From Animal Models To Patient Samples: The Regulatory Rise Of Functional Assays Under The FDA Modernization Act 2.0

From Animal Models to Patient Samples: The Regulatory Rise of Functional Assays under the FDA Modernization Act 2.0

The FDA’s regulatory shift away from animal testing has opened new avenues for preclinical innovation. Functional assays using native patient samples now offer a clinically translatable, ethical alternative for early drug evaluation. Learn how this paradigm is being implemented at Vivia Biotech to bridge discovery and clinical development.
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Why Functional Assays Alone Can Miss Drug Mechanisms

Why Functional Assays Alone Can Miss Drug Mechanisms

In the preclinical phase of drug development, assessing how a compound affects diseased cells is fundamental. Traditionally, this has relied on functional assays that measure outcomes such as viability, proliferation, or cell death. These readouts provide a first indication of drug efficacy, particularly in systems that attempt to reproduce the biological context of the disease.
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