Stephen Stein Email & Phone Number

Overview: A leading expert in development and characterization of orally inhaled drug products with track record of commercializing inhaler products. Extensive knowledge of pMDI and DPI devices and formulations. Experienced taking products from feasibility to commercialization. Detailed understanding of requirements for demonstrating bioequivalence to regulatory authorities including IVBE and PK study design and execution. Frequent presenter at industry meetings and workshops with more than 100 industry publications and presentations. More than 20 granted US patents and numerous pending and granted worldwide patent applications. Track record of identifying solutions to complex technical and regulatory challenges. Key Expertise: Knowledge of Orally Inhaled Drug ProductsLow GWP Propellants pMDI Design and ManufacturingDesign and Execution of IVBE and PK StudiesRegulatory Submission Preparation and Responses to Challenging Request from Regulatory Agencies IP Development, Patent Filings and Patent LitigationWriting, Presentation and Communication Skills

Listed skills include Aerosol Expertise, Research Skills And Statistical Analysis, Project Leadership, Ip Strategy Expertise, and 4 others.