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Center for Biologics Evaluation and Research (CBER)

2013 Preceptor


 

Picture of Elizabeth SutkowskiElizabeth M. Sutkowski, Ph.D.
Chief, Regulatory Review Branch 3
Division of Vaccines and Related Product Applications (DVRPA)
Office of Vaccines Research and Review (OVRR)
Center for Biologics Evaluation and Research (CBER)
Rockville, Maryland

Background:
B.A. – Chemistry, Manhattanville College
Ph.D. – Biochemistry, Georgetown University, School of Medicine and Dentistry
FDA Experience – 20 years
 

Research Interests:

The Preceptor is Chief of a Regulatory Review Branch in the CBER division responsible for the regulatory aspects of assuring the safety and efficacy of vaccines and related products. She has experience in the regulation of both investigational and licensed bacterial and viral vaccines for infectious disease indications with a focus on vaccines for seasonal and pandemic influenza and a special interest in novel vaccine adjuvants.

Proposed Regulatory Research Project for the FDA Commissioner's Fellow:

An important component of evaluating the safety of vaccines is an analysis of the serious adverse events (SAEs) experienced by the subjects enrolled in clinical trials evaluating these products. This project will involve exploratory analyses of SAEs that have occurred during clinical trials of vaccines that have been conducted under IND.

A Fellow who agrees to undertake this project may also be able to gain experience as a project manager and/or regulatory reviewer of vaccine applications.

Applicant Requirements:

Doctoral level degree, computer expertise and experience in creating queries and analysis in a variety of analytical environments.

Selected Recent Publications/Presentations:

Sutkowski, EM. “Regulatory Considerations in the Safety Assessment of Novel Adjuvants and Adjuvanted Preventive Vaccines” AAPS National Biotechnology Conference, Seattle, WA, June 24, 2009.

Sutkowski, EM. “Regulatory Perspectives (EU and US)” DIA International Workshop on Nonclinical Testing of Vaccines, June 5, 2007.

Sutkowski, EM and Gruber, MF. Regulatory Considerations in the Nonclinical Safety Assessment of Adjuvanted Preventive Vaccines. Chapter 19 In: Immunopotentiators in Modern Vaccines; Schijns, V, O'Hagan, D, eds; Elsevier, London, 2006.