The recent years have witnessed major growth in the inhaled drugs market driven by rising prevalence of chronic pulmonary diseases, the evolution of inhaled therapies and technological advancements in device development. Challenges still remain to ensure safe and efficient respiratory drug delivery - including device and drug integration, particle engineering and formulation technologies, clinical studies and regulatory pathways. Our meeting facilitates hands-on experience sharing of successful development of inhaled drug products for enhanced patient care.
08:00 Registration and Welcome Coffee
08:30 Opening Address from the Chairman
08:40 Clash of the cultures: Requirements for inhalation bioequivalence – contrasts between US, EU, Australia, Japan, Brazil.
09:15 Speed Networking
09:55 Applying the TRIZ Methodology to Medical Device Innovations.
10:30 The pMDI, issues, opportunities and the future for the current generation of products.
Director, Paul Johnson Consulting Limited, Cambridge, UK
11:05 Morning coffee and networking break
11:35 Development of a generic triple combination product – hurdles and opportunities.
12:10 Re-thinking the opportunities for nebulised drugs.
Dr. John N Pritchard
Independent Business Owner, Inspiring Strategies, Leicester, United Kingdom
12:45 Business lunch
13:45 An approach to developing existing pulmonary API’s into adjacent dosage forms and understanding the in-vitro / in-vivo relationship..
14:20 ‘Bitter Matters’ – Assessing Inhaled Medicine Taste Preclinically.
14:55 Afternoon coffee and networking break
15:25 Considering Human Factors in Inhaled Drug Products..
16:00 Inhaled antimicrobials: Current strategies and future challenges.
16:35 Panel Discussion
17:15 Chairman’s closing remarks and end of day one
19:00 Business dinner
08:30 Registration and Welcome Coffee
09:15 Opening Address from the Chairman
09:25 The Soft Mist Inhaler Respimat® - Performance and test requirements.
10:00 Dosing and process control technologies to cover the wide variety of Dry Powder Inhalers.
Dosing systems to fill DPI have to be adapted to the type of containment to be filled, the dosing range and the powder properties.
The functional principle of the different technologies, the integration into production machines and the requirements regarding powder properties will be described.
To mitigate the risk for under-filling during production, not being detected by statistical in-process controls, systems for the 100% in-line verification of fill weights have been developed.
Three different approaches will be presented.
10:35 Morning coffee and networking break
11:05 Engineering particles to deliver high dosed and sensitive drugs to the lung using standard inhaler systems.
11:40 Nano-structured Microparticles for pulmonary application.
12:15 Business lunch
13:15 Rethinking DPI packaging environment. Using integrated three-phase Activ-polymer to control moisture ingress and improve performance.
13:50 Material selection for OINDPs (orally inhaled and nasal drug products).
14:25 New lung disposition software: Derisking inhaled product changes using predictive models.
15:00 Chairman’s closing remarks and end of summit
15:10 Afternoon coffee and networking break
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chaired a panel discussion on the digitisation of clinical trials and next gen injectable devices, with speakers from Novartis, Roche, Janssen, Sanofi, SHL Group and Corvus Device.