Founder and Principal, Pharmaceutical Consulting LLC, USA
Keywords of expertise: 1. Engineered Spray Dried Particles, 2. Pulmonary Toxicology, 3. Particle-Macrophage Interactions, 4. Infectious Disease Pathology, 5. Patient Inhalation Education, 6. Device Design and Development
Golden Paragraph: My areas of focus over the past 25 years include both the mechanistic aspects of Pulmonary Disease Pathophysiology as well as the optimization of drug delivery to the whole lung for both local/regional disease states and for drug delivery using the lungs as a portal for entry to the systemic vasculature. Local/Regional disease states have included research into the etiology of Silicosis, mycobacterium tuberculosis infections, Cystic Fibrosis and Asthma/COPD, while systemic delivery has included efforts related to the treatment of diabetes and CNS diseases such as Schizophrenia using respirable engineered spray dried particles. The resulting work has assisted in the following product approvals-in January 2006 for the first-generation dry powder inhaled Insulin (Exubera), in December 2012 for thermal aerosol vapor generation and inhalation of Staccato Loxapine (Adasuve) and in March 2013 for dry powder inhaled Tobramycin (Tobi PodHaler). My current interests are in the positioning and placement of 505(b)(2) applications involving respirable engineered spray dried particles using both small molecule and macromolecule APIs delivered via inhalation as a dry powder using very simple off the shelf, low resistance devices thus delivering low cost, efficient and useful therapeutic strategies for both local and systemic applications.