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Pharmaceutical Medical Devices

Dry Powder Inhalers: Annual Conference

27-28 Jun 2017

GBP EUR USD
Standard 1399 1959 2182
Excluding VAT @ 20.00%

Venue: Rembrandt Hotel, London

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Course Overview

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

Speakers to include:

Dr Elizabeth Baker, Group Manager, Licensing Group 1 and Drug/Device Enquiries, MHRA
Peter Daley-Yates, Director, Clinical Pharmacology, GSK
Dr David Lewis, Head of Laboratory, Chippenham Research Centre, Chiesi

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KEY TOPICS TO BE COVERED INCLUDE

  • Generic DPIs – The Future
  • Human Factors in the Development of DPIs
  • Qualcomm Life: Connecting Inhalers Globally
  • Addressing the Needs of the Elderly Patient Requiring Orally Inhaled Therapy at Home – Focus on Dry Powder Inhalers
  • Aiming for the Lungs – Formulation Strategies for Delivery of Inhaled Biologics
  • Why are there Surprises When Correlating IVIV?
  • Regulatory Perspective on Inhalation Products
  • Oral versus Inhaled Drug Delivery for Respiratory Pharmacotherapy
  • Simplicity in Inhaler Design
  • Integrated Development and Scale-up of Combination Products
  • The In-Vivo Behaviour of Particles in the Extra Fine Region
  • Formulating Powder-Device Combinations for DPI Products
  • Mannitol as an Alternative to Lactose Dry Powder Inhalation

Sponsorship available

Why you should attend

  • Hear the latest technology in DPI formulation and development
  • Establish where the DPI market is going and the innovations being applied for patient compliance
  • Network with your peers and increase your business partnership potential

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

09.30 Chairman’s Welcome and Introduction
Dr Steve Nichols, Director, OINDP Consultancy, UK

09.40 Review of DPI Developments over the Last Year
Dr Steve Nichols, Director, OINDP Consultancy, UK

10.20 Generic DPIs – The Future

  • What is happening?
  • Where is it going?
  • Future market opportunities
  • Influence of the East on the West

Philippe Rogueda, Executive Director, Aedestra, UK

10.50 Discussion

11.00 Refreshments

11.30 Human Factors in the Development of DPIs

  • Examples of how human factors can help you to develop a better DPI
  • Generic versus originator brand DPIs – human factors and the switch proposition

Richard Featherstone, Managing Director, Medical Device Usability, UK

12.10 Qualcomm Life: Connecting Inhalers Globally
Novartis case study on how Qualcomm Life´s Internet of Medical Things technology connects millions of inhalers

Thomas J. Olesen, Commercial Director, Qualcomm Life, Europe, Germany

12.50 Discussion

13.00 Lunch

14.10 Addressing the Needs of the Elderly Patient Requiring Orally Inhaled Therapy at Home – Focus on Dry Powder Inhalers

  • Introducing the elderly patient needing chronic inhaled therapy at home
  • The likely disease scenario: asthma, COPD, asthma-COPD overlap
    syndrome, other respiratory diseases, comorbidity, polypharmacy
  • Cognition or lack thereof: importance of intuitive patient interface for the patient/care-giver
  • Manual dexterity: can the patient operate the device
  • Instructions for Use: Are they useful to the patient/caregiver?
  • Importance of human factors analysis in the design of dry powder inhalers for the elderly: ISO 20072: 2009 – importance of the device functionality profile
  • How do we improve the elderly patient/care-giver experience

Jolyon Mitchell, Owner and CEO, Jolyon Mitchell Inhaler Consulting Services Inc., USA

14.50 Aiming for the Lungs – Formulation Strategies for Delivery of Inhaled Biologics

  • Formulation and delivery of biologic molecules via dry powder inhalation
  • Opportunities and challenges in the field.

Charlotte Yates, Team Leader – Pharmaceutical Development, Vectura, UK

15.30 Discussion

15.40 Refreshments

16.10 Why are there Surprises When Correlating IVIV?

  • Current approaches
  • Case studies showing unexpected IVIVC
  • Is a risk-based approach helpful?

