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 dif cult 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.
Those involved in
A personalised medicine approach to the design of dry powder inhalers
Novel DPI Delivery Platforms
Experiments with Dry Powder Inhalers
In-vivo extra fine particles
High dose delivery utilising a DPI
The iSPERSETM platform
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
Bioequivalence research with the FDA
Dissolution and beyond: the use of advanced characterisation tools for demonstrating pharmaceutical equivalence of orally inhaled drug products
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.
Developing inhaled Lactose formulations
Dr Paul Royall
Robert Price has a personal chair at the Department of Pharmacy and Pharmacology, University of Bath where he leads the Pharmaceutical Surface Science research group. His research interests are primarily focused on investigating the physico-chemical properties which govern particle adhesion, surface stability issues of respirable particles and the general areas of particle technology and crystal growth.
He is a co-founder and managing director of Nanopharm Limited, a company providing a specialised service in advanced surface science for understanding the relationship between materials and processes in the development of pharmaceutical products.
David Howlett is the Director of PharmaDelivery Solutions Ltd. In 2003 he established the company as a highly specialised consultancy service in the field of drug delivery device technology. This has led to involvement in projects with focus in pulmonary, nasal and other delivery routes, with an international client base. Much of the activity of PharmaDelivery Solutions Ltd is focused in the area of development programme support, regulatory GAP analysis, establishing design control systems and design verification, planning and execution, materials strategies and type III device Drug Master Files (DMFs).
PharmaDelivery Solutions Ltd has provided key programme inputs in various forms including due diligence, regulatory GAP Analysis, strategic and detailed planning, implementation, mentoring and training.
In addition to activities supporting commercial organizations, has been involved in the following roles;
Honorary Teaching Fellow in the School of Pharmacy and Pharmaceutical Sciences at the University of Manchester and is author/ tutor for the Pharmaceutical Industry Advanced Training (PIAT) MSc module on Inhalation dosage forms
A UK national expert representing the British Standards Institute developing international standard ISO 20072:2009 for pulmonary and nasal delivery, and a committee member on other standards committees
Worked with the United Nations and various national governments to develop and establish transition strategies from the use of CFC in Metered Dose Inhalers and to secure appropriate budgets from the Multi-lateral fun for the implementation of the Montreal Protocol
An invited speaker at a number of international meetings and symposia on device development related subjects, including regulatory expectation, DPI development, extractables and leachables control and emerging markets
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.
Dr. Hava was promoted to CSO in November of 2012 after previously acting as Vice President of Research and Therapeutic Strategy at Pulmatrix. As CSO, Dr. Hava leads the Research and Development organization in the development of iSPERSE products across all stages of preclinical and clinical development.
In addition, Dr. Hava directs and manages the company’s therapeutic strategy to identify and prioritize drug targets and drugs that are enabled by the iSPERSE dry powder delivery platform.
Dr. Hava joined Pulmatrix in 2006 as one of the first Senior Scientists and has been involved in the early stage research and development programs that identified and characterized several of the key aspects of the Pulmatrix technology. Dr. Hava earned his PhD. in Molecular Biology and Microbiology at Tufts University and completed his post-doctoral training studying immunology and host-pathogen interactions at Harvard Medical School.
Dr. Hava has co-authored over 20 papers and abstracts focused on pulmonary infectious disease, immunology and chronic lung diseases.
David leads the Respiratory Drug Delivery sector at PA Consulting and enjoys the challenge of balancing commercial and technical activities.
“One of the best things about working at PA is being surrounded by like-minded and intelligent people – many of whom are leaders in their field. Drug delivery is a hugely exciting sector to work in and it offers a wide range of technical and scientific challenges. It’s also very rewarding – the products that we and others like us develop have the potential to massively improve people’s lives. It’s a great pleasure working with clients who share these aspirations.”
David is a physicist and has been working in the field of medical device development since 1994, where he started his career in the Respiratory Physics group at Fisons. He specialises in respiratory drug delivery and enjoys applying solid aerosol science and fluid dynamics to improve the efficacy of inhaler technology. David has numerous patents and publications in this area and regularly presents at conferences.
Dr. Lewis is Head of Laboratory at Chiesi’s research centre in Chippenham, UK. He holds a B.Sc. in Physics (1989) and M.Sc. and Ph.D. in Aerosol Science (1990 & 1994), from Essex University, England.
David joined the Centre for Drug Formulation Studies at Bath University, England, in May 1996 to lead a start-up HFA programme sponsored by Chiesi Farmaceutici. The resultant successful development of HFA solution formulations lead to a rapid expansion of his group which transferred to Vectura in 1999 as a result of CDFS spin-out by the University of Bath. He has authored over 50 research publications within the fields of pharmaceutics, analytical chemistry, and aerosol science, and is co-inventor of 16 granted patents relating to pressurized metered dose inhaler formulations and devices. These inventions led to the Chiesi Modulite technology which has seen formulations of beclomethasone dipropionate, budesonide, formoterol and a beclomethasone dipropionate-formoterol combination becoming commercialized in several European countries.
David joined Chiesi Limited in 2008 and established the UK Research Centre in Chippenham, UK which opened in July 2009.
