The second generation of DPIs have become either established on the market or are a significant 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 and these bring about their own challenges of formulation and bioequivalence. Amazingly, new DPIs are still being created, with some moving in to development programmes. 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 will address many of the issues around generic inhalers, provide case studies of bioequivalence testing, focus on the difficult formulation challenges and the strategies used so that they may be overcome, and discuss in-depth patient and human factor issues when developing a DPI to gain regulatory approval.
Those involved in
Current and future challenges for DPI formulations
Novel DPI delivery platforms
Design and characterisation of breath actuation mechanisms (BAMs)
Methods for the determination of delivered-dose uniformity and aerodynamic particle size distributions of DPIs
Sampling and analysis of inhalation devices in accordance with ISO 18562
Development of a new moisture-resistant DPI which performs well irrespective of orientation
How can the physicochemical properties of DPIs and their stability impact product performance? A process and delivery perspective
Spray drying of nanopharmaceuticals into microsphere formulations
INFORM 2020: new analytical insights into dry powder formulations for inhalation
Dry powder formulations: from low dosage API delivery to biopharmaceuticals
Inhalation products, transitioning from less to more regulated markets, can it be that difficult?
Challenges with generics
Overcoming the need for comparative clinical endpoint bioequivalence studies in a 505(j) ANDA weight of evidence approach for orally inhaled products
Dr Rob Price
The 1nhaler and its two jobs
Opportunities and challenges in the design of a high-performance unit-dose DPI
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.
Paul Ballington is an experienced General Manager in the pharmaceutical industry with particular knowledge of the oncology, respiratory, medical device and drug delivery marketplaces. Formerly a director with Innovata plc, he has led commercial and R&D teams in the evaluation, creation and implementation of research, development and marketing programmes to deliver inhaled respiratory products, medical devices, nutraceuticals and pharmaceuticals to European, US and Japanese markets.
He has also been actively involved in mergers, acquisitions and sale of businesses and Intellectual Property.
Since 2008, Paul has operated as a freelance business development professional offering bespoke consultancy services and interim management with a primary focus on strategy and commercialisation aspects of product and service offerings. Through his extensive network he has helped multinational companies gain a foothold in the Japanese market and worked with Japanese companies to develop and introduce products for the European and US markets.
In 2003 David established PharmaDelivery Solutions Ltd as a specialised consultancy service in the field of drug delivery combination products (especially respiratory) 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 and generation of documentation supporting development and test programmes, together with data review and contingency evaluation.
David has over 35 years experience in the development, industrialization and approval of inhalation drug delivery systems, combination products and medical devices.
PharmaDelivery Solutions Ltd has provided input ranging from GAP analysis and comment to complete remedial implementation in areas including
• Design Control
• Risk Management
• Materials strategies
• Regulatory documentation
• Technical reviews and opinion
In addition to activities supporting commercial organizations, David 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 on ISO TC84 developing new international standards for pulmonary and nasal delivery devices syringes and catheters.
David has also 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 in emerging markets around the world.
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.
James Tibbatts is Head of Business Development a Coalesce, a Cambridge-based drug delivery device development company. He has commercial responsibility for Coalesce’s technology licensing and co-development contracts, as well as technical responsibility for some of Coalesce’s inhalation device developments.
James’ background is in Computational Fluid Dynamics (CFD) and he holds and MEng in Aeronautical Engineering from the University of Cambridge. He arrived in inhalation science as a CFD application specialist and independent consultant, having developed a technical expertise in fluid-particle interactions that occur within Dry Powder Inhalers (DPIs). Over the years, James has broadened his activities within the inhalation sector, developing considerable business development, programme management, and technical expertise including, device development, in-vitro performance optimisation,
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.
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.
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.
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.
Don Smith – Founder and Inventor, 1nhaler.
Until 2016, Don was an award winning Creative Director in the Advertising and Digital Marketing field. He left to begin a new career as an inventor, looking to bring his philosophy on innovation and invention into the fields of health, energy, environment and sustainability. His first invention, the 1nhaler is a revolutionary, single dose, dry powder inhaler.
Don also consults on innovation, invention and disruption theory, helping businesses in a number of sectors to embrace the value of innovation.
He has recently been involved with projects relating to Artificial Intelligence in life sciences, business modelling in financial services, blockchain technology in healthcare, and marine conservation in tidal energy.
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).
Dr Nikhil Sahotra is the Materials Emission Specialist at Markes International. His role focuses on the sampling and analysis of airborne chemicals, specifically volatile organic compounds, found in air as well as those emitted by products and materials. He also aids the development of standard methodology for sampling and analysis of volatile chemicals and is a voting member of ASTM. Prior to this, Dr Sahotra attended the University of Birmingham where he received his Ph.D. in Organic Electro/Photo Luminescent Materials. This was following his completion of a master’s degree in Medicinal Chemistry from Newcastle University.
Joana Pinto is a Senior Scientist at RCPE an Austrian research center for pharmaceutical process and product design that aims to support the development of pioneer novel drugs and associated production routes. She studied Pharmacy at the University of Lisbon and is presently concluding her PhD in Pharmaceutical Technology at the University of Graz. Her PhD research aimed to develop innovative particle engineering techniques for the development of novel DPI formulations, particularly focusing on the characterization of particles solid-state and physical properties and understanding their influence on product performance.
Presently, Joanna’s research interests include inhalation biopharmaceutics and the factors affecting OIPs stability.
Eunice Costa, is Group Leader Inhalation, R&D Drug Product Development, Hovione.
Eunice Costa joined the R&D Drug Product Development group at Hovione in 2011 and has been since then working on particle engineering and formulation development, particularly for Inhalation drug products. At Hovione, she has also been the scientific advisor for PhD programs in spray drying, inhaled product characterization and biopharmaceuticals. Eunice holds a PhD in Bioengineering Systems from the MIT-Portugal Program that integrated polymer chemistry, materials characterization and tissue engineering. Before pursuing her PhD, Eunice worked as a researcher in different institutions such as the Early Stage Pharmaceutical Development Group at Genentech, USA, as well as on the Human Physiology department at TNO, The Netherlands.