Aerosol School 2018 will be held Oct 3-5, 2018

Faculty Bios

Myrna Dolovich is Professor of Medicine (Part-time) in the Faculty of Health Sciences, McMaster University, Hamilton, Ontario and associated with the Firestone Institute of Respiratory Health. She is an Electrical Engineer (McGill University, 1963) and worked initially in research in the Cardio-Respiratory Department at the Royal Victoria Hospital in Montreal, joining McMaster University in 1968. Her research at McMaster involves inhaler characterization and performance, investigations into the behaviour of therapeutic aerosols in patients with asthma and COPD with special interest in the measurement of drug delivery to the lung using 2D Planar and 3D PET imaging. Current work involves investigations of the delivery of vaccine aerosols as well as the function of ciliated epithelial cells in COPD. She was involved in the design and characterization of the Aerochamber™, a holding chamber spacer device for pressurized inhalers used worldwide by patients with respiratory disease. She has published 140 book chapters and peer-reviewed papers in the medical literature and has spoken extensively on pulmonary drug delivery systems and imaging. She currently serves as Chair of the Canadian Standards Association (CSA) Technical Sub-Committee, the group that prepared the national standard for spacers (CAN/CSA Z264.1-02:2002) and other drug delivery devices. She is also Head of the Canadian Delegation to the Canadian Advisory Council for the ISO Technical Committee 84 that developed the standards for aerosol drug delivery devices (ISO 27427, ISO 20072). She is a member of the Health Canada Scientific Advisory Committee for Respiratory and Allergy Therapies (SAC-RAT) and has served on the Board of Directors of the International Society for Aerosols in Medicine (ISAM). Currently, she is a member of the Editorial Boards of the Journal of Aerosols in Medicine Pulmonary Drug Delivery and Pediatric Allergy, Asthma and Immunology. In 2006, she was awarded the AAAR/ISAM Thomas T Mercer Prize and in 2009, the ISAM Career Achievement Award. An ISAM Student Travel Award has been established in her name. She has organized and co-chaired 4 international meetings on drug delivery devices under the DIA umbrella and also for the AARC. In 2009, she arranged a 2-day teaching program for practical laboratory experience in aerosol basics, aerosol measurements and techniques, including applications to research and pharmaceutical laboratory and clinical settings. With contributions from the Aerosol School faculty, the program has been expanded and will be held for the 9th year in 2017.

mdolovic@mcmaster.ca

Currently Chief Science Officer for Aerogen Pharma Corporation and Sr. Fellow Clinical Aerosol Product Development for Dance Biopharm Inc., Brisbane, CA., For the past 8 years Jim was an Independent Consultant serving the biotech industry, and Chief Clinical Officer for Aerogen Ltd, Galway, Ireland, Dr. Fink is an Adjunct Professor for the Respiratory Therapy Program at GA State University in Atlanta, Rush Medical School in Chicago, and Visiting Professor, Department of Physical therapy, Universidade Federal de Pernambuco, Recife, Brazil. He has a PhD in Pharmaceutical Innovation from Bradford University, UK. Previously Dr. Fink was Fellow of Respiratory Science at Nektar Therapeutics and Aerogen Ltd. developing novel aerosol delivery systems for critically ill adults and infants with more than 20 issued patents.

A respiratory therapist for 40+ years, Jim was Technical Director of Respiratory Care at University of California, San Francisco for 14 years. At Hines VA Hospital and Loyola Stritch School of Medicine, Chicago he developed an aerosol research lab emphasizing aerosol delivery to critically ill patients.

A strong patient care advocate, he served as Chair for the Chicago Asthma Consortium. Jim has authored several textbooks, multiple chapters, reviews and original research concerning use of medical aerosols.

He is a member of the International Society of Aerosols in Medicine, Society of Critical Care Medicine, European Respiratory Society, American Thoracic Society and a Fellow of the American Association for Respiratory Care and the American College of Chest Physicians. Dr. Fink serves on the editorial board for the Journal of Aerosol Medicine and Pulmonary Drug Delivery and Inhalation. Since 2003, Jim has worked with the inhaled measles vaccine initiative of the WHO, and is actively involved in developing liquid aerosol delivery systems for mass campaigns in the third world.

