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 difficult 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.
If you would like to contribute a presentation at the 2019 event please contact firstname.lastname@example.org
Those involved in
THIS IS THE 2018 PROGRAMME THE 2019 PROGRAMME WILL BE AVAILABLE IN DUE COURSE
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
THIS IS THE 2018 PROGRAMME THE 2019 PROGRAMME WILL BE AVAILABLE IN DUE COURSE
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
Paul 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.
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.
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.
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.
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.