Charting the Course for Pulmonary Drug Development
Abstract: Pulmonary drug delivery is no longer limited to asthma and COPD. The field now spans hundreds of active programs, many led by emerging biotechs that must make early, high-impact decisions with limited data. In this expert article, Catalent’s Carolyn Berg and Dr. Alan Watts map the key inflection points that shape pulmonary development success, from feasibility and dose constraints to formulation and device platform selection. You will learn why inhalation programs demand earlier commitment than oral products, how dose uncertainty can ripple through analytical methods and manufacturing strategy, and where teams most often get trapped by avoidable CMC and scale-up surprises. Use this practical guidance to reduce rework, strengthen your regulatory path, and build a development plan designed for clinical progress and commercial viability.