Dr. Herbert Wachtel, Analytical Development, Boehringer Ingelheim Pharma GmbH & Co. KG

16.50 Regulatory Perspective on Inhalation Products
Dr Elizabeth Baker, Group Manager, Licensing Group 1 and Drug/Device Enquiries, MHRA, UK

17.30 Discussion

17.45 End of Day One

17.45 – 18.45 Drinks reception for Delegates and Speakers

Programme Day Two

09.15 Review of Day One
Mike Holroyd, Senior Director, Mylan

09.30 Oral versus Inhaled Drug Delivery for Respiratory Pharmacotherapy

  • Oral and inhaled drugs approved and in development
  • The pros and cons of the inhaled versus the oral route of administration
  • The pros and cons of dual and triple inhaled therapies versus monotherapies
    and oral drugs

Peter Daley-Yates, Director, Clinical Pharmacology, GSK, UK

10.10 Simplicity in Inhaler Design

  • The making of PowdAir: how simple inhalers drive success in human factors studies
  • Scaling up TwinCaps DPI delivered dose four-fold

João Ventura, Business Development Manager, Hovione Technology Ltd, Portugal

10.50 Discussion

11.00 Refreshments

11.30 Integrated Development and Scale-up of Combination Products
Smaller and smarter combination products to support the trend toward patient-administered drug delivery

  • Integrating HFE and DFM/DFA as foundations of the combination product development process
  • Early manufacturing involvement to speed up time-to-market and reduce risk by “getting it right the first time”
  • Development of a manufacturing scale-up strategy, concurrent with the development process

Bill Welch, Chief Technology Officer, Phillips-Medisize Corporation, USA

12.10 Case Study: New Combination DPI
Yorick Kamlag, Head of Pharmaceutical Development, Zentiva Inhalationsprodukte, GmbH

12.50 Discussion

13.00 Lunch

14.10 The In-Vivo Behaviour of Particles in the Extra Fine Region: Exploring the Potential Advantages of Extra Fine Particle Delivery and the Technology that can Help to Achieve it

  • The potential advantages of extra fine inhaled drug delivery: a number of studies have shown that there may be important clinical advantages to using extra fine drug delivery to, for example, enhance deposition in the peripheral airways and to control the consistency of drug delivery in the face of device use by different patients, with different inhalation profiles
  • Formulating with extra fine particles: although many formulations already contain extra fine particles they are difficult to detect and study. Effective formulation with extra fine particles may require the refinement of certain measurement strategies to provide the data needed to progress
  • The practicalities of delivery: effective dispersion of a DPI dose is always a prime area of concern when developing a new product. Dispersion into the extra fine region intensifies the challenge but there is device technology that can help

Dr David Lewis, Head of Laboratory, Chippenham Research Centre, Chiesi, UK

14.50 Formulating Powder-Device Combinations for DPI Products

  • The role of the device in formulation development
  • The impact of different powder and device parameters on product performance • Robust formulation development best practices

Mark Parry, Technical Director, Intertek Melbourn, UK

15.30 Mannitol as an Alternative to Lactose Dry Powder Inhalation

  • General requirements for carriers in dry powder inhalation
  • Properties and advantages of mannitol in comparison to lactose
  • Case studies of mannitol in dry powder inhalation

Dr Regina Scherliess, Christian-Albrecht University of Kiel, Department of Pharmaceutics and Biopharmaceutics, Germany

Discussion

Chairman’s Closing Remarks

Close of Conference and Refreshments

Presenters

Steven Nichols

Steve Nichols is a Consultant to the Pharma Industry for OINDPs and devices and has 27 years of experience in product development. He has a PhD in physical chemistry from the University of London.
He joined Fisons Pharmaceuticals in 1980 working on developing a range of drug products, including respiratory products, ophthalmic product tablets and sustained release capsules.
In 1998 (Rhone-Poulenc Rorer) he was responsible for MDI Analytical Development and Respiratory Physics, then became head of Drug Delivery Research, focusing on the appraisal and the development of new inhalation systems.
In 2000 within Aventis he was appointed manager of Materials Science which focused on API characterisation and selection. In 2001 he took up the role of New Technology Co-ordination Manager, assessing new inhalation delivery technologies and focusing on inward and outward licensing opportunities of inhalation delivery platforms. Latterly, (sanofi-aventis) he was leading a team working on late phase DPI product development and strategy.
He is a member of the European Pharmacopoeia Inhalanda working group and BP Pharmacy experts group. He is founder and past-chair of the European Pharmaceutical Aerosol Group (EPAG).

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.

Richard Featherstone

Richard Featherstone is Human Factors Director of Medical Device Usability Limited, a specialist human factors consultancy that works exclusively with new and emerging medical technologies. He has been designing and conducting human factors studies for over 10 years, and his experience includes a wide range of drug delivery technologies including inhalers, auto-injectors, nasal sprays and associated devices such as tele-health systems. He and the MDU team regularly test in the US, UK, Europe and Australia and undertake formative and summative testing for some of the world’s largest pharmaceutical and medical device companies as well as small start-ups. Based in Cambridge, MDU has grown rapidly to become Europe’s largest specialist medical HF consultancy with clients around the world. Over 10 years of testing has meant that Richard has built a considerable body of knowledge of the practical aspects of designing, undertaking and reporting of both types of testing.

