Accelerating Alternatives: UK Funding and US FDA Guidance Aim to Reduce Animal Testing in Drug Development

The United Kingdom and the United States are launching programmes to replace animal-based pre-clinical testing with human-relevant models. The UK government will unveil a £20 million Pre-clinical Translational Models Hub in Cambridge on August 12, 2026, while the US Food and Drug Administration (FDA) has a draft oncology guidance scheduled for public comment on June 1, 2026. Both efforts focus on organoids, organs-on-a-chip and new-approach methodologies (NAMs) for cancers, inflammatory bowel disease and other serious conditions.

Can tissue chips overcome the limitations of animal testing?

Animal testing has long underpinned drug safety assessment, yet more than 90 % of compounds that clear animal studies fail in human trials. The UK’s “Replacing Animals in Science” strategy and the FDA Modernization Act 2.0 (2022) have each called for alternatives. Government figures show 2.54 million animal-testing procedures in Great Britain in 2025, a 3.8 % decline from 2024, prompting coordinated investment in human-derived tissue models and regulatory reforms.

Push to reduce animal testing and speed up life-saving treatments

• 2025 – UK reports 2.54 million animal-testing procedures, down 3.8 % (UK government).

Government sets out multi-million-pound plan to move UK away from animal testing in science

• June 1, 2026 (scheduled) – FDA releases draft guidance proposing risk-based, weight-of-evidence (WoE) assessments to reduce animal studies for oncology drugs (FDA).

Stakeholders call for flexibility in guidance aimed at reducing animal testing for cancer drugs

• August 12, 2026 (scheduled) – Science Minister Chris McDonald will announce the new hub and £2 million Innovate UK funding for nine projects (UK government).

Patients to benefit from faster access to medicines as UK moves away from animal testing in science

• £22 million total UK investment: £20 million for the hub plus up to £2 million for nine pilot projects.

Patients to benefit from faster access to medicines as UK moves away from animal testing in science

• The life-sciences sector generates roughly £147 billion in annual turnover and employs about 360 000 people in the UK.

Push to reduce animal testing and speed up life-saving treatments

• Innovate UK’s nine projects target safety studies that traditionally rely on dogs and non-human primates.

Push to reduce animal testing and speed up life-saving treatments

The agency invited early-stage feedback through INTERACT, pre-IND and Type D meetings.

Stakeholders call for flexibility in guidance aimed at reducing animal testing for cancer drugs

• “We’re excited the FDA sees value in developing tissue chips, and we will work hard to go through the remaining steps to ensure the research community can more widely leverage this technology for drug discovery,” — Joan Adamo

The Debrief

• “The document would benefit from a stronger statement on the utility of NAMs,” — C-Path

Stakeholders call for flexibility in guidance aimed at reducing animal testing for cancer drugs

• “ACLAM supports that the draft guidance correctly frames NAMs as an optional supplement to WoE ('could be supplemented with new approach methodologies (NAMs), as appropriate') rather than as standalone replacements,” — ACLAM

Stakeholders call for flexibility in guidance aimed at reducing animal testing for cancer drugs

The FDA will accept public comments on its oncology draft guidance until the end of the comment period following the June 1, 2026 release. The UK government plans to publish a delivery update on the Replacing Animals in Science Strategy later in 2026, providing performance metrics for the hub and its partner projects. Successful FDA qualification of tissue-chip platforms could allow pharmaceutical companies to submit human-relevant data as part of new-drug applications, potentially reshaping pre-clinical safety assessment worldwide.

Can tissue chips overcome the limitations of animal testing?