Based on the expertise and strong involvement of all partners of its consortium, NeurATRIS will be more specifically in charge of delivering didactic and pedagogic guidelines, specific of translational research in biotherapies to :
- Understand and apply the principles of translational research design and execution (project management techniques and tools), including clinical trials. This will include overview of methodologies for designing and executing pre-clinical and clinical research studies with biotherapies. Topics related to problems specifically associated with cell-based or gene-based strategies (clinical grade products, study design, placebo/sham controls, biosafety constraints, etc…) and more generally with biobanking, design of the first-in-human clinical trials, principles of bioinformatics, pharmacogenomics, diagnostics and biomarkers, and identification of molecular targets will be included in the pedagogical program.
- Detail the ethical and regulatory issues of biotherapeutic preclinical and clinical trials in Europe and North America. Topics will cover good clinical practice (GCP), quality care assurance, good manufacturing practice (GMP), relationships and how to navigate between academic structures and the pharmaceutical and biotech industry to develop new drugs or methodologies, and intellectual property.
The pedagogical program will be designed in coordination with the EATRIS training organization. However whereas the NeurATRIS contribution per se will focus on biotherapies applied to neurological issues the remaining issues associated with drug-based strategies will be treated in the already existing training program of the IHU. Subscription revenues will be perceived through training programs and scientific conferences aiming at promoting NeurATRIS excellence and strengthening its visibility. NeurATRIS will take an active part in the European training program developed by EATRIS i.e. multidisciplinary teaching for all actors in translational research (i.e. basic researchers, clinicians, MSc and PhD students, nurses, technicians, etc.). Its participation will involve scientists from all NeurATRIS nodes, along with dedicated staff members, and will promote Neuroscience at the national and European levels. Partnersphip with European scientific societies interested in biotherapies will allow to develop interactive training programs for clinicians and scientists and to initiate international research programs.
The main NeurATRIS organizations involved in the EATRIS training program will be the CEA, through I2BM scientists and possibly INSTN teachers (coordinator of EMMI European teaching program in Molecular Imaging to which selected NeurATRIS members already participate, www.e-mmi.eu), the IHU and the Universities of Paris area.