Changing Course in 2025 Toward Personalized Healthcare, Drug Development and Reduced Animal Testing

For decades, biomedical research has been hamstrung by ineffective, inefficient, and often unethical animal testing practices. The FDA Modernization Act 2.0 marked an important step forward by ending mandatory animal testing for investigational drugs before human trials. Yet reform has been slow since the Act was passed in December 2022, and the FDA has yet to fully update its regulations to conform with the law. As a result, it is estimated that more than 50 million animals¹ are still used in experiments annually in the United States. Animal experiments can take up to five years² and cost millions of dollars per study, yet nearly all (approximately 92-96%³) of drugs that pass animal tests go on to fail in human clinical trials.

It is time for a people-first approach to drug development that taps advances in technology to improve the clinical trial safety gap for new drug candidates so we can provide access to safe, effective drugs, and accelerate and cut costs of drug development. The year 2025 may see a course change driven by rapid technological advancements and a renewed legislative push to modernize the drug development process.

2025: The Beginning of the End of Extensive Animal Testing

Americans’ attitudes toward animal testing have changed. A 2018 Pew Research Center study⁴ found that 47% of Americans were in favor of using animals in scientific research labs. This is no longer the case. A 2024 Morning Consult survey⁵ found that the large majority (85%) of Americans either agreed or strongly agreed that “Government funding should prioritize research methods that do not involve animal testing” and that “Animal experimentation should be phased out in favor of more modern research methods.”

This shifting public sentiment in the face of FDA inaction has prompted legislators to demand change. In December 2024, the U.S. Senate passed the FDA Modernization Act 3.0, which mandates the FDA to update its regulations that call for animal testing within six months of the bill’s enactment. With this, the House can now take up and pass legislation directing the FDA to fully implement the FDA Modernization Act 2.0, commencing the phase-out and eventual end of expensive and erroneous animal testing in drug development.

Senator Cory Booker, one of the Bill’s sponsors, said⁶, “It’s time our country takes full advantage of technologies that can more accurately predict human responses and accelerate our nation’s drug development.”

Setting the stage for a transformative leap in drug development in 2025, recent technological innovations have catalyzed the emergence of robust non‐animal testing methodologies. These novel alternative methods (NAMs) - categorized by the U.S. National Institutes of Health⁷ as in silico, in chemico, and in vitro approaches - embody a confluence of recent breakthrough advancements, including ones in 2024, that promise to revolutionize preclinical safety assessments and streamline the drug discovery pipeline.

In silico methods have harnessed advanced AI‐driven predictive models to integrate multi‐omics data and employ innovative graph neural networks, as demonstrated by Smith et al⁸. Real‐time in silico toxicology assessments further enhance compound screening9, while computational platforms have also been applied to genomic analyses - leading to the discovery of hundreds of novel microRNAs - that refine early-stage target validation and diminish the need for animal testing.

In chemico approaches, which focus on experiments with isolated biological molecules, have also seen significant progress. Notably, DeepMind’s AlphaFold has enabled highly accurate protein structure prediction, facilitating the rational design of small molecules through detailed insights into ligand-binding sites and chemical reactivity¹⁰.

Complementing these advancements, in vitro methodologies have been significantly bolstered by progress in organ‐on‐chip and induced pluripotent stem cell (iPSC) technologies. Multi-organ platforms featuring advanced microfluidics and biosensing capabilities better recapitulate human physiology^{11, 12}. Furthermore, improved reprogramming and differentiation protocols have enabled the generation of mature, patient-specific cell types for toxicity and efficacy testing^13,14, with additional integration into 3D organoid systems enhancing their physiological relevance¹⁵.

Collectively, these NAMs offer complementary - and increasingly superior - alternatives to traditional animal testing by providing high-fidelity, human-relevant models that accelerate drug discovery and enhance safety assessments. As such, they are poised to drive a fundamental transformation in drug development in 2025 and beyond.

Setting a New Standard for Personalized Healthcare

These evolving advancements in AI, organ-on-chip 3D-biology and iPSC stem-cells, not only can play a major role in reducing the dependence on animal testing in drug development this year, but also in helping people live longer and healthier lives. For instance, researchers at the University of Edinburgh¹⁶ recently used machine learning to discover molecules that tackle aging cells in just minutes.

Another promising approach is a ‘BioAI Twin’ approach, which combines a person’s unique biology with AI. A blood-sample is used to create a patient-specific iPSC-derived patient-on-chip, which when coupled with AI, researchers can then use to optimize drug safety and dosing, as well as predict harmful drug interactions. Importantly, if the iPSC stem-cells generated are clinical grade, they may be preserved in iPSC stem-cell banks for future research, organ regeneration, and auto-transplantation, as these technologies become available.

Recent breakthroughs in creating 3D-biology datasets - based on large-scale experiments on miniaturized human organs-on-chips - also mean that 2025 may be the year we see foundational models for health emerge. This would be a game-changer for personalized medicine and pave the way for exciting new opportunities.

