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Opportunity to Grow and Explore: Lessons from a Bioinnovation Graduate Student Summer Internship Program at the U.S. Food and Drug Administration

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Conference

2016 ASEE Annual Conference & Exposition

Location

New Orleans, Louisiana

Publication Date

June 26, 2016

Start Date

June 26, 2016

End Date

August 28, 2016

ISBN

978-0-692-68565-5

ISSN

2153-5965

Conference Session

Entrepreneurship & Engineering Innovation Division Technical Session 4

Tagged Division

Entrepreneurship & Engineering Innovation

Page Count

9

DOI

10.18260/p.25839

Permanent URL

https://peer.asee.org/25839

Download Count

89

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Paper Authors

biography

Anne-Marie Jacob Job Tulane University

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Anne-Marie Job received her doctorate in Biomedical Engineering from Tulane University in 2011. Soon thereafter, she assumed the role of Program Manager to a newly-minted Interdisciplinary Phd Program at Tulane in Bioinnovation. This graduate program fosters the design and development of innovative biomedical technologies and products through a balanced educational approach that combines strong foundations in science and engineering and direct collaboration with healthcare professionals and business and regulatory partners. Bioinnovation graduate students participate in transformative biotechnology development in collaborative teams that link partners from Tulane's Schools of Science & Engineering, Medicine, Public Health & Tropical Medicine, Business and Law. Additional business and regulatory training through local biotech incubators and accelerators as well as a summer internship at the US Food and Drug Administration help to sharpen student's entrepreneurial acumen and prepare them for advanced careers as leaders at the interface of academia and industry.

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biography

Rebecca Zarch SageFox Consulting Group

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Rebecca Zarch is an evaluator and a director of SageFox Consulting Group. She has spent the last 10 years evaluating projects supporting young adults moving through the STEM pipeline and workforce development projects. Rebecca’s work often involves evaluations of innovative approaches to STEM education, typically at community colleges and graduate school programs. Rebecca received her MBA in non-profit management at the Heller School for Social Policy and Management and her M.Ed. from the Harvard Graduate School of Education.

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biography

Alan R. Peterfreund SageFox Consulting Group

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Alan Peterfreund is Executive Director of SageFox Consulting Group, an education research, evaluation located in Amherst Massachusetts. Alan has a Ph.D. in Geology from Arizona State University, and has been a research faculty member at Brown University. A career-shift in 1984 led to 16 years of consulting in the private and public sector with primarily emphasis on organizational change, quality management, and employee participation. Starting in 2000, Alan began to focus on supporting higher education partners in projects that address broadening participation in the sciences, graduate student development, curriculum innovation, instructional technology, teacher professional development and other education reforms. For the past five years, Alan has been the lead evaluator for Epicenter, an NSF-funded STEP Center focused on infusing entrepreneurship and innovation into undergraduate engineering education.

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biography

Donald P. Gaver Tulane University

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Donald Gaver is Chair of the Biomedical Engineering Department and Director of the Interdisciplinary Bioinnovation PhD Program at Tulane University. In addition, he directs research in Tulane’s Biofluid Mechanics Laboratory, which aims to develop an understanding of the interrelationship between the mechanical and physicochemical behavior of biological systems. These investigations focus on the pulmonary system with the goal of developing improved therapies for pulmonary diseases such as infant and acute respiratory distress syndrome (RDS and ARDS) and the prevention of ventilator-induced lung injury (VILI). At present, his research focuses on study of the dynamic interplay between transport processes, interfacial phenomena and fluid stresses that alter the pulmonary epithelial structure and function during respiratory distress. In addition, his research extends to the design of optimized microfluidic devices for biosensor technology. These integrated studies bring together basic and applied scientists (including computational scientists), device developers and physicians to study problems of high clinical importance.

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Abstract

The development of biomedical technologies and devices and their translation to the healthcare market requires a strong foundation in science and engineering, an understanding of clinical need, and well-honed entrepreneurial skills. Tulane University’s Bioinnovation PhD program was initiated in 2012 through the National Science Foundation’s Integrative Graduate Education and Research Training (IGERT) grant mechanism to provide emerging entrepreneurial scientists and engineers with the skills needed to bring research from “bench to bedside.” A hallmark of the program is a summer internship at the Food and Drug Administration (FDA) in the Division of Postmarket Surveillance – this is a Division in the Office of Surveillance and Biometrics of the Center for Devices and Radiological Health (CDRH). All degree candidates spend the summer working at the FDA in Silver Spring, MD after the first year of academic study to understand the practical and regulatory considerations that are required for the successful development of biomedical technologies and devices.

Over the past three years, twelve fellows in three cohorts have participated in this summer internship program. The internships were a first for FDA; as such, expectations about what could be accomplished over a 12-week period were minimal. What occurred in the first couple of years was remarkable: Bioinnovation fellows were given considerable latitude and opportunity to discover and work on real world issues that the FDA needed to address. Fellows matriculated through the FDA along a path of relatively unstructured discovery, wherein they learned about the agency and the processes and issues associated with product regulatory practices. Likewise, the agency came to realize the value of an exploratory approach to orientation and training that is currently under consideration for new FDA analysts.

The FDA internship has also proven to be influential to the professional growth of the graduate fellows. They found particular value in their role as “active witnesses” to the agency’s Signal Review Meetings, where they were able to observe, reflect and follow up with professionals on the decision making process associated with the adverse effects of a medical device. These interactions taught them how to network and learn through observation and to work within the confines of a hierarchical non-academic organization. The process also challenged analysts to expand their understanding of what is possible by considering new approaches to confronting regulatory issues.

Job, A. J., & Zarch, R., & Peterfreund, A. R., & Gaver, D. P. (2016, June), Opportunity to Grow and Explore: Lessons from a Bioinnovation Graduate Student Summer Internship Program at the U.S. Food and Drug Administration Paper presented at 2016 ASEE Annual Conference & Exposition, New Orleans, Louisiana. 10.18260/p.25839

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