Nonclinical Tests: Advanced Engineering Strategies Inspired by the FDA Modernization Act 2.0

Friday, October 25, 2024

2:00 PM – 3:30 PM EST

Location: Room 347

Primary Investigator(s)

Samantha G. Zambuto, PhD MPHS (she/her/hers)

Postdoctoral Research Scholar
Washington University in St. Louis
Affton, Missouri, United States

Presenting Author(s)

Adrienne Scott, PhD (she/her/hers)

Postdoctoral Research Scholar
Washington University in St Louis, Missouri, United States
Marley Dewey, PhD (she/her/hers)

Assistant Professor of Bioengineering
University of California Santa Barbara
Santa Barbara, California, United States

Moderator(s)

Aleczandria Tiffany, PhD (she/her/hers)

Scientific Program Manager
New York Genome Center
New York, New York, United States

Panelist(s)

Michelle L. Oyen, PhD (she/her/hers)

Associate Professor, Biomedical Engineering
Washington University in St. Louis
Wilmington, North Carolina, United States
Kristin Myers, PhD (she/her/hers)

Associate Professor of Mechanical Engineering
Columbia University
New York, New York, United States
Caroline Beyer (she/her/hers)

Associate Editor
Springer Nature
Berlin, Berlin, Germany
Kyung Sung, PhD (she/her/hers)

Chief, Cellular and Tissue Therapy Branch
FDA, United States

Moderator(s)

AG

Aidan Gilchrist, PhD (he/him/his)

Assistant Professor
University of California Davis, United States

Session Title for Website and App: Nonclinical Tests: Advanced Engineering Strategies Inspired by the FDA Modernization Act 2.0

Special Session Program Description: Because of the high failure rates in drug testing, the FDA Modernization Act 2.0 was passed unanimously in the senate in September 2022 and was signed into law by President Biden in December 2022. The FDA Modernization Act 2.0 amended Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) by replacing “preclinical tests” with “nonclinical tests.” Nonclinical tests are defined by the bill as tests “conduced in vitro, in silico, or in chemico, or a non-human in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug, and may include animal tests, or non-animal or human biology-based test methods, such as cell-based assays, microphysiological systems, or bioprinted or computer models.” In this interactive panel discussion with key experts, we will highlight important considerations for the design and implementation of nonclinical tests in the context of the newly passed FDA Modernization Act 2.0. These discussions will be especially pertinent for human health issues where the translation failure rate from animal to human testing is especially high, including neurodegenerative disorders, asthma, inflammation, and pregnancy complications.

Committee, Sig, or Organization Title: N/A