NC3Rs/Innovate UK workshop: Delivering the Government’s alternative methods strategy – Pharmacokinetic and cardiovascular safety studies

Advances in in vitro and in silico approaches are reshaping drug development by improving the prediction of efficacy, safety and pharmacokinetics. This workshop will focus on two priority targets identified in the UK Government’s 2025 alternative methods strategy: reducing reliance on animal studies in pharmacokinetic and cardiovascular safety studies.

Sessions will bring together scientists and stakeholders to discuss the current landscape and identify gaps and opportunities where replacement technologies could improve study outcomes, increase human relevance and minimise animal use. The outputs will help to define how the Government targets can be delivered in practice through supporting research collaboration and innovation.

Registration

This event is intended for scientists and other professional stakeholders working in related scientific fields. Please register with an institutional email address. Registrations will be reviewed in line with our terms and conditions and policy on attendance at NC3Rs events (PDF). 

When registering, please indicate your preferred workshop topic for breakout sessions: cardiovascular safety, pharmacokinetics or no preference.

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.