Preclinical Development Team

Preclinical Development Team

The Preclinical Development Team coordinates the company’s activities in the area of preclinical studies of selected drug candidates. With its vast skills and experience, the Team can efficiently assess if molecules are ready for phase 1 clinical trials (known as first-in-human, FIH) and provide significant support for finished value-added dosage forms, allowing Adamed to obtain regulatory approval for bringing new medicines to the Polish and international markets.

The Team’s numerous tasks mainly include the assessment of a drug candidate’s safety (toxicology studies), which is primarily aimed at estimating the MRSD in clinical trials. This assessment is a multi-stage process, starting with in vitro tests using a cell line panel and in vivo tests on animal models which are aimed at establishing the maximum tolerated dose, to proper toxicology studies as per the mandatory Good Laboratory Practice standards. In addition to general toxicology studies, the Team also coordinates genotoxicity, reproductive toxicology, local tolerability, hypersensitivity, and ecotoxicology studiesdepending on project needs.

Some of the Team’s other tasks include planning and the supervision of studies to determine the optimal effective dose and dosage regimen for the drug candidate; pharmacokinetic (PK) studies; tissue distribution and mass balance studies to understand the fate of the compound in the body; pharmacodynamic (PD) studies and the PK/PD ratio in an in vivo system; studies of interactions with metabolic pathways and cell transporters; and pharmacokinetic studies on animal models supporting the selection of a previous drug formulation. The Preclinical Development Team is also responsible for conducting a thorough assessment of the necessary preclinical studies in a project as per the current guidelines of the competent public authorities and non-governmental organisations, primarily the European Medicines Agency.

The Preclinical Development Team also plays a very important role as it manages innovative drug development programmes and coordinates the work of the research groups involved, both within the company and externally, including academic groups and contractors. Research Programme Managers in the Team control project schedules and budgets, collect and file project documents, ensure the uninterrupted flow of information between research groups, and verify and consult the accuracy and legitimacy of R&D projects while constantly monitoring the competitive environment.