Dry Powder Inhalers: Annual Conference

Key annual conference for Pharmaceutical and Medical Device Professionals in the DPI market.

Course overview

The second generation of DPIs have become either established on the market or are a signi cant way along
the approval process. These have been a great success story in improving inhaled drug delivery. However, we now have to tackle the technical and regulatory issues with ‘generic’ inhalers and their approval. The development of triple therapies is well underway, these bring about their own challenges of formulation and bioequivalence. Amazingly, new DPIs are still being created, with some moving in to development programs. Furthermore, one of the areas where much study and recent guidance has been applied is in considering the patient use, compliance and human factors associated with DPIs. These linked topics are creating a whole new area that requires better understanding during product development and associated studies.

This conference aims to: address many of the issues around generic inhalers, provide case studies of bioequivalence testing, focus on the difficult formulation challenges and the strategies used so that they may be overcome, and to discuss in-depth patient and human factor issues when developing a DPI to gain regulatory approval.

Conference programme to include

  • personalised medicine approach to the design of dry powder inhalers n Novel DPI delivery platforms
  • In-vivo extra ne particles
  • High dose delivery utilising a DPI
  • The next generation combinations
  • Connected DPI devices
  • New medical device and combination product regulations on DPI development
  • Human factors in the design of DPIs
  • Challenges with generics
  • The use of advanced characterisation tools for demonstrating pharmaceutical equivalence of orally inhaled drug products
  • Bioequivalence research with the FDA
  • Get it right: 100% in-line veri cation of dosed mass in inhalation devices n Developing inhaled Lactose formulations

Media partners and exhibitors

 

Media partners


 

Exhibitors

 

Who should attend

Those involved in

  • Respiratory drug development
  • Inhalation product development
  • Device engineering
  • Formulation development
  • Scientific research
  • Medical marketing
  • Marketing and Business development

Programme - Day one

A personalised medicine approach to the design of dry powder inhalers

  • Summary of inter-patient performance issues for dry powder inhalers
  • Proposing a physiological approach to DPI design to address inter-patient variability
  • Strategies for computational DPI design optimization achieving personalization of inhaled therapy
  • Evidence to validate a CFD-guided DPI design approach
    Professor Darragh Murnane

Novel DPI Delivery Platforms

  • Marketed DPI platforms
  • Novel DPI Platforms
  • Capability gaps
  • Value in the eyes of the customer
    Paul Johnson

Experiments with Dry Powder Inhalers

  • Findings and results
    David Harris

In-vivo extra fine particles

  • Introduction to extra ne particles
  • History and current research
  • Product design and inhalation pro le
  • Future opportunities
    Dr David Lewis

High dose delivery utilising a DPI

  • Formulation strategy for high drug content powders
  • Selection of appropriate adjuvants
  • Multiple inhalation act device for dose release
    Dr Francesca Buttini

The iSPERSETM platform

  • Inhaled Dry-Powder iSPERSETM formulation of Itraconazole
  • The treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with Asthma
  • Clinical trial of Pulmazole
    David Hava (invited)

The next generation combinations

  • Selecting triple and quadruple API combinations
  • New requirements on the device
  • Formulation challenges
    Dr Orest Lastow

Connected DPI devices

  • Unmet needs
  • Device strategies for connectivity
  • Learnings from non-drug connected devices
  • Hurdles:
    • Devices and services – Evidence
    • Data infrastructure
    • Business models
  • Future directions
    Tom Oakely

Programme - Day two

New medical device and combination product regulations on DPI development

  • Overview – The guiding documents and principles
  • Medicinal product – delivery device – container closure – combination products, where do DPIs fit?
  • International Standards Vs National Regulation – Which takes precedence?
  • Medical Devices Regulation vs Quality Systems Regulation (the destination vs the journey)
  • Acronyms and jargon (DHF, DHR, DMR, DMF, Technical les) what do they really mean?
  • How much time (and cost?) will it add to my DPI programme?
  • Retrospective/ late stage application of controls, can it work?
  • Developing a global strategy – is it possible?
    David Howlett

Human factors in the design of DPIs

  • Usability and human factors engineering – what is required?
  • User centred design
  • Considerations and learnings from experience
    Greg Thay

