Clinigene
European Network for the Advancement of Clinical Gene Transfer and Therapy
The field of gene therapy has matured and the prospects are exciting and hopeful, particularly since some treatmentshave now been shown to be effective in the clinic. However, precise quality and safety standards for clinical genetransfer have yet to be defined. In this context, defining optimal methods for the production of standard vector systemswould pave the way for accelerated development and improved safety. This would be of enormous value to industry,individual investigators and regulators.The goal of this proposal is the creation of a European Network for the Advancement of Clinical Gene Transferand Therapy (CLINIGENE) integrating multidisciplinary research and development in gene therapy as well asmobilising all major stake holders involved in the development of gene therapy medicinal products: academia,industry, regulatory bodies, clinics and patients. The network will generate platform databases for particular vectorswith respect to their safety and efficacy to ensure product manufacturing according to well-defined quality and safetystandards in order to accelerate clinical trials. This will be achieved by compiling all available information and thenranking test and control methods by comparison, and through validation by expert partners.The joint programme of activities comprises1. Integration activites: sharing facilities, exchange and high-level training of personnel, e-communication andcollaboration with the ESGT.2. Research activities: six horizontal activities serving integration towards the generation of reference/standard profiledata-bases - AAV, γ-retrovirus, lentivirus, adenovirus, genetically-modified cells & non-viral vectors - and fourvertical activities defining a path to optimised clinical protocols - quality and efficacy (manufacture), safety (pharmtoxand virus safety); pre-clinical models and novel assessment tools, clinical trials.3. Dissemination activities: training, high-level education, communication (including a web-site with scientific &medical data-bases) and management of shared information and intellectual property rights.Within a strong integration plan, the Network is planning for flexibility in order to adapt to : (i) progresses recorded ina stepwise manner and (ii) novelty arising during the CLINIGENE workprogramme.
Partners
Academic Partners
FCSR-TIGET, San Raffaele Telethon Institute for Gene Therapy, Milano, Italy
Institute of Ophthalmology, University College London,
Div. of Molecular Therapy, London, United Kingdom
TIGEM - Telethon Institute of Genetics and Medicine, Napoli, Italy
Orphanet - INSERM SC11
Hôpital Broussais, Paris, France
Medizinische Hochschule Hannover
Dept. Experimental Hematology, Hannover, Germany
INSERM, France
CBATEG - Autonomeous Univ. of Barcelona, Centre de Biotec. Animal i Teràpia,
Bellaterra, Spain
Academy of Sciences of the Czech Republic,
Institute of Molecular Genetics,
Prague, Czech Republic
IBET - Instituto de Biologia Experimental e Technologica, Oeiras, Portugal
Paul-Ehrlich-Institut, Langen, Germany
Ecole Normale Supérieure de Cachan, Cachan Cedex, France
Royal Holloway & Bedford University, School of Biological Science,
Egham, Surrey, United Kingdom
Mayo Clinic, Molecular Medicine Programme, Rochester, United States
Karolinska Institutet, Department of Medicine, Huddinge University Hospital,
Stockholm, Sweden
Technischen Universität München, Institut für Experimentelle Onkologie und Therapieforschung, München, Germany
Helmoltz Centre for Infection Research, Braunschweig, Germany
Klinik für Neurologie der Universität zu Köln,
Labors für Gentherapie & Molekulares Imaging am MPI für Neurologische Forschung, Köln, Germany
APHP - UMR 7087, UPMC/CNRS-CERVI, Hôpital de la Pitié, Paris, France
University of Ulm, Division of Gene Therapy, Ulm, Germany
Institut de Biotechnologie - Univ. de Lausanne, Lausanne, Switzerland
Genethon, Evry, France
CNRS, UMR 8121, Institut Gustave-Roussy, Villejuif, France
CHU Hotel Dieu Nantes, Laboratoire Therapie Genique, Nantes, France
The Hebrew University, Hadassah Medical School, Jerusalem, Israel
ISTEM (Unité INSERM), Evry Cedex, France
INSERM, Faculté de Sciences Pharma. et Biologiques, Paris, France
German Cancer Research Center (DKFZ), NCT-Heidelberg im Otto-Meyerhof-Zentrum, Heidelberg, Germany
University of Eastern Finland, A.I.Virtanen Institute, Kuopio, Finland
Industry Partners
Bioalliance Pharma, Paris, France
Bioreliance Ltd, Stirling, Scotland, United Kingdom
CellGenix, Freiburg, Germany
CleanCells, Bouffere, France
Epixis, Paris, France
Genosafe, Evry, France
Oxford BioMedica, Oxford
Plasmid Factory, Bielefeld, Germany
Transgene, Strasbourg, France
Speaker
Hansjörg Hauser
Coordinator
École normale supérieure de Cachan (F)
Homepage
Funding agency
EU-Projects