Series Description

The FDA Grand Rounds highlights cutting-edge research underway across the agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities.

Lecture Description
Despite advances in testing and the 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.

References

• Jiangqin Zhao, Hanxia Huang, Sherwin Lee, Viswanath Ragupathy, Santanu Biswas, Christelle Mbondji-wonje, et al. Identification, genetic characterization and validation of highly diverse HIV viruses for reference panel development. Viruses 2021,13(7):1-12.
• Haleyur Giri Setty MK, Kurdekar A, Mahtani P, Liu J, Hewlett IK. Cross-Subtype Detection of HIV-1 Capsid p24 Antigen Using a Sensitive Europium Nanoparticle Assay. AIDS Res Hum Retroviruses 2019; 35(4):396-401.
• Biswas S, Haleyurgirisetty M, Lee S, Hewlett I, Devadas K. Development and validation of plasma miRNA biomarker signature panel for the detection of early HIV-1 infection. EBioMedicine 2019; 43:307-316.

Series Objectives

• Discuss the research conducted at the FDA
• Explain how FDA science impacts public health

Learning Objectives After completion of this activity, the participant will be able to:

• 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.

Target Audience
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency and external scientific communities.

Registration Information
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.

Requirements for Receiving CE Credit

All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.

Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor®. If you do not see your credit reflected on CPE Monitor®* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov.
*CPE Monitor® sets a strict 60-day limit on uploading credits.

Disclosure

Faculty

• Hewlett, Indira, PhD, Laboratory Chief, CBER - nothing to disclose

Planning Committee

• Dinatale, Miriam, DO, Team Leader, Food and Drug Administration - nothing to disclose
• Pfundt, Tiffany, PharmD, Program Coordinator, FDA/CDER/OTBB - nothing to disclose
• Shahidzadeh, Rokhsareh, RN, MSN, Senior Regulatory Health Education Specialist, FDA - nothing to disclose

CE Consultation and Accreditation Team

• Faberlle, Alexandra M., Training Specialist / FDA/CDER/OEP/DLOD - nothing to disclose
• Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose