TransQST Translational quantitative systems toxicology to improve the understanding of the safety of medicines

www.transqst.org

The development of all new medicines requires extensive nonclinical and clinical testing prior to drug approval by regulatory agencies and consequent marketing launch. Although clinical trials are generally conducted safety based on nonclinical results, a significant number of potential medicines (drug candidates) fail during clinical testing due to safety signals in human subjects, and high profile safety failures do occur. Thus, determining when nonclinical results reflect increase clinical risk prior to clinical testing remains challenging.

The TransQST project is gathering together existing data and will generate new data under the project goals to support the development of tools that should make it easier to assess the safety profile of drug candidates before undergoing clinical testing phase. This will be achieved by an increased understanding of when results in nonclinical testing can be reliably extrapolated to humans, and by developing models to predict exposure-based biological responses in human tissues, which is an important element of safety assessment for all new drug candidates. Since liver, kidney, cardiovascular and gastrointestinal-immune systems are among more common target organs when safety signals are encountered during clinical testing, TransQST work focuses on these four systems.

During the project’s life participants envisage also working toward improved methods to visualise and analyse large and complex datasets covering different types of available information (ie. drug metabolism, transcriptomics, proteomics, metabolomics, toxicology, pathological phenotype, biomarkers) to aid decision making on drug safety.

Associated Staff

Prof Jos CS Kleinjans PhD
Professor

Prof. Kleinjans studied biology at the Catholic University of Nijmegen and took a training in general biology and further trainings in physiological p more ...

Danyel GJ Jennen PhD
Assistant Professor

Dr. Danyel Jennen is Assistant Professor in the field of toxicoinformatics at the UM Department of Toxicogenomics and he heads its core unit on toxico more ...

Daniela Ferreira Garcia Rodrigues MSc
PhD Student

Daniela Rodrigues was born on March 1st 1993 in Porto, Portugal. In 2011, she started her Bachelor in Biochemistry at the Faculty of Sciences of the U more ...

Terezinha M de Souza MSc
PhD Student

Terezinha Souza was born on December 7th 1988 in Fortaleza, Brazil. In 2007 she started her Bachelor studies in Biological Sciences at Federal Univers more ...