As the Founder and Principal at Pharmaceutical Consulting LLC, Dr. Das coordinates the interface between client needs and external services/capabilities to facilitate strategic positioning for optimal product development and global registration. Services provided to clients in response to specific requests include regulatory input, risk analysis, cost estimates, process design, and combination (drug/device) product development for both small and macromolecules. He has been involved in combination biopharmaceutical product development for more than 30 years related to parenteral (pulmonary, transdermal, intravenous and implanted) and oral drug delivery therapeutic strategies.
Dr. Das has authored and coordinated the filing of 29 IND’s for both small and macromolecules and assisted with the successful submission and registration of 3 CTD/NDA’s (for Dry Powder Inhaled Insulin, “Exubera®”, approved by the FDA and EMA in Jan 2006; Thermal Aerosol Vapor Generated Staccato Loxapine, “Adasuve®” approved by the FDA and EMA Dec 2012 and Dry Powder Inhaled Tobramycin, “Tobi Podhaler®” approved by the FDA and EMA March 2013). These efforts were directed to both single drug and combination products used for the treatment of infectious, allergic, genetic and neurological diseases.
He is an Inventor on 8 issued Patents covering thiocationic lipids for gene delivery, a taste masked Ibuprofen suckable tablet and spray dried formulations for nasal and inhaled drug delivery. Dr. Das earned his Ph.D. degree in Chemical Engineering studying the effects of inhaled inorganic dusts and their role in the etiology of silicosis at a joint program between West Virginia University and the National Institutes for Occupational Safety and Health and an MBA (Strategy) from the University of California at Irvine.
He also earned an MS degree in Chemical Engineering from Carnegie Mellon University supported by a Mellon Fellowship and a BS degree in Chemical Engineering from the University of New Hampshire supported by Scholarships from the International Students Office and a Fellowship from the Winchester R. Wood Memorial Foundation.
