Gregor Anderson
Pharmacentric Solutions
Greg set up Pharmacentric Solutions in late 2017 offering consultancy services specialising in packaging and device strategies and solutions for the Pharma industry. He advises both small and large Life Science companies on topics such as sustainability, human factors, design for manufacture and leveraging new technologies. Prior to this he spent 30 years working at GSK with his last role there being Senior Device and Packaging Director.
His career started at Smiths Industries Medical Systems as a device designer where he focused on surgical equipment development working closely with healthcare professionals. He then joined the R&D Device Development Unit at Glaxo and worked on the conceptualisation, design and scale-up of various injectors and key inhaler device platforms and the ongoing lifecycle for these novel inhalers. In 2009 Greg moved to GSK Manufacturing as Head of Global Technical Packaging. More recently he has focused 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 wrote and published the UK Pharma roadmap for Innovation and Technology. He holds over 40 patents and has expertise in ideation and conceptualization, integration of sustainable technologies and patient centric design and has presented papers on these topics globally. Greg sits on the UK Institute of Materials Packaging Board representing Pharma. He has a B.Sc. in Industrial Design, a M.Sc. in Polymer Science & Engineering and a Postgraduate Diploma in Marketing.
Martyn Biddiscombe
Imperial Clinical Respiratory Research Unit
Martyn Biddiscombe is a medical physicist and respiratory physiologist currently working at the Imperial Clinical Respiratory Research Unit (ICRRU) in London. He obtained a BSc in Physics at the University of Exeter (1980) followed by an MSc in Medical Physics at the University of Aberdeen (1986). Martyn worked at University College Hospital between 1988 and 1993 and obtained a PhD researching the delivery of asthma medication to the lungs from various inhaler devices using gamma scintigraphy to visualise the resulting deposition patterns. He has over 35 years of clinical research experience in the field of aerosol science and pulmonary drug delivery and his research focus has covered a broad range of subjects. These include the investigation of particle size influences on the pulmonary delivery of monodisperse aerosols in asthma, COPD and Idiopathic Pulmonary Fibrosis and the investigation of the potential link between coronal ions discharged from high voltage overhead powerlines and childhood leukaemia. He has a number of publications, conference talks and a book chapter and has been a reviewer for several medical and scientific journals. He is currently a member of the editorial board of the journal of Aerosol Medicine and Pulmonary Drug Delivery and was a member of the Standardisation of Lung Imaging Methodology Committee which was commissioned by ISAM (International Society of Aerosols in Medicine) with the aim of standardising lung imaging and deposition assessment methods. He is also experienced in the field of lung physiology measurements including the more recent techniques of Impulse Oscillometry (IOS) and Multiple Breath Nitrogen Washout (MBNW).
Francesca Buttini
University of Parma
Francesca Buttini is currently holding an Associate Professor position at the Food and Drug Department, University of Parma (Italy) and where now she is leading the unit dedicated to design of drug products for inhalation. Since 2014, she was appointed as Visiting Lecturer at the Institute of Pharmaceutical Science of King’s College London (UK). Combining her background in pharmaceutical technology, regulatory aspects, and device design, she is executing research programs aimed to deliver medicinal products that take into consideration the patient, industrial and regulatory requirements.
As a result of her research achievement, she obtained in 2017 the DDL Emerging Scientist Awards from the UK Aerosol Society.
Francesca’s research is mainly focused on dry powders for inhalation also as a tool of peptides and probiotics delivery. However, she is also involved in research projects on the current transition of MDIs towards new sustainable propellants.
Up to date, she has published more than 90 original papers, and she is the inventor of 9 patents.
She is a founder of PlumeStars, an innovative small-medium company, dedicated to development of orphan drug products to treat lung and systemic disease by inhalation therapy.
Jeremy Clarke
GlaxoSmithKline
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.
Lea Ann Dailey
University of Vienna
Lea Ann Dailey is a pharmacist by training and completed her PhD at the Philipps University of Marburg, Germany, on the topic of biocompatibility testing of 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 positions at King’s College London, UK, the Martin Luther University Halle-Wittenberg, Germany, and the University of Vienna. Her research has focussed on the design of dosage forms for the delivery of anti-infectives to the lung as well as the biocompatibility assessment of novel excipients for inhaled products.
Shyamal Das
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
Craig Davies-Cutting
Nob Hill Therapeutics
Craig has over 30 years’ experience in the development, approval and commercialization of both innovator and generic pulmonary and nasal drug-device combination products.
