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U.S. Department of Health and Human Services

Emergency Preparedness and Response

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Sally Hojvat, MSc, PhD: Faces Behind MCMi

 

 Dr. Sally Hojvat 

I’ve always been fascinated by how much microorganisms have altered world history through the ages — from the "black death" and smallpox that swept through Europe in the Middle Ages, killing millions, to the numbers of individuals, great and small, rich and poor, like Byron, the Bronte sisters, and apparently one of my grandmothers,  who succumbed to "consumption,” or tuberculosis, as we now know it. For me, a career as a microbiologist just came naturally.  


As recently as the early 20th century, young children often failed to survive their first year, succumbing to infectious diseases like diphtheria, measles, whooping cough, and numerous enteric microorganisms. Thousands died of yellow fever building the Panama Canal. Polio was a debilitating disease during the middle part of the century, and Malaria still kills millions in the developing world.

In the mid 1990s, I was already working to develop diagnostic tests for infectious diseases like hepatitis when the human immunodeficiency virus (HIV) was linked to the immunodeficiency syndrome, now known as AIDS. A diagnosis of infection by this virus was considered a death sentence. I was involved directly with the development of the first test used to screen blood donations for the presence of HIV and I spoke regularly to schools, medical students, and professional organizations here and abroad on the disease and how to prevent infection. This experience led naturally to my involvement during the past decade with the post 9/11 anthrax attacks, the 2003 SARS epidemic, and the 2009 H1N1 influenza pandemic.

The courses I took early in my FDA career at the Armed Services University in Bethesda on chemical, biological, radioactive, and nuclear (CBRN) agents covered not only the various medical aspects of CBRN events, but also the concepts of operation and emergency preparedness — we saw vividly the potential impact of a CBRN event and how critical it was to prepare.

During the influenza pandemic of 2009, the FDA Task Force, including my Division, was able to very quickly clear, approve, and license the products that were needed. Working with the Centers for Disease Control and Prevention, we authorized a diagnostic test for the 2009 H1N1 influenza virus within 4 days of their call telling us this was "no ordinary bug." During the following year, we authorized 18 additional tests once it became clear that the public health labs could not cope with the surge in requests for testing. It was an extremely satisfying experience to be a member of this extraordinary Division/Office/Center/FDA/HHS team and to feel we had made a significant contribution with our public health response to the pandemic.

Today we know that no one agency can be responsible for preparing and protecting the Nation for a CBRN event or emerging infectious disease threat. Interagency collaboration in development and  review of MCM diagnostics is a case in point. FDA is working side by side with colleagues at the Centers for Disease Control and Prevention, the National Institutes of Health, the DoD, and others in support of MCM diagnostics development. One of our key priorities is to facilitate the development of multiplex diagnostic tests, ushering in a new era in the diagnosis of infectious diseases. We have a common mission. Although much work remains, the support we have received through the MCMi is helping us achieve our goal.

Biography

 
Since 2003, Dr. Hojvat has been the Director of the Division of Microbiology Devices, Office of In-vitro Diagnostic (IVD) Device Evaluation and Safety in the Center for Devices and Radiological Health at FDA. She is responsible for ensuring that all commercial and non-commercial devices developed to detect and diagnose infectious disease agents are safe and effective. Before joining FDA, Dr. Hojvat’s spent 18 years in the IVD industry, holding positions in IVD research and development and manufacturing quality control. Her last commercial position was as Director of Clinical Research for the Diagnostic Division of a major U.S. Pharmaceutical Company. Dr. Hojvat received a B.Sc. (Hons.) from the University of Wales, UK, a M.Sc. in microbiology from the University of Alberta, Canada, and a Ph.D. in biochemistry from Loyola University Medical School, Chicago. She completed postdoctoral training fellowships in clinical chemistry (Loyola Medical School) and pharmacology (University of Chicago). Her numerous research publications and presentations are concentrated in the fields of clinical microbiology, pharmacology, neuroendocrinology, human subject protection, clinical research, and the regulation of emerging/neglected infectious diseases and CBRN agents.