Dry Powder Inhalers

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

19-20 Jun 2019

GBP 1,499
EUR 2,099
USD 2,338

Book now

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.

Please note that this programme relates to the 2018 event and the 2019 brochure and programme will be available in due course.

If you would like to contribute a presentation at the 2019 event please contact andrea.james@management-forum.co.uk

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

THIS IS THE 2018 PROGRAMME THE 2019 PROGRAMME WILL BE AVAILABLE IN DUE COURSE

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

THIS IS THE 2018 PROGRAMME THE 2019 PROGRAMME WILL BE AVAILABLE IN DUE COURSE

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

Presenter

Helen Muirhead

Helen now is an independent Respiratory Medicine Expert, acting as a consultant after 30 years with GSK in both R&D and Manufacturing. Helen is also now involved in teaching at Universities and supports Lung Disease charities.

In GSK, Helen headed up the Respiratory Centre of Excellence during the late stages of Product Development through Regulatory Filing and Commercial Launch and supply of new Medicines – in the Ellipta Portfolio (Including the recent Trelegy, triple drug therapy). Helen was also responsible for the classic and establish brands; the existing Diskus Portfolio (Including Advair).

Helen and her team were based in Ware (UK), Evreux (France) and Zebulon (USA): it comprised of Pharmacists, Chemists, Material Scientists, Engineers and Device designers and she was Accountable for the robustness and reliability of the Respiratory Products and Processes, as well as the skills and competency of the Global Respiratory Technical Organisation.

Helen was also the Technical Lead on the Global Ellipta and Diskus Manufacturing Excellence Forums.

A Fellow of the Royal Society of Chemistry, with 42 years of Industrial experience from Quality Control, Quality Assurance, Analytical method development, including 15 years in R&D Respiratory Product Development (in pMDIs and DPIs development), through Clinical Trials Design and manufacturing… heading up the Respiratory Pilot Plant. Helen has been in Technical roles within Manufacturing for 15 years.

Book now

19-20 Jun 2019
19-20 Jun 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

Previous customers include...

  • 3P Innovation Ltd
  • Astech Projects Limited
  • BATTELLE MEMORIAL INSTITUTE
  • BfArM
  • Celanese Emulsions BV
  • Chiesi
  • Chiesi Limited
  • Clariant Plastics & Coatings UK
  • CPI BIOCORP
  • GlaxoWellcome Production
  • Harro Hoefliger Verpackungsmaschinen GmbH
  • IBSA, Institut Biochimique SA
  • Intertek
  • Job Consultoria
  • LAB PHARMA OY
  • Laboratorios CINFA SA
  • Molkerei MEGGLE Wasserburg GmbH & Co KG
  • Nemera Services
  • Nexus6
  • Orion Corporation Orion Pharma
  • PERLOS LTD
  • PFIZER GLOBAL R&D
  • Qualicaps Europe SAU
  • QUINTILES LTD
  • Rexam Pharma GmbH
  • RPC Formatec GmbH
  • Sympatec Limited
  • Teva
  • University of Warwick
  • Zentiva Inhalationsprodukte GmbH

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

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

Mahmoud Farag, Scientific Business Development Manager, Qualicaps

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

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

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

Richard Turner, Director, Presspart Manufacturing Ltd

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