There are many challenges to progress your new molecule through the various stages of clinical development: Will the molecule have the appropriate pharmacokinetic, safety and efficacy profiles? How do I set up the clinical studies to obtain proof of concept?
Typically, concerns around formulation options receive little attention, let alone any considerations around scale-up. Nevertheless, the path you start in early development will typically determine the route into late stage development and commercialization and the challenges you might face.
Join Kaspar van den Dries as he discusses how developing a solid understanding of the API, formulation, and process during early stage development can ensure your molecule is prepared for scaling to late stage development and commercialization.