Dry Powder Inhalers

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

19-20 Jun 2019

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 9 Apr

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.

Media Partner

Inhalationlogo

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

Presenters

Paul Ballington

Paul is an experienced General Manager in the pharmaceutical industry with particular knowledge of the oncology, respiratory, medical device and drug delivery marketplaces. Formerly a director with Innovata plc, he has led commercial and R&D teams in the evaluation, creation and implementation of research, development and marketing programmes to deliver inhaled respiratory products, medical devices, nutraceuticals and pharmaceuticals to European, US and Japanese markets.

He has also been actively involved in mergers, acquisitions and sale of businesses and Intellectual Property.

Since 2008, Paul has operated as a freelance business development professional offering bespoke consultancy services and interim management with a primary focus on strategy and commercialisation aspects of product and service offerings. Through his extensive network he has helped multinational companies gain a foothold in the Japanese market and worked with Japanese companies to develop and introduce products for the European and US markets.

Mike Holroyd

Mike Holroyd is Senior Director with responsibility for the design, development and scale-up of inhalation devices within the Mylan Global Respiratory Group. He has an MA in Engineering from St. Catharine’s College, Cambridge. He started his career at Rolls-Royce Aero engines, before moving to PA consulting group where he was a Partner and manager of the product development group. He then joined Norton Healthcare in 1993, where he directed all inhalation device development, including engineering, formulation development and analytical laboratory services and the subcontract manufacture of devices. At Norton he developed, scaled-up and launched Easi-Breathe as well as developing the Spiromax MDPI. He was awarded the Royal Academy of Engineering MacRobert award for the development of Easi-Breathe.
He left Noton (now part of IVAX) to start his own consultancy business, before joining Phoqus Pharmaceuticals as Vice President Engineering to develop novel drug delivery systems based on electrostatic deposition technology. He then returned to consultancy, operating as Programme Director on a major new respiratory device development, until he joined Myland in 2013.

Ben Forbes

Ben Forbes is a Reader in Pharmaceutics at King’s College London. He is currently the Head of the Pharmaceutics Teaching Section and the Drug Delivery Research Group of the Pharmaceutical Science Division. He has a B.Pharm from King’s College London (1987) and a Ph.D. in Drug Delivery from Strathclyde University (1995).

Dr Forbes performed post-doctoral work in respiratory drug delivery at King’s College London from 1995 until he was appointed to the academic staff in 1997.

He is a registered pharmacist in the UK and serves on the committee of the Academy of Pharmaceutical Sciences focus group for Inhalation and the organising committee of the Drug Delivery to the Lung conference.

The research group led by Dr Forbes has nine members of academic staff working collaboratively on different aspects of inhaled drug delivery from particle engineering through to aerosol interaction with the respiratory epithelium and in vivo pharmacology.

James Tibbatts

James Tibbatts is Head of Business Development a Coalesce, a Cambridge-based drug delivery device development company. He has commercial responsibility for Coalesce’s technology licensing and co-development contracts, as well as technical responsibility for some of Coalesce’s inhalation device developments.
James’ background is in Computational Fluid Dynamics (CFD) and he holds and MEng in Aeronautical Engineering from the University of Cambridge. He arrived in inhalation science as a CFD application specialist and independent consultant, having developed a technical expertise in fluid-particle interactions that occur within Dry Powder Inhalers (DPIs). Over the years, James has broadened his activities within the inhalation sector, developing considerable business development, programme management, and technical expertise including, device development, in-vitro performance optimisation,

Mark Copley

Mark Copley graduated from the University of Bath, UK in 2000 with a Masters Degree in Aerospace Engineering. For 8 years he was Technical Sales Manager and product specialist for Copley Scientific’s range of inhaler testing equipment, before coming the Sales Director in 2009. He is now Chief Executive Officer for the company. Mark is considered a leading authority in testing methods and systems for metered-dose inhalers, dry powder inhalers, nebulisers and nasal sprays; authoring and contributing to more than 50 published articles. He also provides application support and consultancy, runs focused training workshops for the inhaled drug testing sector of the pharmaceutical industry and sits on the editorial advisory panel of Inhalation Magazine. An invited member of the European Pharmaceutical Aerosol Group (EPAG) impactor sub-team, Mark has also made recommendations to the Inhalanda working group, leading to subsequent revisions to Ph. Eur. and USP monographs. As part of Copley Scientific’s associate membership of the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS), Mark participates in a number of working groups with a view to enhancing the regulatory science of orally inhaled and nasal drug products (OINDPs).

