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What Is the NAMs Initiative and How Does the U.S. Government-backed Health Program Constitute an Animal Alternative?

This blog post was written in partnership with Eurofins Discovery, a global leader in scientific testing and laboratory services for advancement of drug discovery and human health.

Alternatives to animal testing in the drug discovery process, like the name suggests, refer to methods and technologies used as substitutions for in vivo animal models. With regulatory guidelines such as NAMs (New Approach Methodologies) backed by the US Environmental Protection Agency (EPA), FDA Modernization 2.0 (Food and Drug Administration) and the European Union’s 3R policy becoming increasingly more relevant, the industry is quickly looking for existing validated platforms to meet this new animal alternative demand. Eurofins Discovery’s team has long offered animal alternatives and other validated options that conform to the current NAMs initiative.

These scientific methods aim to reduce or replace use of animals in drug development and safety testing, as well as refine existing animal studies to overall improve animal wellbeing. The alternate approaches can include in vitro testing using human cells or tissues, and even includes AI modeling and Machine Learning.

Eurofins Discovery’s BioMAP® Validated Platform

A leading validated platform offered by Eurofins Discovery is BioMAP, which provides an unbiased, target-agnostic and data-driven approach to understanding the effect of mono- or combination therapies on human disease models and translational biomarkers. Validated with clinically approved drugs and known test agents, the BioMAP Platform is powered by human primary cultures or co-cultures stimulated to recapitulate specific disease states and qualified with clinically approved and investigative test agents, a Reference Database of over 4,500+ molecules, data analytics, and expert interpretation to provide clients with actionable insights.

BioMAP profiling is the broadest, most physiologically relevant method to quickly and robustly determine the efficacy, safety and mechanism-of-action of candidate drugs or test molecules to support decisions on pipeline progression. Our BioMAP Platform offers:

  • 60+ human primary cell-based models of tissue and disease biology
  • 150+ clinically relevant protein biomarkers
  • 4,500+ reference molecule profiles in the proprietary BioMAP Reference Database
  • A suite of bioinformatics-based approaches for mechanism class characterization and predictive efficacy and safety determinations

Shown here is a schematic of BioMAP systems composed of human primary cells pooled from healthy donors, in mono- or co-culture conditions, stimulated to capture the complexity of human disease biology.

The three pillars of the BioMAP Platform include: BioMAP systems, the comprehensive BioMAP Reference Database and advanced data analytics. The BioMAP Platform supports phenotypic drug discovery across several areas of human disease biology in a robust and medium-throughput screening-format to enable unbiased discovery of molecules relevant to biological outcomes. Profiling test agents in this platform provide translational insights on mechanisms-of-action, efficacy and safety related pharmacology; identifies potential response biomarkers; and helps with indication and dosing guidance.

Eurofins Discovery’s Broad Biology Capabilities

Eurofins Discovery is a leader in translational biology and phenotypic approaches, with cell-based functional assays that empower our clients worldwide with a human-focused approach to drug discovery.

Human phenotypic approaches have reemerged as a powerful screening and profiling technique for prioritizing hits and lead candidates, elucidating novel mechanisms of action and developing commercially successful therapeutics for unmet medical needs. Because these in vitro human primary cell models mimic human disease states, and therefore patients, their importance to integrated discovery programs and drug discovery more broadly, is widely recognized. This includes an increasing acceptance of non-animal alternatives by regulatory agencies. The renaissance in translational, phenotypic assays using in vitro approaches is here — easing clinical translation and expediting drug development programs.

At Eurofins Discovery, our Translational Biology Center of Excellence is driving the phenotypic drug discovery renaissance forward with human translational cell models for important therapeutic areas in oncology, immunology, fibrosis and cardiovascular disease. Our translational biology assays are reflective of specific clinical outcomes, with optimized cell types, culture conditions, formats and endpoints for relevance to the human clinical data you care most about. Working in partnership, we can provide valuable tools to empower confident decision-making early and throughout the drug discovery process, helping you choose the best candidates for further development or to identify drug repurposing opportunities.