Sanofi Set To Jump Zika Vaccine Scientific and Regulatory Hurdles
In an interview, Sanofi's global head of research Nicholas Jackson discusses firm's 'jumpstart' and where FDA and WHO should step in.
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FDA and NIH officials propose three strategies for clinical trials, saying it will be challenging to identify the most promising candidates; Sanofi and Walter Reed researchers note challenges in vaccine development, including manufacturing scale up.
FDA’s Amy Abernethy describes how agency’s use of real-world data has evolved in response to COVID-19 and the ‘a-ha’ moment of leveraging different data sources to understand the coronavirus. Takeda R&D President Andrew Plump notes difficulties with platform trials and limitations on data sharing.
If Biden administration wants to nominate the acting commissioner, Vacancies Reform Act would dictate the timing. Woodcock can still get the nod and remain head of the agency during the confirmation process, just as Andrew von Eschenbach retained his acting title following his nomination in 2006.