Translational Science (CCTS) works with investigators to advance clinical applications with special consideration of vulnerable populations across the life span, including newborns and small children. CCTS Investigator David Askenazi, M.D., M.P.H., and his team founded the new venture, ZorroFlow, Inc., to design an external urine collection device for newborns. This device is safe, comfortable and easy to use for continuous measurement of urine output and sampling. This technology has overcome major barriers to monitoring health outcomes and disease progression related to kidney function in infants. It allows more accurate and timely intervention and care.

1. Biomedical Innovation Program (BIP): The Biomedical Innovation Program (BIP) at the Oregon Health & Science University Clinical and Translational Research Institute speeds the delivery of health care technologies. The program cultivates, evaluates, funds and removes translational barriers for promising innovative projects and moves them forward. BIP also provides tailored and dedicated project management, customized mentoring, and help to quickly identify and overcome barriers to success, as well as support for finding follow-on funding.
2. Co-Design Studio: The Co-Design Studio at The Ohio State University (OSU) Clinical and Translational Science Institute (CTSI) was an interdisciplinary workspace focused on medical device innovation. It brought together faculty, students and industry experts from medicine, engineering and business. Together, these experts supported product development from concept to prototype. With advanced prototyping tools, participants refined designs for producibility and clinical application through ideation, usability testing and iterative design. The studio provided entrepreneurial guidance on regulatory pathways, intellectual property and product–market fit. The studio also provided mentorship and access to fabrication techniques like 3-D printing and injection molding. By integrating technical innovation with business strategy, the Co-Design Studio sped up medical technology development to improve patient care.
3. NC TraCS Design Lab: The NC TraCS Design Lab at the University of North Carolina provides advanced facilities for medical device design, rapid prototyping and testing. The laboratory is supported by engineers with expertise in ISO 13485, ISO 10993 and FDA 21 CFR Part 820 standards. Strategic on- and off-campus partnerships further expand access to specialized resources, ensuring high-quality, cutting-edge innovations in medical technology.
4. Human-Centered Design (HCD): The University of Pittsburgh CTSI Human-Centered Design (HCD) service provides HCD training, consultation and facilitation for health science research teams across the university. Resources include facilitation of HCD sessions, methods consultation, and a reference and resource repository. The HCD service also offers a Human-Centered Design Foundations for Health Research Certification training program, which is customized for the university’s health science researchers.
5. University of Minnesota (UMN) CTSA: The Office of Discovery and Translation (ODAT) in UMN’s CTSI speeds health innovation by providing funding and expert guidance to turn research into real-world solutions. Rather than offering traditional entrepreneurship training, ODAT provides practical, hands-on guidance and funding to help researchers translate their work beyond academia and into practical use. By collaborating with the UMN technology transfer office and industry partners, ODAT has played a key role in UMN’s record-breaking startup creation. As of early 2025, ODAT programs have funded more than 230 innovations, with over 50 ODAT-supported technologies licensed to UMN start-up companies. 
   References: https://pmc.ncbi.nlm.nih.gov/articles/PMC4268415/; https://pmc.ncbi.nlm.nih.gov/articles/PMC6676500/
6. AppHatchery: Increasingly, patient issues in modern medicine are being solved with mobile app solutions. Mobile apps also have the potential to transform how clinical research is run. To address key challenges in the app development process that slow down bringing these new technologies to patients, the Georgia Clinical and Translational Science Alliance (Georgia CTSA) launched an academic subunit. The subunit, called the AppHatchery, supports clinical investigators as they create and translate their mobile medical app ideas. AppHatchery has built and launched more than 15 digital health tools to support clinical research and research activities. It has partners at Emory University, Morehouse School of Medicine, University of Georgia and Georgia Tech. Reference: Navigating the complexities of mobile medical app development from idea to launch, a guide for clinicians and biomedical researchers
7. Medical Device Development (MDD): Advancing From Product to Market: Medical Device Development (MDD): Advancing From Product to Market is a course offered by Harvard University. It studies the current climate for the development of medical devices. The course is offered each year, with the option for an online-only or hybrid learning experience. MDD begins with a nine-week online session that includes case examples featuring real-world critical aspects and challenges in device development, key factors in regulatory decision-making, and techniques for technology valuation and finding potential sources of funding. There also are three live virtual sessions with medical device experts. An in-person, one-day pitch competition lets students work on best practices for a customizable pitch that delivers public information to key stakeholders. The competition is coached and judged by Boston-area medical technology professionals.

