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Joan E. Adamo, Ph.D.

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Office of Regulatory Support

About Me
Credentials
Research
Publications

About Me

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.

Faculty Appointments

Adjunct Assistant Professor - Department of Biomedical Engineering (SMD) - Joint

Credentials

Education

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

BS | Cornell University. Biochemistry. 1996

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.

Publications

Journal Articles

National landscape assessment of academic medical center support for expanded access to investigational products.

Gravelin M, Adamo JE, Ellison S, Segear E, Parrish AB, Deeter C, Hamill J, Rigan L, Mashour GA, Weatherwax KJ

Journal of clinical and translational science.. 2023 7 (1):e4. Epub 11/16/2022.

The integration of emerging omics approaches to advance precision medicine: How can regulatory science help?

Adamo JE, Bienvenu RV, Fields FO, Ghosh S, Jones CM, Liebman M, Lowenthal MS, Steele SJ

Journal of clinical and translational science.. 2018 October 2 (5):295-300. Epub 12/06/2018.

Regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic products.

Adamo JE, Grayson WL, Hatcher H, Brown JS, Thomas A, Hollister S, Steele SJ

Journal of clinical and translational science.. 2018 October 2 (5):301-304. Epub 11/29/2018.

Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?

Holbein ME, Berglund JP, Weatherwax K, Gerber DE, Adamo JE

Clinical and translational science.. 2015 October 8 (5):526-32. Epub 01/15/2015.

Advancing a Vision for Regulatory Science Training.

Adamo JE, Wilhelm EE, Steele SJ

Clinical and translational science.. 2015 October 8 (5):615-8. Epub 06/17/2015.

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.

Holbein ME, Berglund JP, O'Reilly EK, Hartman K, Speicher LA, Adamo JE, O'Riordan G, Brown JS, Schuff KG,

Journal of investigative medicine : the official publication of the American Federation for Clinical Research.. 2014 June 62 (5):797-803. Epub 1900 01 01.

Options for Financially Supporting GLP and GCLP Quality Assurance Programs within an Academic Institution

Adamo, J.; Hancock, S.; Bens, C.; Marshall, M.; Kleinert, L; and Sarzotti-Kelsoe, M.

Journal of GXP Compliance. 2014; 18(1).

Production and characterization of mammalian virus-like particles from modified vaccinia virus Ankara vectors expressing influenza H5N1 hemagglutinin and neuraminidase.

Schmeisser F, Adamo JE, Blumberg B, Friedman R, Muller J, Soto J, Weir JP

Vaccine.. 2012 May 1430 (23):3413-22. Epub 03/29/2012.

A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure.

Adamo JE, Bauer G, Berro M, Burnett BK, Hartman KA, Masiello LM, Moorman-White D, Rubinstein EP, Schuff KG

Academic medicine : journal of the Association of American Medical Colleges.. 2012 March 87 (3):279-84. Epub 1900 01 01.

Smallpox vaccines induce antibodies to the immunomodulatory, secreted vaccinia virus complement control protein.

Adamo JE, Meseda CA, Weir JP, Merchlinsky MJ

The Journal of general virology.. 2009 November 90 (Pt 11):2604-2608. Epub 07/08/2009.