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  1. Biologics Research Projects

Improving Vaccine Manufacturing Evaluation for Bacterial Respiratory Pathogens

Drusilla L. Burns, PhD

Drusilla L. Burns, PhD

Office of Vaccines Research and Review
Division of Bacterial, Parasitic, and Allergenic Products
Laboratory of Respiratory and Special Pathogens

[email protected]

Biosketch

Dr. Drusilla Burns Dr. Burns received her Ph.D. in Biochemistry from the University of California, Berkeley and did postdoctoral training at NIH. After her postdoctoral work, she joined FDA. She is currently Deputy Director of the Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review at the Center for Biologics Evaluation and Research, FDA. Her lab conducts research in the areas of bacterial pathogenesis and host responses, with emphasis on the biochemistry and immunology of bacterial vaccines. In addition, she is involved in the regulation of bacterial vaccines, live biotherapeutic products, and allergenic products.

General Overview

CBER is responsible for ensuring that the vaccines that are made available to the public are safe, pure, potent, and effective. To carry out this responsibility, a solid understanding of the science of vaccines is required. The research in this Laboratory supports science-based regulation of bacterial vaccines, particularly toxoid-based vaccines, by building on the foundation of knowledge needed to ensure vaccine safety, purity, and potency. Our studies provide new scientific tools and knowledge that support the development, manufacturing, and clinical evaluation of bacterial vaccines.

Scientific Overview

Our research focuses on the study of bacterial protein toxins and virulence factors that, in inactivated forms, are included as components of bacterial vaccines. These studies examine protein structure/function relationships and mechanisms of action by which these virulence factors cause disease. Such studies help guide the regulatory review of the safety and efficacy of vaccines based on these factors. To better understand how these vaccines provide protection against disease, we also study host immune responses to these antigens and seek to determine which immune responses might correlate with vaccine-induced protection. Knowledge of both pathogenic mechanisms and host responses are essential for proper understanding of the features of vaccine antigens that are critical to ensure safe and effective vaccines.

Publications

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