1. The University of Alabama at Birmingham (UAB) CTSA: The Center for Clinical and Translational Science (CCTS) at The University of Alabama at Birmingham, a CTSA Program institution and Partner Network, works closely with Southern Research. The partnership promotes innovation, entrepreneurship and commercial development in the Southeast to speed the translation and impact of new discoveries and technologies. The partnership provides resources, environment and wrap-around services that can help emerging products and teams get off the ground.
2. Innovation Funding Programs: Innovation Funding Programs at the University of Pittsburgh (Pitt) CTSI funded 11 program cycles and awarded $2.37 million to 42 project teams through five individual programs, including the flagship Pitt Innovation Challenge. A total of 222 project applications were received across all program cycles. The programs develop multimodal milestones, science communication, Path to Impact planning and commercialization guidance. Projects include devices, therapies and public health programs in the areas of pain management, health sustainability, women’s health, small-molecule therapeutics, neurosensors and stimulators, oral health, surgical tools, mental health, lung health, Lyme disease, ocular care, physical therapy, and cardiovascular care.
3. Licensing & Ventures Group: The University of Virginia (UVA) CTSA Program affiliate is the Licensing & Ventures Group at UVA. The group offers seed funding, consultations and entrepreneurial mentorship for research faculty and trainees. In 2023, 150 inventions were disclosed, 217 patents were filed and 67 new licensing deals were made across UVA. Of these, 53% were from the School of Medicine.
4. Innovation Catalyst: Innovation Catalyst is a program at Emory University and within the Georgia Clinical and Translational Science Alliance. It provides early-stage commercialization consultation and digital health development support. The program regularly provides training on customer discovery, SBIR/STTR grant writing and regulatory strategy for medical products. The program also has built and launched more than 15 digital health tools to support clinical research and research activities with partners Emory University, Morehouse School of Medicine, University of Georgia, and Georgia Tech. In addition, the leaders of the Georgia CTSA program support Emory-wide entrepreneurship activities at the School of Medicine and Provost levels. References: https://med.emory.edu/ic and https://innovate.emory.edu
5. Stablix: The Irving Institute for Clinical and Translational Research supported a team led by Dr. Henry Colecraft. The team raised $63 million in for their startup, Stablix. Series A funding is the first round of funding after the seed stage. Stablix is pioneering a new field of , which uses small molecules to stabilize specific proteins.
6. Northwestern University CTSA: The Northwestern University Clinical and Translational Sciences (NUCATS) Institute has long supported entrepreneurship training and education, as well as product commercialization. NUCATS collaborates with both the university’s Innovation and New Ventures Office (INVO) and its faculty start-up incubator, the Querrey InQbation Lab, or “the Q.” NUCATS helps INVO distribute information about its programs, INVOForward and FoundHer. The NUCATS contact multi–principal investigator participates in panels advising entrepreneurs in the INVOForward program. As part of a recently awarded UM1, NUCATS is starting office hours at the Q in Evanston to better share information about NUCATS and medical school resources with the Q’s entrepreneurial community. NUCATS also is working with INVO to plan an “Innovator Access” program onsite at their adult hospital to identify and serve the needs of entrepreneurs based there and at the medical school, with a focus on data scientists and informaticians. An updated version of “Studio Consultations” (“Innovation Studios”) soon will provide navigation and advice to academic innovators that fits their interests at an early stage of product design/validation. This includes resources on such topics as U.S. Food and Drug Administration regulatory education/advice, commercialization/market potential, customer discovery and community engagement, and implementation science. One of NUCATS’ Research Programs (in Module E) also capitalizes on the institute’s collaborations with the Consortium for Technology & Innovation in Pediatrics to study approaches to ethics, and regulatory science issues needed to develop a regenerative medicine device that can then be generalized to other pediatric products.