DDL Conference Chair
Dr Gary Pitcairn is currently Senior Director, Pharmaceutical Technology and Development at AstraZeneca, and is responsible for the CMC aspects of projects across both the early and late phase respiratory portfolio. Gary previously held senior positions at Mylan Pharmaceuticals and Pfizer, focusing on developing new inhaled drug products. Prior to joining Pfizer, Gary spent 15 years working at Pharmaceutical Profiles, evaluating drug delivery from a wide range of pulmonary and nasal drug delivery devices in both in vitro studies and early clinical studies.
Gary holds a BSc (Hons) in Biological Chemistry and a PhD in Pharmaceutical Sciences from the University of Nottingham and has published over 40 peer reviewed papers. Gary has been a member of the organizing committee for Drug Delivery to the Lungs (DDL) for 11 years, and has been the conference Chair for the last five years.
Imperial College London
DDL Conference Vice Chair
Dr. Omar S Usmani, MBBS PhD FHEA FRCP,
Reader in Respiratory Medicine & Consultant Physician in Respiratory & Internal Medicine,
National Heart and Lung Institute (NHLI), Imperial College London & Royal Brompton Hospital
Omar Usmani leads the Clinical Research Group within the Airway Disease Section at NHLI. His clinical research is focussed on asthma, chronic obstructive pulmonary disease (COPD) and chronic cough. His research disciplines are in inhaled drug delivery, lung imaging, small airways pathophysiology, respiratory pharmacology, and digital respiratory health.
He is Vice-Chair of Drug Delivery to the Lungs (DDL), a Board member of International Society of Aerosols in Research (ISAM), and a steering committee member of the Small Airways Working Group of the World Allergy Organization (WAO). He is also Associate Editor to the journal Respiration and on the Editorial Board of COPD: Journal of the COPD Foundation.
In 2012, Dr Usmani was awarded a UK National Institute for Health Research (NIHR) Career Development Fellowship to investigate the lung deposition of inhaled bronchodilator aerosols of different particle size within the airways of patients with COPD. This is the first time this award category was been given to Respiratory Science research in the UK.
He is currently clinical lead and co-PI at Imperial College on a highly prestigious EU Horizon 20-20 consortium project, myaircoach, focussing on the role of tele-monitoring and e-health in asthma self-management, where the proposal was ranked 4th highest of all 256 submissions to the call.
In 2015, he was awarded one of the highest accolades in aerosol science, the Thomas T Mercer Award from the American Association of Aerosol Research (AAAR) and ISAM, recognising his international research excellence in pharmaceutical aerosols and inhalable materials.
DDL Conference Organiser
Sheila joined The Aerosol Society in 2007 as the Society’s Administrator following many years with The Institute of Chartered Accountants in England & Wales.
Sheila has worked closely with the Aerosol Society and DDL Committees to develop the wide ranging Events offered to its membership and more recently has focused entirely on the DDL Conference helping to increase the audience and exhibitor participation from across the World.
DDL Conference Organiser
Nikki joined The Aerosol Society in 2014 as the Society’s Administrator managing the running of the society’s membership, awards and grants and event organisation. Since 2015 Nikki has focused solely on supporting the growing success of the DDL Conference helping to ensure it runs smoothly and effectively and that it continues to develop and encompass all aspects of the inhalation science field.
Director – Pharmaceutical Development
Nick Childerhouse, Director – Pharmaceutical Development, Vectura
After graduating from Waikato University (NZ) and moving to the UK, Nick has worked over 20 years in the inhaled pharmaceutical industry primarily within GSK and Vectura. Initially focussed on DPI product analysis, formulation and technology transfer he has had increasing involvement in nebuliser product and technology development in recent years, working on products in feasibility, early and late stage development.
Through a number of on-going university collaborations and internal development activities Nick maintains an active interest in the ever-evolving technology utilised across the inhalation development field; from novel particle engineering, formulation and processing technologies to improving understanding of related formulation-device interactions to analytical techniques including more realistic in-vitro testing techniques. Nick joined the DDL committee in early 2016.
