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December 26, 2007

How individualized medicine might be approved with existing regulations

Dr. Eric Hoffman envisions that some parts of the approval process may be developed for DNA-like molecular medicine as a 'class' of drugs, rather than individual testing of hundreds of different sequences.

Dr. Hoffman is a world-renowned human geneticist, who is the Director of the Research Center for Genetic Medicine, a James Clark Professor of Pediatrics at Children’s National Medical Center and George Washington University.

"The patients and their families are crossing their fingers that the drug’s overall chemistry can be shown to be safe," he says.

How can DNA-like drugs specific to a single patient’s mutation go through the existing approval process" Are the current standards of rodent and monkey toxicity studies relevant and appropriate for DNA-like drugs, when the animals do not have the same DNA target (or off-target) sequences as humans" These and other questions are certain to pose exciting challenges to both the approval and marketing processes of drugs.

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