Optimal combination of toxicology and ADME in early drug development



Dr. Gerhard Hager
CEO, The NCD Company, Austria

The combination of toxicology and ADME is an important aspect of the translation of safety data from animals to humans and determines important safety parameters such as the starting dose for the first human clinical trials and safety margin. Despite extensive preclinical testing, more than half of the drug candidates in Phase I clinical trials still fail due to safety concerns. In the preclinical phase, safety concerns are by far the most frequent reason for failure with a share of ¾ of the candidates. Important factors for the failure of drug candidates in Phase I are the appearance of toxicities as a result of altered ADME properties in comparison to the animal and insufficient PK/PD correlation and subsequently insufficient efficacy. The earlier these problems are recognized and the combined consideration of toxicity and ADME is integrated into the development strategy, the greater the potential to save considerable development costs and significantly increase the chance for development success, which provides essential advantages in the highly competitive field of drug development.

This course shows how toxicology and ADME can be combined in early stages of development. During the 2-day training, the interaction and optimal combination of toxicology and ADME in early development will be covered. Participants will learn how the combination of both disciplines affects the planning of development and the design and conduct of studies and experiments. In the context of increasingly extensive outsourcing of studies and development activities, the requirements for studies and development management as well as the quality and reporting of results will be discussed and trained in the different phases of preclinical development. In this form, the course offers researchers from different disciplines of non-clinical development a unique forum for exchanging knowledge and experience. It gives project managers and managers of smaller companies important suggestions for planning their own development and putting it on a successful path.