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Drug/Diagnostic Co-Development: When to Begin the Tandem Ride

Targeted drug development raises a new conflict of interest possibility when a company hoping to market a drug is also trying to win approval for the diagnostic that proves the drug's efficacy. That problem of "self-validation" is one aspect of the even broader drug/diagnostic question: when and how a company should go about validating a biomarker it wants to incorporate onto a drug label.

Targeted drug development raises a new conflict of interest possibility: the company hoping to market a drug may also be trying to win approval for the diagnostic that proves the drug's efficacy.

That's what Pfizer Inc. realized when it decided to participate in the Alzheimer's Disease Neuroimaging Initiative (ADNI), a consortium...

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In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

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.

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