New Approach Methodologies (NAMs)

The future of preclinical research will be driven by new in vitro and in silico methods with a stronger match to human results. These NAMs are increasingly recognized by regulatory agencies worldwide as valid alternatives, reflecting a shifting paradigm in drug development. Learn more about why.

The advantages of New Approach Methodologies (NAMs) in preclinical research

Only 5% of traditional preclinical research succeeds in human trials

Traditional animal testing faces numerous challenges such as high costs, lengthy timelines, and ethical concerns. Moreover, animal studies often fail to accurately predict human responses. Statistics show that approximately 95% of drugs that pass animal testing do not succeed in human trials, with failures mostly caused by ineffective results and severe toxicities affecting critical organs like the heart, liver, and brain. Our in silico NAMs are grounded in accuracy and confirmed against clinical trials that followed our predictions.

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The superior insights of human-based models

Knowing the 6-in-1000 drugs that will succeed protects investment and lives

NAMs transform preclinical research by leveraging human-based models, which significantly enhance the relevance and reliability of safety and efficacy predictions. Phase Advance's in silico models of lifetime disease progression can reliably predict how well a drug will perform, even into Phase 3 trials. In vitro NAMs use human cells or tissues to provide better insight into how a drug will perform in people, identifying potential problems early in development. This approach avoids costly delays and reduces the risk of late-stage trial failures or product withdrawals.

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How Phase Advance helped write the guidance for NAMs

FDA & EMA Move toward NAMs

Our founders worked with the FDA and the EMA to establish frameworks for measuring the accuracy of NAMs. In 2013, the Critical Path Institute (C-Path), FDA, and International Society of Pharmacometrics co-sponsored a workshop in D.C. to examine integrated approaches to developing and applying model-informed medical-product development (MIMPD). The workshop united an international group of scientists from industry, academia, FDA, and the European Medicines Agency to discuss MIMPD strategies and their applications. Our cofounders co-authored the publication out of that summit which explored how to measure the accuracy of forecasting technologies.

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Our models have met the most stringent regulatory reviews

Leading the progress towards in silico NAMs

The FDA and the EMA commented on Phase Advance's NAM modeling systems as early as 2015. The benefits were clear: our models offer detailed mechanistic insights through detailed forecasting of cellular responses, shedding light on the underlying causes of disease or toxicity that are difficult to capture in animal models.

We followed their advice to launch Phase Advance after the 2022 FDA Modernization Act clearly paved the way for NAMs to bring preclinical and clinical research into its next era.

Read FDA & EMA Commentary