A report published today by the House of Lords EU Sub-Committee on Social Policy and Consumer Affairs has highlighted that 90% of medicines given to newborn babies have only been tested on adults, and that half of drugs given to children have not been tested adequately in children.
The Committee was reporting on the European Commission’s proposals for paediatric medicines and their attempts to set up a common EU-wide procedure for testing and approving medicines for use in children.
This is a longstanding issue, and one which has been a focus of attention within Simcyp Limited, a Biofusion spin-out company from the University of Sheffield, which specialises in the development of software that assists the pharmaceutical industry in predicting the behaviour of drugs and new drug candidates in the body.
Traditionally drug dosages for babies and young children were simply scaled down from those in adults based on body weight or body surface area.
Dr Trevor Johnson, of Simcyp and the Sheffield Children’s Hospital, has shown that this approach may result in up to 3-fold under or over dosing.
Simcyp Paediatric, a module within the Simcyp Interaction and Clearance software platform, used by most of the major global pharmaceutical companies, analyses developmental changes that affect the handling of drugs in neonates, infants and children, to assist in the establishment of safe and effective doses. By using Simcyp Paediatric, pharmaceutical companies will be able to predict doses that should result in drug exposure similar to that in adults.
Professor Geoff Tucker, the chairman of Simcyp, said:
“This is an important new development area for Simcyp and whilst the use of the software does not replace clinical studies in paediatric patients, it helps to optimise the design of such studies to ensure that the benefits of new drugs will be available to children in a safer and faster manner. In this way, it will facilitate the implementation of new legislation, established in the USA in 2002 and soon to be introduced in Europe, in ensuring that new medicines will be tested adequately in children.”
David Baynes, CEO of Biofusion, said:
“Simcyp continues to lead the way in developing software applications for predicting drug clearance interactions for the major pharmaceutical companies and with the new EU law due to be introduced in 2007 Simcyp is again well placed to capitalise on this developing sector of the market.”