Extractables and Leachables (E&L) USA 2023 Conference

Hello again it’s me Dr Candice Johnson. The E&L conference took place on May 17th – 18th and it was so nice meeting colleagues and hearing about all the developments in the E&L field. The E&L community is eagerly anticipating the changes that the ISO-10993-17 standard and the ICH Q3E guideline will bring. Several presentations …

Assessing carcinogenicity risk of nitrosamines and supporting the ICH S1B guideline

At this year’s SOT in Nashville (March 19-23, 2023), Instem will be organizing two workshops related to cancer assessments.1 In the first workshop, to be held on Tuesday, March 21, 4:30 PM – 5:30 PM (CT) in Room 101B, we will discuss carcinogenicity assessments aligned with the ICH S1B guideline2, specifically focusing on the weight …

Nine Instem Posters at the 2023 SOT Meeting

Instem will again have a large presence at this year’s Society of Toxicology meeting in Nashville.1 As part of the scientific program, we will be co-authoring on nine posters covering the spectrum of scientific topics where we are undertaking research and development activities. This work supports many regulatory mandates and guidelines, including SEND, carcinogenicity risk …

Final meeting of the current eTRANSAFE consortium

The eTRANSAFE project1 is a strategically important project that has been developing a translational technology infrastructure to support drug safety assessments. The project started around 5 years ago and has been jointly funded by the European Innovative Medicines Initiative alongside the pharmaceutical industry. The partners on the project include representatives from the pharmaceutical industry, academia, …

FDA Modernization Act 2.0

The U.S. Congress recently passed the FDA Modernization Act 2.01 which permits the use of alternatives to animal studies as part of the FDA’s regulatory approval process. The new legislation explicitly identifies in silico models as one of these alternatives. This legislation is an important step forward in the use of alternative methods and will …