PHARMA-COG aims to develop a new integrated model to accelerate the development of drug candidates for MS, PKD and AD. The innovation relies on a 'multidimensional matrix' approach, integrating all available and renewed inputs (biomarkers/animal, human models/physiological and pharmacological challenges, Phase 0/1/1b to reduce the attrition rate, to allow an early and pertinent GO/NOGO decision before entering phase II trials for both symptomatic treatment and disease modifiers approaches. The hypothesis is that effective long term drugs will normalize markers artificially modified. The general objective is to test the efficiency of the 'matrix' on drug candidates for the enhancement/protection of cognitive functions. the final objective is to improve the detection and selection of new drugs candidates within a shorter time-frame.
Our consortium gathers 13 academics and clinicians, 8 SMEs, 1 European patient organization (Alzheimer Europe) as well as 1 regulatory body (EMEA), coming form six different EU Members States. Excellence Centres gather representatives of the different sectors: biomarkers (proteomics, transcriptomics), pharmacodynamic markers ( electrophysiology, psychophysiology, morphological and functional imaging), preclinical model specialists (cellular, transgenic mouse, monkey), clinicians, and clinical pharmacologists.
By the end of this (-year project, the following achievements are expected; definition of the most predictive combination of pharmacodynamic markers; validation of parallel models (in healthy volunteers, ApoE 4 subjects, patients and animals) to establish effective exposure ranges and support proof of mechanism studies. The predictive value of the 'matrix' will be evaluated using different pharmacological target acting drugs. Suggestions for revised/new recommendations and guidelines will help to standardize the pre-clinical and clinical phases of drugs' development in neurodegenerative diseases.
Universita Degli Studi Di Verona
The University Of Exeter
Institut National De La Sante Et De La Recherche Medicale
Innovative Concepts In Drug Development (Icdd-Sas)
Istituto Di Ricerche Farmacologiche Mario Negri
Ucb Pharma Sa
Novartis Pharma Ag
Universite De Lille Ii - Droit Et Sante
F. Hoffmann-La Roche Ag
Provincia Lombardo Veneta - Ordineospedaliero Di San Giovanni Di Dio- Fatebenefratelli
Universidad De Murcia
Irccs Fondazione Sdn Per La Ricerca E L'Alta Formazione In Diagnostica Nucleare
Consorci Institut D'Investigacions Biomediques August Pi I Sunyer
H. Lundbeck As
Boehringer Ingelheim Internationalgmbh
Innovative Health Diagnostics
Elliniki Etairia Nosoy Alzheimer Kai Syggenon Diatarachon Somateio
University Of Bristol
Universite D'Aix Marseille
Universita Degli Studi Di Foggia
Universita Degli Studi Di Genova
Institut De Recherches Servier
Universita Degli Studi Di Perugia
Centre National De La Recherche Scientifique Cnrs
Eli Lilly And Company Limited
Universita Cattolica Del Sacro Cuore
Janssen Pharmaceutica Nv
Glaxosmithkline Research And Development Ltd.