FDA Representative Gives Insights into Success and Accuracy in Genotoxicity and Carcinogenicity Testing in Exclusive Podcast Interview



Pharma IQ News
09/09/2010

Pharma IQ has interviewed Dr. Timothy Robison, Pharmacology and Toxicity Reviewer at the US Food & Drug Administration (FDA) and CDER, in an exclusive podcast ahead of his presentations at the Genotoxicity & Carcinogenicity Testing conference taking place in London in October.

In the podcast interview, entitled Success and Accuracy in Genotoxicity and Carcinogenicity Testing, Dr. Robison, FDA, shares the latest insights into achieving successful characterisation of genotoxic impurities and accurate implementation of regulatory guidelines to guarantee a streamlined regulatory submission process.

The discussion encompasses two key areas. Firstly, the interview covers in vitro mammalian cell genotoxicity assays, the challenges in dealing with them, the controversy surrounding the interpretation of positives in these tests and how people in the industry can overcome these challenges to avoid potential delays in drug development.

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Following this, the second part of the interview focuses on dealing with genotoxic impurities, from the regulatory perspective. This covers how QSAR data can be used to predict potential mutagenic activity and how this will help the industry. Dr. Robison also talks about what changes he thinks need to be made at an industry level to overcome problems in dealing with genotoxic impurities, together with his thoughts on the future of addressing genotoxic impurities from a regulatory perspective and what regulatory changes he anticipates for the future.

Dr. Robison will be representing the FDA at the Genotoxicity & Carcinogenicity Testing conference, taking place 18th – 20th October 2010 at Le Meridien Piccadilly in London. On Conference Day One he will share his insights on “Dealing With Positive In Vitro Mammalian Cell Genotoxicity Assays”, while on Conference Day Two Dr. Robison will discuss “Dealing With Genotoxic Impurities From A Regulatory Perspective”.

Pharma IQ has also recently produced a podcast with Dr. Andrew Teasdale, Senior QA Executive at AstraZeneca, entitled How to Identify and Control Genotoxic Impurities in advance of his participation at the Genotoxicity and Carcinogenicity Testing event. Both podcasts are available to access free of charge on the event website at www.genotoxconference.com/PR

 

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Editors Notes.IQPC has an established reputation for delivering the highest standard of industry specific conferences, seminars and internal training programmes. We aim to keep business executives up-to date with the forefront of their industries’ trends, technological developments and regulatory landscape.

For any more information please contact:

Lucy Reece, +44 (0)20 7368 9300
lucy.reece@iqpc.co.uk

Web www.genotoxconference.com/PR