Accelerating Toward Human Relevant Nonclinical Test Methods

Among its stipulations, the FDA Modernization Act would allow researchers to use the most accurate model systems when assessing a new compound’s safety, eliminating the requirement that all drugs be tested in animals before clinical trials.

Groups like Animal Wellness Action are pushing lawmakers to pass the FDA Modernization Act.  The bill allows an applicant for market approval for a new drug to use methods other than animal testing to establish the drug’s safety and effectiveness.

Ample evidence shows organ-chips closely mimic in vivo counterparts and can serve as powerful tools for predictive toxicology, particularly when predicting drug-induced liver injury (DILI).

Animal testing isn’t just ethically questionable — it’s actually not that effective. Several biotech firms are developing technology that could change that.

Bill provision would allow for alternative test methods in drug development

SCIEX relates that STORMing Cancer researchers are using organ-chips and proteomic analyses to understand how cancer is driven by inflammation

A growing body of evidence suggests that animal models are seriously lacking in both sensitivity and specificity when it comes to predicting drug toxicity in humans.

Quris describes how a new AI approach can improve predictions of which drug candidates will work safely in the human body

New advancements in computer modeling, tissue engineering and other bio-convergence technologies have made the need to test on animals obsolete.

Some studies estimate that as much as 89% of novel drugs entering clinical trials ultimately fail, with as much as 50% of those failing due to toxicities unanticipated by animal models.

New legislation will allow more innovative and human-relevant testing platforms to expedite the development of promising drugs

This past week, a handful of bipartisan lawmakers introduced two bills aimed at ending one of our nation’s most-barbaric practices — mandatory animal testing of new pharmaceuticals destined for human trials.


At the hearing before the House Energy and Commerce Health Subcommittee on the FDA Modernization Act, Congressmen Kurt Schrader and Tony Cardenas spoke in favor of the landmark bill, which now has 40 Democrat and 35 Republican cosponsors in the House and more than 125 endorsing organizations, including major medical associations, biotech companies, and even some major pharmaceutical companies.