With a PhD in Colloids and Interfaces from the University of Bristol, UK he has contributed to the research and development of new chemical entities, drug delivery technologies and drug products from the development/discovery interface through to commercial manufacturing processes and, subsequent, post-marketing support. His formative career was spent in the Glaxo organization prior to spending almost 20 years in the CDMO space with Catalent Pharma Solutions, following which he joined Nob Hill Therapeutics, a US-based start-up company, where he serves as VP of Research and Development and is focused on the progression of the company’s novel dry powder nebulizer technology and drug-device combination product portfolio. He has served as a board member for the International Pharmaceutical Aerosols Consortium on Regulation and Science (IPAC-RS) and is a member of the editorial advisory board for Inhalation Magazine
Rebecca Fransson
AstraZeneca
Dr. Rebecca Fransson is an Associate Director within Advanced Drug Delivery, Pharmaceutical Sciences at AstraZeneca in Gothenburg, Sweden. Rebecca joined AstraZeneca in 2014 and has since then been supporting drug projects with inhaled biopharmaceutics assessments. In her research she has been focusing on dissolution and delivery of inhaled drug products. She has also worked with and contributed to the development of Lung-SIM, an in silico tool for physiologically based biopharmaceutics predictions for inhaled drug delivery. Currently she is leading a team of experts in biopharmaceutics, supporting oral and inhaled projects from the pre-clinical stage up to phase 2 clinical development.
Jacob Harker
Consultant
Jacob is a consultant and formulator, with some 20 years’ experience in developing drug device combination products.
He has a passion for novel formulation technologies and developing dry powder oral and nasal inhalers.
During his career as formulation chemist and product development specialist, Jacob has worked at Pfizer, AsteraZeneca
and Circassia, before starting his own consultancy in 2018. He now works with a variety of companies to help
develop their respiratory assets.
Marie Hellfritzsch
Sandoz Development Centre
Marie is currently a scientist at Sandoz in the development of inhalation products. She is a pharmacist by training. After finishing her studies, she completed her diploma with a topic on medication of COPD patients in collaboration between the FSU Jena and University Hospital Carl Gustav Carus in Dresden. In 2021, she finished her PhD in the field of respiratory immunisation at Kiel University at the Department of Pharmaceutics and Biopharmaceutics. During her studies and PhD, Marie had the opportunity to collaborate with different people, e.g., with Ben Forbes’s group at Kings College London (thanks to the DDL Early Career Development Grant), Camilla Foged’s group at University of Copenhagen (thanks to the Nordic POP Mobility Grant) and Daniela Traini’s and Paul Young’s group at Woolcock Institute of Medical Research in Sydney. In 2019, she co-founded the DDL New Researcher Network with Snezana Radivojev and Magda Swedrowska to develop a broad community of early career scientists to help facilitate discussions surrounding research ideas/challenges, exchanges, joint projects and personal and professional development. Marie’s passions include not only science, but also the people behind science and the development of early career researchers.
Marcel Hoppentocht
PureIMS
Marcel Hoppentocht is Head of Program Management at PureIMS. In view of his broad interest and organisational capacities this role suits him well. He is an avid visitor of DDL for many years and was able to present his work here at several occasions. He studied Pharmacy at the University of Groningen and started working as a PhD student in the inhalation group of the Department of Pharmaceutical Technology and Biopharmacy of this University in 2009. This group developed air classifier technology for dry powder inhalation which finds application in the Novolizer®, Genuair® and Twincer® dry powder inhalers. Main topic of his research was dry powder inhalation of antibiotics and this ultimately led to the development and clinical validation of a new dry powder inhaler called Cyclops®. He continued as a post-doctoral researcher for two years during which he was project leader of formulation and inhaler development within the Innovative Medicines Initiative (IMI) iABC project dedicated to developing inhaled antibiotics. Thereafter, he was involved in the founding of PureIMS to further develop and valorise Cyclops® to improve the quality of life of patients
Alison Lansley
University of Brighton
Alison Lansley is a Principal Lecturer in Pharmaceutics at the University of Brighton (UoB). She obtained her degree in Pharmacy and PhD in mucociliary clearance from the UoB and then undertook post-doctoral positions at UCLA (cellular control of ciliary activity) and, subsequently, King’s College London (the use of airway cell lines as drug absorption models of the lung) where she then took up a lectureship. Following a career break, she was awarded a Daphne Jackson Fellowship which she undertook at the University of Sussex before accepting her current position at the UoB. Her research interests include the use of in vivo-reflective in vitro models to study the effect of mucus on drug/particle deposition behaviour and absorption in the respiratory tract, factors affecting mucociliary clearance and inhalation toxicity.
