May 11, 2011 -- A scientific programme to investigate new ways to develop drugs for infants received 1.2 million euro European research grant from PRIOMEDCHILD ERA-NET. Research groups across Europe, including innovation organisation TNO, participate in this major programme.
Infants (children from 0 - 2 years) are underrepresented when it comes to developing new drugs. Most of the drugs available today have been designed for and exclusively tested in adults. As a consequence, doctors prescribe infants drugs off-label, meaning that the drugs have never been tested for safety or therapeutic effect in this young age group. The goal of the study is to validate the microdosing technology (administering of a very small dose of drug) to obtain pharmacokinetic data that can, in the future, be used to study new drugs in infants. Several partners across Europe, including TNO, have started this research last April.
According to Professor Garner; expert in the field of microdosing and microtracer studies: “Due to the ethical, regulatory and practical issues of testing potential new drugs in infants, very few drugs are specifically developed for or tested in infants. This is potentially dangerous, since growing children do not react to drugs in the same way as adults do. The risk that children receive either a dose that is too high or too low is real.”
Dr. Wouter Vaes from TNO: “One of the hurdles in developing drugs for use in children is how to measure the extremely low concentrations of drug candidates in tiny blood samples. This is a fundamental question that the collaborative research program is designed to answer”. The program will use a sensitive analytical instrument, an Accelerator Mass Spectrometry or AMS, to measure the drug concentration in these small blood volumes. Dr. Babs Fabriek, scientist at TNO involved in this project: “TNO will deliver the technology that makes conducting these studies in infants feasible”.
The research program known as PAMPER (Pharmaceutical Accelerator Mass Spectrometry Microdose Pediatric Evaluation Research Study) is funded through the PRIOMEDCHILD-ERA-NET program (www.priomedchild.eu) for three years. The grant was won on a competitive basis with the scientific assessors scoring the research programme as outstanding. Collaborators are TNO (NL), University of Liverpool (UK), Alder Hey Children’s Hospital (UK), Tartu University Hospital (EE), Pharmaceutical Research Institute (PL), Good Clinical Practice Alliance (BE) and Garner Consulting (UK).