TranspireBio Leaders Advise FDA on Complex Generic Inhalation Standards

Joining Dr. Zeng at the October 14–15 workshop were Chief Scientific Officer Abhishek Gupta, Chief Medical Officer Mark Lepore, and R&D Director Chirag Shah. The panel of experts convened to weigh advancements in in vitro, in vivo, and in silico methodologies, aiming to refine how the industry evaluates complex respiratory therapies.

Dr. Zeng’s contribution highlighted the industry’s outlook on implementing these innovative approaches. The discussion centered on balancing rigorous scientific requirements with the need for more efficient development pathways. According to the company, refining these standards is a critical step toward broadening patient access to high-quality inhaled treatments for conditions ranging from pulmonary fibrosis to obesity.