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US FDA Issues Guidance on Pharmacogenomic Data Formats

2005-04-06 - Rockville, MD, USA and Gaithersburg, MD, USA: The United States Food and Drug Administration (FDA) has issued Guidance for Industry on Pharmacogenomics Data Submissions. Issued March 22 by the FDA Office of Clinical Pharmacology and Biopharmaceuticals, the guidance is expected to clarify and strengthen the role of pharmacogenomics in new drug discovery and development. The FDA has directed attention to pharmacogenomics, a field of study that examines individual and population responses to therapeutics under preclinical and clinical evaluation, as a new way to improve drug safety and speed development of new medical products.

FDA and industry experts believe that ultimately pharmacogenomics can be a basis for medicines individualized for efficacy and safety. The FDA intends to ensure that their policies are based on the best science, encompass the many methods of gathering and analyzing pharmacogenomics data, and instill public confidence in the field.

A 2004 report by the Swiss Centre for Technology Assessment (TA-SWISS) said that metaphors such as "personalized medicine", "designer drugs" and "personal pills" that are often encountered in texts on pharmacogenetics and pharmacogenomics are misleading. These metaphors can actually obscure the true potential, namely the development of new drugs that can be used more selectively and with fewer side-effects. "In the future we will still be buying our drugs off the peg", stresses Klaus-Peter Rippe, Project Manager of the TA-SWISS Study. But Rippe goes on to say that developments are moving towards a splitting up of the population into different genetic sub-groups, which could then be administered the drug most suitable for them in each case.

Within pharmacogenomics, Gene Logic has particular expertise in toxicogenomics, an area that assesses the toxic potential of drug candidates using sophisticated predictive and mechanistic capabilities based on gene expression variation. A research agreement between the FDA and Gene Logic, begun in August of 2003, aims to help the FDA develop data quality metrics for the toxicogenomics portion of new drug submissions. Donna Mendrick, Ph.D., who is vice president (toxicology) for Gene Logic, is a member of the FDA/Drug Information Association (DIA) steering committee. This committee focuses on integrating pharmacogenomics in clinical trials for new drugs.

"We believe this new guidance will enhance observatory and predictive drug evaluation systems, alerting drug developers earlier to possible adverse risks of compounds," said Mark Gessler, president and CEO, Gene Logic. "We anticipate that clear guidelines from the FDA will encourage wider use of our pharmacogenomics solutions by pharmaceutical companies. The combined efforts of the FDA and industry will improve drug development and review, offering improved possibilities for a healthier, safer future."

Gene Logic says it has one of the world's most comprehensive toxicogenomic databases as well as gene analysis software systems and expertise. The company's reference database is used by pharmaceutical companies to predict compound toxicity in humans. The guidelines released clarify how pharmacogenomics data should be submitted for FDA review prior to approval for marketing as well as how the data will be evaluated.

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