Peter Marks On How He Wants To Prepare For The Next Pandemic
Acknowledging the toll that vaccine opponents have taken on FDA operations, the CBER director emphasizes the need to create stand-by manufacturing capacity, conduct faster studies in special populations, and better understand the mRNA platform.
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US FDA Leaves Pfizer’s Efficacy Data Out Of Under 5 EUA Due To ‘Data Maturity,’ Lack of ‘Confidence’
Moderna’s ‘more mature’ vaccine efficacy data in children under 6 get agency highlight due to what Peter Marks called a ‘confidence’ difference in the numbers, the but CBER chief also said differences between Moderna’s and Pfizer’s vaccines are ‘subtle’ in this age group.
Commissioner Califf is questioned about the backlog of inspections and fact FDA staff are continuing to work remotely at Senate HELP Committee hearing. Senator Burr promises to be a roadblock to emergency COVID-19 funding.
Pink Sheet Podcast: Regeneron’s COVID Monoclonal Deal, New FDA Advisor, Project Optimus In Cancer Combos
Pink Sheet reporter and editors discuss the somewhat novel pricing language in Regeneron’s deal with the US government to develop a COVID-19 monoclonal antibody, US FDA Commissioner Robert Califf hiring a new senior advisor, and optimizing dosing in cancer combination therapies.