Cell-based assays in regulatory submissions

Moving towards in vitro from a regulatory perspective: Considerations from the FDA Modernization Act 2.0

Supporting human-relevant disease models

In late 2022, the US Senate passed the FDA Modernization Act 2.0, S.5002. For the first time, this allowed non-clinical tests (such as cell-based assays and microphysiological systems) to be used instead of animal tests. This includes methods such as human iPSC derived cell models.

“To allow for alternatives to animal testing for purposes of drug and biological product applications.”

In vivo models have been the standard for testing for decades. While they do offer a great deal of information, they take a high toll on animal life – animals that often lack significant similarities to human physiology; famously, mice don’t get Alzheimer’s. The passing of this bill opens the regulatory window for non-animal regulatory data to be submitted including cell assays and data driven approaches.

The FDA Modernization Act is a strong signal for change, encouraging and enabling drug discovery to invest in novel, non-animal, more human models. You can read the full bill here.

A Regulatory expert’s perspective on the FDA Modernization Act 2.0

A person in a suit and tie Description automatically generated with medium confidenceSimon Hoffman is a principal quality assurance and regulatory affairs consultant with over 30 years of experience in the Biopharmaceutical and medical device industry.

Simon Hoffman, Regulatory Expert

Pharmaceutical companies… who embrace the change will thrive

Read our interview with Simon Hoffman, Principle Quality Assurance & Regulatory Consultant, to hear what he thought of the FDA Modernization Act 2.0 and how it will impact drug discovery.

Simon provides insightful commentary into the changing regulatory landscape, including what the Act changes, how biopharma and the wider industry should- and will- respond, and how the FDA Modernization Act 2.0 will affect cell suppliers, investment and partnerships in drug discovery.

You can read the full interview here: Simon Hoffman interview with Axol.