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Pharmaceutical Medical Devices

Inhaled Drug Delivery

13-14 Nov 2017

GBP EUR USD
Standard 1499 2099 2338
Excluding VAT @ 20.00%

Venue: Rembrandt Hotel, London

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Course Overview

This annual conference includes presentations on each of the four principal technologies of inhaled drug delivery – dry powder inhalers, metered dose inhalers, nebulizers and liquid inhalers. It will also cover the future European and UK regulatory processes following Brexit, which will be critical when developing product approval strategies in the future.

There are a number of key areas that are currently evolving and the latest thinking and progress on these will also be presented, including Human factor design and sensing/connecting technologies. These key evolving areas are subject to much debate and require careful consideration whilst developing an inhaled drug product.

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Programme Day One

09.30 Chairman’s welcome and Introduction

Dr Steve Nichols, Director, OINDP Consultancy, UK

09.40 Future needs for inhaled drug delivery

  • What are unmet needs and drivers for change in inhaled delivery systems?
  • How do the delivery systems in common use stack up against unmet needs and change drivers?
  • What are some alternative approaches one might take to enhance a delivery system or develop a new delivery system?

Dr Paul Johnson, Senior Director of Inhaled Product Platforms, GSK, UK

10.20 Innovation in nebulized therapy

  • Nebulized therapy is growing faster than other inhaled dosage forms, albeit from a smaller base
  • There are significant unmet medical needs for patients that would benefit from nebulised therapy, which will be reviewed
  • There are potential commercial advantages to develop nebulized therapies ahead of the corresponding inhaler
  • The use of electronics facilitates the introduction of patient management solutions

Dr John Pritchard, Director PMO and Technology, Respiratory Drug Delivery, Sleep & Respiratory Care, Philips Healthcare, UK

11.00 Discussion

11.10 Refreshments

11.30 Nebulizers – modern advances

  • New vibrating mesh technology
  • Deepro HCM-860

Irene Wu, Operations Director, HCMed Innovations, The Netherlands

12.10 Functional respiratory imaging: how does it help to optimise drug delivery in the lung

  • What is Functional Respiratory Imaging (FRI)
  • Relation of FRI to APSD methods and scintigraphy
  • FRI as a translational tool
  • Examples

Dr Wim Vos, Co-Founder, FLUIDDA, Belgium

12.50 Discussion

13.00 Lunch

14.10 Developing triple combination inhalers – the challenges

Francesca Usberti, Head of Respiratory Technical Leadership, CMC R&D, Chiesi, UK

14.50 Development of propellant free MDIs

  • AeroMist non pressurized metered dose inhaler
  • Human factors considerations for a new technology in an existing look and feel

Wilbur de Kruijf, Business Development, Medspray, Netherlands

15.30 Discussion

15.40 Refreshments

16.10 The ADI – low velocity aqueous spray device

  • Patient perspective

Tomas Norling, Director Inhalation R&D, Xellia Pharmaceuticals ApS, Denmark

16.50 The feasibility of aerosol-mediated delivery of next generation drugs: vaccines and cell-based therapies

  • Overview of next generation drugs
  • Rationale for pulmonary targeting of vaccines
  • Review of existing vaccine/device combinations
  • Requirements for optimal vaccine delivery
  • Rationale for cell therapy targeted to the lung
  • Review of existing cell therapy/device combinations
  • Requirements for optimal cell therapy delivery
  • Summary and Q&A

Dr Ronan MacLoughlin, Head of Science, Aerogen, Ireland

17.30 Discussion

17.45 End of day one

17.45-18.45 NETWORKING DRINKS

Programme Day Two

09.15 Review of day one

Mike Holroyd, Senior Director, Mylan, UK

09.30 The UK regulatory future – the way forward after Brexit

  • What are the key issues for the pharmaceutical industry for UK and EU 27
  • What have we learnt so far and what are the next stages of the negotiations
  • Preparations for March 2019
  • What should we expect from March 2019

Dr David Jefferys, Senior Vice President, Global Regulatory, Eisai Europe, UK

10.10 Human factor regulations

  • Human factors studies – a hype or a real need?
  • Which guidelines cover human factors for pharmaceutical products? What do the guidelines say?
  • Questions and problems

Dr Stefan Leiner, CMC Expert, Quality and Records Management, Boehringer Ingelheim Pharma GmbH and Co. KGm, Germany

10.50 Discussion

11.00 Refreshments

11.30 How the demands of engineered particles are impacting filling technology…

  • The trend towards engineered particles, including spray-dried powders, is changing the game with regard to development, clinical manufacturing and industrialisation of new formulations and devices
  • We explore the key challenges and what they mean for lab, clinical and commercial manufacturing

Alex Jezequel, Projects Director, 3P Innovation, UK

12.10 Connected Asthma

  • 1 in 11 in UK suffer from Asthma; 6 million Asthmatics
  • 8 people die daily in the UK because of Asthma
  • 75% of these deaths and associated costs can be avoided if medications were taken on time
  • 67% Asthmatics don’t take their medications correctly