A qualified pharmacist, after completing her PhD from University of Cardiff in 1997 on the re-formulation of MDIs in novel hydrofluoroalkanes, Michelle started her industrial career developing dry powder inhalers at Novartis Horsham Research Centre (UK). She moved to GlaxoSmithKline R&D in 1999 where she has since led the formulation development of a number of dry powder inhaler products, from Phase 2b to launch and post launch commitments. She has significant experience in both formulation and process development to QbD principles, technology transfer and regulatory interaction, and applies her technical acumen and experience in leading scientific understanding initiatives within the department. Michelle is currently leading regulatory lifecycle activities for five marketed respiratory assets
University of Algarve
Assistant Professor in Pharmaceutical Technology
Ana Grenha has received her PhD in Pharmacy-Pharmaceutical Technology from the University of Santiago de Compostela – Spain in 2007. She is Assistant Professor in Pharmaceutical Technology at the University of Algarve in Portugal since 2007 and is a Senior Researcher at both the Centre for Marine Sciences (CCMAR) and the Centre for Biomedical Research (CBMR), at the same University. She is the PI of the Drug Delivery Laboratory, which is dedicated to the design and development of particulate carriers for drug delivery, with a particular focus on inhalation. The research group is also keen on exploring the potential of natural materials, namely polysaccharides, fostering new applications that benefit from their intrinsic properties. At the moment, she is a member of the Board of Directors of the Centre for Marine Sciences (since January 2018).
Cambridge Healthcare Innovations
Chief Technology Officer
David is the Chief Technology Officer for Cambridge Healthcare Innovations, who develop novel healthcare and medical products to improve people’s quality of life. David has been working in the field of respiratory drug delivery for over 25 years, so one of the key focus areas for CHI is the improvement of inhaler devices, which are currently difficult to use and deliver inconsistent performance. He is a practicing physicist, who specialises in aerosol science, fluid dynamics and understanding lung function and its application to good inhaler design. He is a visiting lecturer at Kings College London, joined the organising committee in 2013, and enjoys working with those involved in progressing the science of delivering drugs to the lungs.
Inhalation Product Development Consultant, Chairman of Cambridge Healthcare Innovations
Phil Haywood is a consultant in inhalation and intranasal product development. He works with large pharmaceutical, device and small biotech companies assisting with CMC aspects of their pulmonary product development programmes.
Previously head of Inhalation and Device Development department at Novartis from 2002 to 2005 responsible for inhalation product development.
He also worked for 28 years at GSK in pharmaceutical and respiratory product development in increasing roles of seniority including head of Respiratory Analysis, Analytical Research 2, Clinical Supplies UK and Inhalation Product Development UK departments.
At GSK, he worked for over 15 years in inhalation product development and was a senior member in the GSK inhalation development departments during the CFC/HFA transition and the development of Servent, Flovent and Seretide/Advair in both MDI and DPI formats.
At both GSK and Novartis he was part of or led teams developing their inhalation and intranasal products and sat on senior strategy and research boards.
He has been a member of IPAC-RS and now serves on the DDL organising committee.
He obtained his PhD via CNAA through the University of Hertford and his BSc from the University of London.
Yorick Kamlag, is since 2017 Senior Director at AstraZeneca where he holds the position of Head RIA CMC Project leadership. In this role he is responsible for the CMC aspects of projects in the early phase up to phase 2b Respiratory, Inflammation and Autoimmunity portfolio.
Yorick started his career at Vectura and moved in 2007 to Siegfried Pharmaceutical Development as Head of Pharmaceutical development which was acquired in 2010 by Zentiva. In this position he was responsible for design and development of robust formulation / manufacturing / analytical processes and technologies of several inhalation products.
He has significant experience in both formulation and device development from preclinical development to late stage, to which he holds several patents. His experience includes technology transfer to commercial production, regulatory interaction, preclinical and clinical set up.
