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The agency’s existing technical standards are better-suited to clinical trial data, and mapping RWD to these formats will result in the loss of granularity and introduce new opportunities for human error, pharmaceutical industry representatives and data companies say in comments on a draft guidance.
McKinsey senior partner Joseph Hughes outlines the shape of things to come as new technologies transform life sciences manufacturing, while new modalities around cell-, gene- and RNA-based therapeutics could have “profound implications” on global operations networks.
Heading into the J.P. Morgan Healthcare conference, pharmas have been focusing on discovery alliances. J&J’s deals look into novel tissue-targeted drugs, ionic liquid delivery technology and cancer vaccine R&D. Lilly teams with Entos on novel methods for delivering neurology drugs.
Chinese firm RareStone licenses Rhythm’s Imcivree in greater China and will help enroll label-expansion studies for the drug. Omeros sells ophthalmic surgery drug Omidria and its commercial team to Rayner Surgical Group.