Ali Moiyed, CEO and Founder, Aerobit Health Ltd, UK

12.50 Discussion

13.00 Lunch

14.10 MDIs getting connected – Inspair sensor converts any device into a connected device

  • The proper use of the device is one of the major issues in the respiratory field, specifically for PMDIs
  • Inspair, a smart sensor compatible with all PMDIs, can record critical information: the pressure on the canister and the inhalation
  • Inspair is a treatment monitoring solution designed to help patients follow the instructions for use of the device, educate them on the importance of the inhalation technique, and guarantee medication is properly delivered
  • Highly customisable solution, can even be adapted for some DPIs
  • Easy to industrialise for pharma, easy to adopt for patients

Arnaud Guillet, Business Development, Biocorp, France

14.50 *Smart inhalers – Improving adherence and reducing healthcare costs

  • Global health data confirms that poor patient adherence to long-term therapies, such as asthma and COPD, contribute significantly to rising healthcare cost
  • Smart Inhalers are emerging which enable more effective monitory of patient compliance and adherence, including remotely
  • Clinical studies using smart devices have demonstrated improvements and translate directly to a reduction in healthcare cost
  • Smart Inhalers face numerous challenges, from a wide range of stakeholder, for successful adoption on a global scale

Dana Shears, Director, Future Market Development, H&T Presspart, USA

15.30 3M Intelligent Control Inhaler

Sam Van Alstyne, New Products Marketing Manager, 3M Drug Delivery, USA

16.10 Discussion

16.20 Chairmen’s closing remarks

16.30 End of conference and refreshments

Presenters

John Pritchard

A graduate in physics from Birmingham University, John joined the UK Atomic Energy Authority in 1977, leading research into the deposition and clearance of particles in the respiratory tract. During this time he gained a PhD from the University of Essex on research into the lung deposition of tar from cigarette smoking.

John moved into the pharmaceutical industry in 1991, initially with Glaxo, then with 3M and AstraZeneca. At different stages in his career he held roles in line management, project leadership, technology development and commercial product strategy. During this time, he has been directly associated with the launch or life-cycle management of 11 different inhaled marketed products. Since January 2011, John has been Chief Technology Officer for Philips Respironics Drug Delivery, with global accountability for the development of advanced delivery systems for the monitoring and treatment of respiratory diseases.

John has published widely in the respiratory drug delivery field, been editor to several journals, as well as having served as President of The Aerosol Society, Board Member for the International Society for Aerosols in Medicine and on the UK Government Committee on the Medical Effects of Airborne Pollutants. He is currently a member of the United Nations Medical Technical Options Committee, which makes recommendations on the essential use of CFC propellants, is an editor for Pharmaceutical Technology and sits on the Scientific Advisory Board of Prosonix.

David Jefferys

Dr David Jefferys is currently Senior Vice President with Eisai responsible for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia). After qualifying in medicine he worked in clinical and academic medicine, before spending 20 years as a senior regulator for both medicines and medical devices. He was executive director of the UK Medicines Control Agency, CEO and Director of the MDA, joint CEO of MHRA. He was involved in the establishment of the European Medicines Agency, CPMP/CHMP member and MRFG and PER scheme chairman. For the last ten years he has worked in industry and chairs several key committees for ABPI, Efpia and IFPMA. He has lectured and published extensively in drug and device regulation and on benefit risk evaluation.

Stefan Leiner

Dr. Stefan Leiner is a pharmacist by training and joined Boehringer Ingelheim in Germany in 1987. After a couple of years in manufacture, galenical and analytical development, he focussed on inhalation forms.

He now holds the title of a “CMC Expert”. This means he is responsible for the scientific standard of the Module 3 of MAAs. He wrote the Quality Overall Summaries for many of Boehringer Ingelheim’s new inhalation developments.

Stefan represents Boehringer Ingelheim in the International Pharmaceutical Aerosol Consortium – Regulation and Science (IPAC-RS) and was chair of this organization. He participated in the development of the ISO 20072 Standard on “Aerosol Drug Delivery Devices”. He is active in the German Pharmacopeia.

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.

Ronan MacLoughlin

Dr Ronan MacLoughlin is Head of Science at Aerogen, Ireland.

Dana Shears

Dana has over 25 years’ experience within the Pharmaceutical Drug Delivery industry. He has spent the past 11 years with H&T Presspart, part of the Heitkamp and Thumann Group, currently as the Sales and Business Development Director for the Americas region. He is also responsible for commercial activities for the eMDI platform technology. Prior to joining Presspart, Mr. Shears held business development and marketing positions with Bespak, Allied Signal, Honeywell, AAI Pharma and Nypro Healthcare. Dana received his B.S. Degree in Engineering from West Virginia University in 1981.

Presspart is a division of the Heitkamp & Thumann Group, a leading global partner for the supply of world class precision formed components in both metal and plastic. Founded 1978, the Group today comprises more than twenty medium-sized companies located in 10 different countries. Annual sales revenues for the group are over 350 million Euros from a global work force of just under 2000 employees. Presspart is the global leader in the supply of metal canisters and actuators for metered dose inhalers, operating from three manufacturing sites – Blackburn, UK, Marsberg, Germany and L’Arboc, Spain.

