Jayne Hastedt of JDP Pharma Consulting described an ongoing project to create a biopharmaceutical classification system (BCS) for inhaled drugs in her talk titled, “Classification of Inhaled Medicines: Development of an Inhalation-based Biopharmaceutical Classification System.” This project was initiated by the now defunct AAPS Inhalation and Nasal Technology Focus Group, which held a workshop in conjunction with the FDA and USP to explore this issue in 2015 and is now funded by the Product Quality Research Institute (PQRI).
Other speakers addressed the need to solve drug delivery problems that have challenged OINDP developers for years in order to maintain the relevance of inhaled drug in the future. Tony Hickey declared during the DDL Lecture, “I fundamentally believe that the future is 50 mg or more.” Hickey, who is currently Director of the University of North Carolina Catalyst for Rare Diseases, presented his lecture on the topic, “Why We Need to Deliver Large Amounts of Powder to the Lungs and the Concurrent Challenges.” The answer to the question, he explained, is that large payloads are urgently needed for delivery of antibiotics to treat lung infections such as tuberculosis, nontuberculous mycobacteria, and P. aeruginosa, particularly with the rise in resistant organisms.
Among the devices capable of large dose delivery that he discussed were the Cyclohaler, Twincer, Orbital, and Manta DPIs, as well as the KAER Supraer aerosol platform. In addition to reviewing available high dose devices, he provided an update on development of inhaled CPZEN-45 for the treatment of tuberculosis, which he said is ready for preclinical studies, adding that an IND for CPZEN-45 is tentatively expected by 2023.
Discussing another difficult challenge for the industry, Gary Anderson of the University of Melbourne gave a plenary talk on the subject of “Inhaled Biologics for Respiratory Disorders,” telling the audience that “It’s really difficult to make an inhaled biologic, but we should not give up.” After reviewing past failures such as inhaled Xolair, and cataloguing difficulties inherent in inhaled biologics (too fragile, too viscous, too large, too immunogenic), he described work by Pieris Pharmaceuticals on inhalable anticalin proteins that avoid many of the pitfalls and which he said “may offer unique solutions.”
During his talk, Anderson called out former Novartis executive Mark Fishman for putting a stop to research on inhaled biologics due to “nihilism and lack of confidence” in the face of uncertainties surrounding development of those products. When challenged by Otmar Schmid, however, Anderson conceded that, while the result was a blow to progress on inhaled biologics, Fishman’s decision was a logical one from a financial point of view.
