Expediting early-phase development of small molecules: An integrated approach
November 18, 2022
Small molecule drug development has changed substantially
in recent years. With the heightened focus on molecularly
targeted therapies, small molecule active pharmaceutical
ingredients (APIs) and drug products are more complex
and potent than ever, requiring increasingly specialized
manufacturing processes and drug delivery solutions. At
the same time, the competitive demand for rapid entry into
clinical development—combined with accelerated review
pathways—translate into compressed manufacturing and
delivery timelines.