Don’t Call It Outsourcing: Merck Serono’s Broad Deal with Quintiles
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Biopharmaceutical companies have been outsourcing R&D activity to CROs for a while, but neither they nor CROs have sorted out which side should bear the burden of what kind of risk and how to best structure operations.
Rather than partner its implantable formulation of exenatide, the biotech turned to hedge funds and other non-traditional investors for the year’s largest round of private capital. The deal enables Intarcia to begin Phase III trials on lead program ITCA-650 for type 2 diabetes, which it believes could be a blockbuster.
This year marks the 30th anniversary of the NIH revitalization act that required women and minorities to be included in clinical research in the US. Putting that into perspective, we have only really been collecting data at scale on women and minorities since the movie Jurassic Park was launched. If we want more people to participate in clinical trials, it is time to get real about reducing the burden of research on volunteers.