Joan E. Adamo, Ph.D.

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.