
In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
Bristol-Myers Squibb Company and Samsung BioLogics announced the companies have entered into a 10-year agreement.
Financial terms were not disclosed. Technology transfer and trial production will commence in July 2013 and commercial production will immediately begin following regulatory approvals.
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