HESI’s work enriches the existing body of scientific evidence and improves our understanding of how to apply science to improve human and environmental health. The following are selected examples of HESI scientific programs that have completed their multi-year work plans with measurable global impacts.
Take a look at how HESI’s collaborative efforts have helped to…
Enhance Patient Safety
In response to series of public health reports on unanticipated, drug-related cardiac arrhythmias (Torsades des Pointes - TdP), HESI undertook a program to evaluate the utility of nonclinical safety testing assays for predicting clinical TdP. The published results of these studies served as supporting experimental data for the subsequent development of the S7B guideline by the ICH Expert Working Group – the first ICH guideline to use safety pharmacology data from a nonclinical safety setting to inform potential clinical risk. Since the implementation of this guideline, the occurrence of unanticipated TdP effects from approved drugs has been largely eliminated.
Reduce Animal Use in Testing
The multi-sector, international HESI Agricultural Chemical Safety Assessment (ACSA) Technical Committee developed a highly awarded and widely cited proposed testing framework for agricultural chemicals with an emphasis on enhanced efficiency, predictivity, and reduced animal usage. The ACSA program recommendations are cited as the basis for the OECD Guideline for Testing of Chemicals-Extended One-Generation Reproductive Toxicity Study and are referenced in the removal of the canine study requirement in EPA pesticide testing guidelines. Additionally, the program is cited in two National Academy of Sciences reports for impact and relevance, awarded the US Environmental Protection Agency Scientific and Technological Achievement Award (Honorable Mention), and the UK National Center for the Replacement, Refinement, and Reduction of Animals in Research “Highly Commended Prize.”
Protect Against Potential Carcinogens
HESI’s program on Alternatives to Carcinogenicity Testing generated a critical dataset that continues to guide the selection of appropriate supporting assays for carcinogenicity testing. The program was designed in relation to a 1995 International Conference on Harmonization Expert Working Group on Safety declaration that data from alternative assays could be used in safety evaluation in place of a second bioassay. The $33 million collaborative effort, provided first of its kind comparative data to guide the selection of either the p53+/– heterozygous knockout mouse, the rasH2 transgenic mouse, the TgAC transgenic mouse, the homozygous XPA knockout and the XPA/p53 knockout, and/or neonatal mouse models as well as the Syrian Hamster Embryo transformation assays. These assays, and the data they generate, provide foundational information that is to make safety and protection decisions by scientists and regulators worldwide.
Enhance Safety Evaluation with Novel Safety Biomarkers
The HESI Committee on Biomarkers of Nephrotoxicity’s non-clinical data set on urinary protein biomarkers gained European Medicines Agency and the US Food and Drug Administration qualification for use in toxicology studies in 2010. The markers provide data on the location and timing of drug effects in the kidney allowing for enhanced drug development. These markers have subsequently become routine points of assessment in discovery and safety studies throughout the industry and have become a critical component in research efforts to protect the public from unanticipated drug and chemical induced toxicities in the kidney.
HESI’s work provides the science to support data-driven decisions on safety. For more examples of HESI science in action take a look at our current publications list, upcoming workshops and trainings, and list of global members.