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Joan E. Adamo, Ph.D.

Contact Information

Phone Numbers

Office: (585) 275-0742


Professional Background

Dr. Joan E. Adamo is the Director for Regulatory Support Services at the University of Rochester and is located in the Clinical and Translational Science Institute. She provides advice and guidance on clinical and basic research projects and serves as an FDA liaison for University investigators working on Sponsored and Sponsor-Investigator clinical studies. This includes supporting researchers in IDE- and IND-governed clinical studies and managing a framework for preclinical GLP compliance within the University. Prior to joining the University of Rochester, Dr. Adamo served as a researcher and regulator at the Center for Biologics Evaluation and Research in the U.S. Food and Drug Administration. Her work in the Division of Viral Products was focused on the research and approval of vaccines for Influenza, Smallpox and West Nile Virus and as a credentialed FDA inspector, she audited domestic and international vaccine manufacturers.


The majority of Dr. Adamo's work focuses on Regulatory Affairs, which is understanding the product development lifecycle as well as the application and adherence to current regulatory requirements. This work includes assisting investigators with preparing and submitting drug, biologic and medical device applications that are compliant with all levels of FDA regulations. Dr. Adamo's research interests are focused on the development of new tools, standards and approaches to assess product safety and efficacy; an area known as Regulatory Science. Regulatory Science relies on a multitude of diverse components such as science, law and policy that underlie research on regulated products, including its review to meet current regulations. Her current consortium activities include an IND/IDE taskforce and co-chairing the Regulatory Science workgroup to explore joint FDA-Academic-NIH Regulatory Science initiatives. Her teaching interests are in Regulatory Affairs, Regulatory Science and Compliance and she supports students and postdocs in expanding their skill sets through the NIH-Supported URBEST program. Dr. Adamo provides several lectures each year on regulatory topics throughout the University and Medical Center and recently co-led a Regulatory Science workshop to develop curricular guidelines and core competencies on the subject. In addition, she co-teaches a newly-developed course in Medical Device Innovations which focuses on FDA regulatory challenges as well as the commercialization and intellectual property protection processes.



BS | Cornell University

PhD | Weill Graduate School of Medical Sciences of Cornell University
Molecular Biology


Journal Articles

Gravelin M, Adamo JE, Ellison S, Segear E, Parrish AB, Deeter C, Hamill J, Rigan L, Mashour GA, Weatherwax KJ. "National landscape assessment of academic medical center support for expanded access to investigational products." Journal of clinical and translational science.. 2023 7(1):e4. Epub 2022 Nov 16.

Adamo JE, Bienvenu RV, Fields FO, Ghosh S, Jones CM, Liebman M, Lowenthal MS, Steele SJ. "The integration of emerging omics approaches to advance precision medicine: How can regulatory science help?" Journal of clinical and translational science.. 2018 Oct; 2(5):295-300. Epub 2018 Dec 06.

Adamo JE, Grayson WL, Hatcher H, Brown JS, Thomas A, Hollister S, Steele SJ. "Regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic products." Journal of clinical and translational science.. 2018 Oct; 2(5):301-304. Epub 2018 Nov 29.