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Pipeline Spotlight: NAM Success Stories !

New Approach/Non-animal methods (NAMs), such as organoids, organs-on-chips, computational modeling, and AI-driven toxicity prediction, represent a revolution in biomedical research. Unlike animals, these systems use human-derived cells, tissues, or computational models to deliver directly human-relevant results.



NAMs bring three main advantages:

  1. Human Predictivity – Capturing human biology better than animal surrogates.

  2. Speed & Cost Efficiency – Reducing the years and billions wasted on failed pipelines.

  3. Ethical Progress – Aligning science with 21st-century values of humane research.


The success of NAMs is real! Here's a drug development pipeline spotlight of NAM success stories :


Gene Therapy & Human Kidney Organoids

  • Researchers used kidney organoids derived from human stem cells to test the safety of adeno-associated virus (AAV) vectors. They discovered unexpected toxicities (inflammation, DNA damage, fibrosis) that would have gone unnoticed in animal models. Importantly, they identified a protective therapy by blocking the NFκB pathway.

  • Implication: Organoids detected hidden dangers earlier than animal testing, making gene therapy safer.

  • Source: News Medical, 2025


Organoids for Drug Metabolism & Toxicity

  • Patient-derived liver and intestinal organoids are now used to assess drug absorption, metabolism, and off-target toxicities, outperforming traditional animal models.

  • Implication: These organoids predict human-specific drug effects and are already integrated into pharma pipelines.

  • Source: British Journal of Pharmacology, 2025


Cancer Drug Development Using Organoids

  • Companies like HUB Organoids have screened libraries of bispecific antibodies in colorectal cancer organoids, eliminating weak candidates before animal studies.

  • Implication: Reduces wasted resources and prevents unnecessary animal use.

  • Source: Labiotech.eu


Paradigm Shift in Preclinical Models

  • Reviews confirm organoids and microphysiological systems outperform animals for modeling genetic diversity, disease pathways, and drug safety.

  • Implication: The foundation is being laid for NAMs to replace animals even in regulatory approval pipelines.

  • Source: MDPI, 2025

What This Means for Mauritius

Mauritius is positioning itself as a biomedical research hub. Yet some actors continue lobbying to continue and pissibly expand primate testing, using local macaques as “research material.” This would not only endanger wildlife and tarnish Mauritius’ global image, but also tie the nation’s future to outdated science just as the world is moving away from it.

Instead, Mauritius could leapfrog into leadership by investing directly into NAMs infrastructure:


  • Organoid and organ-on-chip facilities.

  • Computational toxicology labs.

  • Partnerships with global leaders like PCRM, CAAT (Johns Hopkins), NC3Rs, FRAME, and EPAA.


Such a strategy would align Mauritius with global scientific momentum, attract ethical investment, and ensure sustainability.

Sources & Further Reading

  • FDA. FDA announces plan to phase out animal testing requirement for monoclonal antibodies and other drugs. April 2025. Link

  • British Pharmacological Society. No More Lab Animals? FDA to Phase Out Animal Testing Requirement. August 2025. Link

  • News-Medical. Improving gene therapy safety with human kidney organoids. August 2025. Link

  • British Journal of Pharmacology. Opportunities of patient-derived organoids in drug development. 2025. Link

  • Labiotech.eu. The organoid era: patient-relevant models for the lab. 2025. Link

  • MDPI. Stem Cells and Organoids: A Paradigm Shift in Preclinical Models Toward Personalized Medicine. 2025. Link

Remember !

Numerous high-profile drug failures highlight the limits and dangers of animal testing. Substances that appeared safe in animals have caused severe harm or even death in humans. Such cases illustrate the poor predictive power of animal models and have been widely documented in peer-reviewed analyses (see: NCBI – Why Animal Research Fails). See also our article on the 6 famous drug desasters.

