Series Description

The FDA Grand Rounds is webcast every other month to highlight 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
1) Zika virus (ZIKV) is able to be sexually transmitted and can result in birth defects or fetal loss. Presented is an evaluation of non-human primate testicular organoids for use as an in vitro model of ZIKV infection. Once developed, this model might be useful for evaluating potential vaccines or treatments for ZIKV infection in the male reproductive system.

2) Liver microphysiological systems (MPS) are novel cell culture approaches aimed at better maintain the functions of in vitro cultured liver cells and recapitulate liver responses observed under in vivo conditions. Major commercial liver MPS will be introduced, focusing on how they work and the pros and cons of each platform. The challenges in using liver MPS to help reduce or refine animal tests will be discussed.

This activity may reference off-label use of FDA-approved products.

References

• Liver-on-a-chip devices: the pros and cons of complexity. Dalsbecker P, Beck Adiels C, Goksör M. Am J Physiol Gastrointest Liver Physiol. 2022 Sep 1;323(3):G188-G204. doi: 10.1152/ajpgi.00346.2021
• Liver organ-on-chip models for toxicity studies and risk assessment. Messelmani T, Morisseau L, Sakai Y, Legallais C, Le Goff A, Leclerc E, Jellali R. Lab Chip. 2022 Jun 28;22(13):2423-2450. doi: 10.1039/d2lc00307d.
• Co-Culture of Human Primary Hepatocytes and Nonparenchymal Liver Cells in the Emulate® Liver-Chip for the Study of Drug-Induced Liver Injury. Shi Q, Arefin A, Ren L, Papineau KS, Barnette DA, Schnackenberg LK, Hawes JJ, Avigan M, Mendrick DL, Ewart L, Ronxhi J. Curr Protoc. 2022 Jul;2(7):e478. doi: 10.1002/cpz1.478

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 the ways Zika virus is transmitted among the human population and the negative outcomes associated with Zika virus infection.
• Discuss how in vitro testicular organoid models can be used as a model of Zika virus infection.
• Explain the definition of liver microphysiological systems .
• Describe how the major commercial liver microphysiological systems work.
• Discuss the hopes and challenges of using liver microphysiological systems to aid drug discovery and development.

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

Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.

Disclosure

Faculty

• Petibone, Dayton, PhD, Research Biologist, National Center for Toxicological Research US FDA - nothing to disclose
• Shi, Qiang, PhD, Visiting Scientist, FDA - 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
• Wheelock, Leslie, RN, MS, Director, OSPD, FDA, OC, OCS, OSPD - nothing to disclose

CE Consultation and Accreditation Team

• Bueide, Rachel E., MPhil, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose

Registration Information
Registration is complimentary; therefore refunds are not applicable.