Predicting the appropriate levels of human exposure to a new drug (pharmacokinetics) forms a critical part of drug development.
The Centre for Applied Pharmacokinetic Research (CAPKR) was established in the Manchester Pharmacy School in 1996 by Professors Malcolm Rowland, Brian Houston and Leon Aarons to address problems of generic interest to the pharmaceutical industry.
By setting the Centre up, they recognised the need for an independent, academic-led centre of excellence for research and training in drug metabolism and pharmacokinetics (DMPK).
CAPKR is a consortium operating in collaboration with, and supported by, 14 research-led pharmaceutical companies. It has been highly influential in informing regulatory practice in Europe and the USA by:
- establishing and optimising industrial practices relating to drug development;
- reducing the use of animals in research by promoting in vitro testing of drugs;
- allowing the commercial development and extensive use of simulation software tools for the prediction of pharmacokinetics to improve patients' safety.
CAPKR's influence is worldwide. Government regulatory organisations across the globe, responsible for producing guidance to the pharmaceutical industry on the conduct of appropriate safety and efficacy studies prior to licensing new drugs for the market, actively request the Centre's views and act on them.
As a result of CAPKR's promotion of in vitro techniques (testing drugs in a laboratory environment using test tubes etc, rather than in vivo in a living organism), there has been a reduction in the usage of animals in drug research by pharmaceutical companies.
The Centre's work led to the setting up of a spin-out company specialising in early scientific trials in humans, Medeval, in 1983.
By the time it was taken over by global research giant ICON for £14.75 million, it employed 180 staff, had an annual turnover of £10.5 million and had forged a worldwide reputation in 'first-in-man' clinical trials.
“Members of the group views are sought by government regulatory organisations, responsible for producing guidance to the pharmaceutical industry on the conduct of appropriate safety and efficacy studies prior to licencing new drugs.”Brian Houston / Professor of Drug Metabolism and Pharmacokinetics