Services Available

Although regulatory genetic toxicology testing has been around for nearly 30 years, interpretation of the reliability of negative results and of the relevance of positive results continues to pose problems. The occurrence of positive results from in vitro tests, particularly in mammalian cells, that do not predict in vivo genotoxic or carcinogenic activity, is uncomfortably high. The frequency of “misleading” positive results ranges from 25-40% depending on the database used. The process of interpreting whether a positive result will inhibit the development of a new substance (perhaps rejection of a clinical trial application, or delays in regulatory acceptance) is not simple and requires expert evaluation.

 

In order to help clients make the best decisions, the services available can be summarised as follows:

• Literature reviews
• Criticial review of data
• Recommendations on study design and conduct
• Monitoring of genotoxicity studies at contract facilities
• Expert advice and problem solving
• Preparation of expert commentaries/”white” papers
• To accompany regulatory submissions
• To defend a regulatory position
• For potential out-licensing
• In respect of potential in-licensing
• Preparation of strategy or position papers
• Advocacy at meetings with regulatory agencies
• Advice on go/no go decisions