Don’t Call It Outsourcing: Merck Serono’s Broad Deal with Quintiles

“I’ve banned the word ‘outsourcing’ from our organization,” says Merck Serono SA EVP and Head of Global Development and Medical Annalisa Jenkins. It seems like a strange thing to say, coming from someone who’d just crafted an extensive five-year clinical development agreement with Quintiles Transnational Holdings Inc., which bills itself as “the world’s largest provider of biopharmaceutical development and commercial outsourcing services.”

But Jenkins persists. It’s not outsourcing; rather, in an increasingly complex industry, organizations need to work together to address the...

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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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