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To evaluate the design of I-Corps@NCATS as a translational scientist training program, we mapped specific elements of the program’s content and pedagogy to the characteristics of a translational scientist, as first defined by Gilliland et al. []: systems thinker, process innovator, boundary spanner, team player, and skilled communicator. Using a mixed-methods evaluation, we examined how the I-Corps@NCATS training program, delivered across twenty-two Clinical and Translational Science Award Hubs, impacted the development of these key translational scientist characteristics.

Abstract Introduction As a local response to the COVID‐19 global pandemic, the University of Alabama at Birmingham (UAB) established the UAB COVID‐19 Collaborative Outcomes Research Enterprise (CORE), an institutional learning health system (LHS) to achieve an integrated health services outcomes and research response. Methods We developed a network of expertise and capabilities to rapidly develop and deploy an institutional‐level interdisciplinary LHS. Based upon a scoping review of the literature and the Knowledge to Action Framework, we adopted a LHS framework identifying contributors and components necessary to developing a system within and between the university academic and medical centers. We used social network analysis to examine the emergence of informal work patterns and diversified network capabilities based on the LHS framework. Results This experience report details three principal characteristics of the UAB COVID‐19 CORE LHS development: (a) identifying network contributors and components; (b) building the institutional network; and (c) diversifying network capabilities. Contributors and committees were identified from seven components of LHS: (a) collaborative and executive leadership committee, (b) research coordinating committee, (c) oversight and ethics committee, (d) thematic scientific working groups, (e) programmatic working groups, (f) informatics capabilities, and (g) patient advisory groups. Evolving from the topical interests of the initial CORE participants, scientific working groups emerged to support the learning system network. Programmatic working groups were charged with developing a comprehensive and mutually accessible COVID‐19 database. Discussion Our LHS framework allowed for effective integration of multiple academic and medical centers into a cohesive institutional‐level learning system. Network analysis indicated diversity of institutional disciplines, professional rank, and topical focus pertaining to COVID‐19, with each center leveraging existing institutional responsibilities to minimize gaps in network capabilities. Conclusion Incorporating an adapted LHS framework designed for academic medical centers served as a foundational resource supporting further institutional‐level efforts to develop agile and responsive learning networks.

Abstract Introduction: A key barrier to translation of biomedical research discoveries is a lack of understanding among scientists regarding the complexity and process of implementation. To address this challenge, the National Science Foundation’s Innovation Corps™ (I-Corps™) program trains researchers in entrepreneurship. We report results from the implementation of an I-Corps™ training program aimed at biomedical scientists from institutions funded by the National Center for Advancing Translational Sciences (NCATS). Methods: National/regional instructors delivered 5-week I-Corps@NCATS short courses to 62 teams (150 individuals) across six institutions. Content included customer discovery, value proposition, and validating needs. Teams interviewed real-life customers and presented the value of innovations for specific end-users weekly, culminating in a “Finale” featuring their refined business thesis and business model canvas. Methodology was developed to evaluate the newly adapted program. National mixed-methods evaluation assessed program implementation, reach, effectiveness using observations of training delivery and surveys at Finale (n = 55 teams), and 3–12 months post-training (n = 34 teams). Results: Innovations related to medical devices (33%), drugs/biologics (20%), software applications (16%), and diagnostics (8%). An average of 24 interviews was conducted. Teams reported increased readiness for commercialization over time (83%, 9 months; 14%, 3 months). Thirty-nine percent met with institutional technology transfer to pursue licensing/patents and 24% pursued venture capital/investor funding following the short courses. Conclusions: I-Corps@NCATS training provided the NCATS teams a rigorous and repeatable process to aid development of a business model based on customer needs. Outcomes of this pilot program support the expansion of I-Corps™ training to biomedical scientists for accelerating research translation.

OBJECTIVES/SPECIFIC AIMS: The goal of this abstract/presentation is to share lessons learned from participation in the NIH SBIR I-Corps Train-The-Trainer Program, discuss our experiences offering programs at our local institutions, and communicate our plans to develop an I-Corps@NCATS program that can be disseminated across the CTSA network. We believe that an I-Corps@NCATS program will enhance the process of scientific translation by taking best practices from NSF I-Corps and adapting the program to meet the needs of biomedical scientists in academic medical centers. By integrating I-Corps@NCATS training, we hypothesize that the clinical and translational investigator base will be better prepared to identify new innovations and to accelerate translation through commercialization. METHODS/STUDY POPULATION: The diverse, interdisciplinary team of investigators involved in this project span 9 CTSA Hubs, including UAB, Rockefeller, UC Denver, HMC-Penn State, UMass, UC Davis, Emory/Georgia Tech, Miami and Michigan. This team was funded by NCATS in 2015–2016 to participate in the CTSA I-Corps Train-The-Trainer Program in conjunction with the NIH-SBIR/STTR I-Corps national program. The goals were to observe the curriculum, interact with and learn from the NSF National Teaching Team and begin implementation of similar programs at our home institutions. Our I-Corps@NCATS team has been holding monthly, and more recently weekly, conference calls to discuss our experiences implementing local programs and to develop a strategy for expanding CTSA offerings that include innovation and entrepreneurship. Our experience revealed several challenges with the existing NSF/NIH I-Corps program offerings: (1) there is no standard curriculum tailored to academic clinical and translational research and biomedical innovations in the life sciences, and (2) the training process to certify instructors in the I-Corps methodology is a much more rigorous and structured process than just observing an I-Corps program (eg, requires mentored training with a national NSF I-Corps trainer). Our team is proposing to address these gaps by taking best practices from NSF I-Corps and adapting the program to create the I-Corps@NCATS Program, tailored to meet the needs of researchers and clinicians in academic medical centers. RESULTS/ANTICIPATED RESULTS: There are 3 primary anticipated results of our project. First, develop a uniform curriculum for the I-Corps@NCATS Program using the National Teaching Team of experts from the NIH’s SBIR I-Corps program. Second, build the I-Corps@NCATS network capacity through a regional Train-The-Trainer Program. Third, develop a set of common metrics to evaluate the effectiveness and impact of the I-Corps@NCATS Program across the community of CTSA Hubs and their respective collaborative networks. DISCUSSION/SIGNIFICANCE OF IMPACT: Over the past 10 years, CTSA Hubs have accelerated science by creating/supporting programs that provide research infrastructure, informatics, pilot funding, education/training, and research navigator services to investigators. These investments help to ensure that we are “doing science right” using the best practices in clinical research. Even so, it is equally important to make investments to ensure that we are “doing the right science.” Are our investigators tackling research problems that our stakeholders, patients, and communities want and need, to make sure that our investments in science have real-world impact? In order to accelerate discoveries toward better health, scientists need to have a better way to understand the needs, wants and desires of the people for whom their research will serve, and how to overcome key obstacles along the path of innovation and commercialization. To fill this gap, we propose that the CTSA Hubs should include in their portfolio of activities a hands-on, lean startup program tailored after the highly successful NSF Innovation Corps (I-Corps) program. We hypothesize that by adapting the NSF I-Corps program to create an I-Corps@NCATS program tailored to medical research, we will better prepare our scientists and engineers to extend their focus beyond the laboratory and broaden the impact of their research. Investigators trained through I-Corps@NCATS are expected to be able to produce more innovative ideas, take a more informed perspective about how to evaluate the clinical and commercial impact of an idea, and quickly prototype and test new solutions in clinical settings.