Dr. Jayne E. Hastedt has over 35 years of experience in pharmaceutical product development. She has had management and technical leadership responsibilities for the development of small molecules, peptides, and proteins using various dosage forms, routes of delivery, and technologies and has supported successful US and European regulatory product approvals. Her experience includes leading physicochemical characterization and CMC development activities spanning early drug product development through product registration and launch. She has supported the development of oral, transdermal, oral controlled release, and inhaled drug delivery dosage forms. She is currently co-leading an initiative within the PQRI BTC to develop a BCS-like classification system for inhaled medicines. Dr. Hastedt is the Managing Director of JDP Pharma Consulting, LLC and throughout her career, she has had the opportunity to work at ALZA, Inhale, Glaxo/Glaxo Wellcome, and Boehringer Ingelheim. She received her MS and PhD degrees from the University of Wisconsin – Madison School of Pharmacy and holds adjunct faculty positions at the UW School of Pharmacy and the University of the Pacific. Dr. Hastedt is also an Editor for the AAPS Open journal.