Darragh Murnane PhD BSc. (Pharm.) MRPharmS
Associate Dean (Enterprise)
Principal Lecturer in Airways Pharmaceutics
Darragh Murnane is a pharmaceutical technologist developing formulations for inhaled drug delivery. He graduated with a degree in Pharmacy from Trinity College Dublin (2001) and became a licensed pharmacist (2002) following work in the pharmaceutical industry and hospital pharmacy. He obtained a PhD from the University of London (King’s College London) in 2007 and was Lecturer in Pharmaceutics at King’s College London until his appointment as Principal Lecturer in Airways Pharmaceutics at the University of Hertfordshire in 2010. Since September 2012, Darragh is Associate Dean for Enterprise in the School of Life and Medical Sciences at the University of Hertfordshire.
Darragh 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.
Greg Thay is the founder and principle human factors consultant at THAY Medical, and has over twenty years’ experience in the medical and pharmaceutical industries. He has worked in many therapy areas (orthopaedics, infusion therapy, wound-care) before finding a vocation in human factors and usability engineering nearly a decade ago. He now leads the human factors engineering team at THAY Medical to assist large and small pharmaceutical and medical organisations to develop usable, safe and effective technologies. Recently, THAY Medical CE-Marked their first wearable drug delivery device, which Greg project managed and tested, to ensure its first-rate usability and timely completion. Greg also has been involved in the human factors and usability engineering of many drug delivery technologies, and loves nothing more than to present on this subject!
Jag began his career with Profile Drug Delivery where he was developing inhalation drug delivery systems for cystic fibrosis patients.
He then went on to work for GlaxoSmithKline, following which he completed his PhD entitled “Formulated Muco-Regulatory Agents in the Airways of Patients with Cystic Fibrosis” at Portsmouth School of Pharmacy.
Jag is currently a research fellow at the University of Bath where he is investigating bioequivalence of inhaled products.
Dr. Karlheinz Seyfang
Principal Consultant Pharmaceutical Technology,
Harro Höfliger GmbH.
Karlheinz Seyfang served as head of the business unit Pharma Service for Harro Höfliger GmbH and is now Principal Consultant Pharmaceutical Technology. Before joining HH he spent 20 years in different positions in the pharmaceutical industry. His experience covers pharmaceutical development, clinical trial supplies, manufacturing and packaging of solid dosage forms. He graduated in Pharmacy from the University of Würzburg, Germany, and received his Ph.D. in pharmaceutical chemistry. At HH his focus is on powder dosing systems and sensors for dose verification.
Dr Orest Lastow is the co-founder and CEO of Iconovo AB. He is responsible for the development of Iconovo’s inhalation device platform. He is also the founder and previous CEO of Medicon Valley Inhalation Consortium, MVIC AB. Orest was with AstraZeneca for over 15 years and is the principal inventor of AstraZeneca’s new dry powder inhalation platform. Orest is the inventor behind over 50 patents and patent applications.
Orest received a M.Sc. in Engineering Physics and a Licentiate of Engineering degree in Aerosol Science from Lund University. He has also a Ph.D. in electrohydrodynamic atomisation from Brunel University. His expertise is device development, electrostatics, Computational Fluid Dynamics (CFD), aerosol science and inhalation technology.
He is the author behind a textbook on EHD atomisation, several journal publications and book contributions. He is frequently invited to speak at conferences and teaches aerosol drug delivery at Lund University. Orest is a co-author of the Aerosol drug delivery device design verification standard (ISO 20072).
Paul Royall lectures in pharmaceutics at King’s College London and is the Programme Director of the MSc Pharmaceutical Analysis and Quality Control at King’s.
Paul Royall has many years of experience in applying thermal analysis and calorimetry to the characterization of pharmaceutical materials and has published extensively in these areas (70 peer reviewed papers and abstracts). He has been on the committee of Thermal Analysis group of the Royall Society of Chemistry and is on the Editorial Board of Thermochimica Acta and the Journal of Pharmacy and Pharmacology.
Paul’s first degree was Chemistry and his Ph.D. supervised by Prof A.E. Beezer was an investigation of the thermodynamics and kinetics of transfer across model biophases in particular DPPC SUV liposomes. Both of these degrees were awarded by the University of Kent at Canterbury.
Since then Paul’s area of research has progressed towards solid state issues, namely processed induced disorder, amorphous formulation and polymorph stability. These research themes were developed during his post-doctoral positions at the School of Pharmacy University of London and The Queen’s University of Belfast.
Tom Oakley is co-founder and Director of Drug Delivery Device Development at Springboard.
His first degree was a Master of Engineering from Cambridge University, and he was later appointed the Choate Fellow in human physiology and pathology at the Harvard School of Public Health.
Since 2001, he has focused on creating safety-critical designs for mass production and is named inventor on numerous medical device patents.
From 2005 to 2013, Tom led scientific and engineering teams developing new technology in the areas of injection devices, infusion pumps, inhalers, cryogenic surgery, regenerative medicine and electronic blood lancing.
Tom has delivered lectures and workshops on innovation at the Cambridge University Engineering Department, mentored MBA research projects at the Judge Business School, and been a speaker at various international conferences on innovation and medical device development such as Pure Insight Masterclasses, MEDTEC and EphMRA.
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.
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.
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 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.