The FDA Modernization Act 3.0 is an important step forward for preclinical innovation.
By updating regulations to replace references to “animal” testing with broader “nonclinical” language, the Act further enables New Approach Methodologies (#NAMs) such as human-relevant in vitro models and computational tools. This creates regulatory space for approaches that better reflect human biology.
The need is clear: many drugs that succeed in animal studies still fail in humans, highlighting the demand for more predictive models.
For Myomaker Bio, this shift is especially impactful. NAM-based muscle and neuromuscular models can deliver earlier insight into efficacy and safety and improve translational confidence. While animal testing remains part of development, this legislation accelerates innovation toward more human-relevant science.
Dr. Andrew Capel (CSO) says ” This announcement is another landmark moment in the transition away from animal model use within drug development. However, the emphasis will now be upon bioengineers to develop assays that deliver highly consistent and scalable human relevant outputs. Our focus at Myomaker Bio will be to accelerate industry acceptance by demonstrating that the predictive capacity of our systems is high, and that human tissue models can positively impact key decision making processes within preclinical testing.”