Adrian Goodey is a Principal Scientist in the Biopharmaceutics & Specialty Dosage Forms department of Merck Research Laboratories. In this role, Dr. Goodey has led analytical activities for a number of both early and late stage inhalation, nasal and long-acting parenteral product development teams. Prior to joining Schering-Plough in 2007, Dr. Goodey earned a B.Sc. in chemistry from Emory University, completed a Ph.D. in chemistry at the University of Texas at Austin, and then served as an American Chemical Society/ Petroleum Research Fund Alternative Energy Postdoctoral Fellow at the Pennsylvania State University. Dr. Goodey currently chairs the IPAC-RS Cascade Impaction working group. His research interests include the analysis of cascade impaction data, automation of inhaler testing and clinically relevant testing. To date, he has authored eighteen peer reviewed scientific articles and holds two patents.

Adrian.goodey@merck.com

My primary research training is as a physiologist. My MSc training was in the field of exercise physiology, investigating the factors limiting oxygen uptake during exercise. Following this, I switched to the study of ventilator mechanics for my doctoral studies. My interest at that time was the contribution to ventilation during exercise from the expiratory muscles. After my medical training, I switched my focus to the study of asthma. While I have been involved in several distinct research directions within the study of asthma, my prime interest has always been to better understand the mechanisms of airway hyperresponsiveness in asthmatic patients.

My research activities have included patient based clinical research. This has included looking at the impact of several pharmacological interventions on airway responsiveness, as well as using controlled allergen exposures to alter the degree of airway responsiveness in asthmatic patients. In addition to this, I have developed several mouse models of exposure to allergen. The focus of the animal model work has also been to understand that factors that result in airway hyperresponsiveness in allergen exposed mice. Currently, as well as ongoing interest in the basic mechanisms of airway hyperresponsiveness, I am interested in improved patient education as a means for improving control in asthma.

A major use of my time recently has been the development and running of a course on Research Methodology in Health Sciences. This course is aimed at beginning level graduate students, with the goal of providing greater insight into the processes of designing and running a research study.

During my research training, I held research awards from the National Science and Engineering Research Council as well as from the Canadian Respiratory Society and Medical Research Council of Canada. Since joining the faculty of Health Science at McMaster, I have held the positions of Assistant Professor, Associate Professor and now Professor. I have received funding for my research from the Canadian Thoracic Society, The Medical Research Council, the Canadian Institute of Health Research and from the US based National Institute of Health. I have published over 130 peer reviewed manuscripts relating to my research.

Dr. Heidi M. Mansour is a faculty member in the College of Pharmacy, College of Medicine, and the BIO5 Research Institute at The University of Arizona (UA) in Tucson, Arizona (USA) with faculty member affiliations in the UA Institute of the Environment, and the UA NCI Comprehensive Cancer Center.

She is an elected Fellow of the Royal Society of Medicine, Co-Chair of the Drug Delivery: New Devices & Emerging Therapies Group in the International Society of Aerosols in Medicine (ISAM), and has been an expert member of NIH NICHD U.S. Pediatric Formulations Initiative New Drug Delivery Systems Aerosols Working Group for several years. She regularly serves as an expert reviewer for scientific journals and grant funding agencies including NIH study sections, NSF study panels, AAAS, Catalent Drug Delivery Institute and international funding agencies such as the German-Israeli Foundation, German International Exchange Service (DAAD), Cochrane Airways Group of the National Health Service (London, England), Engineering and Physical Sciences Research Council (London, England), PRESTIGE Postdoc Fellowship Programme of the European Commission (Paris, France), and the Biomedical Innovation Program of the French National Research Agency (Paris, France). In addition to presenting two webinars on therapeutic inhalation aerosols for precision pulmonary medicine, she has published over 80 peer-reviewed scientific journal papers, 9 book chapters, over 100 scientific conference abstracts, and is co-editor of a nanomedicine book published in 2013 by CRC Press/Taylor & Francis.

