Winner of Innovator/09 International Innovation Award
Recognising an international innovation
Simcyp
Simcyp, based in Sheffield and winner of the Yorkshire Forward International Innovation Award, is the hub of a truly international network of pharmaceutical organisations around the globe. Currently, most of the major pharmaceutical companies worldwide, including 9 of the top 10, have access to Simcyp expertise through the company’s consortium membership. Simcyp’s clients include major global pharmaceutical and bioscience companies, leading academic institutes and regulatory authorities.
On winning the International Innovation Award, John Evans, Managing Director of Simcyp, says, “We are very proud indeed that our international links, educational workshops overseas and e-learning activities that have complemented our regional operation have received such recognition. It has given a tremendous boost to the team at Simcyp.”
The company has become widely known within the industry as the prime developer of a platform for modelling and simulation of drug absorption, distribution, metabolism and excretion (ADME) in virtual populations. John Evans explains: “The process of clinical trialling has, by its very nature, been one of trial and error. Newly developed drugs are tested on volunteers to ascertain performance and suitability. We develop and license a Simulator for drug discovery and development that increases the use of computer-simulated models and reduces unnecessary testing in live subjects.”
Simcyp overcame one of the main limitations of simulations, in that projections were usually made for an ‘average’ healthy, young, Caucasian, male individual. Simcyp accounts for differences of gender, age, body size, genetic makeup, ethnicity, and even dietary factors and smoking habits. Using Simcyp computer-simulation, this information, when linked to drug-specific physico-chemical data and in vitro data on absorption and disposition, allows the prediction of drug behaviour in a ‘virtual patient population’. This means significant savings in time and costs, considering a typical clinical trial can cost £1m. As well as helping the drugs reach the market safely, effectively and quickly, there are also ethical savings as testing on people becomes more focused as the result of simulations.
Further research enabled the company to develop a Paediatric Simulator which allows the behaviour of drugs to be modelled in infants and children. This helps with decision-making regarding dosing of drugs that have been tested in adults but not on children. As John Evans adds: “Obvious issues have arisen as the industry needs data on children and young people. The paediatric module of the Simulator was felt necessary after the regulatory bodies introduced tighter controls over approvals. Clinical trials were demanded which raised ethical issues – of course, no parent would agree to testing drugs on healthy children. The metabolism of children is significantly different to that of adults, and historically GPs have only been able to reduce adult dosage, basically treating children as small adults.” The Paediatric Simulator offers data to model in all age ranges from birth to 16 years.
Not only is Simcyp’s science innovative, but so is the Consortium of international members. An annual consortium meeting is held in Sheffield where agreements are made on progress and development between Simcyp scientists and industry giants from the USA, Japan and Europe. “A lot of ground-breaking research is debated and put into action, and fortunately we have the team who can address those challenges … and of course it is also helping to put Sheffield on the map.” added John. “Simcyp has increased its human resources by 25% already this year, including hiring many specialists from overseas, which is important for the company’s development and, just as importantly, brings incredible talent and scientific skills into Yorkshire.”
Recently Simcyp has developed a further module for the Simulator called Simcyp Rat. Like the Simcyp human population Simulator, Simcyp Rat holds information relevant for whole-body physiologically-based modelling which allows for plasma and organ concentration profiles in rats to be predicted. Researchers can use this information to validate and compare drug properties, which can reduce the amount of testing on animals.
