PHILADELPHIA--(BUSINESS WIRE)--Instem, a leading provider of IT solutions and services to the global life sciences market, announced today that it has been awarded a European Medicines Agency (EMA) grant as part of an EMA-funded research project to better understand the mutagenicity of N-nitrosamines.
Nitrosamines (NAs) are a class of organic chemical compounds that humans may be exposed to by tobacco use or by consuming certain foods. N-nitrosamines have been categorized in the ICH M7 guideline as belonging to the “cohort of concern” group of high-potency mutagenic carcinogens. Some active pharmaceutical ingredients carry NAs as impurities from production and/or storage or may cause their formation in the gastrointestinal tract.
As part of an industry and academic consortium of 9 beneficiaries, funded by EMA and led by Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Instem is collaborating on a 2-year research project to further investigate the mutagenicity of different classes of NAs to distinguish highly potent from less potent carcinogens.
Experts from Instem’s In Silico Solutions group will be participating in the project, and the Leadscope Model Applier computational toxicology software suite and toxicity and carcinogenicity databases will be used to help the consortium develop novel in silico test systems that will improve risk assessment and derive reference doses such as acceptable intake values.
Dr. Glenn Myatt, VP Informatics, Instem commented, “We are delighted to have been invited to contribute to this important research program and to have the opportunity to work with leading researchers in developing new testing methodologies to help reduce drug safety risks.”
Renowned for their advanced informatics and prediction technology, together with comprehensive database solutions, Instem’s in silico solutions enable organizations around the world to effectively unlock valuable knowledge contained in both public and proprietary sources of research data. Clients can also access well over 500,000 toxicology studies for more than 200,000 chemicals, enabling fast, accurate, defendable and regulatory-accepted predictions.
In Silico Insider
For the latest in silico industry and regulatory insights, visit In Silico Insider, a bi-weekly Blog developed specifically for scientists and professionals working in the field of Computational Toxicology.
About Instem
A global provider of leading software solutions and scientific insight services, Instem is helping clients to bring their life enhancing products to market faster.
We enable organizations in the life sciences to more efficiently collect, report and submit high quality regulatory data, while offering them the unique ability to generate new knowledge through the extraction and harmonization of actionable scientific information.
Every day, across the entire drug development value chain, Instem solutions are meeting the rapidly expanding needs of life science organizations for data-driven decision making, leading to safer, more effective products.
Instem supports its global roster of clients through offices in the United States, United Kingdom, France, Switzerland, Japan, China, and India.
