Inhaled drug delivery is achieved using four principle technologies, dry powder inhalers, metered dose inhalers, nebulizers and liquid inhalers. Although there are many differences between these technologies there are many fundamental principles that are followed to achieve an effective delivered dose, as such there is much shared learning
across the technologies.
This meeting includes presentations on each of these delivery technologies with the intent to share knowledge and learning across the inhaled drug development business. The future European and UK regulatory processes following Brexit will be critical when developing product approval strategies, we shall be considering regulatory issues on this and other important hot topics.
There are a number of key areas that are currently evolving and the latest thinking and progress on these will 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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Chairman’s welcome and Introduction
You can breathe easily now; modern respiratory medicines…
Innovation in nebulized therapy
Discussion followed by refreshments
Current and future challenges for DPI formulation
Opportunities of nanoformulations in the lung
Discussion followed by lunch
The role of lung protease in delivery of inhaled biopharmaceuticals
Mimetikos preludium: a new pharma friendly aerosol drug deposition and disposition simulator
Could smart inhalers dramatically change the way that asthma and COPD patients are treated?
Decoding FDA’s recent combination drug product guidance: Applications to DPIs, pMDIs, and nasal sprays
Networking drinks reception
End of day one
Review of day one
The UK regulatory future – the way forward after Brexit
Methods for the determination of delivered-dose uniformity and aerodynamic particle size distributions of OINDPs
Navigating human factors in device development
The 1nhaler and its two jobs
Discussion followed by lunch
Opportunities and challenges in the design of a high-performance unit-dose dry powder inhaler
Design and characterisation of breath actuation mechanisms
Digitally enabled inhalers
Chairman’s closing remarks
Close of conference and refreshments
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.
Stephen is an independent consultant with a successful record in innovation and the development of technologies and teams. He founded Vectura Delivery Devices in 2002 and was a member of Vectura’s Executive Leadership Team until 2016 with responsibility for technology and IP. He led the invention and development of the core device technology used in a range of inhalers including GyroHaler®, now approved and marketed in over 30 countries as Sandoz’s AirFluSal® Forspiro®.
From 1987 to 2002 Stephen worked for Cambridge Consultants Limited (CCL). Whilst at CCL he set up and led CCL’s Drug Delivery Devices Group, which carried out significant product developments in the areas of inhalation, injection and infusion products. Before specialising in drug delivery, Stephen managed a number of healthcare, telecoms and consumer product developments for clients in Europe and the US. Prior to joining CCL Stephen worked in design and development for Baxter Healthcare. He studied Mechanical Engineering at Imperial College.
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.
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.
Since April 2007 James has been working as an independent consultant specialising in Computational Fluid Dynamics (CFD) analysis for pharmaceutical applications.
James’ academic background was originally in Aeronautical Engineering where he specialised in external aerodynamics with a particular focus on Formula 1 cars. Working as a CFD applications engineer for Fluent UK (which later became ANSYS) James transferred his focus from aerospace and automotive applications towards Chemical Process and latterly Pharmaceutical applications. Since 2005 James has focused entirely on CFD applications for the pharmaceutical industry. During this time most of his work has been on the assessment of fluidisation and deaggrgeation within DPIs.
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.
Prof. Dr. Regina Scherließ (*1979) is a professor for Pharmaceutics and Biopharmaceutics, director of the section Pharmacy and chair of the Department of Pharmaceutics at Kiel University, Germany. As such she leads the research unit in Pharmaceutics and is responsible for all teaching in Pharmaceutics and Biopharmaceutics at Kiel University. She is a pharmacist and received her Dr. rer. nat. (doctor of natural sciences) in 2008 for a work on “Formulation of inhalation combination products by co-precipitation”. In 2015 she finished her “habilitation” working on “Mucosal vaccination via the respiratory tract”. During her academic education she had research stays in Denmark, the US, New Zealand and Australia. She also received several young researcher awards including The Pat Burnell New Investigator Award 2010 of the Aerosol Society and is member of the DDL scientific committee (since 2015). Her research interests include disperse systems and nanoparticles, stabilization of biomolecules in spray drying and formulations for mucosal vaccination with a focus on respiratory (nasal and pulmonary) dry powder delivery.
Dr Anselm Ebert is Global Business Developer at Presspart.
Studies of Molecular Biology and Neuroscience at the Universities of Würzburg (Germany), Hamburg (Germany), Rutgers (New Jersey, US) and Edinburgh (Scotland)
PhD in Neuroscience at Edinburgh University
2009-2011: Senior Business Consultant at FMC Consultancy, spezialized on strategy and restructuring
2012-2015: Director Product Development at Hartmann AG, spezialized on medical products
2016-current: Global Business Developer at Presspart
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.
Dr Arcadia Woods is a holder of the CW Maplethorpe Postdoctoral Research Fellowship in the School of Cancer and Pharmaceutical Sciences, King’s College London. She graduated with BSc Hons in Chemistry from the University of Edinburgh in 2010 and completed her PhD in Pharmaceutical Science at King’s College London in 2015, supervised by Professor Ben Forbes. Arcadia’s research interests lie in developing advanced in vitro systems to understand the fate of biopharmaceutical therapeutics and drug carriers in the lung, and investigating the ability of biocompatible drug carriers to enhance inhaled drug delivery.
