Paul Johnson is an independent consultant to the pharmaceutical industry who has specialised in the CMC aspects of NCE and generic inhaled product development since 2018 serving clients in large/small pharma companies, pharmaceutical component suppliers, and pharmaceutical service providers.

Paul gained 20 years of experience leading teams and projects involved for the development of inhaled products at Glaxo Smith Kline in a range of delivery systems, including dry powder inhalers, pressurised metered dose inhalers, and nebulisers. He is most proud to have led the CMC teams from early development, through clinical stages, registration, launch and lifecycle management for Relvar/Breo Ellipta, and provided leadership for the CMC aspects for the entire GSK inhaled franchise.  

Dr. Stefan Leiner is a pharmacist by training and joined Boehringer Ingelheim in Germany in 1987. After a couple of years in manufacture, pharmaceutical and analytical development, he focussed on inhalation forms. He is responsible for the scientific standard of the module 3 of marketing authorisation applications. He authored the quality overall summaries for a lot of Boehringer Ingelheim’s inhalation developments. Stefan represents Boehringer Ingelheim in the Inter­national Pharmaceutical Aerosol Consortium – Regulation and Science (IPAC-RS) and was chair of that organisation. He was a member of the development group of the ISO 20072 Standard on ‘Aerosol Drug Delivery Devices.’ He is active in pharmacopeias.

Beatriz Martin Yague is a pharmacist by training and joined Novartis in 2014 at the facility site located in Barberà del Vallès (Spain). Her experience in­cludes over 20 years in the pharmaceutical industry, and prior of belonging to Novartis, Beatriz worked at Almirall (a Spanish-based pharmaceutical company) for more than 15 years and collaborated as a researcher with the pharmacy faculty at the University of Barcelona, where she graduated as a pharmacist with a specialty in pharmaceutical technology. Although her first working experience in the pharmaceutical industry was focussed on manufacture, pharmaceutical and analytical development of oral and topical dosage forms, after four years she focussed her career on orally-inhaled drug products. In this sense, she was responsible for the develop­ment of various NCEs at Almirall, understanding the different properties that are affecting the aerosol performance of such inhaled drug products and optimising manufacturing processes. She also participated in the setup of the micronisation unit operation for the inhalation APIs at the develop­ment centre of Almirall, where she worked applying QbD tools. During all these years, Beatriz has worked in several multidisciplinary and multilingual teams that included people from different disciplines and cultures (market­ing, chemistry, manufacturing, analytics, medical department, etc.). Her career in Novartis is currently focussed on the manufacturing, science and technology department (MS&T), improving manufacturing processes and drug product performance by the appropriate statistical tools for the inhala­tion production unit. In this sense, her responsibilities have been focussed on the setup of a new inhalation manufacturing facility in Barberà del Vallès and then transferring all Novartis inhalation portfolios.

Mark Milton-Edwards, global commercial senior director, has been employed by Teva for 10 years with responsibility for global branding and commer­cial strategy specific to respiratory and inhaled brands, including the global launch of the Spiromax®/RespiClick® dry-powder inhaler. Mark is currently responsible for product and health solutions within digital health. Mark is a native to Britain but lived and worked abroad for 11 years in Japan, Den­mark and Sweden. He held various positions throughout those countries, including VP of sales and marketing, strategic planning and business devel­opment and global brand lead. Mark first graduated in aeronautical sciences and later completed his MBA at Durham University, UK. During his career, he has led inhaler development teams through engineering definition, CMC characterisation, clinical evidence generation and ultimately to successful launch. Two of these products have been approved as either medical device (510K/CE) or NDA/sNDA products. Mark has numerous patents granted and pending in the area of electronic communications, inhaled pharmaceutical development and respiratory physiological function.

Dr. Holger Memmesheimer studied chemistry at the University of Kaiser­slautern. Following the completion of his Ph.D. in organic chemistry and some post-doctoral studies in the UK, he started his industrial career at Shell (later American Cyanamid) in 1993, working on Agrochemicals (En­vironmental Chemistry and Chemical Process Development). In 2000, he joined Boehringer Ingelheim as head of an analytical laboratory in R&D. In 2003, he was appointed as a director, with responsibility for drug product analytics and formulation development of Respimat® and metered- dose inhaler projects. In 2010, he took responsibility for all analytical functions in respect to the development of inhalative dosage forms. From 2013 to 2014, he was in charge of the respiratory drug delivery department, which includes the disciplines drug product analytics, formulation and process development, device and packaging development. Since 2015, he is re­sponsible for the quality unit chemical production (API) in operations.

