Glossary
(Agence Française de Sécurité Sanitaire de Produits de Santé). French Agency for the Safety of Healthcare Products.
A peptide from the human Disintegrin domain of ADAM-15.
(Agence Nationale de Valorisation de la Recherche). The French Agency for Innovation.
(Bons de Créateur d’Entreprise, formerly BSPCE – Bons de Souscriptions de Parts de Créateurs d’Entreprise. Special Founders' Share Purchase Warrants) Share purchase warrants offered to employees and executives of innovative French companies established for less than 15 years.
(Banque de Développement des Petites et Moyennes Entreprises). French Development Bank for Small and Medium-sized Companies.
The ratio between a drug’s expected benefits and its possible risks.
Study or experimentation conceived for and conducted on human subjects in view of developing biological or medical knowledge.
(Bons de Souscription d’Actions). French Share Purchase Warrants.
The systematic study of a drug on human subjects (either healthy or sick volunteers), in order to discover or verify drug effects, adverse reactions, and to study the absorption, distribution, metabolism, and extraction of the drug in question, for the purpose of establishing its safety and efficacy.
(Centre National de la Recherche Scientifique). French National Scientific Research Centre.
The patient’s adherence to treatment (good therapeutic follow-up).
(Clinical Research Organisation). A research organisation under contract.
Substance or combination of substances presented as possessing curative or preventive properties regarding human disease, as well as any product that can be administered to man in order to establish a medical diagnosis or to restore, mitigate, or modify his biological functions.
Any harmful and undesirable effect experienced by a participant in a clinical trial, regardless of the effect’s connection to the drug(s) under study and regardless of what caused the effect.
European Medicines Evaluation Agency, currently known as the European Drug Agency.
(Food and Drug Administration). American agency overseeing drug registration.
The group of measures ensuring the quality standard of clinical trials.
An aspect of pharmaceutical quality assurance that ensures drugs are manufactured and controlled in a consistent manner according to quality standards suitable for the drug’s intended use and in accordance with the drug’s specifications.
Hepatocellular Carcinoma – HCC or Carcinome HépatoCellulaire in French – Primary liver cancer.
(Human immunodeficiency virus).
(Herpes simplex virus).
(International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).
(International Financial Reporting Standards). European accounting standards.
Institut Gustave Roussy.
All the techniques that enable us to monitor the immune system’s induction and kinetic response. The monitoring of T responses (mediated by T-cells) is especially relevant to immunotherapy.
Manipulation taking place in the body of a human or animal.
(Investigational New Drug). Application filed with the FDA requesting authorisation to start clinical trials for investigational new drugs.
(Institut National de la Santé et de la Recherche Médicale). The National Institute of Health and Medical Research, a French institution.
The individual(s) who conduct(s) and monitor(s ) the clinical trial and is(are) responsible for the protection, health, and well being of trial participants. The investigator is a qualified physician with adequate experience. When a trial is entrusted to several investigators, a coordinating investigator is appointed by the trial’s sponsor.
(The International Organization for Standardization of International Standards for Quality Management). A system designed to ensure quality in design, development, production, installation, and related services.
A defined quantity (of a raw material, an item used in packaging, or a product manufactured in a process or a series of processes) that may be deemed a consistent unit.
A type of cellular extract (a product of lysis).
Marketing Authorisation.
A multi-drug resistant gene encoding transmembrane proteins that reject products or drugs outside of cells.
Minimum Inhibitory Concentration.
New chemical or biological entities.
French equity note (a bond redeemable in shares).
The PCT is an international treaty that stipulates a standardised filing process for obtaining foreign patents in the signatory countries.
The study of a drug’s effective dosage and length of therapeutic efficacy.
The study of a drug’s kinetic parameters (uptake and clearance) in various compartments (the bloodstream, tissues).
This phase corresponds to the first clinical trials. It must evaluate drug tolerance in a small number of volunteer subjects (usually healthy) and enable initial studies on the administration of the drug in the human body.
This phase is divided into two sub-phases: Phase II-A and Phase II-B. The purpose of Phase II-A is to study the effects of the drug on a small number of volunteer subjects (usually healthy) and to complete pharmacokinetic studies. Phase II-B must evaluate drug tolerance (adverse effects) and efficacy on a limited number of sick subjects and establish the administration of the drug.
The purpose of this phase is to confirm and supplement the results regarding drug tolerance and efficacy on a sufficient number of sick subjects. This phase must also allow for the study of adverse effects and evaluate the safety/efficacy balance vis-à-vis a reference treatment.
This phase corresponds to post-marketing authorisation studies. It is conducted on a large number of patients with the purpose of refining our knowledge of the drug and its adverse effects, adapting the drug’s doses to individual cases, and evaluating treatment protocol.
The clinical trial used to register a drug.
Document describing the rationale, goals, methodology, and statistical methods of the trial and which specifies the terms and conditions under which the trial must be conducted and managed.
Quality Assurance is a concept encompassing everything individually or collectively capable of influencing product quality. Quality assurance means all the measures taken to ensure that available products are suitable for their intended use and includes good practice in the following areas: sampling, transportation, manufacturing, and preservation.
A trial in which selected patients are randomly distributed among various groups under study.
A serious adverse effect is an adverse effect that contributed to death or is likely to endanger life, causes disability or incapacity, or leads to or prolongs hospitalisation.
(Société d’Investissement à Capital Variable). A French open-ended investment or mutual fund.
Stock Option
Individual or entity that assumes leadership of a clinical trial and is responsible for its launch and management.
Dose of a given drug at which toxicity first appears. This dose makes it possible to define the therapeutic dose which must necessarily be lower than the TDL.
All the information and measures taken to monitor and rapidly retrace each stage of a process.)
The establishment of proof that the implementation or use of any process, procedure, equipment, raw material, activity, or system actually enables the realisation of planned outcomes and set specifications.