Presentations of the Speakers at the 8th MVIS, Medicon Valley Inhalation Symposium, 2019

Future Opportunities of Inhalation

Per Bäckman

Per Bäckman, PhD

Dr Per Bäckman assists clients with the discovery and development of inhaled medicines. This includes for example: establishing in vitro-in vivo correlations in support of specifications and product design targets and IVIVC model-based batch selection for BE studies. His contribution is based on more than 20 years of industry experience encompassing discovery and development of large and small molecule inhaled medicines.

During the last 8 years, Dr Per Bäckman has focused on the application and development of computer-based models to link in vitro critical drug product attributes and clinical performance.

Dr Per Bäckman is the author of 25+ original research papers and a frequently invited lecturer at international conferences.

Johan Peter Bøtker

Johan Peter Bøtker, PhD

Dr Johan Peter Bøtker is an assistant professor at the University of Copenhagen and has worked with in fields such as  image analysis and computer vision approaches for pharmaceutical systems. Solid state analysis (thermal analysis, Raman spectroscopy, synchrotron SAXS and WAXS diffraction, powder X-ray diffraction) with Matlab® programming and multivariate methods for extraction of the chemical relevant data for subsequent analytical purposes. Custom produced setups by 3D printing. Acoustic treatment of data and inhaled drug delivery. Finite element method (FEM) simulation of dissolution setups specifically intended for obtaining a better understanding of such systems.

Göran Conradson

Göran Conradson is a chemical engineer from the Royal Institute of Technology, Stockholm. He founded Ziccum AB in 2017 together with Dr Per Gerde, CSO Inhalation Sciences AB, who is the inventor of Ziccum’s core technology, the LaminarPace air drying technology.

Göran Conradson’s experience is focusing on commercializing key cutting technologies for LifeScience research and manufacturing of protein and biology-based pharmaceuticals. Göran Conradson is focusing on the dry formulation of vaccines to generate temperature stable products that can be transported all over the world outside the cold temperature chain into remote areas of the world. LaminarPace is also particularly suitable to generate micronized powder for inhalation, potentially opening up new routes of administration of vaccines and other biologics.

Göran Conradson is a member of SwedenBIO’s working group for Business Development and Financing.

Andrew Cooper

Andrew Cooper, PhD

Dr Andrew Cooper obtained his PhD in Pharmaceutical Analysis from the University of Bath. After several years working in the public service in the field of veterinary drug residue control, he now has more than 20 years pharmaceutical R&D experience with Pfizer and now with Mylan Global Respiratory Group in Sandwich, UK.

Dr Andrew Cooper’s main focus throughout has been the analytics associated with complex dosage forms, with the last 10 years devoted to development of orally inhaled products.  In a distinctly non-professional capacity, Andrew is locally well-known for production of chillies and associated products.

Johanna Eriksson

Johanna Eriksson

Johanna Eriksson got her master degree and licensure as pharmacist in 2015 from Uppsala University. Her master degree project was within the field of intestinal drug absorption. She then started her doctoral studies with the group of biopharmaceutics, at the department of Pharmacy, Uppsala University in collaboration with AstraZeneca. The working title of her project is “Fundamental parameters governing the absorption of inhaled drugs – opportunities for optimizing pulmonary drug development”. Within the project Johanna Eriksson has mainly worked with an ex vivo lung model – the isolated perfused rat lung model, in combination with physiologically based biopharmaceutical modelling.

Pär Ewing

Pär Ewing, PhD

Dr Pär Ewing has earned a PhD from Karolinska Institutet 2008, has published more than 10 peer-reviewed articles within the field of inhaled pharmaceuticals.

Dr Pär Ewing currently holds a position as Senior Research Scientist role at AstraZeneca, mainly focusing on the interface between preclinical and clinical development of inhaled medicines.

Erika Fredriksson

Erika Fredriksson is a pharmacist graduated from Uppsala University. Since 2010 she works as a Pharmacokinetic assessor at the Medical Products Agency, Sweden, mainly focusing on assessment of bioequivalence for generic products, hybrids, line extensions, fixed dose combinations etc.

Erika Fredriksson has a special focus on pharmacokinetic studies with orally inhaled products and is a member of the MPA internal expert group for inhaled products as well as a member of the EMA Respiratory Drafting Group, working on the revision of the OIP guideline.

Since April 2019 Erika Fredriksson is also an additional assessor of the EMA Pharmacokinetic Working Party.

