Nereïs Dévelopment

 

 This entity will have as its mission, to use the chain of active expertise in the pre-clinical development in the phases II and III of clinical development. Both for the molecules coming from its own research and for the molecules or methodologies coming from an external research; the latter also includes private research as well as public research. The competences of this entity, at the same time through their complementarity and through their management and their harmonisation, constitute an incontestable and unique increment in such a structure, clearly distinguishing it from a simple CRO service type company.

 

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The pre-clinical development  

This large group includes the following activities : metabolism and pharmaco-kinetic, toxicology, general pharmacology, clinical pharmacology and legislation, as well as a scientific coordination unit assigned to ensure the global management of the development of the project. Its objective is to provide a global approach, targetted and efficient, permitting the rapid identification of the products having a good chance of therapeutic and commercial success. All the research realised is performed in accordance with the BPL norms and leads to the writing of the reports necessary for the processes of registration.

Within the context of the Nereïs project, besides the development of the "leads" coming from the internal anti-infectious research, each of the units described below will be able to integrate, within the framework of specific contracts, the development of molecules from external research, public or private, within the frameworks of specific contracts eventually resulting in participation to the financing of the group.

 

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Metabolism and pharmacokinetics unit  

Its mission consists of determining the ADME characteristics of a molecule, at the lead stage for products selected for clinical studies. Such studies are conducted to the norms in force, whether performed internally or sub-contracted. 

 

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Toxicology Unit  This unit is structured into three services: general toxicology, toxicology of reproduction and genotoxicity and integrates units of biochemistry and of pathology. It must be able to performed toxicity research in the short and medium term (up to 3 months) on rodents, rabbits and dogs.  Next

Pharmacology legislation unit

  

This unit is able to approach all the legislation problems which can confront any molecule. This service possesses all the tests required by pharmacology legislation and is capable of undertaking, on request, all the general pharmacology tests covering all the functions (cardiovascular, nervous system, respiratory, endocrinology, renal function…). In addition, certain tests such as the HERG, used in the USA, could be quickly introduced at Romainville. Most of the necessary expertise and equipment is already existing. This unit possesses the equipment necessary to work both with rodents as well as with large animals (dogs, monkeys…).

 

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Zootechny unit

 

Zootechny constitutes a fully-fledged science at the present time. It therefore seems necessary to approach the problem as such, both in terms of the premises as in terms of the personnel.

A monkey unit equipped to work by telemetry and meeting the international norms, is currently operational, but investments are planned for further premises meeting the norms in force and anticipated in the future. 

Note that all the premises and work methods of this unit, as those of toxicology and DMPK, meet the international norms in force, the site is classed as a " class A " site, the optimal classification. This offers a guarantee of quality, ensuring the acceptability of the files written for the molecules, of both internal or external origin.

 

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