Cambridge Alliance in Medicines Safety
Safety is a key driver of attrition during drug development, and this could be improved with greater fundamental understanding of the drivers influencing how humans respond to medicines. Increasingly, drug developers place a focus on safety evaluation during the discovery phase, where there is a clear opportunity to apply novel scientific findings to significantly advance our understanding of medicines safety.
As a fundamental investigative science, medicines safety also offers fascinating opportunities to understand complex biological control processes, when homeostatic mechanisms are experimentally disrupted. In some cases, unintended pharmacological effects have themselves been found to have direct clinical application.
The Cambridge Alliance on Medicines Safety (CAMS) has been established to:
- Connect researchers at the University of Cambridge whose work relates to medicines safety/toxicology (experimental and clinical) to build an active academic community with strong collaborative links to pharmaceutical and human-safety related companies.
- Share pre-competitive, open publication research on medicines safety and toxicology at the University of Cambridge, to create a visible network of medicines safety biomedical scientists
- Advocate an inclusive definition of Toxicology: “fundamental biological processes through which chemicals can cause harm, the forward translation of experimental studies on mechanisms of toxicity to improve human safety and reverse translation: utilising adverse effects observed clinically or experimentally, as tools to understand fundamental processes in biomedical science”
- Expand and invigorate the science which underpins assessment of Medicines Safety and Toxicology, via a wider network of collaborations with other academic centres, to advance the translational relevance of experimental safety studies.
The Alliance is a partnership between GSK, AstraZeneca, the MRC Toxicology Unit and the University of Cambridge. Three broad themes have been identified for the Alliance, aiming to improve the predictive accuracy of future experimental safety studies and drive innovative partnerships between scientists and physicians:
- Human-relevant mechanisms of toxicity: encompassing innovative humanised, in vitro systems and safety assessment of new therapeutic modalities such as gene therapy and precise genome engineering
- Bioinformatic analyses: combining experimental data with clinical safety data to influence the computational design of molecules and the development of algorithms to translate organ toxicities from experimental systems to humans
- Safety monitoring in early clinical trials and clinical studies of translational safety biomarkers: addressing high individual variations that can confound pre-clinical safety predictions