Parmesh Gajjar

Parmesh Gajjar, Phd

Dr Parmesh Gajjar is a researcher in the Henry Moseley X-ray Imaging Facility, within the Department of Materials at the University of Manchester. He has a Master of Mathematics (2010) from Sidney Sussex College at the University of Cambridge and a Ph.D. in Applied Mathematics (2016) from the University of Manchester.

Dr Parmesh Gajjar’s current research involves developing three dimensional powder characterization techniques for inhaled formulations using X-ray computed tomography, and builds on his Ph.D. experience of modelling granular materials. The current work is part of the INFORM 2020 Consortium of five UK universities and several industrial partners that is looking to improve inhaled therapies by examining molecules up to manufacturing processes.

Dr Parmesh Gajjar also has skills in developing new applications for X-ray computed tomography, and has an expertise in programming X-ray systems to perform custom tasks. He takes a keen interest in teaching and developing soft skills, and alongside academic interests, he enjoys cricket and philosophy.

Igor Gonda

Igor Gonda

Igor Gonda is the founder of Respidex LLC. His current research interests include use of large health-related data bases (“cloud medicine”) to develop better products cheaper and faster; diagnostic methods to detect early signs of evolution of severe respiratory diseases; and management of the respiratory microbiome.

Igor Gonda was previously in various executive roles (Chief Scientific Officer, CEO and President) at Aradigm Corporation – a US  company developing inhalation therapies for the prevention and treatment of serious respiratory and systemic diseases, with a focus on products that would optimally meet the needs of patients to help them manage their health.

Igor Gonda previously conducted health-related aerosol research and product development at Genentech Inc. (USA) and at universities in the UK, USA and Australia.  He was also the CEO and Managing Director of the transdermal company Acrux Ltd in Australia.

He has over 120 US patents and patent applications, and many equivalents in other territories.  He published over a hundred papers and is on the editorial board of the Journal of Pharmaceutical Sciences. Igor is a Board member of The Alpha-1 Project – the venture philanthropy arm of the not-for-profit Alpha-1 Foundation searching for cures for the alpha-1 antitrypsin deficiency that leads to emphysema. He is also active in the California Life Sciences Institute to mentor start-up companies on corporate development. He received the British Pharmaceutical Society Astra-Zeneca Industrial Achievement Award and the Thomas T. Mercer Joint Prize of the International Society for Aerosols in Medicine and the American Association for Aerosol Research, for Excellence in Pharmaceutical Aerosols and Inhalable Materials.

Johanna Husman Piirainen

Johanna Husman-Piirainen, M.Sc

Johanna Husman-Piirainen graduated in Chemical Engineering in 1995 from Helsinki University of Technology.

In 2001 Johanna Husman-Piirainen started as a research scientist at Orion Corporation, in Inhalation process development group. In 2004 she was appointed as a research scientist into the Laboratory of Physical Analytics and in 2012 as Senior Research Scientist.

Johanna Husman-Piirainen has been responsible for the physical analytics of Orion’s inhalation raw materials and products since 2008. Her research interests include material sciences, especially the critical physical properties of inhalation raw materials, powder technology and preformulation.

Kevin D Kee

Kevin D. Kee

Kevin D. Kee is Executive Director of Analytical Development and Quality Control at Acorda Therapeutics. Since 2001, he has held key roles in product development, strategic planning and oversight of drug product candidates with particular focus on DPI’s.

Accomplishments include transforming a start-up analytical laboratory into an FDA approved commercial QC release and stability laboratory; planning and executing product development activities spanning the entire clinical developmental cycle (IND to NDA), worked closely with clinical groups to design and execute in-vitro drug product characterization studies to ensure potential patient-use scenarios were adequately supported, directed analytical method development/validation activities, designed and executed expansive stability studies related to all aspects of the manufacturing process.

Charles Oh

Charles Oh

Charles Oh is the Senior Vice President of Clinical Development at Acorda Therapeutics. He is responsible for advancing Acorda’s development programs and has oversight of the clinical development, clinical operations, and biometrics functional groups.

Charles Oh has over 15 years of experience in the pharmaceutical/biotech industry and led clinical development programs resulting in multiple drug and device approvals in the US and Europe. He has development experience in several therapeutic areas including pain, cardiology, and neurology.

