Articles by Ray Dogum
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From Concept To Confidence: A Collaborative Path To Validating NAMs
8/15/2025
On August 1, 2025, the Foundation for the National Institutes of Health (FNIH) released a Request for Information (RFI) inviting proposals for pilot projects to accelerate the development, validation, and regulatory acceptance of New Approach Methodologies (NAMs). For drug developers, participating in this process offers not only scientific collaboration but also the potential to co-develop regulatory-grade NAMs aligned with FDA and NIH priorities.
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The Rise Of NAMs
7/31/2025
New Approach Methods (NAMs) are rapidly being accepted as replacements for preclinical animal tests long considered to be the gold standard. NAMs include systems of organoids, organs-on-chips, AI-based prediction models, and non-mammalian species.
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FDA Leading The Decline Of Animal Testing
7/16/2025
The gold standard practice of conducting animal studies for evaluating toxicity, pharmacodynamics, and immunogenicity is being challenged by innovative alternatives – New Approach Methods (NAMs).
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Five Takeaways from BIO 2025 and Why You Should Stay Tuned
6/26/2025
New chief editor of Drug Discovery Online shares insights from BIO 2025’s global biotech gathering and spotlights the impacts to early-stage drug research.