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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. Further, 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
9.00 Registration and refreshments
9.30 Chairman’s welcome and introduction
Dr Steve Nichols, Director, OINDP Consultancy, UK
09.40 Dry Powder Inhalers – the wrong hammer
David Harris, Leading Respiratory Drug Delivery, PA Consulting Group, UK
10.20 How to develop a generic DPI: from scratch to market
Dr Orest Lastow, CEO, ICONOVO, Sweden
10.50 Discussion followed by refreshments
11.30 Designing drugs for inhalation – achieving solutions
Steve Collingwood, Head of Chemistry, RespiVert, Ltd,The London Bioscience Innovation Centre, UK
12.10 Formulation of biologics for inhaled delivery
Mark Parry, Technical Director, Intertek Melbourn, UK
12.50 Discussion followed by Lunch
14.10 MRX001 and MRX003: how to get generic inhalers right
Phillipe Rogueda, Director and co-Founder, Merxin Ltd, France
14.50 Strategies for an Efficient Development of a Generic DPI Carrier Based Formulation
Lars Asking Vice President MVIC
15.30 Discussion followed by refreshments
16.10 Easyhaler device and performance under simulated real-life conditions
Jussi Haikarainen, Senior Development Manager, Pharmaceutical Sciences Platform, Orion Corporation – Orion Pharma, Finland
16.50 Clinical bioequivalence of OT329 SOLIS and ADVAIR DISKUS
Malinda Longphre, Director, Clinical Research, Oriel Therapeutics, a Novartis Company, USA
Discussion followed by close of day one
09.15 Review of day one
Mike Holroyd, Senior Director, Mylan, UK
09.30 Asthma UK’s 2016 Annual Survey
Cat Broadbent, Senior Insight Analyst, Asthma UK
100.10 The AOS (Axial Oscillating Sphere) add-on device as a novel tool to improve powder dispersion
Francesca Buttini, Assistant Professor, University of Parma, Italy and Visiting Professor-King’s College London, UK
10.50 Discussion followed by refreshments
11.30 Parameters influencing the performance of interactive blends for inhalation
Dr Regina Scherliess, _Department of Pharmaceutical and Biopharmaceutics,
Christian-Albrecht University, Kiel, Germany_
12.10 Particle engineering using a novel dry coating technology – opportunities for DPI formulations
Professor Afzal R Mohammed, Director, Aston Particle Technologies, UK
12.50 Discussion followed by Lunch
14.10 Is dissolution a critical attribute for inhaled products?
Professor Ben Forbes, Professor of Pharmaceutics, King’s College London
14.50 Challenges of industrialisation of a novel user friendly DPI – a DPI case study on Presspart’s new PowdAir Plus
Dr. Anselm Ebert, _Global Business Development Manager, H&T Presspart, Germany*
15.30 Case study: comparing usability of two inhalers with the same drug but different user steps
Richard Featherstone, Managing Director, Medical Device Usability, UK
16.10 Discussion and Chairman’s closing remarks
16.30 Close of forum and refreshments
Lars Asking has an MSc in Physics and has aimed his research towards measurement techniques for assessing aerosols. Lars joined AstraZeneca in 1990 and has since focused on inhaled drug delivery. His main focus has been dry powder inhalers, both development and testing. Furthermore, Lars has paid much attention to aerosol delivery to the lungs in conjunction of the influence of inhalation air flow rate. Lars has also been involved in the development of aerosol test methods including calibration of impactors and establishment of methodology to set accurate flow rates in pharmacopoeial testing. During 2005 and 2006, he was Director of CMC at LAB Pharma where he was responsible for developing a dry powder inhaler for the delivery of fentanyl to treat break-through pain in cancer patients at late stage of life. In Dec 2006, he joined Novo Nordisk to develop inhaled insulin in both a liquid preparation and a dry powder inhaler. When the Novo Nordisk inhaled insulin development program was terminated, he continued at Novo Nordisk developing various injectable products with a main focus on the device. He was part of a team that developed, validated, registered and launched products. Since May 2016, he is the Vice President of Medicon Valley Inhalation Consortium, MVIC. MVIC is a CRO for inhaled products covering all disciplines from medical chemistry and pre-clinical testing via CMC and product development to clinical phase I/II studies.
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 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.
Ben Forbes is a Reader in Pharmaceutics at King’s College London. He is currently the Head of the Pharmaceutics Teaching Section and the Drug Delivery Research Group of the Pharmaceutical Science Division. He has a B.Pharm from King’s College London (1987) and a Ph.D. in Drug Delivery from Strathclyde University (1995).
Dr Forbes performed post-doctoral work in respiratory drug delivery at King’s College London from 1995 until he was appointed to the academic staff in 1997.
