Miruna Sasu was named president and CEO of COTA Inc. In her new role, she will lead efforts to drive broader adoption of real-world data by the life sciences industry to safely accelerate the speed of development and reduce the cost of cancer drugs.
Speaking at an FDA Roundtable on Cell and Gene Therapy, FDA Commissioner Marty Makary questioned the construct of “levels of evidence” as artificial and dogmatic, saying that n-of-1 “stories” can drive regulatory decisions.xxx:more“I think we can learn a lot from individual experiences,” Makary said at the roundtable discussion June 5. “We tend to talk in the lexicon of clinical medicine about Level 1, 2, and 3 evidence, and it’s become this sort of dogma that ‘we