Regina Scherließ

PD Dr. habil. Regina Scherließ (*27.2.1979) is university lecturer and acting chair at the Department of Pharmaceutics and Biopharmaceutics at Kiel University, Germany. She received her Dr. rer. nat. (doctor of natural sciences) in 2008 from the same university for her work on “Formulation of inhalation combination products by co-precipitation” and now leads a research group working on dry powder formulations for vaccines focusing on mucosal vaccination via the respiratory tract. During her academic education she spent a semester (2001/2002) at the Danish School of Pharmacy in Copenhagen and in 2010 was at the Sievers lab at University of Colorado at Boulder, USA, for a research stay. In 2012, she was research visitor at the University of Otago in New Zealand, collaborating with Prof. Rades and Ass. Prof. Hook and in 2016 she had a research stay at the Woolcock Institute of Medical Research (Prof. P. Young) in Sydney, Australia. She was awarded the Pat Burnell New Investigator Award of the Aerosol Society (in 2010) and the Galenus Technology prize (in 2011) and is member of the DDL scientific committee (since 2015).

Francesca Buttini

Francesca is currently holding an Assistant Professor position at the Department of Pharmacy, University of Parma in the group of Prof. Paolo Colombo and Prof. Ruggero Bettini. In October 2014, she was appointed as Visiting Lecturer in the Institute of Pharmaceutical Science of King’s College London.

In 2003 she obtained an MSc in Pharmacy at the School of Pharmacy of the University of Parma and in 2007 she received a PhD dregree in Biopharmaceutics-Pharmacokinetics defencing a thesis on “Novel dry powder inhaler combined formulations to employ in the treatment of asthma and COPD”. In 2008, European Socrates Programme and Chiesi Farmaceutici S.p.A financially supported her post-doc research period at the King’s College London under the supervision of Prof. Christopher Marriott and Dr. Ben Forbes.

She works on the development of innovative pulmonary products such as solutions for nebulisation and metered dose inhalers, but her main research area is the formulation and testing of dry powder inhalers. She is an expert on particle engineering, dissolution test of microparticles and characterization of carrier-based formulations. Up to the present, she has published 4 patents and 18 original research papers. She recently edited of a specialist scientific book on pulmonary drug delivery and she presented her work at numerous international scientific meetings as invited lectures. She collaborates with several international institutions such as King’s College London (UK), University of Sydney (Australia), University of Kiel (Germany) and University of New Mexico (USA).

Finally, in 2013 Francesca founded with three colleagues of University of Parma PlumeStars Srl, an innovative StartUp, focused on the development of antibiotic powders for inhalation.

Afzal Mohammed

Afzal Mohammed read for his PhD on solubility enhancement of difficult drugs and is currently Professor in Pharmaceutics. He also holds a Personal Chair in Pharmaceutics and has research expertise in pharmaceutical material characterisation, excipient functionalisation, process and technology innovation for particle surface modification. He has over 15 years of experience in developing novel pharmaceutical processes and formulations and is the lead inventor for dry particle coater. He is also the Chief Technology Officer and Director at Aston Particle Technologies, which offers dry coating technology for particle surface modification. He has over 100 publications including research articles, review papers, book chapters and patent applications..

Previous customers include...

  • 3P Innovation Ltd
  • 42 Technology Ltd
  • Aarti Industries Ltd
  • Alfred E Tiefenbacher GmbH & Co KG
  • Ballington Hall Associates
  • Bang & Olufsen Medicom AS
  • BIOGEN IDEC FRANCE SA
  • Cad Middle East Pharmaceutical Industries
  • Cambridge Design Partnership
  • CBR Novasome Sp Z.o.o.
  • Chiesi Farmaceutici SPA
  • Copley Scientific Limited
  • CPI BIOCORP
  • GlaxoSmithKline GmbH & Co. KG
  • Harro Hoefliger Verpackungsmaschinen GmbH
  • John Bell
  • Kinneir Dufort Ltd
  • Mikron SA Boudry
  • Mundipharma Research Ltd
  • Mylan Pharma UK Ltd
  • Orion Corporation
  • PERLOS LTD
  • Pfizer Ltd
  • Presspart Manufacturing Limited
  • Qualicaps Europe SAU
  • Ranbaxy Laboratories Ltd
  • Recipharm AB (publ)
  • Respivert Ltd
  • RIWISA AG
  • RTS LIFE SCIENCE INTERNATIONAL