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 …

Computational toxicology 2022 year-end review

The computational toxicology group here at Instem has had another busy year that has resulted in six publications and book chapters1-6, completion of existing and initiation of new collaborative working groups, as well as significant updates to our computational toxicology solutions. We have been collaborating on a number of research topics related to the in …

The Leadscope bacterial mutagenicity expert alerts journey to universal regulatory acceptance

It has taken over 10 years, but now Leadscope’s expert rule-based methodology is used every day to support submissions to regulatory agencies around the world, including pharmaceutical impurity assessments aligned with the ICH M7 guideline1, assessment of extractable and leachables, along with other applications. The following blog reviews this journey. The first step in this …

6-year anniversary of the ICH M7 principles and procedures publication

Over 6 years ago, the ICH M7 pharmaceutical impurities guideline1 was in its implementation phase, and we were approached to consider writing a cross-industry publication to outline a protocol for performing a (Q)SAR assessment aligned with the guideline. A collaborative working group was established and work began to create this publication. The paper was published …

Advancing Prediction of Nitrosamine Carcinogenicity Potency

This week, Dr. Kevin Cross from Instem is presenting at the 2022 Genetic Toxicology Association meeting on recent progress in predicting N-nitrosamine carcinogenicity potency. The presentation outlines progress over the last year and provides an update on different collaborative working groups, including a recently announced EMA-MutAmind project funded by the European Medicine’s Agency and led …

New book on mutagenic impurities

We were delighted to contribute to a new book on Mutagenic Impurities, edited by Andrew Teasdale – “Mutagenic Impurities: Strategies for Identification and Control”.1 The book incorporates a discussion on the ICH M7 guideline and covers the in silico assessment of mutagenicity, including the use of structure-activity relationship methodologies, to support the evaluation of impurities. …

New SD file submission recommendation from the US Food and Drug Administration

Last month, we reviewed some of our Research Collaboration Agreement (RCA) activities with the US Food and Drug Administration (FDA).1 This included a joint project to develop an internal FDA/CDER system (based on the Leadscope technology) to enter, validate, and register chemicals linked to internal (Q)SAR consultation reports. This information, along with access to toxicity …

US FDA collaborations – predicting mutagenicity and beyond…

This week, we are pleased to welcome Dr. Kevin P. Cross, Instem’s Principal Investigator with U.S. FDA Collaborations and VP of Product Engineering and Production, as a guest contributor to the blog. Over the last 15 years I have been working closely with the US Food and Drug Administration (FDA) as a principal investigator on …

Streamlining ICH M7 analyses with an implemented protocol

A major focus of our work over the last few years has been on the development and publication of in silico toxicology protocols, discussed in previous blog posts1. This has resulted in a paper outlining a framework for such protocols2  as well as two published protocols in the areas of genetic toxicology3 and skin sensitization4. …