He is a registered pharmacist in the UK and serves on the committee of the Academy of Pharmaceutical Sciences focus group for Inhalation and the organising committee of the Drug Delivery to the Lung conference.
The research group led by Dr Forbes has nine members of academic staff working collaboratively on different aspects of inhaled drug delivery from particle engineering through to aerosol interaction with the respiratory epithelium and in vivo pharmacology.
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).
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.
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 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.
Philippe Rogueda is an experienced pharma executive with a track record of driving business growth within the drug delivery technology sector. He has driven product developments from initial concept through to clinical studies and registration on oral inhaled and nasal technologies.
He is currently the founder and principal consultant at Aedestra Ltd (www.aedestra.com), an inhalation product development consultancy. He is also a director and shareholder of Merxin Ltd a newly founded generic inhalation device supplier. Four years ago he founded Inhalation Asia (www.inhalationasia.org), the leading open access network in inhalation drug delivery in Asia, of which he remains the CEO. He was appointed a fellow and member of the Woolcock institute of medical research in Sydney in 2015. He is a well published scientist, and is regularly invited at world leading conferences on inhaled drug delivery such as Drug Delivery to the Lungs Respiratory Drug Delivery, Chiesi 3i seminars, and Management forum.
He established the Actavis respiratory team in London which led the filing of a number of generic products: Nasal DPI and pMDI formulations. As Executive Director for the emerging technology group he delivered ANDA filings to exploit first-to-file opportunities and accelerated project plans by 1/3 to realise productivity savings of 35%. At Novartis and AstraZeneca, he initiated systematic approaches to analyse inhaled products, and optimised lab processes for inhalation development. He was instrumental in evaluating a number of device technologies, including the Optinose nasal device and other dry powder nasal delivery systems.
Philippe graduated in Chemistry and Physics from the Ecole de Chimie et de Physique of Bordeaux University. He subsequently joined the school of Chemistry of Bristol University to study for the MSc in Colloid Science and Surface Chemistry. He completed his PhD in Physical Chemistry at the University of Bristol researching the coating of photographic films for Kodak.
Mark Parry, Technical Director, Inhertek Melbourn has worked with Intertek Melbourn for over 13 years after graduating from Cambridge University. He has worked in a range of pharmaceutical analysis and formulation development areas with a particular focus on inhaled and nasal drug products.
Mostly working in the pre-approval stages, his background includes extensive experience with product and formulation development, as well as method development and validation, stability studies, and pharmaceutical development activities for a wide range of clients across the pharmaceutical industry.
He currently oversees the formulation and product development group, as well as acting as a general technical manager across the company. He also serves as a Production Manager, overseeing the manufacturing of clinical trials with a focus on early stage POC studies.
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..
Jussi Haikarainen, M.Sc. (Tech.)is Senior Development Manager, Pharmaceutical Sciences Platform, Orion Corporation – Orion Pharma, Finland.
Jussi Haikarainen has been involved in drug delivery device development since 1997. He has been responsible of many parts of current Easyhaler device development and industrialization at Orion Corporation. Jussi has also worked for Sanofi 2004-2006 in Frankfurt am Main as project manager for SoloStar insulin pen for development, industrialization and regulatory approvals phases. Solostar is globally one of the most sold drug delivery devices used e.g. for Lantus (insulin glargine) administration. Since 2007 he has been back at Orion as CMC leader on budesonide/formoterol Easyhaler development and also later salmeterol/fluticasone Easyhaler at Orion having his team responsible of device, formulation and analytical method development. His educational background is M.Sc. in materials science. He has participated in authoring the Aerosol drug delivery device design verification standard (ISO 20072) as expert of Finland.
Steve Collingwood is a medicinal chemist who has worked in the area of Respiratory Disease research for the last 20 years. He has led several inhalation drug discovery teams at Novartis where he was most recently Director of Respiratory Chemistry. Since 2015 he has led the chemistry efforts for the inhalation respiratory specialist Respivert, which is part of Janssen Pharmaceuticals.
Malinda Longphre, PhD, is the Director of Clinical Research for Oriel Therapeutics, a Novartis company. She has been with Oriel for 8 years and has 20 years of research and development experience in industry with a focus on inhaled drug products. Previous companies include Bristol-Myers Squibb, Bayer Biotechnology and Aerovance where she worked on the early development and clinical programs for a number of small molecule and biologic products for respiratory diseases.
Cat Broadbent is the Senior Insight Analyst at Asthma UK. With experience in insight and analysis in the third and public sectors, Cat ensures that people with asthma are at the centre of Asthma UK’s work, leading on the development of key insight projects gathering the views of people with asthma to inform what Asthma UK seeks to change.
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