Major Pharmas To Collaborate In Non-Profit Initiative To Resolve Clinical Development Hurdles
This article was originally published in The Pink Sheet Daily
Called TransCelerate BioPharma, the initiative funded by 10 big drug firms will work to develop uniform clinical data standards and certification for trial sites and investigators, with deliverables expected by mid-2013.
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Efficient development and review is being hindered by the inability to exchange data freely and truly capitalize on the digital age, CDER director says, challenging industry, regulators and others to creatively think about how to move away from legacy, paper-based processes in clinical trials and regulatory submissions.
Goal is to streamline preclinical development through cross-company sharing of target-based toxicology datasets.
Sanofi CEO says firms and other healthcare stakeholders all need to work together, but “no good deed goes unpunished.”