Sam Van Alstyne

Sam Van Alstyne, New Products Marketing Manager, 3M Drug Delivery Systems.

Wilbur de Kruijf

Wilbur de Kruijf is responsible for new business development at Medspray Pharma BV, the Netherlands. Medspray Pharma develops novel metered dose liquid inhalers and eye spray devices, based on their proprietary micro nano technology spray nozzles. Wilbur joined Medspray ten years ago to start up device development in collaboration with Medspray’s device partners. Wilbur (born in 1971) has a background in Industrial Design Engineering (M.Sc. Design Engineering 1995, M.Sc. Advanced Industrial Design Engineering 1997, Delft University of Technology) with further specialisation in medical device development (acc. ISO 13485), design for six sigma and user centred design. Before joining Medspray, Wilbur worked almost 10 years for a Dutch design consultancy firm, Indes, winning several international design and usability awards for homecare & rehab products and hospital equipment. Wilbur is active in the IPAC-RS consortium’s device work group, in the European COST action SimInhale and he is the secretary of the Dutch medical aerosol scientist network ‘MAD Foundation’.

Wim Vos

Dr. Vos received an MSc degree in aerospace engineering from Delft University of Technology, The Netherlands and a PhD degree in physics from the University of Antwerp, Belgium. Dr. Vos was responsible for the development of frunctional respiratory imaging (FRI) as a tool to better describe disease and disease progression, as well as response to treatment. Dr. Vos is author of many papers in international journals and received several awards for his research. Since 2010 Dr. Vos is Chief Operating Officer at FLUIDDA.

Arnaud Guillet

He is currently business development associate at BIOCORP, in charge of finding partnerships and license opportunities for BIOCORP’s range of connected devices. Previously, he worked for a healthcare consulting firm with a strong focus on connected health strategies for pharma and insurance companies. Other past experiences in the pharmaceutical industry (Sanofi) and the insurance industry (AXA). Graduated from HEC Paris, a major European business school.

About the company
For 20 years, BIOCORP has been designing, developing and manufacturing medical devices for the pharmaceutical industry, enhancing drug reconstitution, safety, packaging and delivery.
Today, Biocorp continues to innovate in medical plastics, bringing new solutions to the market such as the Newguard, an integrated passive safety system for PFS compatible with nest, and the Biopass, a reconstitution system with an integrated needle ready to inject.
Recognized for its expertise in device R&D, BIOCORP has incorporated software development capacities to develop connected drug delivery systems, including: the DataPen, a reusable smart pen injector that automatically transmits data to a treatment mobile app, helping patients to manage their treatment; and a range of add-ons, smart sensors for existing drug delivery devices (pen injectors, MDIs).
On top of R&D capacities, BIOCORP also provides manufacturing services for plastic injection, process assembly and blister packaging.

Francesca Usberti

Francesca Usberti, Head of Respiratory Technical Leadership, CMC R&D, Chiesi.

Tomas Norling

Tomas Norling, Director Inhalation R&D, Xellia Pharmaceuticals ApS.

Paul Johnson

Paul is a senior director at GSK R&D Ltd and is currently the Inhaled Product Platform Lead. He completed his BSc Hons in Applied Chemisty at Hertfordshire University in the 1980s whilst working at Merck Sharp and Dohme. He joined GSK in the early 1990s and lead various analytical chemistry and formulation teams in the UK, and US before becoming focussed on inhaled product development in the late 1990s.

He led the MDI technology group within GSK to enable the development of GSK HFA-134a pMDI products, authuring a number of patents for pMDI formulations and compontents. In the early 2000s Paul led CMC teams responsible for the early development of a number of inhaled NCEs before leading the CMC development of Relvar/Breo Ellipta and subsequently leading the pottfolio of GSK Ellipta products from candidate selection through to launch and lifecycle management.

More recently Paul has been leading GSKs efforts to seek, identify and develop inhaled product platforms tailored towards enhancing customer experience, generating incremental value and ensuring quality throughout the supply chain for GSK’s current and future portfolio.

Alex Jezequel

Alex Jezequel is Projects Director, 3P Innovation, UK.

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Previous customers include...

  • Aptar Pharma
  • Astech Projects Limited
  • Astrazeneca
  • Bayer Pharma AG
  • Boehringer Ingelheim Pharma GmbH & Co KG
  • Catalent Pharma Solutions
  • Cranfield University
  • Dr Reddy's Laboratories Ltd
  • Forteq Healthcare
  • GlaxoSmithKline
  • Health Products Regulatory Authority
  • Kings College London
  • MannKind Corporation
  • MAP Pharmaceuticals
  • Mundipharma Research GmbH & Co. KG
  • Nypro Healthcare
  • Office for Registration of Medicinal Products, Medical Devices & Biocides
  • Omega Life Science
  • Oriel Therapeutics Inc.
  • Pfizer Limited
  • PH&T SpA
  • Pharmazeutisches Institut der Universiat Kiel
  • Prosonix Limited
  • RPC Formatec GmbH
  • Sandoz International GmbH
  • Siegfried Ltd
  • SkyePharma AG
  • Trig1 Ltd
  • UCB Pharma SA
  • University of Greenwich