FDA partnership to apply lung chips to safety evaluation of COVID-19 vaccines and therapies

The U.S. Food and Drug Administration (FDA) has entered into a Cooperative Research and Development Agreement (CRADA) with Emulate, Inc. to enable multiple studies using Emulate’s Organ-Chips across FDA offices in priority research areas. Organ-Chips are in vitro systems that recreate the natural physiology of specific human tissues and organs. Some projects will evaluate COVID-19 vaccines or investigate human immune response against SARS-CoV-2, the virus that causes COVID-19. Under the CRADA, FDA will use a range of Organ-Chips to study the safety, efficacy, and mechanisms of action of drugs regulated by the FDA. This new CRADA agreement follows the successful completion of the first Emulate CRADA with the FDA initiated in 2017 that focused on toxicity studies using Emulate’s Liver-Chip. Details on the CRADA are provided in Emulate’s October 29 press release, available at https://www.emulatebio.com/press/fda-organ-chip-crada-2020.