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Amir Feizi is the Director of Bioinformatics at OMass Therapeutics, a spinout from Professor Dame Carol Robinson’s Laboratory at the University of Oxford. This is where our idea for an R package came from. The package has three main functionalities: schema query functions, custom query functions, and plotting functions.
The pharmaceutical landscape is evolving rapidly, with small and medium-sized biotech companies increasingly taking center stage in innovation. In 2017, small and medium-sized biotech companies accounted for 51% of FDA market approvals, while large pharmacompanies were the originators in only 28% of approvals[4].
Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? A: The FDA’s guidance document indicates the briefing package is submitted four weeks before the meeting. The sponsor-initiated IND is conducted by a pharmacompany seeking commercial approval.
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