What makes nasal delivery systems more challenging than solid dosage forms? How safe is nasal drug delivery? Are there such things as safe excipients? How does all this fit within the regulatory environment in Europe and the USA? How difficult is it to bring all these products to market?
This seminar seeks to explore these and many other questions in the field of nasal drug delivery, while reviewing interesting new data and innovative technologies. Leading industry authorities will cover all the relevant aspects of nasal physiology, anatomy, formulation strategies, the absorption of a variety of drugs in various phases of drug development, and new drugs entering the market. Nasal delivery to the sinuses will also be addressed as will the potential of delivering insulin to the brain. The comprehensive programme will include interesting case histories and provide ample opportunity to discuss all the key issues affecting this fast-growing industry.
Participants will benefit from:
1. Gain an update on the very latest scientific developments and technology advances in this field.
2. Hear from an unrivalled panel of expert speakers.
3. An excellent networking opportunity to build business relationships.
Nasal drugs to treat nasal disorders: a comprehensive review
Nasal drug delivery challenges
Effects of excipients in nasal powder formulations
Advanced characterisation and formulation strategies for nasal drug delivery systems
In-vitro assessment of sinonasal drug delivery – appropriate as substitute for in-vivo studies?
Characterisation of nasal devices for delivery of insulin to the brain
RetroNose: breakthrough technology for nasal drug delivery by oral route using an aerosol
Review of day one
Dr Julie Suman and Dr René Bommer
Review of nasal drug delivery devices
Requirements concerning bioequivalence of nasal drug products from an authority’s point of view
Regulatory science for abridged nasal products
Human factors (HF) studies – a hype or a must-do?
Development of three anatomical nasal models for more predictive in-vitro testing of nasal sprays
Qualification of new nasal drug delivery systems for existing drugs
Nanotechnology for nasal drug delivery
Close of conference and refreshments
Dr. René Bommer is a founder and an owner of pharmAccel Consulting.
He received his Ph.D. in Chemistry from the University of Constance in Germany in 1990. After research positions at the Scripps Clinic in San Diego, USA , at Altana Pharma Germany (now Takeda) and a lectureship at the University of Buenos Aires he joined the device developing and manufacturing company Ing. Erich Pfeiffer GmbH in Germany and became a Director of Business Development. In 2007 René founded a consulting company with a focus on delivery devices. pharmAccel Consulting delivers a service to support an accelerated entry into the market with consideration of technical, regulatory, marketing and pharmaeconomical aspects of the drug delivery device business.
Per Gisle Djupesland
Per G Djupesland, M.D., Ph.D. is the inventor of OptiNose’s patented, Breath Powered™ Bi-Directional™ nasal drug delivery technology. He has been Chief Scientific Officer of OptiNose since 2000 and is in charge of scientific efforts at OptiNose.
Dr. Djupesland is an Otorhinolaryngologist with a specialization in rhinology and more than 25 years of clinical experience in infectious diseases, epidemiology and surgery.
He has been Clinical Research Fellow at the Hospital for Sick Children and Toronto General in Toronto, Canada, primarily studying the role of Nitric Oxide in the upper airways.
He also authored more than 50 peer reviewed articles in international medical journals, and filed 35 patent families/patent applications.
Dr. Julie D. Suman, R.Ph., Ph.D., is a co-founder and President of Next Breath, LLC, an incubator company located at the UMBC Technology Center. Next Breath, which incorporated in April 2002, is a contract research organisation dedicated to the development of nasal and inhalation delivery systems. She directs the contract research division that supports product development for North American and European clients in the pharmaceutical, biotechnology and medical device markets.
Julie holds a B.S. in Pharmacy from Duquesne University (1996) and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore (2002). She is a licensed Maryland pharmacist and a member of the Maryland Pharmacy Volunteer Corp. Julie has also been an affiliate assistant professor in the Department of Pharmaceutics at Virginia Commonwealth University since 2009.
