Società Industria Farmaceutica Italiana –S.p.A. Catania Siciliy, Italy - www.sifigroup.com
SIFI already have a highly skilled in-house research team that can undertake many of the research tasks and regulatory compliance to develop ophthalmic solutions. The company will undertake formulation and stability studies and some in vitro pharmacodynamic and cytotoxicity studies, PK studies and Ocular Tolerance tests. They will also undertake regulatory activities and lead the project management.
Research Toxicology Centre –S.p.A. Rome, Italy - www.rtc.it
RTC are a research organisation specialised in preclinical toxicological studies who will to carry out toxicity models as well as complimentary pharmacokinetics (PK) studies of PHMB formulations. All their work, data and reports will be produced in agreement with defined international regulatory standards: OECD, US EPA – OPPTS, Japan METI or JMAFF. RTC will produce data and integrate information arising from non-clinical pharmacokinetics, pharmacodynamics and toxicology studies for regulatory purposes in order to support the choice of candidate formulations for clinical development.
Laboratoire de Parasitologie, University of ROUEN NORMANDIE, France - www.univ-rouen.fr
The Laboratory of Parasitology, University of Rouen bring expertise in parastiology, ophthalmics and pathology. They will undertake studies using the experimental Acanthamoeba polyphaga keratitis model they have developed, described by Vasseneix et al. (Cornea, 2006). This will provide efficacy data.
Moorfields Eye Hospital, London, United Kingdom - www.moorfields.nhs.uk
Moorfields Eye Hospital is an international centre for opthalmic care. Moorfields will be a clinical trial site for the Phase 3 trials.
PSR Group BV, Hoofdorp, Netherlands - www.psr-group.com
PSR is an SME widely regarded as the leading experts in orphan drug development. The team bring extensive expertise in running challenging clinical trials for orphan drugs. They will work with SIFI and the EMA to design and execute successful clinical trials programmes. Due to the nature of infectious rare disease and challenges this presents ODAK require this high level of expertise to manage the trials and pragmatic experience to implement innovative approaches. PSR also bring good European clinician networks, and links to key opinion leaders, scientific advisors, government bodies and rare disease patient groups, that will help with recruitment and subsequent dissemination and exploitation of results.
Ceratium Limited, Merseyside. United Kingdom - www.ceratium.eu
Ceratium bring a high level of specialist expertise in FP7 project management that will directly compliment the project management skills of SIFI. The company will provide a “helpdesk” function to address FP7 reporting and financial issues raised by any partners. The company will increase the capacity of the consortium to understand EU project management. In addition they have skills and expertise in stakeholder consultations, dissemination strategies and knowledge transfer and will lead the dissemination and stakeholder (including patient) engagement.