Before a drug candidate can reach final approval for commercialization, it has to go through a multistage development process that takes several years. Research at Fraunhofer ITEM is geared to this development sequence, and we accompany our clients through its different phases. Driven by enthusiasm for complex topics, a strong will to solve even difficult problems and to find new approaches, our scientists elaborate innovative concepts and methods to help advance the development of new therapeutics – and thereby help restore human health.
As researchers in translational medicine, working at the interface of basic research, clinical application, and drug regulatory requirements, we aim to translate scientific results into benefits for patients. The central questions in this context are: How can an idea be translated from the lab into an investigational medicinal product for use in clinical trials? How can the efficacy and side effects of this product be studied efficiently and conclusively in suitable models? And how can the proof of concept – the necessary evidence of the product’s mode of action – be provided in humans?