3D Cell Culture Models for Drug PK, Safety, and Efficacy Assessment

Friday, August 14, 2020
12:00 p.m.-4:00 p.m.
Virtual - WebEx
Ann Anonsen

** This meeting has been postponed to August 14, 2020. **

On August 14, 2020, the FDA and M-CERSI will co-host a collaborative workshop - "3D Cell Culture Models for Drug PK, Safety, and Efficacy Assessment." This event will take on a virtual format via WebEx. 

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To ensure the safety and efficacy of drugs, FDA published a number of guidances in the past decade providing recommendations to pharmaceutical indsutry for assessing drug-drug interactions, drug-induced liver toxicity, as well as investigational new drug (IND)'s safety in general. Collectively, preclinical testing has served as a foundation for evaluation of the potential risks and effectiveness of IND drug products in humans. Nevertheless, current two dimensional-based in vitro cell culture systems cannot accurately depict and simulate the rich environment and complex processes observed in vivo, while animal studies present significant drawbacks such as inherited species-specific differences and low throughout scales for increased demands. To improve the preclinical prediction of drug safety and efficacy, researchers continue to develop better models to evaluate and promote the use of improved cell and tissue based assays for more accurate representation of human susceptibility to drug response.

The emerging three-dimensional (3D) cell culture models appear to be a more accurate representation of the natural environment experienced by the cells under physiological and/or pathophysiological conditions and offer great potentials in assessing drug disposition and pharmacokinetics that influence drug safety and efficacy at an early stage of drug development. Currently, there are many different types of 3D culture systems, from simple spheroids to more complicated organs-on-chips and from single-cell type static 3D models to cell-coculture 3D models equipped with microfluidic flow control, each kind of them provides different advantages and disadvantages. It is noteworthy that 3D culture model is a relatively new technique that researchers have not yet fully grasped their phenotypical performance and potential implications. How well these different 3D models have advanced and which of them are suitable models that best reflecting physiologically relevant human situations are critical for improving the quality of drug safety and efficacy assessment. This proposed educational workshop will address an unmet need and an area of regulatory science identified by FDA and University of Maryland scientists in developing better models to identify and accurately predict drug risks and efficacy.


This workshop is designed to:

1) advance regulatory science by modernizing toxicology to enhance product safety

2) promote the use of novel cell and tissue models that better represent human drug responses

3) promote a better understanding of toxicity mechanisms by evaluating physiologically relevant 3D models at multiple molecular biological levels

4) improve the ability of non-clinical models/tests for early risk assessment.

This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 totaling $5,000 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

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