16+ Industry Representatives Share their Latest Insights:

Achieving Successful Characterisation of Genotoxic Impurities and Accurate Implementation of Regulatory Guidelines to Guarantee a Streamlined Regulatory Submission Process

Genotoxic and Carcinogenic Impurities present significant challenges to the pharmaceutical industry. Genetic toxicity and carcinogenicity tests must have a high level of accuracy and sensitivity to ensure that all possible carcinogens are detected while false positives must be identified to avoid the attrition of safe compounds.

In addition to achieving this accuracy, sensitivity and specificity that is required in the regulatory battery of tests (such as the: Ames test, Chromosome Aberration test, comet assay, micronucleus test, mammalian lymphoma assay etc), toxicologists and safety assessors must also ensure that the assays employed and the data generated is sufficient to comply with the regulatory guidelines specified by several differing regulatory bodies.

Genotoxicity & Carcinogenicity Testing 2010 will address these issues to enable you to efficiently detect genotoxic impurities and in turn the production of safe and profitable drugs.

Industry and Regulatory professionals will share their expertise to help you:

  • Employ novel in vitro and in silico systems for the effective toxicological evaluation of genotoxic compounds to ensure the submission of safe pharmaceuticals. Insights from Merck and Johnson & Johnson
  • Avoid misleading false positive results through the creation on an optimal genotoxicity testing battery for the detection of genotoxic carcinogens and in vivo genotoxins with FDA , Kirkland Consulting and sanofi-aventis
  • Understand the best practice implementation of in silico, in vitro and in vivo tools from a regulatory perspective with FDA, AFSSAPS and National Institute of Health Sciences Japan
  • Interpret regulatory guidelines accurately to ensure complete compliance with the threshold of toxicological concern (TTC) and explore the prospect of harmonisation as a result of the upcoming ICH guidelines with Pfizer, Swissmedic and MHRA

Plus Don’t Miss the Full Day Pre-Conference Interactive Workshop!

Interpretation of Genotoxicity Data and the Subsequent Best Practice Decision Making Pathways to Follow

This workshop will be a unique opportunity to work through the interpretation and decision making criteria associated with genotoxcity data analysis with thought leaders in the field. Hear how to identify misleading results, consider real data and reach decisions on risks for human exposure to enable you to draw valuable conclusions about the best strategy to implement for accurate and efficient genotoxic hazard identification.

Dr David Kirkland, Genetic Toxicology Consultant, Kirkland Consulting
Dr Jim Harvey, Genetic Toxicologist, GSK
Dr Patricia Ellis, Genetic Toxicology Lead, Pfizer

What your peers think about Pharma IQ’s toxicology series...

"In today's pharmaceutical environment two themes predominate, patient safety and probability of technical success. As development of new pharmaceuticals becomes more and more time consuming and expensive, any and all approaches which can identify potential problems must be explored. At the Predictive Toxicology Conference 2010, the aim is to provide attendees with practical knowledge which translates to better patient outcomes and better returns on investment"
Dr Mitchell Friedman- Director of Toxicology, Takeda Pharmaceuticals

“Late stage attrition of nascent drugs causes substantial losses, both financially and in terms of effort. Conversely, establishing assays with high false positive rates needlessly eliminates compounds that might well have been efficacious and safe in humans. De-risking strategies that predict clinical disposition are the ideal towards which we are moving; we need compounds to fail early, but for the right reasons. Recent advances on several fronts are providing in silico, cellular and animal models that more faithfully predict clinical reality. I am speaking at Predictive Toxicology again this year to help keep attention focused on mitochondrial dysfunction as a key safety issue, but also to hear about the latest developments on other fronts."
Dr James Dykens- Associate Research Fellow, Drug Safety R&D, Pfizer

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