Transcript Document
Grand Challenges in Global Health AKTIV-DRY 6060 Spine Road Boulder CO 80301 303-350-3060 www.aktiv-dry.com The Project The Collaboration Aktiv-Dry is a proud participant in the Grand Challenges in Global Health Initiative. Our project addresses the Third Grand Challenge: Develop needle-free delivery systems for vaccines. Our specific approach is to develop a stable, dry micropowder measles vaccine that will be administered by inhalation to patients in developing economies. Aktiv-Dry is the system integrator and responsible for project management. We also lead the development of the PuffHaler DPI and participate in micro-powder vaccine formulation using the CAN-BD process. Achieving this goal requires that we • Reformulate an existing Edmonston- Zagreb (EZ) measles vaccine (currently administered by needle and syringe) as a stable dry powder consisting of particles with aerodynamic diameters between 1 and 5 microns, • Develop human-powered, single-use delivery devices costing no more than 10¢ per dose, • Demonstrate safety (toxicity) and efficacy (immunogenicity) in pre-clinical trials, • Scale-up our CAN-BD Bubble Dryers®, build them to cGMP specifications, and transfer the technology to the Indian vaccine manufacturer, • Demonstrate safety in Phase I clinical trials in the year 2010. The Serum Institute of India Ltd (SIIL) provides its EZ measles vaccine and plays a key role in reformulation activities. SIIL also bears responsibility for manufacturing the dry powder vaccine for use in pre-clinical and clinical trials. The University of Colorado leads the formulation of the measles vaccine as a dry and stable micropowder. National Jewish Medical and Research Center undertakes research with small animals to demonstrate pulmonary deposition and viral replication. Becton Dickinson Technologies is developing a second DPI, the Solovent®. Other contributions have been made by Johns Hopkins University, the University of Kansas, The Foundation for the National Institutes of Health, the World Health Organization, and a cadre of consultants from industry and academe. QuickTime™ and a TIFF (Uncompressed) decompressor are needed to see this picture. Causes of vaccine-preventable deaths among children < 15 years, 2000 (From the World Health Organization) A Humanitarian Project To Save Lives In The Developing World