The discovery and development of new drugs is very costly and the rate of failure of drug candidates is high. Initiatives to reduce the rate of attrition during later phases are clearly desirable and, if successfully implemented, will reduce development costs. Main barriers are the failure of preclinical studies to predict safety and efficacy in the clinic and the regulatory process, which has not kept pace with scientific developments.

Improvements in predictive biology and incorporation of new concepts into an improved regulatory framework would decrease the cost of drug development and speed up the delivery of innovative medicines to patients.

“There is enormous scope for this approach to speed up drug development, while at the same time ensuring greater drug safety.”
Dr. Jochen Koenig, InnoMed PredTox Liaison for Genedata AG

InnoMed PredTox involves the construction and delivery of an integrated database populated with comprehensive data from in vivo experiments of 14 compounds that previously failed during drug development, and from two extensively characterized model compounds. The data collected includes traditional toxicological endpoints supplemented with information from new, genome-wide techniques, i.e. transcriptomics, metabonomics and proteomics.

The analysis and data mining of information contained in the database will eventually aid the prediction of toxicities of new drug candidates and also allow different mechanisms of toxicity to be identified. The latter will support informed decision making for compound progression, as different mechanisms of toxicity can have different relevance to potential human toxicities.

In a second phase of InnoMed PredTox, the approach could be extended to cover more compounds and more safety profiles.