GRK 2338 Seminar - Gerhard Weinbauer
Covance Preclinical Services GmbH, Münster, Germany
17.12.2018 at 16:00
Title: Contract research and preclinical safety assessment of new medicines
The development of new human medicines is well regulated and globally harmonized across continents, but is also time-consuming and costly. There is also increased complexity for the nature of drugs that are being developed – from pharmaceuticals (chemically synthesized) towards biopharmaceuticals (derived from recombinant DNA technology), gene therapy and cellular therapies. Drug development can roughly be divided into an investigate phase (identifying lead candidates, establishing efficacy, formulations and early safety) and a regulatory phase (preclinical studies that enable human phase studies). The regulatory phase is very tightly regulated and studies are conducted under good-laboratory practice (GLP) in order to ensure maximal reproducibility of animal study outcomes. Drugs derived from recombinant DNA technology specifically have human targets and, therefore, the use of nonhuman primates (NHP) in safety assessment is currently increasing – despite all efforts to avoid NHP use in drug research and development. Because of the complexity of new medical drugs and increased cost of study conduct under GLP, significant parts of drug development are being outsourced by pharmaceutical industry to so-called contract research organizations (CROs). Covance is globally active CRO and this presentation will provide an overview of drug development from a CRO perspective including preclinical case studies, status of in-vivo versus in-vitro approaches and will also address career development aspects.
Weinbauer presentation: PDF
Venue:
Pettenkoferstr. 12, D030
Host: Thomas Gudermann (P10)