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Vertex: Preparing to Go Commercial

With perhaps little over a year to go before it files its NDA for hepatitis C hopeful telaprevir, Vertex is gearing up for its transition to a commercially focused company. New CEO Matt Emmens talks to IN VIVO about the financial and cultural challenges of building a commercial organization to match Vertex's highly productive R&D.

Melanie Senior

It has got to be one of the most exciting times for any biotech company: preparing to finally launch a product that has taken years, and many millions of dollars, to discover and develop. Not many companies dare try to do it themselves—most, if they get that far, license on their drug candidates to larger partners. Of those that have tried, many fail—either ending up getting acquired (like NitroMed Inc

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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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