Path to Clinic: Fast into Human Approaches for Development of Inhaled products
Sponsored by: Catalent Pharma Solutions
- Nasal Spray
- Product Quality
Date: 9 May
Days to go: 18
Time: 3PM London/10AM New York
This webinar will review the Product Quality considerations necessary to enable the successful development of inhaled drug products administered through either the pulmonary or nasal route. The presentation will cover pressurized Metered Dose Inhalers (pMDI), Dry Powder Inhalers (DPI) and Nasal Sprays.
Emphasis will be placed upon strategies and pre-requisites which enable robust yet rapid progression of the molecule into the clinic.
A spectrum of topics ranging from material inputs, including particle size reduction, characterization and controls, through formulation development, process development to product characterization and stability required to demonstrate product suitability for early clinical studies will be discussed.
Craig Davies-Cutting, PhD,
Director of Inhaled Products & Technologies, Catalent
Dr. Craig Davies-Cutting is the Director of Inhaled Products & Technologies at Catalent. He joined Catalent in 2003 where he led analytical, formulation, and process development for pMDI, DPI, nasal sprays, and liquids for inhalation, as well as sterile product development and analytical research and development. Previously, he worked for seventeen years atGlaxoSmithKline where, in various roles, he focused on the development of pMDIs and DPIs, inhalation product testing, pMDI scale-up and marketed product support, and inhalation technology development. He earned his Ph.D. from the University of Bristol, UK on The Effects of Suspension Stability on Metered Dose Inhaler Performance.
Dr. Davies-Cutting has almost 30years of pharmaceutical industry experience, over 20 of which have been in the development of pulmonary and nasal products. He has actively promoted scientific research in the inhalation field both through his own research and through management of various doctoral and post-doctoral research programs. He has led teams through early and late stage development programs in addition to research and development of inhalation delivery systems/technologies. In 2010he moved from Operations into a strategic R&D functional role and currently serves as the Catalent Global Inhalation Platform Director. His research contributions are evidenced by various publications in scientific journals, conference proceedings, and patents.
Dr. Davies-Cutting was the 2008 Chair for the North Carolina Pharmaceutical Discussion Group. He is an editorial advisory board member for Inhalationmagazine, he represents Catalent on the International Pharmaceutical Aerosols Consortium on Regulation and Science (IPAC-RS) Board of Directors and was Co-Chair of the 2014 Orlando Inhalation Conference organizing committee.
Key Learning Objectives
- An overview of MDIs, DPIs and Nasal Spray products with emphasis on why a specific dosage form might be selected for progression into the clinic and onward development
- Fundamental pre-formulation and formulation considerations to enable FIH that also lay the foundations for the successful onward development of robust products
- An outline of Product Quality data package required to support rapid progression of inhaled products in early clinical studies
- Packaging Engineers
- Supply Chain