Management of cross-functional projects
At the service of projects carried out by the laboratories of the Biotherapies Institute and/or teams of excellence supported by the AFM-Telethon, this expertise ensures the implementation and effective coordination of discovery projects and development of new drugs with the aim of starting a clinical trial.
This support begins as soon as there is scientific proof of concept and ends with regulatory non-clinical toxicity studies of the drug candidate through: the selection and optimisation of drug candidates; evaluation of its activity in experimental models of the disease (in vitro and in vivo); validation of its mechanism of action; evaluation of its biodistribution; toxicology studies aimed at defining the target organs and toxic doses.
All of the studies should allow to define the dose that can be tested in humans.
Managing cross-functional projects includes:
- Elaboration of non-clinical development plans in accordance with current regulations;
- Coordination of the various stages of preclinical development with respect to timelines;
- Identification of suppliers and the role of interface;
- Establishment of budgets and allocation of resources.
Clinical development and regulatory affairs
The clinical development of candidate drugs developed by the laboratories of the Institute of Biotherapies and/or the networks of excellence supported by AFM-Telethon requires highly specialized expertise and experience for the conception, preparation and realization of clinical trials, in collaboration with hospital-based investigators, and must conform to both French and international regulatory frameworks.
The candidate drugs are also subject to a request for the status of “Orphan Drug” from the European Drug Agency (EMA) and/or the US Food and Drug Administration (FDA).
The clinical development is directed by Geraldine Honnet, MD, whose team is based at Genethon and intervenes transversally in all the units of the Institute of Biotherapies.
Partnership and development
Because of its engagement in international projects implicating private (pharmaceutical/biotech) as well as institutional (INSERM, CNRS, AP-HP, etc) partners as well as various funding agencies (NIH, European Community, Oseo, etc.), the Institute of Biotherapies is developing a partnership and valorization strategy which will allow it to take advantage of opportunities for co-development and co-exploitation.
Thus it has the following expertise which allow it to implement:
- An in-licensing strategy for technologies, savoir-faire and patents necessary for the development of projects for the Institute of Biotherapies;
- An out-licensing strategy for projects and technologies developed within the Institute of Biotherapies;
- A scientific and juridical expertise;
- An expertise towards transverse projects;
- A strategy for the development of international collaborations.
This strategy contributes to the international visibility of the Institute of Biotherapies as well as its individual units. It also insures the development of its resources in order to develop its programs and to launch new initiatives.