Dr. Michael S. Benninger has been the Chairman of the Head and Neck Institute at The Cleveland Clinic since 2008. Previously he was the Chairman of the Department of Otolaryngology-Head and Neck Surgery at Henry Ford Health System in Detroit, Michigan. He has also been involved in Regional, National and International medical organizations. He served on the Board of Directors of the American Academy of Otolaryngology-Head and Neck Surgery for 12 years, having been a former Vice President and Chairman of the Board of Governors. Dr. Benninger is on the Board of Directors of the Voice Foundation and the International Association of Phonosurgeons, and has recently been on the Executive Council of the Triological Society. In addition to his numerous professional pursuits Dr. Benninger has authored 6 books, including his most recent books, “The Performer’s Voice” and “The Singer’s Voice”. He has written over 100 scientific articles, focusing primarily on voice care and laryngology, nasal and sinus disease and health care management. Dr. Benninger has also lectured extensively across the US and throughout the world.
Anders Fuglsang graduated in 1998 from the Royal Danish School of Pharmacy, Copenhagen, spending part of his studies at Leiden University, Netherlands. He was awarded his PhD in 2002 specialising in cardiovascular pharmacology. Following work as an Assistant Professor, he worked as a consultant for a number of Originator Pharmaceutical companies at a brand optimisation company in Copenhagen.
In 2005, he joined the Norwegian Medicines Agency as a Clinical Assessor and became Expert Advisor to the WHO and member of the Efficacy Working Party at the EM(E)A. He was Chair of the sub-group for Orally Inhaled Products and was also a member of the PK-subgroup. Other duties included provision of Expert Scientific Advice, GCP-inspection and -training, and responsibility for Assessor Training at the EM(E)A.
Through 2009 to September 2010, he was Clinical and Regulatory Strategy Manager at a world leading generic company. He has now established his own pharmaceutical consultancy. Clients include the World Health Organization, generic companies, innovators, drug delivery firms and investment banks.
He is the author of approximately 30 papers in the fields of Generics, Genetics and Pharmacology, and is a reviewer for some 15+ international journals including Science, Trends in Genetics and Drug Discovery Today.
Alain Regard is Technology Product Manager, with Nemera. He qualified in Mechanical Engineering (1991) and later in Polymer Materials, Structure & Characterisation (1993) at the University of Lyon, France. Following this he then obtained a qualification Polymer Engineering & Processing, at Ecole Superieure de Plasturgie (ESP), Oyonnax ,France in 1995.
Alain was the Product Development Leader at the pharmaceutical packaging company ‘Rexam ETC’ (La Verpilliere, France) and has been working there since 2010.
Alain has worked on a number of engineering projects that have related to the pharmaceutical business, such as PMDI development (Rexam INHALIA® metering valve), nasal spray developments and nasal spray devices bio equivalence.
Alain’s experience has resulted in him gaining particular skills, specifically in functional analysis, product specifications, risk analysis, testing methods development and validation, design validation, limit studies, problem solving and product performance improvement.
Ben Forbes is a Reader in Pharmaceutics at King’s College London. He is currently the Head of the Pharmaceutics Teaching Section and the Drug Delivery Research Group of the Pharmaceutical Science Division. He has a B.Pharm from King’s College London (1987) and a Ph.D. in Drug Delivery from Strathclyde University (1995).
Dr Forbes performed post-doctoral work in respiratory drug delivery at King’s College London from 1995 until he was appointed to the academic staff in 1997.
He is a registered pharmacist in the UK and serves on the committee of the Academy of Pharmaceutical Sciences focus group for Inhalation and the organising committee of the Drug Delivery to the Lung conference.
The research group led by Dr Forbes has nine members of academic staff working collaboratively on different aspects of inhaled drug delivery from particle engineering through to aerosol interaction with the respiratory epithelium and in vivo pharmacology.
Jag Shur began his career with Profile Drug Delivery where he was developing inhalation drug delivery systems for cystic fibrosis patients.He then went on to work for GlaxoSmithKline, following which he completed his PhD entitled “Formulated Muco-Regulatory Agents in the Airways of Patients with Cystic Fibrosis” at Portsmouth School of Pharmacy.
Jag is currently a research fellow at the University of Bath where he is investigating bioequivalence of inhaled products.
