This seminar includes presentations and knowledge-sharing from world-recognised experts from industry, academia and regulation in the area of respiratory medicines and is an essential event for all those new to or experienced in inhaler drug delivery.
Inhaled drug delivery is achieved using four principal technologies: dry powder inhalers, metered-dose inhalers, nebulisers and liquid inhalers. Although there are many differences between these technologies, there are a number of fundamental principles that are followed to achieve an effective delivered dose. This event will provide an excellent forum to share knowledge and explore the opportunities across the dose forms with key industry leaders.
The most recent and innovative developments in inhaled drug delivery will be addressed including the use of triple therapies in lung disease, the development of long-awaited generic inhalers, the use of quality by design (QbD) principles in continuous manufacture, innovation in nebuliser treatment, reviews of connected devices, and the use of human factors in the design process. Regulations are key to respiratory medicines and future European and UK regulatory processes following Brexit will be critical when developing product approval strategies. Regulatory issues on this and other important hot topics will be considered.
This programme will provide valuable insights into inhaled drug delivery from experts in the field and will give you:
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Chair’s welcome and introduction
You can breathe easily now: modern respiratory medicines
Innovation in nebulised therapy
Dr John Pritchard
New concepts for inhaled corticosteroid therapeutic equivalence
INFORM 2020: new analytical insights into dry powder formulations for inhalation
Professor Darragh Murnane
Developing triple combination inhalers
Bringing better inhaled drugs faster to market through functional respiratory imaging (FRI) and artificial intelligence (AI)
- Facilitate the development of novel treatments in COPD
- Assist in tackling environmental challenges such as wildfire exposure
Jan de Backer
Digitally enabled inhalers – a clinician’s perspective
Technology transfer (TT) for inhaled drugs
Review of new inhalation technologies
How to navigate a smooth regulatory pathway for inhaled products
Regulatory alignment between the UK and Europe post Brexit
Dr David Jefferys
Human factors (HF) studies – a hype or a must-do?
Handling fourses for the different use of inhalered devices
Dr Herbert Wachtel
Inhaler devices and the environment
Could smart inhalers dramatically change the way that asthma and COPD patients are treated?
Chair’s closing remarks
Dr John N Pritchard. From January 2011 – September 2018, John was CTO for Philips Respironics Drug Delivery, with global accountability for the development of products for the treatment of respiratory diseases. He is now a private consultant specialising in strategic approaches to developing respiratory devices, drugs and digital health. At different stages in his career across 3 major pharmaceutical companies, he has been associated with the launch of 11 major products and at RDD in April 2018, John received the Charles Thiel award for outstanding research and discovery in respiratory drug delivery. John has published widely in the field, as well as having served as Board member on various scientific and industry bodies. He has sat on a number of Advisory Boards and is currently a member of the UN Committee that makes recommendations on the essential uses of propellants.
Dr. Daley-Yates is Director of Clinical Pharmacology at GlaxoSmithKline with responsibility for respiratory and immuno-inflammation medicines development. He joined the pharmaceutical industry in 1991 and has held various posts in clinical and pre-clinical drug development, initially at Upjohn then Pharmacia&Upjohn before moving to GlaxoWellcome in 1996. Prior to that, he held a number of academic and industry funded positions undertaking doctoral and post-doctoral research in biochemical and clinical pharmacology, toxicology and pharmacokinetics before being appointed Lecturer at Manchester University Department Pharmacy in 1985 where he established a research team in applied pharmacokinetics and drug targeting.
During his career he has contributed to successful drug development projects in oncology, infectious diseases, inflammation, allergy and respiratory diseases. He has authored >130 publications including original research, reviews, book chapters and patents.
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.
Bruce Davis, Senior Consultant, Engineering, QbD and Qualification, Bruce Davis Global Consulting. Bruce is a professional engineer with 20 years’international experience of projects for drug substance and drug product manufacturing facilities. When he was with AstraZeneca, he led major changes to qualification processes globally as well as leading Quality by Design (QbD)cross-functional workshops for newproducts. He is ISPE’s former Chairman and Secretary to ASTM E55.03. For ISPE, he led the QbD case study, now published.
Darragh Murnane PhD BSc. (Pharm.) MRPharmS, Associate Dean (Enterprise), Principal Lecturer in Airways Pharmaceutics, University of Hertfordshire.Darragh is a pharmaceutical technologist developing formulations for inhaled drug delivery.
He has pioneered environmentally-friendly techniques for particle manufacture that avoid organic solvent use. He is most widely known for his work on inhaled formulations and device product testing as well as his work in controlling the solid state of microparticles in drug delivery. Dr Murnane is President of the Aerosol Society, the leading learned society for aerosol research in the UK and Ireland.