Miia Riihimäki, PhD

VMD 1997, Swedish University of Agricultural Sciences, SLU Uppsala, (VMD, SLU, Uppsala). Doctor in Veterinary Medicine, PhD 2008, Faculty of Veterinary Medicine and Animal Science, SLU. Assistant professor/clinical veterinarian at Equine Internal Medicine since 1999 at Department of Clinical Sciences/University teaching hospital (UDS).

During the PhD project (with focus on the inflammatory pathways in equine airways) and afterwards, research focus has been on respiratory diseases in horses.

Current research activities focus on respiratory pathogens in the horse, including antibiotic sensitivity patterns of pleural anaerobes and pathobiology of Strangles.

Dennis Sandell, PhD

Dr Dennis Sandell holds a Licentiate of Science in Mathematical Statistics (1990, U. of Lund, Sweden). He has worked for AstraZeneca, Amgen and Siegfried Pharma Development GmbH in both specialist and management roles and is currently an Adjunct Professor at the Department of Pharmaceutics, University of Florida.

Dr Dennis Sandell is a leading expert in the area of CMC statistics, especially related to development, registration and commercial manufacture of inhalation products. He has a special interest in and long experience of in-vitro bioequivalence as well as correlating in-vitro data with results from pharmacokinetic studies). He has deep experiences from of a wide range of innovator and generic DPIs, MDIs, nasal sprays and nebulization products, as well as different respiratory add-on devices.

Dr Dennis Sandell has 100+ publications and frequently presents at international conferences. He has participated in different industry collaborations such as IPAC-RS, EPAG, PQRI and PhRMA and is a member of USP Statistics Expert Committee, chair of the USP Large N Expert Panel and member of the USP Data Analysis subcommittee.

In May 2010 Dr Dennis Sandell started the consulting firm S5 Consulting, providing CMC statistical support, general inhalation development advice, regulatory writing, and due diligence assistance.

Niklas Sandler

Niklas Sandler, PhD

Dr Niklas Sandler is Chief Technology Officer at Nanoform Finland Ltd. since January 2019 leading the R&D and QC activities with a focus on further developing the company’s innovative manufacturing technology. Dr Niklas Sandler has a PhD from the University of Helsinki and he has worked in various roles both in the pharmaceutical industry and academia. He has more than 20-years of experience in pharmaceutical technology with the focus on manufacturing technologies, material science and process analytical technologies. Dr Niklas Sandler has run numerous academic and industrial R&D and commercialisation projects in the field successfully.  He has been invited speaker in various international conferences and published more than 100 peer reviewed articles in international high-quality journals throughout the years.

Anna Shevchenko

Anna Shevchenko, PhD

Dr Anna Shevchenko graduated in physics of metals and material science in 1987 from Taras Shevchenko National University of Kyiv, Ukraine. In 2013, she received here PhD (Pharmaceutical Technology) degree from Helsinki University, Finland.

Before moving to Finland Dr Anna Shevchenko used to work as a research scientist in the Academy of Science of Ukraine. In 2000, she started as a research scientist at Orion Corporation, Laboratory of Physics, Analytical Dpt. In 2004 she was appointed as Senior Research Scientist and in 2014 as Principal Scientist in the same department.  Since 2014, she holds the position.

Dr Anna Shevchenko’s research interests include material sciences, powder technology, preformulation, polymorphism, salt cocrystals screenings, amorphous materials.

Regina-Scherliess

Regina Scherließ, PhD

Prof. Dr Regina Scherließ (*1979) is a professor for Pharmaceutics and Biopharmaceutics, director of the section Pharmacy and chair of the Department of Pharmaceutics at Kiel University, Germany. As such she leads the research unit in Pharmaceutics and is responsible for all teaching in Pharmaceutics and Biopharmaceutics at Kiel University. She is a pharmacist and received her Dr. rer. nat. (doctor of natural sciences) in 2008 for a work on “Formulation of inhalation combination products by co-precipitation”. In 2015 she finished her “habilitation” working on “Mucosal vaccination via the respiratory tract”. During her academic education she had research stays in Denmark, the US, New Zealand and Australia.

Prof. Dr Regina Scherließ also received several young researcher awards including The Pat Burnell New Investigator Award 2010 of the Aerosol Society and is member of the DDL scientific committee (since 2015). Her research interests include disperse systems and nanoparticles, stabilization of biomolecules and particle engineering in spray drying and formulations for mucosal vaccination with a focus on respiratory (nasal and pulmonary) dry powder delivery.