AIT-ISAM Conference Highlights
ISAM and the Association for Inhalation Toxicology (AIT) jointly sponsored a conference on “Inhaled Medications from the Bench to the Bedside: Preclinical, Clinical and Technical Considerations for ‘First in Human’ and Beyond”, held September 22-24, 2014, in Princeton, New Jersey. A diverse group of over 100 participants from industry, academia (including students), and the regulatory agencies, attended the highly regarded meeting.
The focus was on the practical steps of inhaled drug development required to achieve First in Human studies. Thought leaders provided clinical perspectives on major pulmonary diseases. Eliot Israel of Harvard Medical School and Brigham and Women’s Hospital spoke on “Asthma Etiology and Treatment with Inhaled Medications: Current Trends and Future Patient Need”, Jennifer Goralski of University of North Carolina – Chapel Hill addressed “Cystic Fibrosis and Treatment with Inhaled Medications: Current Trends and Future Patient Needs”, Bart Celli of Harvard Medical School and Brigham and Women’s Hospital presented “COPD and Treatment with Inhaled Medications: Current Trends and Future Patient Needs”, and Ivan Rosas of Harvard Medical School and Brigham and Women’s Hospital talked on “Idiopathic Pulmonary Fibrosis: Potentially Treating Disease by the Inhaled Route? Current Trends and Future Patient Needs”.
Two representatives from FDA also spoke: Marcie Wood (pharmacology/toxicology) addressed “Toxicology Study Designs and Considerations to Support First in Human Trials: The Regulatory Perspective” and Lydia Gilbert-McClain (medical) presented “Inhaled Drug Development for Pulmonary Disease Indications – Regulatory Considerations”.
Other speakers addressed topics related to development of inhaled drugs in vitro and in animals and extrapolation to man, including in vitro screening of drugs that could induce foamy macrophages, mathematical modeling of an inhaled drug’s pharmacologic properties to predict human exposure, comparative anatomy and regional differences in particle deposition in animals and man, using gamma scintigraphy to extrapolate respiratory tract deposition across species, differentiating between adaptive or species-specific and adverse responses in animals, conducting inhalation exposures in animals with select agents, and approaches to select the first in human inhalation dose and device.
Case studies were presented for inhaled gentamicin that had different adverse responses in rats and dogs, and inhaled cyclosporine to prevent chronic lung rejection that demonstrated a highly positive response in a phase II but not in a phase III study.
The challenges of delivering inhaled drugs to patients, including targeting different lung regions, formation and treatment of mucus gels in airways, and adverse events were also addressed. Talks on inhaled therapies now in development included dry powder measles vaccine, epithelial sodium channel inhibitors to increase mucociliary clearance, IL4-IL13 for asthma, and liposomal ciprofloxacin for lung infections. New platforms for inhaled drugs were also presented, including albumin nanoparticles, particles formed using precision molding, spray drying powders for biologics and vaccines, and dry powders with high drug load in a small volume.
All the presentations will be available on the ISAM website.
Other highlights were a tour of Huntingdon Life Sciences Facility, banquet dinner and wine tasting at the Michener Museum of Art, Doylestown PA; as well as evening receptions and posters.
ISAM would like to thank all the participants, sponsors for their financial support, and ISAM members David Cipolla, Ralph Niven, Jeff Tepper, and Ron Wolff, who provided valuable input to the program. Special thanks go to AIT Chairperson Jo Kilgour and Secretary Simon Moore for supporting and hosting the joint conference with ISAM, and AIT board members Aidan Curran, Tim McGovern, Matt Reed, and Adrian Tomkinson, for organizing and running the conference.
Jim Blanchard (ISAM)