DUBLIN, Oct. 24, 2019 /PRNewswire/ -- The "Inhaled Drug Delivery" conference has been added to ResearchAndMarkets.com's offering.
An essential annual update for inhalation professionals. Industry case studies, regulatory updates, latest therapies and technology innovations
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
Benefits of attending
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
Programme Day One
Chair's welcome and introduction
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
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
Duration of action
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
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
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
Analytical method transfers
Programme Day two
Review of day one
Review of new inhalation technologies
What is there to get excited about?
Challenges in delivering inhaled dosage forms
Novel delivery platforms
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
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
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?
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?