COVID-19 And IP: Companies Are 'Taking A Chance' Sharing Clinical Trial Details
While companies often keep clinical trial endpoints a secret, FDA's Peter Marks notes that may not be the case with COVID-19 vaccines; CDER's Patrizia Cavazzoni says agency may expand de-centralized trials.
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US FDA’s Peter Marks says companies are not exchanging information about adenoviral factors, which is probably slowing down the field. He describes NIH's plans for a bespoke gene therapy consortium for vector generation and continued efforts for regulatory harmonization.
Work on guidance that was originally expected in 2020 continues as the agency and industry learn more about the utility and spectrum of decentralized trials as a result of the novel coronavirus pandemic.
Recruiting the right patient population for Phase III trials of COVID-19 vaccines will be a key factor in how fast any candidate can come to market. The challenge, which will likely mean enrolling patients who often are underrepresented in trials, is keeping Moderna's Chief Medical Officer up at night. The company also talked vaccine distribution, what it feels it owes the US government for its financial support, and pricing of its potential mRNA vaccine on a recent New York Academy of Sciences webinar.