Development of a combination product for systemic delivery of drugs via the inhalation route

Challenge: Alexza Pharmaceuticals had demonstrated feasibility of generating thermal aerosol and needed a leader to assemble a development team and implement product development under cGMP and QSR. Dr Soni was hired as the Vice President of Product Research and Development.

Solution: Dr Soni assembled a strong team of mechanical and electrical engineers, physical chemists, process development and manufacturing engineers, and project management personnel.  The technical team worked with the Medical and New Product Planning groups to identify unmet medical needs and develop products for the targeted indications.  The team also worked with the QA group to implement a product development process that was compliant with both cGMP (drugs) and QSR GMP (devices).  A Project Management system was implemented to ensure on-time completion of project milestones, and clinical supplies manufacturing operation was also implemented.

Result: Two product platforms were developed, one for single and one for multiple doses.  A succession of five IND’s was filed within a span of four years.  Two products completed Phase I, two products progressed to Phase II and one progressed to Phase III.-