Challenges with generics

  • Establishing robust analytical methods to test the Critical Quality Attributes (CQA’s) of both test and reference product
  • Using current regulatory guidance to design an appropriate IV-BE study
  • Bridging the gap to IV-IVC (including the use of realistic breathing pro les and lung dissolution models)
    Chris Vernall

Bioequivalence research with the FDA

  • What are the FDA looking for?
  • Research and ndings
  • Experience and opportunities
    Dr Jag Shur

Dissolution and beyond: the use of advanced characterisation tools for demonstrating pharmaceutical equivalence of orally inhaled drug products

  • Achieving Q3 structural equivalence in dry powder inhalers
  • Integrated measurement of structure through dissolution
  • Understanding the state of agglomeration through advanced analytical techniques
    Professor Robert Price

Get it right: 100% in-line verification of dosed mass in inhalation devices

The current good manufacturing practices (cGMP) requirements become more demanding and statistical in-process control (IPC) as well as process analytical technology (PAT), these are key components of quality control in a pharmaceutical manufacturing environment. The lling of powder for inhalation into blister or other receptacles for pre-metered powder is a challenge due to low ll weight and poor powder ow-ability. New technologies are utilizing different control systems to ensure consistent quality of the products and to reduce waste & overall costs.

  • A machine manufacturer’s view on PAT
  • Options to satisfy continuously increasing manufacturing requirements
  • The issues of current inhalation blister ll weight control (destructive in-process control)
  • Actual developments to integrate non-destructive 100% in-line veri cation systems of filled mass in inhalation blisters
    Dr Karlheinz Seyfang

Developing inhaled Lactose formulations
Dr Paul Royall

Book now

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.

Previous customers include...

  • 3M Health Care Ltd
  • Astech Projects Limited
  • Aston Particle Technologies
  • AstraZeneca AB
  • Berlin-Chemie AG
  • Cad Middle East Pharmaceutical Industries
  • Cambridge Consultants Ltd
  • CARDINAL HEALTH
  • CENSDELIVERY
  • Chemo Group
  • Chiesi
  • DFE Pharma
  • Exco InTouch Ltd
  • FRIESLAND FOODS DOMO
  • Harro Hoefliger Verpackungsmaschinen GmbH
  • Hospira UK Limited
  • Iconovo
  • Innovata Ltd (part of Vectura Group plc)
  • Komax Group Ltd
  • Laboratorio Dosa SA
  • Laboratorios CINFA SA
  • MannKind Corporation
  • Medochemie Limited
  • NEKTAR THERAPEUTICS Inc
  • Oy Medfiles Ltd
  • PDL GROUP
  • PH&T SpA
  • Quotient Clinical Ltd
  • Sanofi-Aventis
  • University of Parma

Overall I thought that the course was very useful, mainly due to the networking opportunities. The breadth of attendees was great to get wider conversations underway and broaden understanding. The scientific talks were generally excellent, and although some other talks were more around promoting products / services, the overall impression was positive and useful.

Richard Poole, Team Leader - Pharmaceutical Development, Vectura

I really thought it as well organised with good content, length of presentations and quality of speakers.

Mahmoud Farag, Scientific Business Development Manager, Qualicaps

In general, the course was very interesting and well organized

Berta Fernández Mollar, Formulation Manager , Ferrer Internacional S. A.

One of the best courses I attended

Anna Giulia Balducci, Senior Scientist, Chiesi Limited

Very useful and relevant discussions

David Ward, Senior Formulation Scientist, Intertek

Very good and useful update. Clear messages coming through.

Simon Strothers, Director, 3P Innovation Ltd

The course was very well organised, with a good selection of speakers and topics covered. I will certainly recommend future events to my colleagues.

Christopher Vernall, Business Development Manager, Intertek

Great environment to stimulate debate! And challenge preconceptions and novel ideas

Richard Turner, Director, Presspart Manufacturing Ltd

The course contained a good mix of speakers, the talks were current and relevant, the speakers responded well to lively discussions and challenges from the delegates. This is a good size meeting with questions freely asked and delegate interaction very high.

Tanya Church, Head of Laboratory, Chiesi Limited