Past EU-funded projects supported by ECNP

EQIPD

European Quality In Preclinical Data

The pharmaceutical industry and basic research depend on robust data and scientific rigour as key drivers for decision making. They determine the pace of knowledge gain and ultimately the time needed to make new drug treatments available to patients. Recent publications report challenges with regard to the robustness, rigour and validity of research data, which often impact the transition from preclinical to clinical testing. As a result, the development of new medicines has slowed dramatically in the last 10 years. The EQIPD project seeks to provide simple and sustainable solutions that facilitate data quality without impacting innovation and freedom of research. The EQIPD consortium will:

  • Define those variables in study design and data analysis that influence outcome in pre-clinical neuroscience (focus on Alzheimer’s disease and psychosis) and (neuro-)safety studies conducted in industry
  • Establish whether these are the same variables which influence outcome in academia
  • Define the components which will make up the EQIPD quality management system
  • Define consensus quality management recommendations for non-regulated research and development
  • Validate the feasibility of the quality management system in prospective studies
  • Deliver an online educational platform providing certified education and training in the principles and application of quality and rigour

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Coordinator: Prof. Malcolm Macleod, The University of Edinburgh, United Kingdom
Project leader: Dr. Thomas Steckler, Janssen Pharmaceutica NV, Belgium
Funding scheme: IMI 2; EFPIA
Duration: 3 years
Start: 01.10.2017


PRISM

Psychiatric Ratings using Intermediate Stratified Markers

The current nosology of neuropsychiatric disorders allows for a pragmatic approach to treatment choice, regulation and clinical research that is not based on the biological causes for these disorders. Unfortunately, neuropsychiatric drug development has stalled in the past decades at least in part through the weakness of the link between clinical classification and biological causation.

The PRISM project aims to develop a quantitative biological approach to the understanding of neuropsychiatric diseases that aims to revitalise the discovery and development of more effective treatments for patients. The project will focus on schizophrenia (SZ), Alzheimer’s disease (AD), and major depression (MD), disorders that share in part common symptomatologies, including social withdrawal and certain cognitive deficits, such as attention, working memory and sensory processing.

Innovative technologies will be used to deep phenotype a clinical cohort of SZ and AD patients. The aim will be to derive a set of quantifiable biological parameters from these data that allow to cluster and differentiate SZ, AD and MD patients who are, or are not, socially withdrawn. This set of parameters will:

  • Provide new classification and assessment tools for social withdrawal and cognitive deficits across three neuropsychiatric disorders.
  • Identify clinically relevant biological substrates for treatment development.
  • Provide predictive model systems for future neurobiological and pharmacological studies.

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PRISM video series

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Coordinator: Prof. Dr. Martien Kas, University of Groningen, The Netherlands
Industry Project Leader: Dr. Hugh Marston, Eli Lilly and Company Ltd
Funding scheme: IMI 2; EFPIA
Duration: 3 years
Start: 1.4.2016