2nd Annual Inhaled Drug Delivery Virtual Summit 2021

Tentative Schedule:

Central European Summer Time (CEST, Prague, UTC/GMT +2 hours)

12:00 Registration

12:20 Opening Address

12:30 The climate is changing for metered dose inhalers.

• Increases in global temperature are already having a significant impact on our climate. The hydrofluorocarbon (HFC) propellants used today in pressurized metered-dose inhalers (pMDIs) have global warming potential (GWP) many times that of carbon dioxide. This has prompted calls to switch patients to dry powder inhalers (DPIs)
• Dry powder inhalers are often more expensive than the equivalent pMDI. A wholesale switch of reliever medications would lead to significant increases in the cost of these life-saving medications
• At the same time, it is projected that there may be a 5-fold increase in the cost of pharmaceutical grade propellants in the next few years. This may lead to a price increase in reliever medication
• At least two companies are now working to develop pMDIs using propellants which are potentially cheaper in the long-term and have much lower GWP

Dr. John N Pritchard
Independent Business Owner, Inspiring Strategies, Leicester, United Kingdom

13:00 Questions & Answers

13:10 Practical challenges with developing inhalation drugs during pre-clinical testing.

• Extrapolating from clinical to pre-clinical and regulatory expectations
• Study designs – what is different for inhalation studies – histo, animal numbers or not, dose calculation
• NCEs vs biologics – differences or not
• Aerosol generation, exposure systems, aerosol sampling, additional DFA/FIA support
• Animal welfare considerations – TK blood volumes, BAL collection, limitations of dosing wrt time, dosing large animals – animal compliance

Dr. Simon Moore, BSc(Hons) PhD MRSC,
Global Lead of Inhalation Sciences and Engineering, Covance Laboratories, United Kingdom

13:40 Questions & Answers

13:50 Break

14:00 From perception to use - the patient DPI product interface.

• Patient characteristics and therapeutic complexity
• DPI product administration from a patient perspective
• The role of learning, intuition and standardization
• TDPI product design to improve therapeutic outcomes

Sven Stegemann,
Professor for Patient Centric Drug Development and Manufacturing, Graz University of Technology, Graz, Austria

14:30 Questions & Answers

14:40 Are sustainability, reusability and carbon neutrality major trends for devices in the future? A case study of Respimat® re-usable.

• Historic and upcoming political initiatives
• Carbon footprint and neutrality
• Respimat® re-usable - technology and performance
• Sustainability goes beyond design

Dr. Felix Weiland,
Head of Product & Process Technology, Boehringer Ingelheim microParts GmbH, Gütersloh, Germany

15:10 Questions & Answers

15:20 Break

15:30 The impact of filling technology selection for dry powder formulations on device performance, process consistency and commercial scale-up

• Consistent high efficiency aerosoliation performance is a critical quality attribute for all dry powder inhalers. There is a strong dependant relationship between the powder formulation, filling technology, device design and the device performance.
• The desire to deliver a wider range of molecular types of drug has promoted a large increase in the use of engineered particle technologies e.g. spray drying for DPIs which require careful consideration of process conditions.
• Highlight the impact of filling technology on device performance, process efficiency and manufacturing throughput. Could selection of the right filling technologies enable increased formulation and device design spaces.
• Assess the potential issues due to filling technology with process scale-up to achieve continuity of performance as you move from bench, through clinic to commercial; minimising risk in the development process.
• Affirm the importance of early stage filling trials on formulation selection and device design.

Tom French,
Device Industrialisation Engineer, 3P innovation, United Kingdom

15:10 Questions & Answers

16:20 Postmarket Safety reporting for Combination products in the US

• What are the regulatory requirements
• Discussion of key challenges
• Walk through a reportable event case scenario

Khaudeja Bano, MD,
Executive Medical Director, Combination Product Safety Head Global Patient Safety & Pediatrics, Amgen, USA

16:50 Questions & Answers

17:00 ICOpre - Development of a generic DPI platform for a global market

Generic versions of marketed dry powder inhaler (DPI) drug products represent an attractive market opportunity. In the coming years, GSK’s Ellipta platform is the largest opportunity with several drug substance patents expiring. However, development of generic DPI drug products is a complicated process with many challenges. Complex drug-device interactions represent a major hurdle to achieve therapeutic equivalence. The very intricate patent landscape in combination with the requirement of similar user-handling and flow resistance limits the design options. The need for cost-efficient development and low manufacturing costs adds additional complexity. There is a great need to replace injections with safe and low cost inhaled drug delivery. Iconovo’s unit-dose inhaler ICOone is currently used in two ongoing projects on inhaled oxytocin and inhaled covid-19 vaccine.

• Overview of market and patent situation.
• Regulatory requirements on generic inhalation products.
• Initial choice – copy original or develop new technology.
• Concurrent development of device and formulation.
• ICOone – inhalation instead of injection.

Dr. Orest Lastow,
Chief Technology Officer & Founder, Iconovo AB, Malmo, Sweden

17:30 Questions & Answers

17:40 Closing remarks and end of summit