Her research program has enjoyed funding from federal sources and the pharmaceutical industry. In addition to lecturing in the Graduate Ph.D. and Pharm.D. programs, Dr. Mansour leads her research lab where she trains postdoctoral scholars, visiting scholars, visiting professors, graduate students, Pharm.D. student researchers, and physician-scientist (MD/PhD) fellows. Her research program has produced a number of Assistant Professors employed at research universities in the United States and in the Republic of S. Korea and Senior Research Scientists employed at major pharmaceutical companies in the United States. Dr. Mansour is an active, long-time member of numerous scientific organizations and elected member to honor societies, including the Sigma Xi Scientific Research Honor Society, Rho Chi Pharmaceutical Honor Society, and Golden Key International Honor Society. She serves on the editorial advisory boards for several journals. She has a BS in pharmacy with honors and distinction, a PhD minor in advanced physical and interfacial chemistry (Department of Chemistry), and a PhD major in drug delivery/pharmaceutics (School of Pharmacy) from the University of Wisconsin-Madison. She completed postdoctoral fellowships at the U.W.-Madison and at the University of North Carolina-Chapel Hill receiving the UNC-Chapel Hill Postdoctoral Award for Research Excellence from the Office of the Vice-Chancellor, the AAPS Postdoctoral Fellow Award in Research Excellence, and the PhRMA Foundation Postdoctoral Fellowship award. As an Instructor, she served on the Graduate Faculty at UNC-Chapel Hill.

Dr Lei Mao is Scientific Manager, Pulmonary and Nasal Development of Catalent Pharma Solutions at the Research Triangle Park (RTP) facility where he oversees technical elements of the product development within the inhalation department.

Prior to the current assignment, Lei headed inhalation product development at Catalent from early 2008, the time at which he joined the company. Lei led an Inhalation development team at Vectura plc, UK where he held positions of increasing responsibility between 1998 and 2007. Prior to that he was employed as a Section Leader at IVAX, UK between 1996 and 1998 and earlier held a number of senior positions at IVAX’s joint venture in China.

Lei has twenty year’s experience in the inhalation industry, with substantial expertise and knowledge in dry powder inhaler, metered dose inhaler, nebulizer and nasal product development. He is a named inventor on fourteen patents granted worldwide, has authored one book, contributed to one book chapter and thirty publications in the peer reviewed journals and conference proceedings.

Lei received his PhD in Pharmaceutical Sciences from Shenyang Pharmaceutical University and BSc Pharm from China Pharmaceutical University, China.

Jolyon Mitchell operates his own private consultancy business, Jolyon Mitchell Inhaler Consulting Services Inc., from London Ontario Canada. He has been an adjunct professor at the University of Western Ontario since 2006. He is also an affiliate professor at the Daniel K. Inouye College of Pharmacy of the University of Hawai’i (Hilo Campus), where he taught an elective postgraduate course on medical aerosol physics in early 2015.

Until October 2013, he was Scientific Director of Trudell Medical International, with responsibility for all aspects of in vitro aerosol testing. He is involved in several industry-wide organizations involved with inhaled medical aerosol delivery, in particular the European Pharmaceutical Aerosol Group (EPAG) as well as serving as Scientific Adviser to the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). He played a major part in the development of a Canadian Standard for Spacers and Holding Chambers (CAN/CSA Z264.1-02:2002, revised 2008). He is currently a Canadian delegate to ISO/TC121/SC2, having been involved with the development of a standard (ISO 27427) specifically for nebulizers. He also helped develop ISO 20072:2009, a standard for the design and evaluation of the other forms of orally inhaled product.

He is Chair of the Aerosols sub-committee of the General Chapters Committee at the United States Pharmacopeia (2015-2020 session), He is currently completing the development of an informational chapter <1602> covering spacers and valved holding chambers. He is also involved with the development of a potential new chapter covering Good Cascade Impactor Practices for the USP.

He is a Fellow of the UK Royal Society of Chemistry, a Chartered Scientist, a founder member of the UK-Irish Aerosol Society and a member of the Gesellschaft für Aerosolforschung, American Association of Pharmaceutical Scientists (Inhalation Technology Focus Group) and the American Association for Respiratory Care (AARC).

