At Starodub, we collaborate with pharmaceutical innovators navigating the complex regulatory landscape of drug development. A recent development in this field is the adoption of New Approach Methodologies (NAMs) for nonclinical safety assessment of drug candidates.
NAMs represent a cutting-edge suite of non-animal-based methods, including in vitro assays, in silico modeling, organ-on-chip technologies, and advanced computational tools like quantitative structure-activity relationship (QSAR) models. These approaches may deliver robust, human-relevant data to assess drug candidate safety, providing a scientifically rigorous alternative to traditional animal studies. By embedding NAMs into nonclinical programs, we empower our clients to generate high-quality toxicological insights while aligning with the global 3Rs initiative: Replacement, Reduction, and Refinement of animal use.
Why can NAMs be a game-changer? NAMs may accelerate safety assessments while upholding scientific excellence. For example, in vitro models using human-derived cells may mimic physiological responses, offering toxicity predictions. Organ-on-chip systems may simulate organ-level functions, providing dynamic data on drug behavior. In silico tools leverage artificial intelligence and machine learning to forecast adverse effects based on molecular structures, enabling more efficient early-stage decision making. These methods can enhance predictive safety accuracy, reduce ethical concerns by limiting animal testing, and align with growing societal demands for humane, science-driven innovation.
Global regulatory agencies are increasingly embracing NAMs, recognizing their potential to reshape drug development. The European Medicines Agency (EMA) promotes NAM integration through its 3Rs Working Party, encouraging their use in regulatory submissions when scientifically validated. The U.S. Food and Drug Administration (FDA) advances NAMs via its toxicology research programs, underscoring their role in modernizing safety assessments. Our team stays current in these evolving frameworks, ensuring your nonclinical strategy aligns with the latest ICH, EMA, FDA, and international guidance.
We specialize in designing tailored nonclinical programs that incorporate NAMs to meet your specific needs. We understand the challenges of transitioning to NAMs, including method validation and regulatory uncertainty, and we guide you every step of the way to build confidence in your data.
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