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.
Dr. Stefan Leiner,
Chemical-Pharmaceutical Expert, Boehringer Ingelheim, Germany
09:15 Speed Networking
09:55 Applying the TRIZ Methodology to Medical Device Innovations.
Dr. René Dathe,
Head Medical Devices Quality Dev. Sandoz & LCM, Novartis, Munich, Germany
10:30 The pMDI, issues, opportunities and the future for the current generation of products.
Paul Johnson
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.
Dr. Orest Lastow,
Chief Technology Officer & Founder, Iconovo AB, Malmo, Sweden
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..
Alex Slowey,
Formulation Specialist, Kindeva Drug Delivery, Leicester, United Kingdom
14:20 ‘Bitter Matters’ – Assessing Inhaled Medicine Taste Preclinically.
Robert Ives,
Investigator and Associate Fellow, GlaxoSmithKline, Stevenage, United Kingdom
14:55 Afternoon coffee and networking break
15:25 Considering Human Factors in Inhaled Drug Products..
Tina Rees,
Associate Director-Human Factors, Ferring Pharmaceuticals, New York, USA
16:00 Inhaled antimicrobials: Current strategies and future challenges.
Dr. Carsten Ehrhardt,
Professor in Pharmaceutics and Biopharmaceutics, Trinity College Dublin, Ireland
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.
Dr. Raphael Krampe,
Scientist, Boehringer Ingelheim microParts, Ratingen, Germany
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.
Dr. Karlheinz Seyfang,
Principal Consultant Pharmaceutical Technology, Harro Höfliger Verpackungsmaschinen GmbH, Allmersbach im Tal, Germany
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.
Sven Stegemann,
Professor for Patient Centric Drug Development and Manufacturing, Graz University of Technology, Graz, Austria
11:40 Nano-structured Microparticles for pulmonary application.
Prof. Dr. Marc Schneider,
Full Professor (W3) Chair Biopharmaceutics and Pharmaceutical Technology, Saarland University, Saarbrücken, Germany
12:15 Business lunch
13:15 Rethinking DPI packaging environment. Using integrated three-phase Activ-polymer to control moisture ingress and improve performance.
Badre Hammond, MBA,
Director, Market Development, Aptar Pharma, New York, USA
13:50 Material selection for OINDPs (orally inhaled and nasal drug products).
Andrew Feilden,
Director Analytical Sciences, Bicycle Therapeutics, Shawbury, United Kingdom
14:25 New lung disposition software: Derisking inhaled product changes using predictive models.
Bo Olsson, PhD,
Senior Inhalation Consultant, Emmace Consulting AB, Skane, Sweden
15:00 Chairman’s closing remarks and end of summit
15:10 Afternoon coffee and networking break
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Documentation Package for € 499 includes presentation slide decks and the delegate contact list.*
3M United Kingdom PLC - 4Pharma - Agartee Technology Inc. - AGES - Medizinmarktaufsicht LCM/QUAL - Aptar Pharma - Aptuit Srl - Boehringer Ingelheim - Boehringer Ingelheim microParts GmbH - Covestro Deutschland AG - CSL Behring - CSL Behring GmbH - Emmace Consulting AB - Ferring Pharmaceuticals - GlaxoSmithKline - Graz University of Technology - Harro Höfliger Verpackungsmaschinen GmbH - Iconovo AB - Inspiring Strategies - JSC «FARMAK» - Nanologica - Novartis - Pari - Paul Johnson Consulting Limited - Saarland University - Skyepharma AG (Vectura Group) - Smithers Rapra Ltd - Softhale NV - Trinity College Dublin - Others
