3 results
4015 Evaluation of the Impact of a Clinical and Translational Science Predoctoral Program on Post-Graduate Outcomes
- Alexandra Joelle Greenberg-Worisek, Katherine Cornelius, Becca Gas, Carmen Silvano, Karen Marie Weavers, Lewis R Roberts, Stephen C Ekker, Felicity Enders, Anthony Windebank
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- Journal:
- Journal of Clinical and Translational Science / Volume 4 / Issue s1 / June 2020
- Published online by Cambridge University Press:
- 29 July 2020, p. 62
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OBJECTIVES/GOALS: The Mayo Clinic Clinical and Translational Science (CTS) Predoctoral program aims to develop independent researchers capable of leading multi-disciplinary teams to accelerate the translation of discovery to application. Here, we detail the outcomes of our graduates over the past ten years (2010-2019). METHODS/STUDY POPULATION:): A survey was fielded with all CTS graduates whose degrees were conferred since the program’s inception to 2019. Items addressed their current position, whether they were still involved in research, what type of research they were involved in, and whether they stayed involved with education. They also submitted a recent CV, from which data were collected about publications and grants. A subset were then contacted for a semi-structured interview. Items included questions addressing motivation for pursuing a PhD in CTS, whether the program prepared them for their current work, gaps they felt they had in training, and whether they felt they were making a difference in the lives of patients. RESULTS/ANTICIPATED RESULTS: Of the 41 alumni, 34 responded (83% response rate). Of these, 19 (56%) are at Mayo Clinic, 9 (26%) work for other academic institutions, and 6 (21%) do not work for an academic institution. Most have remained in research (33/34, 97%). The majority (22/33, 67%) are involved in clinical research, 30% (10/33) in basic science, and 24% (8/33) in healthcare delivery research. Most (23/34, 68%) are engaged in educational activities. When asked about changes they have led, 67% (18/27) led quality improvement projects and 44% (12/27) designed a new research method. Several hold leadership positions either in their organization (12/16, 75%) or in a professional organization (10/16, 63%). DISCUSSION/SIGNIFICANCE OF IMPACT: The CTS Predoctoral program successfully prepares scholars for careers involving clinical and translational research; furthermore, alumni remain in research-oriented careers after graduation. We will continue to gather longitudinal data alumni move forward in their careers.
3017 Regulatory Science in Translational and Regenerative Medicine Biomedical Education: A Pilot Course
- Alexandra Joelle Greenberg-Worisek, Luz Cumba-Garcia, Nilay Shah, Anthony Windebank
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- Journal:
- Journal of Clinical and Translational Science / Volume 3 / Issue s1 / March 2019
- Published online by Cambridge University Press:
- 26 March 2019, p. 73
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OBJECTIVES/SPECIFIC AIMS: INTRODUCTION: Many of the innovative therapies used in regenerative medicine, such as additive manufacturing and stem cell engineering, rely on novel technologies and techniques for which standards for safety, efficacy, and quality have not been fully explored and established. As these therapies and technologies develop at a rapid pace, there is a need for the development of scientifically-based metrics to assess whether new treatments are effective and safe for clinical translation. Research and development of such standards is known as “regulatory science,” and is needed by the United States Food and Drug Administration (FDA) to support the creation of the evidence-based guidances and regulations that are used in review of product submissions. As outlined by the FDA’s description of their Centers for Excellence in Regulatory Science and Innovation (CERSIs) and the Association for Clinical and Translational Science’s (ACTS) Regulatory Science Working Group, here is a need to train investigators and clinicians to conduct regulatory science research to support successful clinical translation of regenerative treatments. OBJECTIVE: To develop a course to expose scholars to regulatory science concepts, to empower them to apply these concepts to their personal areas of research, and to challenge them to engage in the dialogue surrounding regulatory science on a national level. METHODS/STUDY POPULATION: METHODS: The “Introduction to Regulatory Science” course was developed jointly by the Yale-Mayo CERSI and the Mayo Clinic Center for Clinical and Translational Science (CCaTS) in 2017 as a didactic in-person survey course. The course objectives included exposing scholars to the ideas of regulatory science and affairs; reviewing the FDA’s Priority Areas for Advancing Regulatory Science; and determining what safety, quality, and efficacy concerns may need to be addressed when using new technologies, such as those used in regenerative medicine research. To meet these intended learning objectives, the course addressed one FDA Priority area each week, with a team of experts providing one-hour of lecture and discussion each class session. Regenerative medicine-related topics included a bioethics of stem cell therapy development, evaluation of additive manufacturing as an emerging technology, and the application of cGMPs to the manufacture of new therapies. Assignments and assessments included a quiz each week, which served as a knowledge check of that week’s lecture content, and a final paper analyzing regulatory concerns associated with a technology or product of the scholar’s choosing. RESULTS/ANTICIPATED RESULTS: RESULTS: The course was first delivered as an elective in 2017, with an enrollment of 8 scholars and 3 auditors. Scholars enrolled included 7 trainees and established investigators from Mayo Clinic Rochester and one from Arizona. Of the 8 scholars enrolled, 7 completed the post-course survey. Scholars strongly agreed that the “course objectives were met” (7/7) and that the “course was well worth the effort I put into it” (7/7). Five scholars stated that they learned “a lot” during the course; two said they learned “an incredible amount.” Scholars unanimously gave the course a grade of “A.” Qualitative feedback was positive, indicating that the team-taught and in-person course design choices were highlights for trainees. The course is currently in its second delivery (2018), with an enrollment of 16 scholars across Mayo Clinic Rochester, Arizona, and Florida. DISCUSSION/SIGNIFICANCE OF IMPACT: CONCLUSIONS: The developed course was successfully piloted and well-received. Scholars reported that they agreed that the course aims were achieved, and indicated that they would like to see additional coursework to continue to learn how to engage in regulatory science. Next steps include utilizing course feedback to iterate on the current course, expanding course delivery to include scholars at the Yale site of the Yale-Mayo CERSI, and the creation of a second course.
3564 Breaking the Mold: Using a learner & faculty centric approach to increase satisfaction and usability
- Katherine Cornelius, Alexandra Joelle Greenberg-Worisek, Ryan Jimison, Jennifer Weisbrod, Karen Marie Weavers
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- Journal:
- Journal of Clinical and Translational Science / Volume 3 / Issue s1 / March 2019
- Published online by Cambridge University Press:
- 26 March 2019, p. 63
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OBJECTIVES/SPECIFIC AIMS: Scholars and faculty in the Clinical and Translational Science (CTS) track of our institution’s biomedical science graduate school reported a lack of satisfaction with our learning management system (LMS); specifically, they reported frustration with the amount of time spent locating learning assignment guidelines, course readings, and submission portals. As a result, we created a new master template to address their concerns. METHODS/STUDY POPULATION: A new template was created within the LMS based on scholar and faculty feedback. Surveys and other tools have been used to determine student and faculty satisfaction as well as measure secondary outcomes of time spent in the online learning space. Some key changes include a redesigned menu and submission portal. RESULTS/ANTICIPATED RESULTS: There was an increase in satisfaction with the new LMS template. Next steps include systematically rolling out the new template, with continued solicitation of feedback from all stakeholders. All courses in the CTS track will be converted to the new template by summer quarter 2020. DISCUSSION/SIGNIFICANCE OF IMPACT: The strengths of this project include the multidisciplinary team-based approach to improving course satisfaction and usability, as well as the use of innovative technologies. Additionally, the analytical capabilities of the LMS will be maximized in the new template, which was a shortcoming of the previously available template.