Future Patient Requirements on Inhalation Devices – the Balance Between Patient, Commercial, Regulatory and Technical Requirements Orest Lastow AstraZeneca R&D Lund Email: Orest.Lastow@astrazeneca.com
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Biography Orest Lastow is the principal inventor behind AstraZeneca’s new dry powder inhalation platform including a new device, a new formulation type and all manufacturing equipment. He is also the project manager responsible for the platform development programme. To secure the delivery of the project, he has developed and introduced a novel product development methodology for complex projects, Redundancy Based Development, to address and mitigate development risks and project delays. Lastow received a M.Sc. in Engineering Physics and a Licentiate of Engineering degree in Aerosol Science from Lund University. He has also a Ph.D. in electrohydrodynamic atomisation from Brunel University. He joined AstraZeneca in 1995 and has worked with TurbuhalerÒ, pMDI’s and nebulizers. His main responsibilities as inhalation specialist are electrostatics, fluid dynamics, inhalation technology and device development. He is the author behind a text book on EHD, several publications and many patents. Lastow is frequently invited to speak at conferences and teaches aerosol drug delivery at Lund University. Company Profile AstraZeneca is a global biopharmaceutical company. AstraZeneca discover, develop, manufacture and market prescription medicines for cancer, cardiovascular, gastrointestinal, infection, neuroscience, and respiratory and inflammation. AstraZeneca employ over 62,000 people and invest over $4 billion in R&D. The worldwide sales is $32.8 billion.
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Abstract When investing in the development of a new inhalation device, careful attention must be given to the user requirement specifications. The new inhalation device must be competitive not only in function and performance but also in cost. The requirements are the definition of the product and will ultimately decide its commercial success. The needs and expectations of all potential customers must be combined. The customers include patients, payers, regulatory bodies, clinicians, manufacturers and suppliers. This has to be combined with the performance and quality required to have a competitive product and efficacious therapy. The patient population is now, in many ways, different and more diverse than traditional asthma patients. A major patient group today is Chronic Obstructive Pulmonary Disease (COPD). These patients typically first start to use an inhaler at a high age and thus have different expectations and needs. User studies show that patients value feedback features the highest. Other highly ranked requirements like hygiene and ergonomics are often in conflict with less specific requirements based on perception. This list of requirements drives the complexity of the device and ultimately the cost. The final cost of the product must be carefully balanced against the payers’ level of acceptance.
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