Yorick has over 15 years of experience in the Respiratory industry and enjoys driving forward the science and understanding of drug delivery to the lungs. He has previously been chairing EPAG and is a member of the DDL organising committee since 2013
Prof. Dr. Regina Scherließ (*1979) is a pharmacist and did her PhD in 2008 on “Formulation of inhalation combination products by co-precipitation”. She then started her own research group working on “Formulations for mucosal vaccination” in the Department of Pharmaceutics and Biopharmaceutics at Kiel University, Germany. During her work she performed research stays in the US, New Zealand and Australia. She received several young researcher awards including The Pat Burnell New Investigator Award 2010 and finished her “Habilitation” in 2015. Her research interests include disperse systems and nanoparticles, stabilization of biomolecules in spray drying and formulations for mucosal vaccination with a focus on respiratory (nasal and pulmonary) dry powder delivery. Since September 2017 she is professor for Pharmaceutics and Biopharmaceutics and chair of the Department of Pharmaceutics at Kiel University. As such she heads the research unit in Pharmaceutics and is responsible for all teaching in Pharmaceutics and Biopharmaceutics
3M Drug Delivery Systems Division
Alex Slowey is a pharmacist with nearly 20 years’ experience in the pharmaceutical industry. Since November 1997, he has held various roles within the R&D function at 3M Drug Delivery Systems, which have given him a broad footing in the pharmaceutical industry, particularly in relation to the research and development activities required to get new products from initial feasibility to registration.
Alex is specialised in early phase development activities related to the formulation of new and existing molecules for pulmonary and nasal delivery. He has expertise in a number of key areas, including providing technical and project leadership to development programmes.
Alex’s interests include the formulation of pMDIs using innovative approaches, and particle engineering, with direct application to the delivery of molecules via the pulmonary and nasal routes. He also has clinical expertise, particularly with respect to PK/PD studies of pMDIs
King's College London
Ben Forbes is Professor of Pharmaceutics at King’s College London. He has a BPharm from King’s College London (1987) and a PhD in Drug Delivery from Strathclyde University (1996). Before doctoral studies, he worked in hospital pharmacy in London and Sydney, and for Inveresk Clinical Research in Edinburgh. Professor Forbes was appointed to the academic staff of King’s College London in 1997. He is a registered pharmacist in the UK. He originated the term ‘Inhalation biopharmaceutics’ to describe the factors that influence the rate and extent of drug absorption from the lungs and has authored many publications in this area, including: (1) inhaled medicine formulation, (2) the development and application of techniques to study respiratory drug transport and metabolism, (3) respiratory toxicology/disease. He is founder and coordinator of the APSGB ‘Drug Delivery to the Lungs’ Network, a UK-based international academia-industry-regulatory group dedicated to pre-competitive collaboration: http://www.apsgb.org/drugsinthelungs/
Director, Scientific Affairs, Aptar Pharma, Prescription Division, France
After obtaining his Ph.D. from the University of Wales, UK in 1985, he has held various industrial positions at Monsanto Inc. (UK), Fisons Ltd (UK), Valois (France) and Inhale/Nektar Therapeutics (USA).
He is now in charge of scientific affairs for the Aptar Pharma Prescription division, Le Vaudreuil, France and is engaged in the development of new devices for nasal, inhaled and injectable drug products.
University of Parma
Dr. Francesca Buttini is currently holding an Assistant Professor position at the Department of Pharmacy and Food Science, University of Parma (IT) leading the unit dedicated to the development of product for inhalation. In 2014, she was appointed as Visiting Lecturer in the Institute of Pharmaceutical Science of King’s College London (UK) and affiliated as Key Researcher at the Research Center Pharmaceutical Engineering (Graz, AT). 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. Her main research area is the formulation and testing of dry powder inhalers. She is an expert on particle engineering using a QbD approach, dissolution test of microparticles and characterization of device-formulation combination. Up to date, Francesca has published 37 original papers, 5 book chapters and 4 patents on drugs and drug delivery systems. Finally, she is a co-founder of Plumestars, an innovative startup focused on the development of product to treat lung diseases.
Jeremy is a Senior Fellow in GSK’s Global Manufacturing Technical Function supporting technology transfer, industrialisation and filing of late stage development candidates in the respiratory portfolio, life cycle management programmes for marketed products and external advocacy in the science and regulation of orally inhaled drug products (OIPs). Jeremy is a Fellow of the Royal Pharmaceutical Society, a member of the Board of Directors of IPAC-RS and co-chairs the Inhalation Focus Group of the Academy of Pharmaceutical Sciences. A pharmacist by training, Jeremy obtained his PhD in non-aqueous colloid & interface science at the Welsh School of Pharmacy, University of Cardiff. Following his doctorate studies, Jeremy joined Ciba-Geigy (Novartis) working on OIPs, where he advanced to leadership of the formulation development group. Subsequently, Jeremy joined Vectura where, as Director of Respiratory Development, he had responsibility for both in-house and contract development programmes for OIPs. Jeremy then joined Pfizer at Sandwich as matrix/line leader with responsibility for development of new products and technologies for both OIPs and IR/MR oral solid dosage forms.
