SIFI (Società Industria Farmaceutica Italiana) is an Italian ophthalmic company dedicated to research, development and manufacturing of innovative safe drugs for eye care. SIFI coordinates the development of the consortium activities.
PSR is an SME with an extensive expertise in clinical trials for orphan drugs. PSR will work with SIFI and the EMA to design and execute successful clinical trials programmes.
MP (Moorfields Pharmaceuticals) has approved manufacturing facilities able to produce sterile batches of PHMB formulations.
At UoR (University of Rouen), the Laboratory of Parasitology, will undertake efficacy studies by using an experimental Acanthamoeba polyphaga keratitis model.
RTC (Research Toxicology Centre) is a research organisation specialised in preclinical toxicological studies. RTC will produce data and integrate information arising from non-clinical pharmacokinetics, pharmacodynamics and toxicology studies for regulatory purposes.
CERATIUM brings a high level of specialist expertise in FP7 project management that will directly compliment the project management skills of SIFI.
Consortium overview and role of the participants
The ODAK project consortium of six European partners is led by SIFI a leading Italian pharmaceutical company dedicated to research, development and manufacturing of innovative safe drugs for eye care. SIFI have coordinated the development of the consortium to ensure the necessary skills to implement the ODAK work plan. The six partners include experts in ophthalmic drugs and med-tech, toxicology, parasitology, designing and successfully implementing clinical trials targeting rare diseases and European (FP7) project management and knowledge transfer.