Inhaled Drug Delivery

This seminar includes presentations and knowledge-sharing from world-recognised experts from industry, academia and regulation in the area of respiratory medicines and is an essential event for all those new to or experienced in inhaler drug delivery.

Inhaled drug delivery is achieved using four principal technologies: dry powder inhalers, metered-dose inhalers, nebulisers and liquid inhalers. Although there are many differences between these technologies, there are a number of fundamental principles that are followed to achieve an effective delivered dose. This event will provide an excellent forum to share knowledge and explore the opportunities across the dose forms with key industry leaders.

The most recent and innovative developments in inhaled drug delivery will be addressed including the use of triple therapies in lung disease, the development of long-awaited generic inhalers, the use of quality by design (QbD) principles in continuous manufacture, innovation in nebuliser treatment, reviews of connected devices, and the use of human factors in the design process. Regulations are key to respiratory medicines and future European and UK regulatory processes following Brexit will be critical when developing product approval strategies. Regulatory issues on this and other important hot topics will be considered.

This programme will provide valuable insights into inhaled drug delivery from experts in the field and will give you:

• A comprehensive update on the advances in inhalation technology and inhaled drug delivery
• An opportunity to keep abreast of global trends
• An excellent forum to discuss challenges and how to overcome them
• A chance to develop business relationships

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Our media partner

• Hear from an unrivalled faculty of speakers
• Discover what is new in nebulised therapy
• Explore new concepts in inhaled corticosteroid therapeutic equivalence
• Gain new analytical insights into dry powder formulations for inhalation
• Understand the challenges with triple combination inhalers
• Consider the environment with inhaler devices
• Discuss success criteria in technology transfer
• Review new inhalation technologies
• Hear about innovation in production technologies
• Understand the regulatory requirements for respiratory products
• Gain an insight into the regulatory position post Brexit
• Learn about human factors and its relevance in product development
• Explore opportunities with smart and digital inhalers

DAY 1

Chair’s welcome and introduction

Mike Holroyd

You can breathe easily now: modern respiratory medicines

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

Helen Muirhead

Innovation in nebulised therapy

• How nebulised therapy is growing faster than other inhaled dosage forms, albeit from a smaller base
• A review of the significant unmet medical needs for patients that would benefit from nebulised therapy
• The potential commercial advantages to develop nebulised therapies ahead of the corresponding inhaler
• The use of electronics to facilitate the introduction of patient management solutions

Dr John Pritchard

New concepts for inhaled corticosteroid therapeutic equivalence

• Potency and clinical efficacy
• Dose response
• Duration of action
• Therapeutic index

Peter Daly-Yates

INFORM 2020: new analytical insights into dry powder formulations for inhalation

• Structural equivalence for inhaled formulations
• Microstructural analytical techniques
• Multi-scale computed tomography approaches to look inside formulations
• Identifying metrics of relevance to inhaled product performance

Professor Darragh Murnane

Developing triple combination inhalers

• The challenges and opportunities

Enrico Zambelli

Bringing better inhaled drugs faster to market through functional respiratory imaging (FRI) and artificial intelligence (AI)

• Conventional lung function tests fail to provide regional information on lung structure and function and regional information matters
• FRI and AI yield clinically relevant regional information
• FRI received FDA support as part of the Biomarker Qualification Program
• FRI and AI can

- Facilitate the development of novel treatments in COPD
- Assist in tackling environmental challenges such as wildfire exposure

Jan de Backer

Digitally enabled inhalers – a clinician’s perspective

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

Richard Costello

Technology transfer (TT) for inhaled drugs

• TT requirements per ICH Q10
• Regulatory (FDA, EU, WHO, Japan) and industry guidance for TT
• Where TT fits in the product life cycle
• Importance of critical quality attributes and control strategy
• Implications for transfer of manufacture to or between third parties
• Success criteria
• Analytical method transfers

Bruce Davis

Discussion session

Review of day one

Helen Muirhead

Review of new inhalation technologies

• What is there to get excited about?
• New innovations
• Challenges in delivering inhaled dosage forms
• Novel delivery platforms

Mike Holroyd

How to navigate a smooth regulatory pathway for inhaled products

• Leveraging pre-submission advice to build a robust development plan
• ‘Crafting’ a strong regulatory submission
• Understanding what regulatory assessors are looking for
• Managing the current regulatory ‘hot topics’ for inhaled products

Ian Ashurst

Regulatory alignment between the UK and Europe post Brexit

• Latest position on Brexit
• Implications for EU 27 and for UK inhaled products
• Future role for the MHRA
• Introduction of Regulation 3027/746 and Article 117 on combination products

Dr David Jefferys

Human factors (HF) studies – a hype or a must-do?

• Legal and regulatory guidelines covering human factors for pharmaceutical products
• HF and risk management
• HF and clinical trials
• Generic combination products – ANDAs and HF
• Questions and challenges

Richard Featherstone

Handling fourses for the different use of inhalered devices

• Human factors engineering (HFE): Do we need tick-boxes for inspectors or real-world data?
• HFE is important for the patient
• Can we test before the design process has started?
• Is the concept of formative testing and confirmative / validation testing still up-to-date?
• The need for quantitative data as guidelines for the engineering process

Dr Herbert Wachtel

Inhaler devices and the environment

• Carbon footprints, an overview of the situation
• Where next for the MDIs and HFAs?

Chris Baron

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?

Alison Moore

Chair’s closing remarks

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.