University of Otago
Dr Shyamal Das is a Senior Lecturer in Pharmaceutical Science at the University of Otago since 2013. He pursued a Research Fellowship at Monash Institute of Pharmaceutical Sciences after obtaining his PhD degree from the same Institute in 2009. He also received research training at the Imperial College of London, the University College of London and the University of Sydney. He also worked in a pharmaceutical industry after his undergraduate degree in pharmacy.
Dr Das leads the research on pulmonary drug delivery of powders in New Zealand. His particular interests are (i) Solid surface characterization for understanding powder behaviour (ii) Particle engineering approaches (eg, spray drying, dry coating, crystallization and milling) to develop efficient and stable powder formulations, (iii) Dissolution of drugs in the lung and subsequent absorption and toxicity. He has published many papers and presented in >50 conferences on fundamental understanding in these areas.
Dr Das has been successful in receiving grants and fellowships as principal applicant including the prestigious nationally competitive grant from Health Research Council of New Zealand and grants from pharmaceutical industries. He has established collaboration with several established research groups worldwide. He has examined PhD theses from Australia, New Zealand, Asia and the UK (eg, Imperial college of London) and consulted to Pharmaceutical industries.
Dr Das is also a passionate teacher. He won the OUSA 2016 Teaching Excellence Award -Top Five Teacher 2016
The University of New Mexico
Dr. McConville is an Associate Professor in the Department of Pharmaceutical Sciences at the University of New Mexico and an Adjunct Professor in the Department of Pharmaceutical Technology at the University of Bonn. He earned an Applied Chemistry degree from the University of Coventry in 1994, before working as a researcher in the field of aerosol drug delivery at the University of Bath, in the Centre for Drug Formulation Studies (CDFS). In 1999, he moved to Scotland and received his Ph.D. at the University of Strathclyde in 2002, working on chronopharmaceutical drug delivery. He then worked as a post-doctoral fellow at the University of Texas at Austin, before later being appointed to the rank of an Assistant Professor in 2006. Here his work was centered on administration of antifungals and cancer chemotherapy agents, via inhalation. Dr. McConville joined the faculty at the University of New Mexico in 2012, and his current research interests focus on using new technologies to improve patient compliance and health outcomes with inhalation, oral, and thin film delivery technologies. Dr. McConville serves as the Associate Editor of Special and Themed Editions for Drug Development and Industrial Pharmacy, on the Editorial Advisory Board of Inhalation, and the Journal of Biopharmaceutics and Therapeutic Challenges, and as a Scientific Advisor for the International Pharmaceutical Excipients Council of the Americas.
Jolyon Mitchell Inhaler Consulting Services Inc
Dr. Jolyon Mitchell, PhD, FRSC (UK), CChem. CSci, is the CEO of Jolyon Mitchell Inhaler Consulting Services Inc., specializing in the laboratory evaluation of all types of orally inhaled products (OIPs). He was formerly Scientific Director of Trudell Medical International, a company manufacturing devices for delivering inhaled medications. His interests include all aspects of laboratory testing of inhalers, including the development of methods that mimic patient use. In the role of Scientific Adviser to the International Pharmaceutical Consortium on Regulation and Science (IPAC-RS), he has helped pioneer simplified but powerful methods for determining aerodynamic size-related parameters of importance for inhaler-generated aerosols through the Abbreviated Impactor Measurement (AIM) and Efficient Data Analysis (EDA). He also has an active role in EPAG, currently participating in their CFD and Device Resistance sub-team. He played a major part in standards development for ISO 20072:2009, ISO 27427:2010, and CAN/CSA Z264.1-02:2002 (rev. 2008). He was appointed to the 2010-2015 and 2015-2020 sessions of the USP Expert Committee: General Chapters – Dosage Forms, and currently co-chairs the Aerosols subcommittee. He is an adjunct professor at the University of Western Ontario and an affiliate professor at University of Hawaii. He is on the Editorial Advisory Board for Inhalation, has published more than 400 articles and contributed to five books relating to aerosol technology and inhaler products in particular.
