FDA, NIH Push for Non-Animal Testing Methods as Experts Cite Research Limitations

FDA and NIH Push Toward Replacing Animal Testing with AI and Human Organoids

In a groundbreaking move, the FDA—under Commissioner Marty Makary—announced plans in April to significantly reduce animal testing requirements for monoclonal antibodies and other therapies. The agency aims to make animal studies “the exception rather than the norm” within the next three to five years, using AI, human organoids, and other “human-relevant methods” as alternatives.

The announcement, which builds on the 2022 FDA Modernization Act 2.0, has been met with a mix of optimism and caution. The Act allowed the FDA to consider non-animal testing methods during drug approvals, eliminating the previous blanket requirement for animal data in some cases.

Momentum Builds with NIH Support

Just weeks after the FDA’s announcement, the NIH revealed it would prioritize funding for research that avoids animal models. It also announced the creation of the Office of Research Innovation, Validation, and Application (ORIVA) to coordinate efforts across its research portfolio to validate and scale alternatives like organoids, AI, and real-world data models.

Industry and Advocacy Respond

The response from organoid manufacturers and animal rights groups has been enthusiastic. Tomasz Kostrzewski, Chief Scientific Officer at organ-on-a-chip company CN Bio, called the move “fantastic,” emphasizing that while animal testing has a place, it shouldn’t be the default.

Joseph Wu, a cardiologist at Stanford Medicine and co-founder of Greenstone Biosciences, echoed this sentiment. “Over-reliance on the mouse model is a detriment to the entire field,” he said, pointing out that mouse models lack the genetic diversity of human populations. Wu supports using induced pluripotent stem cells (iPSCs) and organoids, which allow for high-throughput drug screening in a more cost-effective and human-relevant way.

Aysha Akhtar, CEO of the Center for Contemporary Sciences, warned that companies slow to adopt these technologies risk falling behind. “If companies don’t move in this direction, they’re going to lose out,” she said.

Benefits and Limitations

While alternatives like organoids and AI offer exciting possibilities, experts caution that these technologies aren’t yet ready to fully replace animal testing—especially in later stages of drug development. Most organoids model only single organs, making it difficult to replicate how the full body responds to a drug.

“There are aspects of living systems we can’t yet model,” Wu acknowledged. Scientists are working on connecting multiple organ systems in vitro, but the technology is still evolving.

Irving Loh, Chief Medical Officer of Infermedica, was skeptical of the FDA’s timeline. “It’s a safety issue,” he said, emphasizing the need for extensive validation before animal models can be phased out.

Barriers to Adoption

Transitioning to AI and organoid models presents logistical challenges. Implementing these technologies is costly and requires new infrastructure, training, and skilled personnel. Wu noted that while the FDA Modernization Act opened the door to alternatives, it did not include funding to support their adoption.

Akhtar pointed out that most students are still trained in animal-based methods. “We need to build a workforce familiar with human-relevant models,” she said.

Additionally, recent NIH funding cuts under the Trump administration may slow progress, raising concerns among scientists about whether sufficient resources will be available to support the transition.

Cultural Shifts and CRO Partnerships

Entrenched reliance on animals in biological research and resistance from contract research organizations (CROs) further complicate the transition. Still, some CROs are beginning to embrace change. CN Bio has partnered with CROs like Pharmaron and Altis Biosystems to incorporate non-animal methods.

“CROs are the real heartbeat of the pharmaceutical industry,” said Kostrzewski. “Partnering with them will be critical.”

Industry Adoption Already Underway

Even before the FDA and NIH announcements, companies were moving toward alternatives. Bristol Myers Squibb teamed up with Tempus in 2023 to use AI and organoid technologies in drug target discovery. AstraZeneca, Johnson & Johnson, and Roche have all partnered with organ-on-a-chip companies like Emulate and MIMETAS.

Roche confirmed it is actively exploring “New Approach Methodologies” (NAMs), including organoids and in silico tools. However, a spokesperson emphasized that animal research remains essential for now: “We expect that animal testing will continue to play a key role in drug development in the near to mid-term future.”

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