Specialties: Methods for the determination of delivered-dose uniformity and aerodynamic particle size distributions of OINDPs.

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.

Chris Vernall

Chris is currently the Business Development Director at Intertek Melbourn. He is an analytical chemist by training and holds a Master’s Degree from Loughborough University. Chris started his career at Pfizer, as a Materials Scientist working on novel inhaled compounds, before moving to Nanopharm where he worked in formulation, specifically with DPIs and pMDIs. He then made the move to Intertek Melbourn as a Senior Analyst, before taking up the role of Business Development Manager in 2014. He started in his Director role in April of 2017.

Don Smith

Don Smith – Founder and Inventor, 1nhaler.

Until 2016, Don was an award winning Creative Director in the Advertising and Digital Marketing field. He left to begin a new career as an inventor, looking to bring his philosophy on innovation and invention into the fields of health, energy, environment and sustainability. His first invention, the 1nhaler is a revolutionary, single dose, dry powder inhaler.

Don also consults on innovation, invention and disruption theory, helping businesses in a number of sectors to embrace the value of innovation.

He has recently been involved with projects relating to Artificial Intelligence in life sciences, business modelling in financial services, blockchain technology in healthcare, and marine conservation in tidal energy.

Nikhil Sahotra

Dr Nikhil Sahotra is the Materials Emission Specialist at Markes International. His role focuses on the sampling and analysis of airborne chemicals, specifically volatile organic compounds, found in air as well as those emitted by products and materials. He also aids the development of standard methodology for sampling and analysis of volatile chemicals and is a voting member of ASTM. Prior to this, Dr Sahotra attended the University of Birmingham where he received his Ph.D. in Organic Electro/Photo Luminescent Materials. This was following his completion of a master’s degree in Medicinal Chemistry from Newcastle University.

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%
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 9 Apr
Enrol now

Previous customers include...

  • Aespira Ltd
  • Almirall Sofotec GmbH
  • Aptar France SAS
  • Arven
  • Astech Projects Limited
  • Bayer Pharma AG
  • Cambridge Consultants Ltd
  • Cambridge Design Partnership
  • CARDINAL HEALTH
  • Catalent Pharma Solutions
  • CENSDELIVERY
  • Chemo Group
  • Farmaprojects S.A.
  • Hexal AG
  • Innovata plc
  • Insite Technology Limited
  • Intertek
  • Laboratorios Almirall S A
  • LICONSA
  • Medisize Schweiz AG
  • Neutec Inhaler San. Tic. A.S.
  • Nexus6
  • Nolato Medical Business Area
  • PH&T SpA
  • Plastiape SpA
  • Sandoz International GmbH
  • SANOFI AVENTIS R & D
  • Sortimat Assembly & Feeder Technology
  • Styrolution Koln GmbH
  • Teva Pharmaceuticals

Very good organisation, time keeping, very valuable information delivered by speakers.

Waldemar Wiśniewski, Project Manager, Pulinno sp. z o.o.

Well selected speakers, covering broad range.

Steffen Fredersdorf, Manager Clinical Program, Philip Morris International

Thanks all of them, they share their valuable experience. All of the speakers are valuable people, they are the best in their jobs. Conference met my expectation.

Emre Kisasoz, , Arven

Interesting, helpful, nice examples, informative! Offers good overview on DPI's. Many thanks!

Ina Brueckner, CMC Manager Medical Devices, Bayer Pharma AG

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

Mahmoud Farag, Scientific Business Development Manager, Qualicaps

One of the best courses I attended

Anna Giulia Balducci, Senior Scientist, Chiesi Limited

In general, the course was very interesting and well organized

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

Very useful and relevant discussions

David Ward, Senior Formulation Scientist, Intertek

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

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

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

Very good and useful update. Clear messages coming through.

Simon Strothers, Director, 3P Innovation Ltd