Andrew Martin
University of Alberta
Dr. Andrew R. Martin is a Professor in Mechanical Engineering and Biomedical Engineering, and the Director of the Aerosol Research Laboratory of Alberta, at the University of Alberta in Edmonton, Canada. His research has focused on the development and use of a combination of experimental (in vitro) and computational (in silico) techniques to predict regional drug deposition in the respiratory tract. He is regularly involved in multidisciplinary and international projects, including frequent collaboration with the pharmaceutical industry. He has also made significant contributions in the adjacent field of respiratory support, where his group has developed novel devices and patient interfaces for oxygen therapy and noninvasive ventilation. Collectively, these efforts are motivated by a goal of improving treatment, and access to treatment, for patients with respiratory diseases. Dr. Martin is a member of the Editorial Board of the Journal of Aerosol Medicine and Pulmonary Drug Delivery and Expert Opinion on Drug Delivery. He is a member of the HQP Program Advisory Committee for the Canadian NanoMedicines Innovation Network, and previously served on the ISAM Executive Board from 2015-2021. He was the recipient of the ISAM Young Investigator Award (2013) and the Drug Delivery to the Lungs Emerging Scientist Award (2022).
Jason McConville
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.
Viktoria McDonald
AlbaTox Consulting Ltd.
Viktoria McDonald is a European Registered Toxicologist with over 20 years experience in nonclinical safety evaluation. Working within contract research organisations, biotech and pharmaceutical drug development in employed roles and as an independent consultant, Viktoria has conducted and overseen hundreds of nonclinical studies and safety assessments of novel and repurposed drugs for inhalation as well as multiple interactions with regulatory agencies to support the nonclinical interactions for the approval of clinical trials. Viktoria has also worked within Phase I clinical trial management and served as an ethics committee member for independent review and approval of clinical trials in the UK.
Mary C McElroy
Charles River Laboratories
Dr. Mary C McElroy is Head of Discovery Toxicology and Pharmacology at Charles River Laboratories, Edinburgh and Chair of the Global 3Rs Advisory Group at CRL. Mary joined Charles River as an Inhalation Toxicologist and in response to client demand, established a commercially viable Lung in vivo Pharmacology. The group has expanded in recent years to include an in vitro safety assessment group including the use of lung organotypic cultures for human relevant risk assessment for inhaled chemicals. Mary has an MSc in Toxicology from University of Surrey, PhD in Human Lung Development from the University of Southampton, post-doctoral research on Lung Bell Biology at University of California San Francisco, Lecturer/Group Leader positions at the Trinity College Dublin and University of Edinburgh. Mary is a European Registered Toxicologist and holds an MBA from the Open University.
Jolyon Mitchell
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.
David Morton
Deakin University
David is Professor of Engineering (Hon) at Deakin University and works as a scientific consultant. David has carved a career in both industrial and academic roles, with experiences including:
- PhD in structural chemistry from University of Bristol.
- 1990 Senior Scientist at AEA Technology: R&D in aerosol containment and aerosol synthesis.
- 1997 Via Bath University CDFS and CDD Ltd, was a founding member of Vectura Group plc. As Head of Inhalation R&D, original contributions included PowderHale® technology, utilising formulation additives such as magnesium stearate, and inhaled glycopyrrolate.
- 2007 Emigrated to an academic role with Monash University: Established the Industrialization & Innovation Centre with GSK (Australian Best Collaboration Award winner), and co-inventor of the Monash Inhaled Oxytocin (2013 Australian Innovation of the Year Award).
- 2018 Deakin University: Director of WIL- Introduced core work integrated learning initiatives to enhance student professional skill development through bespoke industrial placements.
Through experiences, David appreciates the importance of encouraging curiosity, fresh critical thinking, versatility and translating patient-centered responses to the key unmet needs and skills in the aerosol sector. He sees DDL and its community as invaluable enablers of these and has been an enthusiastic supporter of the Aerosol Society since 1990 through multiple roles. Elected to the committee in 1992, he has contributed leadership including as General Secretary and through being the link between the Aerosol Society and the DDL committees over significant periods of evolution.
