Inhaled Drug Delivery

Inhaled drug delivery is achieved using four principle technologies, dry powder inhalers, metered dose inhalers, nebulizers and liquid inhalers. Although there are many differences between these technologies there are many fundamental principles that are followed to achieve an effective delivered dose, as such there is much shared learning
across the technologies.

This meeting includes presentations on each of these delivery technologies with the intent to share knowledge and learning across the inhaled drug development business. The future European and UK regulatory processes following Brexit will be critical when developing product approval strategies, we shall be considering regulatory issues on this and other important hot topics.

There are a number of key areas that are currently evolving and the latest thinking and progress on these will be presented, including Human factor design and sensing/connecting technologies. These key evolving areas are subject to much debate and require careful consideration whilst developing an inhaled drug product.

Exhibition stands are available at this meeting, for further information please click here

Our media partner

• Modern respiratory medicines
• Innovation in nebulized therapy
• Current and future trends for DPI formulation
• Opportunities of nanoformulations in the lung
• The role of lung protease in delivery of inhaled biopharmaceuticals
• Lung deposition software: Mimetikos preludium: a new pharma friendly aerosol drug deposition calculator
• Could smart inhalers dramatically change the way that Asthma and COPD patients are treated? n Decoding FDA’s recent combination drug product guidance: Applications to DPIs, pMDIs, and nasal sprays
• The UK regulatory future – the way forward after Brexit
• Navigating human factors in device development
• The 1nhaler and its two jobs
• Opportunities and challenges in the design of high-performance unit-dose dry powder inhalers n Design characterization of breath actuation mechanisms
• Digitally enabled inhalers

Reasons to attend

• A valuable update on the advances in inhalation technology and inhaled drug delivery
• An opportunity to keep abreast of trends in the market
• The chance to develop business relationships

DAY 1

Chairman’s welcome and Introduction

You can breathe easily now; modern respiratory medicines…

• Burden of respiratory diseases
• The patient and the Quality Target Product Profile
• Guidelines for lung disease treatment
• Enhancements of older devices
• Digital advancements for patients

Innovation in nebulized therapy

• Nebulized therapy is growing faster than other inhaled dosage forms, albeit from a smaller base
• There are significant unmet medical needs for patients that would benefit from nebulised therapy, which will be reviewed
• There are potential commercial advantages to develop nebulized therapies ahead of the corresponding inhaler
• The use of electronics facilitates the introduction of patient management solutions Dr John Pritchard, Director PMO and Technology, Respiratory Drug Delivery, Sleep & Respiratory Care, Philips Healthcare

Discussion followed by refreshments

Current and future challenges for DPI formulation

• odays DPI marketplace
• The challenge of formulating New Chemical Entities
• The challenge of developing generic DPIs
• Quality by Design in DPI formulation
• Advanced Manufacturing Technology

Opportunities of nanoformulations in the lung

• What is nano? What are characteristics of nanoformulations and what could be beneficial?
• Possible formulation options
• Challenges and opportunities

Discussion followed by lunch

The role of lung protease in delivery of inhaled biopharmaceuticals

• Proteases are known to play an important role in lung function in health and disease. They can also have a significant effect on the bioavailability and duration of action for inhaled biopharmaceuticals due to their ability to degrade protein-based therapeutics.

• However, as of yet little work has been reported which attempts to model the effects of lung protease activity in an in vitro system.

• This talk will report the development of a biorelevant lung protease activity model, and the key findings from a study using this model to investigate the protease-mediated degradation of albumin nanoparticles, a promising protein-based nanocarrier for inhaled use.

Mimetikos preludium: a new pharma friendly aerosol drug deposition and disposition simulator

• Regional lung deposition from
  - aerosol properties, lung geometry and breath parameters
• PK simulation
  - Mechanistic absorptive and non-absorptive lung clearance – Compartmental systemic disposition and elimination

Could smart inhalers dramatically change the way that asthma and COPD patients are treated?

• The burden of asthma and COPD remains high despite many new medicines
• A major factor is poor adherence
• Smart inhalers are being developed to monitor the way that patients use their
  inhalers
• Can the data from smart inhalers improve patient-clinician communication?
• Can smart inhalers improve adherence and ultimately lead to better health
  outcomes?

Decoding FDA’s recent combination drug product guidance: Applications to DPIs, pMDIs, and nasal sprays

• The basics – medical device, combination product, and packaging components
• NDA/ANDA submissions: regulatory pathway review for combination products
• Human Factor studies in the context of combination product
• Clarify expectations: Sponsor, device supplier, and regulators

Discussion

Networking drinks reception

End of day one

DAY 2

Review of day one

The UK regulatory future – the way forward after Brexit

• What are the key issues for the pharmaceutical industry for UK and EU 27
• What have we learnt so far and what are the next stages of the negotiations
• Preparations for March 2019
• What should we expect from March 2019

• Introduction to inhaled device types and their nuances
• Current regulatory requirements for in-vitro testing of OINDPs
• Delivered dose uniformity testing and APSD measurements by cascade impaction
• Advances in measurement techniques for bioequivalence testing and improving IVIVCs

• Discussion followed by refreshments

• Integration of human factors and device development
• Varying perspectives in application of the regulations and guidance
• Application beyond the procedures

• The functional, emotional and social reasons that there is a growth market for single-dose DPI’s

Discussion followed by lunch

• Design opportunities and challenges for a “fit for purpose” capsule based DPI
• Prototyping challenges
• Preliminary performance data

Design and characterisation of breath actuation mechanisms

• Rationale and user requirements for the use of breath actuation mechanisms (BAMs) in inhaled drug delivery products
• Design considerations for BAMs
• Experimental characterisation of BAMs
• Comparison of the trigger characteristics in different marketed breath actuated inhaler products

• Types of technology that could be included in inhalers
• The value of digital inhaler monitoring

Discussion

Chairman’s closing remarks

Close of conference and refreshments