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  5. FDA Grand Rounds - Advancing blood safety and patient health in HIV/AIDS through FDA’s research on viral genome surveillance, diagnostic technologies, and biomarker discovery - 09/12/2024
  1. FDA Grand Rounds

Webcast | Virtual

Event Title
FDA Grand Rounds - Advancing blood safety and patient health in HIV/AIDS through FDA’s research on viral genome surveillance, diagnostic technologies, and biomarker discovery
September 12, 2024

Date:
September 12, 2024
Time:
12:00 p.m. - 1:00 p.m. ET
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FDA Grand Rounds - Advancing blood safety and patient health in HIV/AIDS through FDA’s research on viral genome surveillance, diagnostic technologies, and biomarker discovery

 About the Speaker

Indira K Hewlett, Ph.D.

Indira K Hewlett, Ph.D.
Senior Biomedical Research and Product Assessment Service Expert
Chief, Laboratory of Molecular Virology
Division of Emerging and Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics Evaluation and Research (CBER)
Food and Drug Administration (FDA)

About the Speaker

Dr. Indira Hewlett received her Ph.D. degree in Biological Sciences/Virology from the State University of New York, Albany and did her postdoctoral work at the Imperial Cancer Research Fund, UK, and the NCI/NIH.  She joined CBER, FDA in 1985 as a Principal Investigator to work on HIV/AIDS and related co-infections.  In 1992 she was appointed Chief of the Laboratory of Molecular Virology in the Office of Blood Research and Review of CBER, a position she has held until the present time. In 1998, Dr. Hewlett was appointed to the Biomedical Research and Product Assessment Service (SBRPAS) and she currently serves as a member of the Scientific Review Board. 

At CBER she initiated a research program on HIV/AIDS with an emphasis on novel diagnostic technologies, viral genomic diversity, and host/viral pathogenesis. She received multiple grants to perform these studies and has published more than 150 papers in peer reviewed journals.  

Dr. Hewlett’s laboratory research on novel detection methods and reference materials for assay standardization was key to advancing implementation of nucleic acid testing (NAT) platforms for blood and plasma donation screening, and viral load testing of patients on therapy. Her research contributed to development of regulatory and technical guidance for validation of NAT for which she was awarded the FDA Commissioner’s Special Citation, Award of Merit and CBER Director’s Distinguished Service Award.

About the Presentation

Despite advances in testing and development of effective anti-retroviral therapies (ART), HIV/AIDS continues to be of global public health concern. This presentation will focus on FDA’s regulatory research efforts to advance effectiveness of testing through 1) development of standards, 2) evaluation of novel detection methodologies to improve virus detection and, 3) identification of biomarkers for latency in the context of Pre-Exposure Prophylaxis (PrEP) and Anti-retroviral therapy (ART) which have been widely implemented.

Learning Objectives

  • Describe and provide background on HIV biology and infection.
  • Discuss studies on HIV genomic surveillance and novel diagnostic technologies.
  • Discuss biomarker studies for early detection in the context of PrEP and ART.

For technical assistance please contact: Isaac.Miller@fda.hhs.gov

Event Materials

Activity Outline - Continuing Education

For technical assistance please contact: Isaac.Miller@fda.hhs.gov

Webcast Recording 

Webcast Recording
 

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