Our Scientific Expertise and Strategy

Know more about our leading expertise in gene regulation, transcription factors and nuclear receptors for unprecedented R&D initiatives.

Our Capabilities

DEVELOP DRUG CANDIDATES UP TO THE THRESHOLD OF PHASE III TRIALS

GENFIT regroups the entire span of capabilities necessary to advance novel therapeutic solutions from identification to proof of efficacy and safety in Phase II clinical trials.

Through its internal know-how, and via privileged collaborations with specialized partners, GENFIT defines and establishes custom-made R&D strategies to maximize product value.

Cutting-edge preclinical and clinical expertise in cardiometabolic disease.
GENFIT employs multiple areas of expertise:
- A strong clinical knowledge of the pathology of cardiometabolic disease,
- An in-depth scientific comprehension of gene regulation and of biological mechanisms,
- A broad technological know-how of the techniques and methods to study and control biological mechanisms, with a constant focus on translational research between animal models and man.

GENFIT is capable of managing the entire range of preclinical studies necessary to prove the therapeutic interest of a new product. A complete in-house range of in vitro and in vivo technologies enables the pharmacological activity of compounds to be assessed. Moreover, GENFIT possesses the expertise necessary to coordinate and manage regulatory toxicology, pharmacokinetic, and ADME studies.

Beyond this preclinical know-how, GENFIT has acquired solid capabilities in the definition, structuring, and management of clinical trials to provide proof of efficacy and safety in man. Thus, for its own proprietary products, GENFIT has managed 15 Phase I or II clinical studies, in Europe and in Northern Africa, with some 600 patients or healthy volunteers.

Pharmaceutical development, from the first feasibility batches to large-scale production for clinical trials.
Since its inception, GENFIT has developed strong capabilities in the production of active principles and formulated products. These skills are a guarantor of the quality of GENFIT’s specialized partners that manage its pharmaceutical development from the first small-scale synthesis for initial preclinical studies, to large-scale production for clinical trials, always in keeping with Good Manufacturing Practices (GMP).

GENFIT applies its knowledge of regulatory procedures throughout product development.
At each step, and in accordance with regulatory requirements, GENFIT completes the necessary product application documents (Investigational Medicinal Product Dossier or IMPD, Investigator’s Brochure or IB), and submits them to the relevant health authorities. Throughout the development process, a document database is maintained for each product according to regulatory guidelines for product registration.

Prior to the R&D process, GENFIT explores new targets and identifies original compounds with novel mechanisms of action.
Thanks to the scientific expertise of its teams in the field of gene regulation and in particular nuclear receptors, GENFIT is able to develop and run the entire battery of primary and secondary screening tests, and to generate series of small molecules that act on nuclear receptors and that are designed to induce specific biological responses.

Share our thorough knowledge of clinical requirements in partnership with the clinical trials architect, Naturalpha.

Our Technological Strengths

Have a look at our state-of-the-art and therapeutic-focused technological platforms, regrouping innovative tools from molecular biology to in vivo models.