Independent Respiratory Medicine Expert
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 established 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, DPIs and intranasal development), through Clinical Trials Design and manufacturing… heading up the Respiratory Pilot Plant. Helen has been in Technical roles within Manufacturing for 15 years.
University of Hertfordshire
Darragh is theAssociate Dean for Enterprise in the School of Life and Medical Sciences at the University of Hertfordshire, where he also carries out his research in the Centre for Topical Drug Delivery and Toxicology (TDDT). He trained as a pharmacist initially, gaining a BSc. (Pharm.) from Trinity College Dublin and then a PhD in Pharmaceutical Technology from King’s College London.
Darragh’s research focuses on improving drug delivery products for topical administration of medicines to patients, particularly for inhaled aerosol therapies. In TDDT the research collaborations revolve around developing an understanding of how inhalable particles can be manufactured and processed such that a stable formulation and product can be developed. Through academic and industrial collaboration, he also investigates the factors affecting on-demand generation of a therapeutic aerosol by the patient. This involves assessment of the biological exposure behaviour and responses after inhalation, and the development of advanced analytical techniques to assess product performance and use by patients.
Steve Newman is a Scientific Consultant based in Norfolk, UK. He has a BA in Physics from the University of Oxford (1971), an MSc in Radiation Physics from the University of London (1974), and a PhD in the Faculty of Medicine of the University of London (1982). Steve was a Medical Physicist at the Royal Free Hospital, London, UK, from 1971 to 1982. From 1982 to 1991 he was a Principal Physicist and Honorary Senior Lecturer in the Department of Thoracic Medicine, Royal Free Hospital and School of Medicine, London, UK. From 1991 to 2004, Steve was a Director and Chief Scientist of Pharmaceutical Profiles, a company based in Nottingham, UK. Steve has published over 250 research papers, invited articles and book chapters. These publications are mostly concerned with aspects of pulmonary and nasal drug delivery. He has given numerous lectures both at international conferences and within the pharmaceutical industry. In 2009, he was principal author and editor of “Respiratory Drug Delivery: Essential Theory and Practice”, published by RDD Online and Virginia Commonwealth University. Steve is a Fellow of the Institute of Physics in the UK (F Inst P). He acts as a reviewer for many medical and pharmaceutical journals, and is a member of the editorial boards of the Journal of Aerosol Medicine and Pulmonary Drug Delivery, and Expert Opinion on Drug Delivery. In 2007 he received the Thomas T Mercer award, jointly presented by the International Society for Aerosols in Medicine and the American Association of Aerosol Research, for “excellence in pharmaceutical aerosols and inhalable materials”.
Dr. Steven Nichols is a Specialist Consultant OINDPs and their devices and has 30 years of industrial experience in inhaled and nasal product development.
Founder of European Pharmaceutical Aerosol Group (EPAG).
Expert Group Membership (Current and Past)
Member of the European Pharmacopoeia “Inhalanda” working group.
Member of the European Pharmacopoeia ‘HFA propellants’ working group
Member British Pharmacopoeia, Committee of Experts – Pharmacy.
Chair British Pharmacopoeia ‘Inhaled products’ working party (formed 2011)
Member of ISOTC 84/JWG 5 – Pulmonary delivery device group that developed standard ISO 20072 ‘Aerosol drug delivery device design verification – Requirements and test methods’. (activity completed).
Has made over 50 presentations at International Conferences and has many papers published in peer reviewed journals.
Research Center Pharmaceutical Engineering
Sarah Zellnitz is a pharmacist by training. During her PhD at the Graz Technical University (AT) she explored glass beads as new model carries in dry powder inhalers (DPIs) and gained expertise in particle engineering via surface modification and detailed material characterization. She currently holds the position of Senior Scientist at Area II “Advanced Products and Delivery” at the Research Center Pharmaceutical Engineering (RCPE) in Graz (AT), where she is leading the Inhalation group and coordinating the different activities in this field. Her research focus is on tailoring DPI formulations via mechanistic understanding of the interplay of material properties, formulation properties, adhesive-cohesive force balance and drug detachment.
Sarah has joined the conference abstract review panel for Drug Delivery to the Lungs (DDL) in 2016.