George BostockGeorge holds a first class Master’s degree in Aeronautical Engineering from Imperial College London. He is also a Chartered Engineer and a Member of the Royal Aeronautical Society. At CDP he works as a Mechanical Engineer, with a particular interest in fluid dynamics. He has gained experience across a wide range of projects, from consumer goods through to medical devices, including a number of performance-critical drug delivery devices within the pharma industry. He was also a named Red-Dot design award winner for CDP’s “First Response Monitor” (FRM).
George enjoys the creative and collaborative aspects of his role at CDP. He is interested in how his previous experiences in Systems Engineering and Robust Design can be leveraged to improve both project and product success. He is also part of the CDP Quality Team, ensuring that projects are run to ISO 9001 and 13485 standards.
Engineer (Human Factors & Design Assurance) – Medical Devices, Vetura.
Graduated in Medicine from the RCSI Dublin and then trained on the Pulmonary and Critical Care Fellowship program at The Johns Hopkins Hospital, Baltimore, USA. Following this, he was appointed Senior Lecturer in Professor Peter Calverely’s Department at the University of Liverpool. He moved back to RCSI Dublin in 2000 as a Consultant Physician and Senior Lecturer and has since been promoted through the academic ranks.
Professionally, he is active as a clinician and teacher in both in-patient and out-patient general respiratory and internal medicine. He leads specialist clinics in severe asthma and he is the clinical lead for the National Severe Asthma program and a board member of two severe asthma registries. He leads specialist sleep and ventilation clinics and is Past President of the Irish Sleep Society.
Educationally, he has served as National Specialist Director of Training in Ireland in Respiratory Medicine from 2002-2012, where he developed a structured training program, a curriculum and assessment process. He now leads a research group in Medical Education Department at the Royal College of Physicians of Ireland. He is President of the European Board of Pulmonology, a Board Member of the ERS HERMES respiratory exam group, a Board Member of the ERS Education council and a Board Member of the Asthma Society.
Academically, he is a Health Research Board of Ireland Clinician Scientist. In the last 10 years, he has led a multi-disciplinary group of academics studying how technology can be used to optimise adherence to therapy and improve outcomes in patients with respiratory disease. He has developed, and copyrighted technology related to the assessment of inhaler adherence. He holds several patents related to the use of digital technology. He has published over 120, original research papers in respiratory medicine and has a h-index of 34. His work is currently supported by grants of over €3 million from industry partners and the Health Research Board of Ireland.
Senior Inhalation Consultant
Dr. Olsson has more than 25 years of experience of inhaled formulations having spent equal time on CMC and clinical pharmacology. His specialty is IVIVC with particular emphasis on predicting in vivo outcomes, such as lung deposition, from in vitro data.
Associate Director – Regulatory Affairs, Vectura
Nicky is a regulatory affairs professional with over 20 years’ experience of pharmaceutical and medical device licensing procedures. She has particular experience in the development of orally inhaled products delivered via dry powder inhalers and a special interest in human factors engineering.
Nicky has recently joined Vectura after having been an independent consultant for 11 years. Prior to this Nicky worked at Innovata Ltd, and as Regulatory Projects Manager at both Cambridge Regulatory Consultants and AKOS Ltd where she worked on a broad range of products at various stages of development. Nicky has a BSc (hons) in Chemistry and is a member of TOPRA.
Alison Moore is the Clinical Lead for the Connected Inhaler System at Glaxo SmithKline. She is guiding the clinical research investigating whether a connected inhaler system, comprising sensors for inhalers which record asthma medication use, a patient-facing app and a health care professional (HCP) dashboard, can improve a patient’s adherence to their asthma medication. A key challenge to good asthma control is poor adherence and HCPs can find it difficult to determine whether a patient’s poor asthma control is due to poor adherence or the need to change therapy. Could a connected inhaler system address this important patient and HCP unmet need?
Alison has a BSc in Chemistry and a MSc in Biochemical Pharmacology both from the University of Southampton. Alison obtained her PhD from the University of Manchester and her research evaluated modelling methodologies for predicting drug delivery to the lung. Throughout her career at GSK, within both Clinical Pharmacology and Clinical Development, Alison has had a special interest in inhaled delivery systems and optimising the delivery of medication to the lungs for asthma and COPD patients.
David Wyatt is Chief Operating Officer at Aston Particle Technologies Ltd. (APT) and a Visiting Academic Fellow in Life and Health Sciences at Aston University. He is an internationally recognised scientist and a key opinion leader in the development and manufacture of respiratory medicines. He joined APT in 2017 after more than 32 years with GlaxoSmithKilne and its heritage companies. During his GSK career, he held key roles of increasing responsibility in the selection, formulation, scale up, clinical testing, registration and manufacture of 5 new respiratory chemical entities in both pMDI and DPI formats. Salmeterol xinafoate, fluticasone propionate, fluticasone furoate, vilanterol trifenatate and umeclinidium bromide are separately, and in combination, at the heart of many of today’s gold standard medicines. He has worked on Rotahaler™, DIskhaler™, Diskus™ and Ellipta™ DPIs and earlier he was co-inventor of Ventolin™ Evohaler™. In his final position at GSK he was responsible for the technical team which supported the introduction of the Ellipta™ family of medicines to the marketplace (4 products in all major territories within a period of less than 2 years).