Working with Innovate UK to deliver the Government’s alternative methods strategy

We are working in partnership with Innovate UK (IUK) to support organisations developing innovative replacement technologies in two priority areas identified by the UK Government. Pharmacokinetic and cardiovascular safety studies typically involve dogs and non-human primates and there is significant potential for in vitro and in silico approaches to replace animals and improve prediction of drug efficacy and safety in these areas.

In their 2025 alternative methods strategy, the UK Government set targets to replace at least 35% of dog and non-human primate use for pharmacokinetic prediction, and 50% in cardiovascular safety studies, by 2030. To support this ambition, we are bringing our expertise in 3Rs-focused innovation to IUK’s ‘Industrial human-relevant drug models’ programme. The Contracts for Innovation competition is focused on delivering non-animal approaches suitable for use by the pharmaceutical industry to improve pharmacokinetic and cardiac safety studies and replace some dog and non-human primate use in drug development.

Scientific background

Pharmacokinetic studies

Currently, no alternative methods exist that can fully predict in vivo pharmacokinetics. Opportunities to accelerate reduction and replacement of animals in this area include:

• Improving access to broader PK datasets across different compound classes to enhance computational and AI models, particularly when combined with human-based in vitro tools such as tissue cultures, organoids or organ‑on‑a‑chip systems. These methods require further development, including for long-term exposure studies in vitro.
• Eliminating dedicated animal PK studies where kinetic data can be generated as part of other study types, such as general toxicity studies.

Cardiovascular safety studies

Standard in vitro assays such as the hERG ion channel assay are widely used prior to regulatory in vivo studies. Emerging frameworks like CiPA integrate in vitro assays, in silico modelling and human stem cell‑derived cardiomyocytes but are not yet fully validated. Opportunities to accelerate reduction and replacement of animals in this area include:

• Further qualification and validation of existing alternative approaches.
• Increasing the combinatorial power of in silico and in vitro approaches.
• Developing a standard framework for alternatives-based cardiac safety assessment in R&D pipelines.
• Developing novel alternative approaches to fill existing gaps in non-animal cardiac safety.

Key dates