Richard Featherstone is Research Director, Human Factors Research & Design, Emergo by UL, and previously Managing Director of Medical Device Usability Limited, a specialist human factors consultancy that works exclusively with new and emerging medical technologies. He has been designing and conducting human factors studies for over 10 years, and his experience includes a wide range of drug delivery technologies including inhalers, auto-injectors, nasal sprays and associated devices such as tele-health systems. He and the MDU team regularly test in the US, UK, Europe and Australia and undertake formative and summative testing for some of the world’s largest pharmaceutical and medical device companies as well as small start-ups. Based in Cambridge, Richard set up and grew MDU into one of Europe’s largest specialist medical HF consultancies. Over 10 years of testing has meant that Richard has built a considerable body of knowledge of the practical aspects of designing, undertaking and reporting of both types of testing.
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. She 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 in spray drying and formulations for mucosal vaccination with a focus on respiratory (nasal and pulmonary) dry powder delivery.
Dr Somavarapu received his master’s degree in pharmacy (MPharm) from Banaras Hindu University, India. His move to England came with the award of a Commonwealth Fellowship from the Association of Commonwealth Universities and he undertook a PhD at the University of Aston in Birmingham. His thesis was entitled “Novel bioadhesive formulations for mucosal and parenteral delivery of vaccines” and was awarded in 2001. Dr Somavarapu has since completed post-doctoral fellowships at the University of Aston and the Centre for Drug Delivery Research at The School of Pharmacy. This has included an international collaboration on a European project on developing vaccination strategies against the Bluetongue virus. In 2005 he was appointed as Academic Fellow at The School of Pharmacy and became a lecturer in 2010. He has over seventy publications, including twenty journal articles, over fifty peer-reviewed abstracts and several international conference presentations. He also has six patents on vaccine formulations. His research focus is on designing, understanding & developing technologies for novel nanocarrier systems in overcoming biological barriers for the targeted delivery of small therapeutic molecules and macromolecules (proteins, peptides, siRNA, miRNA) via the pulmonary route in the treatment of lung diseases (lung cancer, asthma, COPD) and ocular conditions.
Thomas Grinnan, Vice President, Sales & Marketing, Healthcare, Silgan Dispensing Systems, has worked in the pharmaceutical industry for more than 28 years as an executive, innovator, consultant and business development specialist. A biologist, he began his career in the Healthcare practice of Markowitz & McNaughton, Inc., a strategy consulting firm, working closely with pharmaceutical and medical device companies. After receiving his MBA, he began a long career with Mebane Packaging, a healthcare packaging company, and its antecedents Westvaco and MeadWestvaco.
At MeadWestvaco, Tom held various leadership roles in the Patient Adherence and Healthcare Packaging business, leading European sales & marketing, global clinical trial packaging, as well as business development and innovation. After MeadWestvaco (subsequently renamed Westrock), Tom joined Silgan Dispensing Systems, aspin-off specializing in the supply of pump and liquid dispensing solutions. Silgan DispensingSystems is a leading partner to the pharmaceutical industry, supplying pumps and dispensing systems for nasal, ophthalmic, topical, oral and otic applications. Tom received his BA fromthe University of Virginia and his MBA from the University of North Carolina, Chapel Hill.
Laurent Vecellio is Scientific Director at Nemera, and was previously a Researcher for the National Institute for Health and Medicine (INSERM) at University of Tours in France. He obtained a degree in physical engineering from the Paris-Est Créteil Val-de-Marne University
and received PhD in 2002.
His past research interests have included the metrology of medicine aerosols, particularly measurement of nebulizer performance in terms of particle size and output. Laurent has been developing jet nebulizers and optimizing mesh nebulizer performance at DTF Medical for 18 years.
Laurent also conducted basic and clinical studies for evaluating new nebulized drugs for CF, lung cancer and ventilated patients. Most recently he has been involved in the nasal drug deposition.
Dr Cornelia Nopitsch-Mai studied pharmacy at the Free University Berlin and graduated in pharmaceutical biology. She is scientist at the Federal Institute for Drugs and Medical Devices in the assessment of the quality of the dossier since 1991.
She is experienced in the assessment of pharmaceutical dossiers for marketing authorisation applications of medicinal products. She has broad knowledge of the national and EU regulations medicinal products as well as for the corresponding EU guidelines and the European Pharmacopoeia. Since 2000 she is assessor for the Certification Procedure (EDQM) in Strasbourg. She was member of the Technical Advisory Board (TAB) from 2001 to 2010. She was chairperson of the TAB from 2005 to 2010. She was member of the Quality Working Party from October 2007 to February 2011. Since 2014 she is member of the INH Working Party.