His technical interests are primarily in particle sizing methods, experiment design and data interpretation, as well as inhaler performance characterization in the laboratory using methods that provide clinically meaningful data. He has published more than 450 articles in the open literature, of which about 140 are in peer-reviewed journals and 14 are invited review articles. He is co-editor of a book on Good Cascade Impactor Practice, the Abbreviated Impactor Measurement (AIM) and Effective Data Analysis (EDA) concepts. He has contributed to six books on aerosol science and medical inhalers. He also has an interest in human factors-related aspects of inhaler design, in particular for their use by elderly patients.

mitchelljolyon@gmail.com
Tel: +1-519-472-5364;   Mobile : +1-519-619-4560

Dr Helen Neighbour graduated from University College London Medical School in 1997. She undertook specialist training in Respiratory and General Internal Medicine in London. She completed a PhD in respiratory immunopharmacology and allergic airway diseases at The Royal Brompton Hospital and Imperial College London. Since June 2009 she has been working in the Department of Medicine at McMaster University undertaking both clinical and research work. Her specialist interest within Respiratory Medicine is asthma and the measurement of airway inflammation, with particular interest in the relationship between nasal disease and asthma and the treatment of allergic disease.

Dr. Roberts has a broad background in the generation and measurement of particles including in the fields of air pollution control, clean room contamination control, pharmaceutical inhaler testing equipment, and biological cell analysis. He is trained in Chemical Engineering and did his thesis work at Cal Tech (Pasadena, CA) with Dr. Sheldon Friedlander, one of the fathers of modern aerosol science. He is co-inventor of the Next Generation Impactor (NGI), the only cascade impactor designed purposely for the testing of metered-dose, dry-powder, and similar inhalable drug products. He has developed practical methods to allow impactor users to determine whether their impactors are suitably within compendial specifications, including the concept of “effective diameter” calculated from optical measurements of impactor nozzles and including the relationship of pressure drop to particle capture efficiency. He has helped develop a series of labor-saving equipment that assists users to recover the drug product from impactors in a manner suitable for quantitative analysis. In his 19 years at MSP Corporation, he grew the inhaler testing equipment and services business into approximately 50% of MSP’s annual revenues and was responsible for strategic marketing of all of MSP’s products. He is now an independent consultant, assisting customers with their most difficult particle sizing measurements and implementing methods of increasing the speed, precision, and accuracy of inhaler testing.

Dr. Roberts is a guest member of the Impactor Sub-group of the European Pharmaceutical Aerosol Group, a member of the American Association of Pharmaceutical Scientists, a contributor to the USP Aerosol Experts committee, on the editorial board of Inhalation (CSC Publishing Inc.), and a regular contributor and reviewer of articles in the Journal of Aerosol Medicine and Aerosol Science and Technology.

Representative publications

Roberts, D. L., J. P. Mitchell, “Further Investigation of the Maldistribution of Aerosol Deposits on the Upper Stages of the Andersen 8-Stage Non-Viable Cascade Impactor (ACI): Evidence for Pre-Classification of Incoming Aerosol,” Drug Delivery to the Lung, Aerosol Society, Edinburgh, Scotland, December 7-9, 2016.

Roberts, D. L., J. P. Mitchell, “Spatial Aerosol Flow Maldistribution: A Design Flaw Confounding the Proper Calibration and Data Interpretation of Stages ‘0’ and ‘1’ of the Andersen Eight-Stage Nonviable Cascade Impactor,” Aerosol Sci. Tech., 50, 1-12 (2016).

Roberts, D. L., J. P. Mitchell, “The Next Generation Impactor (NGI™) – Manufacturing Control: Part II. Collection Cups and the Critical Jet-to-Plate Distance,” Inhalation, August 2016, pages 9-15.

Roberts, D. L., J. P. Mitchell, “The Next Generation Impactor (NGI™) – Manufacturing Control: Part I. Nozzles,” Inhalation, April 2016, pages 12-19.

Roberts, D. L., C. A. Lavarreda, “Necessity and Simplicity of a Roundness Specification for Impactor Nozzles,” Respiratory Drug Delivery Asia, RDD Online, LLC; Goa, India, November 12-14, 2014.

