The European project CliniGene-NoE is a network of labs promoting the harmonization of ethical, quality, safety, efficacy and regulatory issues of clinical gene transfer and therapy. The project is based on a multidisciplinary approach of the research to ensure a global and accurate vision of the issues inherent at these technologies. The main objectives of the project is to create, develop and sustain interactions between actors: patient’s organizations, scientists, clinical investigators and regulators.
Clinigene-NoE comprises 30 academic teams from 13 countries and 9 private companies. More than 30 clinical trials were proposed and led with the support of CliniGene-Noe program. The initiative led to elevate the European competitiveness in the domain of gene transfer and therapy by improving collaborations between academic laboratories and private companies.
Clinigene-NoE: Goals & presentation
European Network for the Advancement of Clinical Gene Transfer and Therapy: EC funded network of excellence fostering interaction of all stakeholders in the field, in order to facilitate and help harmonize Ethical, Quality, Safety, Efficacy and Regulatory issues. This NoE prolongs and extends the action of the former Euregenethy1 & 2 networks supported by EC-DG research FP4 & FP5 programms.
What is Clinigene?
The role of the European Network for the Advancement of Clinical Gene Transfer and Therapy (CLINIGENE) is to mobilize efficiently all interested parties, mostly involving academic research and production centers together with companies, patients’ groups and regulatory bodies. The main goal is to integrate multidisciplinary research in order to decipher the key elements which can lead to improved safety and clinical efficacy of gene transfer / therapy medicinal products, i.e. for clinical applications. Control and test methods may be applied as platforms for particular gene transfer products. Besides quality control, safety is of germane concern since in the event where the treatment would be proven safe, it could be administered early enough in the course of the disease to achieve genuine cure, so that clinical gene transfer may be called therapy.
The general objectives of Clinigene-NoE thus are the following:
Foster interaction between all stakeholders: regulators, pre-clinical & clinical investigators, scientists, companies (otherwise competitors), patients’ groups, in order to streamline integration of multidisciplinary expertise.
Establish quality, safety, efficacy and morally acceptable standards for clinical gene transfer products.
Identify the “critical path” to accelerate the transit phase from preclinical to clinical phase by integrating expertise and generating new knowledge.
Improve European competitiveness by spreading of excellence and disseminating knowledge.
Obtain clinically significant improvement in the treatment of some human diseases by gene therapy.
For more information and the full project description please visit the project’s website at: http://clinigene.plugis.com