Statistics show that over 90% of drugs that passed animal tests fail in human trials. AND only 5% of animal-tested therapeutic interventions obtain regulatory approval for human applications :


  1. BIO / QLS Advisors / Informa (2021)Biotechnology Innovation Organization (BIO). Clinical Development Success Rates and Contributing Factors 2011–2020. (Executive report and full PDF).BIO’s 2011–2020 report is widely cited in media and advocacy pieces for the figure that ~92% of drug candidates fail in human clinical development even after preclinical success.PDF: https://go.bio.org/rs/490-EHZ-999/images/ClinicalDevelopmentSuccessRates2011_2020.pdf(BIO report page) https://www.bio.org/clinical-development-success-rates-and-contributing-factors-2011-2020

  2. Marshall LJ. (2023)Poor Translatability of Biomedical Research Using Animals — A Narrative Review. Journal/Repository: JRC / SAGE (narrative review).This review states that the failure rate for translation from animal testing to human treatments “remains at over 92%,” attributing most failures to unexpected toxicity or lack of efficacy in humans.Link / record: https://pubmed.ncbi.nlm.nih.gov/36883244/Full text / repository: https://publications.jrc.ec.europa.eu/repository/handle/JRC130396DOI / Journal page: https://journals.sagepub.com/doi/full/10.1177/02611929231157756

  3. Sun D., et al. (2022)Why 90% of clinical drug development fails and how to improve it. (Review article summarizing analyses of high failure rates across development stages.)This review discusses that when preclinical candidates are counted, the overall failure rate exceeds 90% and analyzes drivers (toxicity, efficacy, exposure).PubMed Central (full text): https://pmc.ncbi.nlm.nih.gov/articles/PMC9293739/

  4. Wong C.H., Siah K.W., Lo A.W. (2019)Estimation of clinical trial success rates and related parameters. Biostatistics. 2019;20(2):273–286.This frequently cited quantitative paper provides clinical trial success/failure estimates across phases and is often used as a foundational reference for high attrition in drug development.DOI / Journal link: https://academic.oup.com/biostatistics/article/20/2/273/4817524

  5. Ineichen B.V., Furrer E., Grüninger S.L., Macleod M.R. (2024)Analysis of animal-to-human translation shows that only 5% of animal-tested therapeutic interventions obtain regulatory approval for human applications. PLOS Biology (umbrella review / meta-analysis).This comprehensive analysis found that only ~5% of therapies tested in animals ultimately obtain regulatory approval — a complementary statistic highlighting the low end-to-market rate; it is widely cited alongside >90% failure claims.Full text (PMC): https://pmc.ncbi.nlm.nih.gov/articles/PMC11175415/PLOS Biol DOI: 10.1371/journal.pbio.3002667

  6. Ineichen et al. peer-review / PLOS Biol editorial discussion (2023–2024)Peer review and commentary for the umbrella review above; contextualizes the 5% approval and high failure rate in translation literature.PLOS Biology peer review history and editorial materials: https://journals.plos.org/plosbiology/article/peerReview?id=10.1371%2Fjournal.pbio.3002667

  7. Takebe T., et al. (2018)The Current Status of Drug Discovery and Development as... (Review article; discusses high attrition and translational challenges).PMC article discussing challenges in preclinical-to-clinical translation: https://pmc.ncbi.nlm.nih.gov/articles/PMC6226120/

  8. Hartung T. (2024)The (misleading) role of animal models in drug development. Frontiers in Drug Discovery (2024).Critical perspectives on animal models and their limited predictive value for humans; places high clinical failure into context.Link: https://www.frontiersin.org/journals/drug-discovery/articles/10.3389/fddsv.2024.1355044/full

  9. The Economist (June 14, 2024)Only 5% of therapies tested on animals are approved for human use.A summary article discussing the 2024 umbrella review and the implications for animal-to-human translation and industry practice.Link: https://www.economist.com/science-and-technology/2024/06/14/only-5-of-therapies-tested-on-animals-are-approved-for-human-use

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