ORAQ Leadership and Administration

Susanna Naggie, MD, MHS
Associate Professor of Medicine
Vice Dean for Clinical Research

Email: susanna.naggie@duke.edu
Phone: (919) 684-2584

Susanna Naggie, MD, is the Vice Dean for Clinical Research and Associate Professor of Medicine in the Duke University School of Medicine effective May 20, 2020. Dr. Naggie has direct responsibility for advancing the clinical research mission of the School of Medicine. She works closely with School of Medicine, Health System and Campus leaders including the Vice Dean for Translational Sciences, Vice Dean for Data Science and Information Technology, Executive Vice Dean for Administration, and Vice Dean and Executive Director of the Duke Clinical Research Institute (DCRI). She oversees the Duke Office of Clinical Research (DOCR) and Office of Regulatory Affairs & Quality. She also has a leadership role with the Clinical Research Units (CRUs), working closely with department CRU leadership.

Dr. Naggie is a physician-scientist focused on the care of patients with HIV and viral hepatitis and leads a research program aimed at understanding the mechanisms of accelerated liver fibrogenesis in this patient population and the development of biomarkers to guide medical decision making. She currently serves as chair of the AIDS Clinical Trials Group Viral Hepatitis Transformative Science Group Committee and was recently appointed to the NIH COVID-19 Treatment Guidelines Panel. Dr. Naggie earned her MD from Johns Hopkins School of Medicine and completed her Internal Medicine training at Duke University, where she also served as a Chief Resident in Internal Medicine. She completed her Infectious Diseases fellowship training at Duke, joining the faculty in the Division of Infectious Diseases in 2009.

 

Amanda Parrish, PhD, RAC
Executive Director, Regulatory Affairs and Quality

Email: amanda.b.parrish@duke.edu 
Phone: (919) 668-8772

Amanda Parrish, PhD, RAC is the Executive Director of Regulatory Affairs and Quality in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Parrish oversees a team of Regulatory and Quality professionals who provide guidance on FDA regulations for product development, clinical trials research, and manufacturing at Duke.

Dr. Parrish is responsible for providing support and guidance to investigators regarding the regulatory and quality requirements relevant to their clinical research activities. She performs a variety of services including regulatory/quality education, regulatory/quality consultation, and support for regulatory submissions. She supports Duke investigators and associated project teams with regulatory needs in a variety of therapeutic areas, including drug, biologic, and device regulatory submissions. She has conducted numerous meetings with the FDA, and her regulatory/GMP experience ranges from early Phase 1 activities through product licensing. She was the primary regulatory project leader for the US approval of the Carolinas Cord Blood Bank BLA and continues to support the regulatory and quality assurance activities associated with the Duke BLA. In addition, Dr. Parrish also oversees and manages implementation of new educational, operational, and collaborative initiatives within ORAQ.

After receiving her undergraduate degree in biology from Emory University, Dr. Parrish worked for two years in a laboratory performing prostate cancer research. She came to Duke University in 2004 to conduct her graduate research studies, where she obtained a PhD in Molecular Cancer Biology with a certificate in Cell and Molecular Biology. Her graduate research focused on regulation of the apoptotic cell death process. Following a short post-doc in her graduate lab and an internship with the Duke Translational Medicine Institute (DTMI) Regulatory Affairs office, in 2010, she moved into a role as a Regulatory Affairs Scientist at Duke University. Dr. Parrish holds the US Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.
 

Administrative Support 
 

Susan Nagorski
Administrative Assistant &
Training Program Coordinator

Email: susan.nagorski@duke.edu
Phone: (919) 668-0502

Susan Nagorski is the Administrative Assistant and Training Program Coordinator for the Office of Regulatory Affairs and Quality within the Duke University School of Medicine.  She supports the entire ORAQ staff by coordinating meetings and maintaining all office operations.  Additional duties include website management, expense processing, maintaining departmental databases, workshop coordination and support with regulatory submissions as needed. Susan also functions as the coordinator of the Regulatory Affairs Training Program.  Susan has a BS in Sociology from Western Carolina University and a Technical Excellence Certificate from Duke University Learning and Organization Development. 

 

 

Directors and Associate Directors

Under the direction of Amanda Parrish, PhD, RAC, the Office of Regulatory Affairs and Quality provides guidance and support to Duke Investigators manufacturing, developing, or conducting research with FDA regulated products. This includes investigational drugs, biologics, medical devices, and tobacco products. The leadership team is responsible for providing strategic input on FDA regulations pertaining to product manufacturing, product development, and clinical trials research. In conjunction with regulatory and quality staff, the leadership team advises on early regulatory strategy development, preclinical testing, Good Manufacturing Practice (GMP) regulations, and FDA meetings and inspections. The leadership team is supported by administrative professional staff and oversees the development and implementation of educational, operational, and collaborative programs hosted by the office.

Meet the Leadership Team

Regulatory Affairs Team

The regulatory affairs team is responsible for supporting Duke investigators who are developing or conducting research with investigational medical products. The team is comprised of regulatory affairs professionals that have extensive scientific training. Under the direction of leadership, the regulatory affairs team provides guidance to investigators and study teams involved in clinical research and for which FDA oversight is required. This support includes early regulatory strategy development, regulatory application submission and maintenance, requests for meetings with FDA, as well as regulatory education and training. The regulatory affairs team is supported by document specialist staff and is involved in the implementation of educational, operational, and collaborative initiatives hosted by the office. 

Meet the Regulatory Affairs Team

Quality Team 

The quality assurance team is responsible for quality oversight of investigational product manufacturing at Duke University. The team provides dedicated support to Good Manufacturing Practice (GMP) facilities across campus, including the Marcus Center for Cellular Cures (MC3), the Duke Human Vaccine Institute CGMP Program (DGP), and the Molecular Products and Cellular Therapy (MPACT) Manufacturing Facility. The quality assurance team provides customized support for review of quality documents and agreements, internal and external audits, and general consultations on quality-related matters. The quality assurance team is supported by document specialist staff. 

Meet the Quality Team