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Personalized Medicine

Question: When is the critical time period by which a companion diagnostic for a targeted therapeutic drug should have completed its full characterization and validation of diagnostic test that can determine which patients are right for their experimental drugs?

GRSA Response/Advice: The test must be fully characterized and validated prior to starting the pivotal registration trial.

A fully characterized and validated test not only ensures that the un-met medical need patients will not be deprived from potentially novel therapies, but it will strengthen the probability of winning the FDA approval, because it enables the clinical investigators to enroll the right patients with the right strain of disease being targeted in the pivotal phase III registration trials.

Note: GRSAOnline will take an extensive regulatory review of your planned development program for a phase II to Phase III transition for your targeted drug/with companion diagnostic test, and will provide constructive feedback/recommendations that will minimize any potential FDA approval issues.