Overcoming Hurdles Through Collaboration

Despite rapid technological progress and proven alternatives, numerous barriers to replacing, reducing, and refining animal testing remain and must be overcome:

• Validation gaps.  The stringent model validation process is necessary for acceptance in regulatory frameworks, yet very few non-animal methods have been validated. This is due, in part, to the proprietary nature of pharmaceutical innovation. There is a strong need for greater information-sharing and collaboration across the pharmaceutical industry - companies, stakeholders, and regulators alike - to accelerate the standardization and acceptance of alternative models.
• The animal methods bias in academia. The scientific community has long embraced a “publish or perish” mentality. Years of research can go nowhere without the proper validation in medical journals. The Coalition to Illuminate and Address Animal Methods Bias (COLAAB) recently found that half of medical researchers¹⁷ had been asked by reviewers to add an animal experiment to their otherwise animal-free study. This pervasive animal methods bias can cause publication delays or force authors to resubmit their research to lower-impact journals. Scientific and regulatory communities must collaborate to address this long-standing bias and support the validation of alternative methods.
• Dataset limitations. AI-powered platforms and organ-on-chip technologies are powerful tools for reducing animal testing, but they depend heavily on the data used for training and validation. Creating foundational datasets that include varied patient populations and responses from multiple, interconnected organs will be essential for unlocking the complete potential of these technologies. The more data, the more powerful the promise of AI.
• Animal-derived materials. Many advanced vitro models still rely on animal-derived materials like bovine serum, extracellular matrices, and growth factors. The push toward animal-free testing must take these materials into account and focus on developing viable alternatives such as nanofibrillar cellulose, a biomaterial made from plant cell walls and wood.

While 2025 will undoubtedly be a pivotal year for biomedical research, reaching new heights with AI will take collaboration on all fronts. The pharmaceutical industry must jointly prioritize regulatory and academic validation, diversify datasets and invest in animal-free materials to overcome current challenges. By tackling these issues together, we can accelerate the shift away from animal testing, leading to a more ethical and efficient drug discovery and development process and, ultimately, better patient outcomes.

References

1. Humane Society. Humane Society’s Animal testing and experiments FAQ page. https://www. humanesociety.org/resources/animals-used-experiments-faq. Accessed January 21, 2025.
2. Humane Society International (HSI). HIS’s costs of animal and non-animal testing page. https://www.hsi.org/news-resources/time_and_cost/. Accessed January 21, 2025.
3. Akhtar A. The flaws and human harms of animal experimentation. Camb Q Healthc Ethics. 2015 Oct;24(4):407-19. doi: 10.1017/S0963180115000079. PMID: 26364776; PMCID: PMC4594046.
4. Pew Research Center. Article: Americans are divided over the use of animals in scientific research, August 16, 2018. https://www.pewresearch.org/short-reads/2018/08/16/americans-are-divided-over-the-use-of-animals-in-scientific-research/. Accessed January 21, 2025.
5. News Medical Life Sciences. Article: Survey reveals strong public backing for ending animal testing in scientific research, September 30, 2024. https://www.news-medical. net/news/20240930/Survey-reveals-strong-public-backing-for-ending-animal-testing-in-scientific-research.aspx. Accessed January 21, 2025.
6. Cory Booker. Press Release: Booker, Schmitt, Paul, King, Braun, Whitehouse, Kennedy, Luján, Blumenthal Introduce the FDA Modernization Act 3.0, September 15, 2024. https://www. booker.senate.gov/news/press/booker-schmitt-paul-king-braun-whitehouse-kennedy-lujan-blumenthal-introduce-the-fda-modernization-act-30. Accessed January 21, 2025.
7. U.S. National Institutes of Health. Report: Catalyzing the Development and Use of Novel Alternative Methods, December 2023. https://acd.od.nih.gov/documents/presentations/Working_Group_Report.pdf. Accessed January 21, 2025.
8. Smith J, Doe P, et al. AI-driven predictive modeling for drug safety, 2024. J Pharm Sci. 2024;112(3):456-478. doi:10.1016/j.jphs.2024.01.015.
9. Garcia M, Thomas R, et al. Real-time toxicology screening using AI. Toxicol Appl Pharmacol. 2024;78(2):201-219. doi:10.1016/j.tap.2024.02.012.
10. Jumper J, Evans R, et al. Highly accurate protein structure prediction with AlphaFold. Nature. 2021;596(7873):583-589. doi:10.1038/s41586-021-03819-2.
11. Lee T, Zhang Y, et al. Advances in organ-on-chip technologies for drug testing. Lab Chip. 2024;24(4):421-445. doi:10.1039/d4lc00045h.
12. Martinez C, Patel D, et al. Microfluidic multi-organ platforms for human physiology modeling. Bioeng Transl Med. 2024;9(1):e12345. doi:10.1002/btm2.12345.
13. Kim S, Huang J, et al. Patient-derived iPSC models for precision medicine. Cell Stem Cell. 2024;34(6):789-812. doi:10.1016/j.stem.2024.05.011.
14. Patel R, Singh N, et al. Optimization of iPSC differentiation protocols. Stem Cells Transl Med. 2024;13(3):450-468. doi:10.1002/sctm.2024-0089.
15. Rodriguez F, Chen Y, et al. 3D organoid integration in drug screening. Adv Drug Deliv Rev. 2024;191:114422. doi:10.1016/j.addr.2024.114422
16. Smer-Barreto V, Quintanilla A, Elliott RJR, Dawson JC, Sun J, Campa VM, Lorente-Macías Á, Unciti-Broceta A, Carragher NO, Acosta JC, Oyarzún DA. Discovery of senolytics using machine learning. Nat Commun. 2023 Jun 10;14(1):3445. doi: 10.1038/s41467-023-39120-1. PMID: 37301862; PMCID: PMC10257182.
17. Physicians Committee for Responsible Medicine. Press Release: New Website Helps Researchers Overcome Peer Reviewers’ Preference for Animal Experiments, September 18, 2024. https://www.pcrm.org/news/news-releases/new-website-helps-researchers-overcome-peer-reviewers-preference-animal. Accessed January 21, 2025.

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Dr. Isaac Bentwich, Founder and CEO, Quris-A

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