FDA Delivers Analysis of Future Predictive Toxicology Trends and Techniques



IQPC- Geno
05/27/2010


Dr Martha Moore (Director of the Division of Genetic and Reproductive Toxicology) and Dr Vasily Dobrovolsky (Senior scientist at the Division of Genetic and Reproductive Toxicology), of the FDA (US Food and Drug Administration) will be speaking at the Predictive Toxicology conference this February in London.

Dr Moore, currently also chair of an international effort for protocol harmonization for the in vitro gene mutation mouse lymphoma assay, will provide an overview of Predictivity and Future Directions in Genetic Toxicology. Among the issues covered will be the use of genetic toxicology assays to predict cancer and heritable mutation, mechanistically based genetic toxicology assays and her thoughts on promising new approaches and assays.

Dr Dobrovolsky will present findings from “An In Vivo Gene Mutation Assay For Hazard Identification And Risk Assessment: The Pig-A Story”. This will examine cost efficient high throughput approaches to better predicting genotoxic hazards that may impact on human health. Also scrutinized will be limitations of the current ICH battery of genotoxic tests for safety assessment, the design of a novel high throughput model for detection of in vivo gene mutation, laboratory animals (background and induced Pig-A mutation in rats and monkeys) and the Human PIG-A model with analysis of results from healthy and exposed populations.

Dr Moore and Dr Dobrovolsky will be joined by Dr David Cook, Associate Director for Global Safety Assessment at AstraZeneca for an insight into the future of Predictive Toxicology and what changes are needed. Looking at the current challenges, they will discuss how best to improve the reliability of Predictive Technology to avoid late stage drug attrition, build upon established techniques, evaluate of new tools and certification of new technology with regulatory bodies.

Sarah Haynes, Event Director at Pharma IQ responded to the confirmation saying “This is a great opportunity for the FDA to answer the attendees’ most important questions. Having an official onsite is a rarity at any European conference and I am sure that this will make for interesting and varied discussion. It will certainly help support the event’s aim to allow participants to take home essential practical advice and guidance.”

Also addressing the conference will be Dr Eric Blomme (Director of Investigative Toxicology, Abbott), Dr James Dykens, (Associate Research Fellow, Drug Safety R&D, Pfizer ), Dr Andrew Worth (Project Leader Computational Toxicology, Systems Toxicology Unit Institute for Health and Consumer Protection (IHCP), European Commission - Joint Research Centre), Constantine Kreatsoulas (Senior Research Chemist, Chemical Modelling and Informatics Group Merck & Co.) and Dr David Jones (Principle Scientific Officer, MHRA)

The conference, now in its second year, brings together leading authorities in the field of Predictive Toxicology with the aim of delivering insight and practical solutions to reduce costs and increase efficiency of drug development through innovative technologies to ensure pipeline compounds pass legislation and result in safe, profit-making drugs.

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Editors Notes.

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FDA - The Food and Drug Administration (FDA) is a government agency of the United States Department of Health and Human Services. The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.