European researchers today launched an ambitious project to tackle some of the major problems of developing new drugs to treat brain diseases. The €9.5m EQIPD project will last 3 years, and unite more than 20 research groups from industry and academia. It aims to establish systematic guidelines, and ensure drug safety, for researchers developing new neurological drugs for conditions such as Alzheimer’s disease.
Development of new psychiatric medicines has slowed dramatically in the last 10 years, with the number of drugs in development down by 70% since 2005 (ref1). This is mostly due to the complexity of development leading to a significant failure rate. Now at a meeting today in Beerse, Belgium, scientists from industry and from academic institutions across Europe have for the first time agreed to develop strategies to ensure that early drug development research proceeds along structured lines.
The European Quality in Preclinical Data (EQIPD) project is supported through the Innovative Medicines Initiative a partnership between the EU and the European Federation of Pharmaceutical Industries and Associations. It is coordinated by Prof Malcolm Macleod from the University of Edinburgh, who commented:
“There are concerns that findings from laboratory research often do not translate to success in human studies, and even that findings from one lab cannot be replicated in other labs. This might be because of as yet undiscovered biological factors; or because of unwanted differences in how the experiments were done. By developing quality tools to minimize these unwanted differences we expect to enhance reproducibility and to make it easier to identify as yet undiscovered biological reasons for the differences between labs. Controlling these factors should enhance translatability and reduce failure in drug development.
For instance, being able to demonstrate that studies were randomised, and blinded, supported by an adequate sample size calculation and that the hypothesis being addressed has been described in advance would give the research user substantially greater confidence in the reported findings.
It is extremely important that this project combines the insights of academic groups studying the problems of drug development, of academic laboratory researchers and of industry based researchers. This means that the eventual guidelines will emerge from a cross-discipline group of researchers with expertise across the whole field of drug development. This is probably the first large scale project on neuroscience drug-development methodology to cross industry-academia lines in this way.”
Project leader Thomas Steckler from Janssen Pharmaceutica NV said:
“The European pharmaceutical industry brings substantial economic and societal benefits, but developing new drugs for complex conditions such as psychosis and dementia is increasingly challenging. For some time industry has had concerns over the reliability of preclinical research findings, so the development of a fit-for-purpose quality management system that will be used by industry, biotech, contract research organizations and academia would represent a major step forward. While this project focusses on developing drugs in neuroscience and on safety studies, we aim to develop tools which might have much wider applicability across R&D.”
The project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777364. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation program and EFPIA (the European Federation of Pharmaceutical Industries and Associations).
EQIPD website: http://eqipd.org/
IMI website: www.imi.europa.eu
EFPIA website: https://www.efpia.eu/
This communication reflects the author's view. Neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein
List of partners
The University of Edinburgh, PAASP GmbH, Concentris research management GmbH, Imperial College, London, Arlenda SA, University of Aberdeen, University of Groningen, University of Bern, Johannes Gutenberg University Mainz, Eberhard Karls University Tuebingen, Charite Universitaetsmedizin Berlin, Ludwig-Maximilians University Munich, European College of Neuropsychopharmacology, Sylics (Synaptologics BV), Science Exchange, INC., Science Exchange, INC., Porsolt SAS, Radboud University Medical Center, Noldus Information Technology BV, Janssen Pharmaceutica NV, Abbvie INC, Boehringer Ingelheim International GmbH, Novartis Pharma AG, Orion Corporation, Pfizer Limited, Psychogenics INC, F. Hoffmann-La Roche AG, Institut de Recherches Servier, UCB Biopharma Sprl, Sanofi-Aventis Recherche & Developpement.