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Joan E. Adamo, Ph.D.

Contact Information

Phone Numbers

Office: (585) 275-0742

Research Labs

Office of Regulatory Support

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Research Network

Biography

Professional Background

Dr. Joan E. Adamo is the Associate 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.

Research

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.

Credentials

Education

1996
BS | Cornell University
Biochemistry

2001
PhD | Weill Graduate School of Medical Sciences of Cornell University
Molecular Biology

Publications

Journal Articles

10/2015
Holbein ME, Berglund JP, Weatherwax K, Gerber DE, Adamo JE. "Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?" Clinical and translational science.. 2015 Oct 0; 8(5):526-32. Epub 2015 Jan 15.

10/2015
Adamo JE, Wilhelm EE, Steele SJ. "Advancing a Vision for Regulatory Science Training." Clinical and translational science.. 2015 Oct 0; 8(5):615-8. Epub 2015 Jun 17.

6/2014
Holbein ME, Berglund JP, O'Reilly EK, Hartman K, Speicher LA, Adamo JE, O'Riordan G, Brown JS, Schuff KG, . "Recommendations from the Investigational New Drug/Investigational Device Exemption Task Force of the clInical and Translational Science Award Consortium: developing and implementing a sponsor-investigators training program." Journal of investigative medicine : the official publication of the American Federation for Clinical Research.. 2014 Jun 0; 62(5):797-803.

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