Felix is a pharmacist by training with a PhD in pharmacology. In 2006, he joined Boehringer Ingelheim as a trainee, focusing on launch and transfer activities of inhalative products. He then took over different roles at BI microParts in Dortmund at the development site of inhalation devices as development QA manager, senior project manager, and lab head of device development. In 2010, he joined the Gerresheimer Group at Bünde as a QC head and later on as quality director. Buende is a large-scale manu­facturing site of sterile primary packaging components, i.e.RTF®-syringes and insulin cartridges. In 2015, he returned to Boehringer Ingelheim to implement systems for systematic lifecycle management of the Respi­mat® Platform Technology, including ownership of the design history files. Currently, he is the director of product- & process-technology including responsibilities for project management, design verification laboratories, clinical trial supply, and design & process technology of devices.

Dr. Marc Schneider is a professor in the department of pharmacy at Saarland University. He has a PhD in experimental physics from Postdam University and also conducted graduate research at the Max Planck Institute of Colloids and Interfaces. He studied physics for six years at TU Kaiserslautern, Ruprecht- Karls University Heidelberg and FU Berlin. Marc has over 20 years of experi­ence within academia and has published numerous books and book chapters.

Lea Ann Dailey is a pharmacist by training and completed her PhD at the Philipps University of Marburg (Germany) on the topic of developing poly­meric nanoparticles for the controlled release of drugs in the lung. She con­tinued working in the field of formulation science for inhalation therapies at Nektar Therapeutics (now Novartis, San Carlos, CA, USA), followed by a position as lecturer in drug delivery at King’s College London (UK), where she expanded her interests in nanotoxicology, with an emphasis on investi­gating the safety of nanomedicines for inhalation treatment. In April 2016, she joined the Institute of Pharmacy at Martin Luther University, where she continues to expand her research in the design and safety testing of novel nanomedicines and nanodiagnostics.

Gregor Anderson founded Pharmacentric Solutions Ltd in late 2017 to offer consul­tancy services for the pharma industry specialising in device and packaging strategies from early concept through to development. Prior to this, Gregor was senior device and packaging design director at GSK, based at Ware, UK. He has a bachelor’s in industrial design and a master’s in polymer science and engineering and after complet­ing a postgraduate in marketing from Heriot-Watt University in 1986, he worked for Smiths Industries Medical Systems as a device designer. In 1989, he joined the device development unit at GSK R&D. He worked on the design of various device platforms including injectors and respiratory devices. In 2009, Greg moved to GSK manufactur­ing to head up technical packaging. More recently, he has focussed on supporting the launches of the Ellipta inhaler, respiratory training devices and also researching and preparing GSK’s respiratory and packaging strategy for emerging markets. In 2016, he joined the Medicines Manufacturing Industry Partnership and the REMEDIES team. He holds over 40 patents and has presented widely on topics such as digital, patient-centric design and pharma road mapping.

Francesca Ungaro is Associate Professor in the field of Pharmaceutical Technology at the Department of Pharmacy, School of Medicine of Univer­sity of Napoli Federico II, Italy. She received her Degree in Pharmacy in 1999 and a Ph.D. in Pharmaceutical Sciences in 2003, all from the Universi­ty of Napoli Federico II. She became Assistant Professor of Pharmaceutical Technology in 2005 and Associate Professor in 2015. In 2016, she attained the National Scientific Qualification as Full Professor. Since 2003, Prof Un­garo’s research activity has been focused on the design and development of innovative drug delivery systems, with particular regard to nano- and micro-particulate systems. She actively participated to the design, writing and activities of research projects funded by local institutions, Italian Min­istry of resesarch and research foundations. In 2007, she was involved in a project funded by Italian Research Foundation for Cystic Fibrosis (FFC) and started to investigate new strategies for local treatment of severe lung diseases. Since then, she has been Principal Investigator, local coordinator and external collaborator of several FFC multicentre projects. Results are documented by 63 original research articles, 6 invited reviews, 1 Editorial and 1 Commentary in ISI-WoS peer-reviewed journals; 1 European patent; 4 book chapters; more than 100 presentations at symposia and 15 oral communications (also invited).

Jussi Haikarainen has been involved in drug delivery device development since 1997. He has been responsible for current Easyhaler device development and indus­trialisation at Orion Corporation. Jussi worked for Sanofi 2004-2006 in Frankfurt am Main as project manager for SoloStar insulin pen for development, industrialisation, and regulatory approvals phases. Since 2007, he has worked at Orion as CMC leader on budesonide/formoterol Easyhaler development and salmeterol/fluticasone Easy­haler at Orion, where his team is responsible for device, formulation, and analytical method development. He has an M.Sc. in materials science. He participated in authoring the Aerosol drug delivery device design verification standard (ISO 20072) as an expert of Finland.

Dries Cardoen received his Ph.D. from the Faculty of Biology at the University of Leuven (Belgium) in 2011. After his academic career as a post-doctoral researcher, he started at Nelson Labs (formerly Toxikon Europe) in 2013 as study director in the Extractables & Leachables Department. He is currently team responsible for the group of study directors that is specialized in E&L testing of inhalation drug products and topical and transdermal drug products.