Mark your calendars for "3D Cell Culture Models for Drug PK, Safety, and Efficacy Assessment," a conference sponsored by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).

Scheduled for Monday, April 20, 2020, "3D Cell Culture Models for Drug PK, Safety, and Efficacy Assessment" will bring together researchers from across academia, government, and industry to address an unmet need in developing better models to identify and accurately predict drug risks and efficacy.

Important Event Information
Date: April 20, 2020
Time: 8:30 a.m. - 5:00 p.m.
Location: U.S. Food and Drug Administration
White Oak Campus
10903 New Hampshire Ave.
Building 31, Great Room
Silver Spring, MD 20993
Registration: Online Registration Available Here

About the Event:

To continue to ensure the safety and efficacy of drugs, the U.S. Food and Drug Administration (FDA) has published a number of guidances in the past decade providing recommendations to the pharmaceutical industry for assessing drug-drug interactions, drug-induced liver toxicity, as well as investigational new drug (IND) safety, in general. However, current two-dimensional (2D) based in vitro cell culture systems cannot accurately depict and simulate the rich environment and complex processes observed in vivo, and animal studies present significant drawbacks, such as inherited species-specific differences and low throughput scales for increased demands.

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 potential 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 &emdash; from simple spheroids to more complicated organs-on-chips, as well as from single-cell type static 3D models to cell-coculture 3D models equipped with microfluidic flow control. Each model provides different advantages and disadvantages. This workshop will address an unmet need in developing better models to identify and accurately predict drug risks and efficacy.

Scope of the Workshop:

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.

Special Accommodations:

If special accommodations at the workshop are needed due to a disability, please email Ann Anonsen at at least seven (7) days in advance of the workshop. Requests for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made two (2) weeks in advance of the workshop, and should be sent directly to the FDA Interpreting Services Staff at

For More Information:

More information about this workshop, including registration, an agenda, and information about parking and directions, is available on this website.

If you have any additional questions about this workshop, please contact