Mohammed, H., D. L. Roberts, M. Copley, M. Hammond, S. C. Nichols, J. P. Mitchell, "Effect of Sampling Volume on Dry Powder Inhaler (DPI)-Emitted Aerosol Aerodynamic Particle Size Distributions (APSDs) Measured by the Next Generation Pharmaceutical Impactor (NGI) and the Andersen Eight-Stage Cascade Impactor (ACI)," AAPS Pharm. Sci. Tech., DOI: 10.1208/s12249-012-9797-0, on-line publication, June 2012.

Roberts, D. L., J. P. Mitchell, “Influence of Stage Efficiency Curves on Full-Resolution Impactor Data Interpretation,” Drug Delivery to the Lung, The Aerosol Society, Edinburgh, Scotland, December 7-9, 2011, pp. 181-4.

Roberts, D. L., “Theory of Multi-Nozzle Impactor Stages and the Interpretation of Stage Mensuration Data,” Aerosol Sci. Tech., 43, 1119-29 (2009).

Roberts, D. L., C. Lavarreda, “Controlling Flow Resistance as a Means of Reducing Inter-Impactor Variability,” Respiratory Drug Delivery 2008, Scottsdale, AZ, May 11-15, 2008; pages 661-4.

Roberts, D. L., C. Lavarreda, K. Milhomme, C. Shelton, “Managing Impactor Quality with Measurements of Flow Resistance and Effective Diameter,” Drug Delivery to the Lung 17, Edinburgh, Scotland, November 30 – December 1, 2006.

Roberts, D. L., F. J. Romay, “Relationship of Stage Mensuration Data to the Performance of New and Used Cascade Impactors,” J. Aerosol Med., 18 (4), 396-413 (2005).

Marple, V. A., B. A. Olson, K. Santhanakrishnan, D. L. Roberts, J. P. Mitchell, B. L. Hudson-Curtis, “Next Generation Pharmaceutical Impactor: A New Impactor for Pharmaceutical Inhaler Testing. Part III. Extension of Archival Calibration to 15 L/min,” J. Aerosol Med., 17, 335-43 (2004).

Marple, V. A., D. L. Roberts, F. J. Romay, N. C. Miller, K. G. Truman, M. Van Oort, B. Olsson, M. J. Holroyd, J. P. Mitchell, D. Hochrainer, “Next Generation Pharmaceutical Impactor -- Part I: Design,” J. Aerosol Med., 16, 283-99 (2003).

Marple, V. A., D. L. Roberts, B. Y. H. Liu, “Efficient High-Productivity Cascade Impactors,” US Patent 6,453,758, September 24, 2002.

droberts@particleprinciples.com
www.particleprinciples.com

Dr. Stapleton is currently an executive with Qrum Pharmaceuticals where he leads the CMC and aerosol development operations. Dr. Stapleton started his career in sales and marketing at Hewlett-Packard (Canada) Ltd. Dr. Stapleton received his Ph.D. from the University of Alberta where he created a Lagrangian dynamical model for predicting the deposition of hygroscopic aerosols in the human respiratory tract, working under the tutelage of Dr. Warren Finlay. In 1996, Dr. Stapleton worked at the Aerosol Research Institute at PARI GmbH where he led the Advanced Platform Development Group which created novel liquid aerosol nebulization systems and a valved holding chamber. In 1998, Dr. Stapleton moved to Advanced Inhalation Research (purchased by Alkermes Inc. in 1999) where he led a group that developed a family of inhalers for delivering the AIR Porous Particles. In 2003, Dr. Stapleton took the position of Director, Inhalation Technology at Corus Pharma Inc. (purchased by Gilead Sciences) where he was responsible for the development of respiratory drug products. Dr. Stapleton was involved in the development of Cayston (aztreonam inhalation solution), from the early formulation development through product approval, launch, and was involved in reimbursement discussions. In 2011, Dr. Stapleton moved to MAP Pharmaceuticals, where he worked on a novel inhaled treatment for migraine. In 2013, MAP was acquired by Allergan Pharmaceuticals, where he continued as CMC team leader for the inhaled migraine program, and was a team member of numerous complex combination projects. Dr. Stapleton joined Qrum Pharmaceuticals in late 2017, and consults with a number of other companies on formulation, device, and aerosol delivery projects.