David is an author on over 40 distinct patent families yielding over 250 granted patents largely across pharmaceutical aerosol applications and has a current publication h-index of 46.
Darragh Murnane
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.
Mark Nagel
Trudell Medical International,
Mark leads Aerosol Science at Trudell Medical International, a Canadian medical device company specializing in respiratory solutions. With over 30 years of experience, he has spearheaded the development and testing of aerosol drug delivery devices, contributing to numerous regulatory submissions and over 130 publications, patents, and presentations
Sarah Neugebauer
Research Center Pharmaceutical Engineering
Sarah Neugebauer 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.
Steve Newman
Scientific Consultant
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”.
Steven Nichols
Specialist Consultant-OINDP
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.
Mark Parry
Intertek
Mark Parry has worked with Intertek for over 20 years after graduating from Cambridge University and currently works as the Senior Scientific Director supporting the wide range of analytical, formulation, product development, and research activities across the company.
Mark has worked in a range of pharmaceutical analysis and formulation development areas with a focus on inhaled and nasal drug products. Mostly working in the pre-approval stages, Mark’s background includes extensive experience with product and formulation development, as well as method development and validation, IVBE studies, and pharmaceutical development activities for a wide range of clients across the pharmaceutical industry.
Mark is a member of the EPAG cascade impactor and nasal working groups, as well as the JPAG organising committee. He routinely presents at conferences as well as contributing to articles, research papers, and posters on a range of respiratory topics.
Emily Resseguie
LabCorp
Emily Resseguie is an inhalation toxicology subject matter expert at LabCorp, where she provides scientific leadership and strategy for inhalation toxicology and is responsible for training and mentoring for nonclinical safety assessment. She earned her Ph.D. in Toxicology from the University of Rochester, after obtaining a B.Sc. in Biology from Calvin College. Her research focused on the molecular mechanisms of oxygen toxicity in lung epithelial cells. Emily joined Labcorp (formerly Envigo) as a Study Director and was responsible for the overall design, conduct, interpretation, and reporting of nonclinical studies. In her current position, she advises internal staff and clients on regulatory requirements and study designs. Emily has authored and co-author peer-reviewed articles and participates in the American College of Toxicology and Society of Toxicology.
Kyrre Thalberg
Lund University
Dr. Kyrre Thalberg is Adjunct professor in Pharmaceutical Technology at the Department of Food Technology, Engineering and Nutrition at Lund University, Sweden. He holds a M. Sc. in Chemical Engineering (1982) and a Ph. D. in Physical Chemistry (1990), from the same university.
For almost thirty years, Kyrre worked as a specialist and team leader at Astra and AstraZeneca, focusing on dry powder formulations for inhalation and inhaler devices. Since 2020, Kyrre is affiliated with Emmace Consulting AB in Lund as a senior adviser, and in 2021 he was appointed adjunct professor at Lund University. Kyrre’s research is focused on dry particles and powders for inhalation, including manufacturing aspects and the performance of DPI products. Kyrre has published more than 50 peer-reviewed papers, co-authored a couple of patents and book chapters, and has spoken at several international conferences. Kyrre is an active fellow of the Swedish Pharmaceutical Society, Apotekarsocieteten.
Jo Wallace
Charles River
I have a PhD from Queen Margaret University (Edinburgh) in oncology (in vitro). Since then I have worked for Charles River, a leading preclinical safety assessment CRO. Currently I’m Principal Research Scientist in the Discovery Pharmacology and Toxicology department, heading up the in vitro part of the team, and before this worked as a Study Director in a number of in vitro teams. I’ve held this role for 12 years, and spent that time working to develop in vitro respiratory toxicology testing strategies using commercially produced in vitro organotypic lung models such as EpiAirway™ and MucilAir™ that fit within a GLP pre-clinical safety assessment setting. This initially revolved around assay development but over the years has moved far more towards advising on study design within testing strategies, data collation to define acceptance criteria, SOP generation, collaboration with model developers to optimize products, and feeding into regulatory strategy and New Approach Methodologies. I’ve also been involved in OECD validation ring trials for other (now adopted) guideline safety assessment methods. I’m a member of a cross industry working group to develop reporting standards and eventually an OECD guideline for acute in vitro respiratory toxicity. My team has developed and optimized assays for a number of in vitro techniques for our models, including cilia beating frequency and mucociliary clearance. We are also working to optimize and deliver aerosols to our test systems.