Darragh has developed a research group with international collaborations dedicated to cross-disciplinary research involving chemical engineering, physical and analytical chemistry to understand the link between patient physiology and pulmonary drug delivery. Current projects include work funded by the NC3Rs to develop better screening systems to characterize the toxicity of inhaled particulate medicines (Crack It Inhalation Challenge) as well as performing in-tissue drug and metabolite analysis (DM-MAP). The research group also works in collaboration with several leading international pharmaceutical and medical device companies in the area of clinical pharmaceutics, in order to improve patient-device matching and overcome physical barriers to inhaler use.
As Associate Dean for Enterprise, Darragh provides strategic leadership for the development of academic-industrial and academic-health service liaisons including consultancy, knowledge transfer, collaborative research and external professional development activities with a value in excess of £1M per annum. Recent successes include securing £2.5M of Government funding to ignite innovation in the Hertfordshire Local Enterprise Partnership, with up to 28 industrial knowledge exchange and PhD studentships between 2015-2022.
Dr. Wachtel’s current focus is Drug Delivery based on Medical Devices. Working as a Senior Principal Scientist at Boehringer Ingelheim he has gained experience in the design and testing of complex drug delivery systems, e.g. inhalers and autoinjectors. He is interested in the interface between devices and the respective parts of the body, be it for humans or animals. His aim is basic modelling of drug delivery processes and in doing so he relies on structural and functional modelling e.g. computer aided design, CAD (Solid Works), finite element modelling, FMEA (Solid Works), and computational fluid dynamics, CFD (ANSYS Fluent).
By training, Dr. Wachtel is a physicist. Connecting industry and university, Dr. Wachtel is also affiliated to the Department of Biopharmaceutics and Pharmaceutical Technology at the University of Mainz.
Richard Featherstone is Research Director, Human Factors Research & Design, Emergo by UL, and previously Managing 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, Richard set up and grew MDU into one of Europe’s largest specialist medical HF consultancies. 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.
For the last 6 years Chris has been based at Aptar Pharma’s manufacturing facility in Le Vaudreuil, Normandy, where he oversees the Global business development activities for inhalation drug delivery devices pertaining to the application fields of Asthma and COPD. Chris has an Honors degree in Mechanical Engineering and has spent the last 25 years working in the field of Inhalation Drug Delivery (IDD) with specific focus on metering valves for pMDIs and their accessory device technologies, including dose indicators/counters and more recently Dry Powder Inhalers (DPIs). Chris previously worked at 3M Health Care (Drug Delivery Systems Division – UK), for 19 years, holding various positions and responsibilities within 3M’s R&D (Valve Development Specialist), Manufacturing (Manufacturing Technology Leader), Six-Sigma (Site Coach), Technical Sales and New Business Development functions. During this period Chris was closely involved in the development, optimization, commercialization and sale of IDD componentry (valves, canisters and accessory devices) for several innovator pMDI products.
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.
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.
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.
Ian works at DLRC as a CMC Regulatory expert where he advises clients on both inhaled and non-inhaled product developments and submissions.
Previously, Ian has worked in the Pharmaceutical Industry since 1985 where he started as a senior formulation scientist with May & Baker. He then moved to Glaxo Group Research (now GSK) in 1987 and worked there for 28 years. Prior to the formation of GSK in 2001, Ian worked as a team and project leader in Pharmaceutical Development and played a key role in the Inhaled products developed during that period including Serevent pMDI and Seretide pMDI/Diskus. In 1994-5, Ian also spent 2 years working at the US site leading the team developing and registering Ventolin HFA pMDI. Since the formation of GSK, Ian acted as a senior technical leader for the development of a variety of products by leading technical teams across pharmaceutical and chemical development, CMC Regulatory, manufacturing and supply chain. Ian then worked at the MHRA as a pharmaceutical assessor from 2016 prior to joining DLRC in 2018.
Ian has a B.Sc. in Pharmacy, an M.Sc. in Colloids & Surface Chemistry and a Ph.D. in Pharmaceutics. Ian is also a G.Ph.C. registered Pharmacist.
Jan De Backer
Dr. Jan De Backer, CEO, FLUIDDA. Jan graduated from Delft University of Technology, The Netherlands as an aerospace engineer. He attained an MSc degree in aerodynamics and specialized in applied biomedical computational fluid dynamics leading to a PhD from the University of Antwerp, Belgium. He is an alumnus of the MBA programs at London Business School, London and Columbia Business School, New York. He has received several awards for his innovative research in the field of airway modeling in respiratory and sleep medicine. His work has been published in international journals. Jan founded FLUIDDA in 2005 and he has held the position of Chief Executive Officer since 2007.
Enrico Zambelli is currently Lead Formulator Scientist at Chiesi Farmaceutici, (Italy, Parma). He is responsible for the formulation and manufacturing process development of inhalation products. Enrico has more than 10 years of experience in the development of MDI and DPI from early phase to life cycle management. He has also worked as a Formulator Leader and Risk Management Manager of Trimbow MDI, the first triple fixed combination products for inhalation approved in Europe.