On the path to first-in-human clinical trials one of the main challenges is “velocity, ensuring rapid delivery of delivered drug product into the clinical program,” says CDMO.
Industry executives are welcoming the FDA’s draft guidance on expansion cohort use in first-in-human clinical trials – the increasing use of which is evidence of a changing drug development paradigm, says CRO.
Modeling and simulation can provide “meaningful prediction” of a drug’s pharmacodynamic range and maximum dose – the use of which might have prevented the tragic outcome of the BIAL 10-2474 trial in 2016, says Certara VP.
