The pathway towards first in human (FIH) studies is complex, with drug developers facing a multitude of challenges as they navigate the route from formulation development and small-scale GMP manufacture through to the management of their Phase I clinical trial. Many developers struggle to meet their desired timelines, adhering to changing regulations, overseeing trial complexity and getting clinical material manufactured, creating a real need for a more strategic roadmap that enables them to generate data quickly and build value into their compound.
Torkel Gren, General Manager at Recipharm Pharmaceutical Development, and Anders Millerhovf, CEO at Clinical Trial Consultants (CTC), discuss the key considerations in early phase formulation development and suggest a more integrated approach to take new drugs quickly and safely to proof of concept.
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