Since the initial approval of Herceptin ten years ago, it has become the poster child for personalized medicine. But for almost as long as the drug has been on the market there have been questions about the diagnostics used with the drug and the degree to which they correlate with clinical response. Spurred by testing guidelines in 2007, there's a new-found focus on the nitty-gritty of laboratory conduct and test concordance that could serve as a useful model for addressing the broad issues of drug-diagnostic convergence.
Mark L. Ratner
It’s been a decade since the initial approval of Genentech Inc.’s breast cancer drug trastuzumab (Herceptin). Its approval was...
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The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.
Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.
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