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 other questions within the field of nasal drug delivery while reviewing interesting new data, innovative technologies and the very latest scientific developments. Leading authorities in nasal drug delivery will cover relevant aspects of nasal physiology, anatomy, absorption of a variety of drugs in various phases of drug development, and new drugs entering the market. In addition, nasal delivery to the sinuses will be discussed and the programme will include interesting case histories.
This seminar will offer an excellent networking opportunity to build business relationships and discuss all these issues with an unrivalled panel of experts in this field of drug delivery.
Those already involved in nasal drug delivery will benefit from updating their knowledge and sharing experiences with some of the leading practitioners in this field. If you are involved in nasal drug delivery or are just considering the potential, this seminar is an excellent route to understanding all aspects from the basic physiology through to launching a successful product.
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
Nasal formulation of drugs
Developing next generation powder nasal delivery using POD technology
Rethinking nasal packaging environment
Key insights for a successful device development to achieve nasal bioequivalence requirements
The unique challenges of nasal drug delivery to treat chronic rhinosinusitis (CRS); considerations before and after sinus surgery
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 associated with BE/TE for nasal products
US/FDA regulatory guidance on combination products
Qualification of new nasal drug delivery systems for existing drugs
Investigations regarding the developability of nasal metered dose inhalers
What are chemisimilars and what’s the problem?
Close of conference and refreshments
John Warren is a clinical scientist who established Medicines Assessment Ltd as a pharmaceutical consultancy in 2011 (www.medicinesassessment.com).
He advises multiple pharmaceutical companies on clinical development. He trained in medicine at Guy’s Hospital, where he wrote a thesis on the human physiology of epinephrine. He worked for the UK Medicines Healthcare products Regulatory Agency (MHRA) as an Expert Medical Assessor from 1995-2010 evaluating new drug applications for Europe across the therapeutic spectrum. Member of the European Scientific Advice Working Party 2003-2010; Pharmacokinetic Subgroup of the Efficacy Working Party 2007-2008. He contributed to the EU Notes for Guidance on Asthma, COPD, ARDS and Bioequivalence. When appointed to the MHRA in 1995 he took a concomitant Honorary Senior Lectureship in Clinical Pharmacology at St Thomas’ Hospital. Previously a Senior Lecturer at the National Heart and Lung Institute, with Honorary Consultant status at the Brompton, Charing Cross and Chelsea & Westminster Hospitals, 1990-1994. This followed a Senior Registrar post in Clinical Pharmacology at the Royal Postgraduate Medical School 1986-1990. Specialist UK accreditation was granted in General Medicine, Clinical Pharmacology and Cardiology. He is the author of over 100 publications on pharmacology and a book on the Endothelium. Guest speaker at the 2010 Annual Austrian Pharmacological Society meeting. British Pharmacology Society Guest Lecturer at the 2013 Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists. Guest speaker at Inhalation Drug Delivery Association 2016 Conference, China. For a review of drug development please see “Drug Discovery: Lessons from Evolution” BJCP 2011;71:497-503. Previously a Member of the Editorial Board of Clinical Pharmacology & Therapeutics and Microvascular Research. Currently Executive Editor for British J Clinical Pharmacology and member of the Joint Speciality Committee for Clinical Pharmacology of the Royal College of Physicians, London. Member of the research committee for the Cure Parkinson’s Trust.
Valerie LundValerie Lund is Professor Emeritus of Rhinology at the Ear Institute, University College London and is an Honorary Consultant ENT Surgeon at the Royal National Throat Nose and Ear Hospital (University College London Trust), University College Hospital. She deals with all nose and sinus conditions with a particular interest in sinonasal tumours and has been involved in endoscopic sinus surgery and its extended applications since the early 1980’s. She has contributed extensively to the literature with 36 books and monographs, 86 chapters and over 320 peer-reviewed papers and has lectured widely, delivering 19 eponymous lectures, including the Semon, Stirk Adams, Stell and Wilde lectures in the last 5 years. She has received several prizes including the George Davey Howell (1990, 2008, 2015), W J Harrison (Royal Society of Medicine 2012), BMA Book awards and Jobson Horne Prize (2018) . She is the only non-American editor of ‘Cummings Otorhinolaryngology’ and her most recent book, ‘Tumors of the Nose, Paranasal Sinuses and Nasopharynx’ was published by Thieme in April 2014.
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.
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.
Jag 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.
Pascale Farjas is a Global Category Manager for the ENT (ear, nose, and throat) segment at Nemera, a leading developer and manufacturer of healthcare packaging and devices. Her role encompasses understanding patients’ needs and regulatory requirements to develop and market packaging solutions that improve the patient experience. She is also in charge of the market introduction of new pump platforms for nasal sprays.
Prior to joining Nemera, Pascale held various positions in strategic market intelligence and operational marketing for international markets in the pharmaceutical industry.
Pascale holds a degree in chemical engineering from the National Institute of Applied Sciences of Rouen in France. She also earned a marketing-focused Master Degree from the Business Administration Institute (France).
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.
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.
Lee Lucas is Vice President of Applications and Business Development, Aptar CSP Technologies. He has over 25 years of project management and manufacturing experience. Lee has spent the last 8 years with Aptar CSP Technologies developing custom product solutions using its material science technology going from concept to commercialization into both domestic and international markets. His responsibilities include R&D, regulatory, design and development for both the US and France locations. Prior to joining CSP, he spent 10 year of his career as a General Manager directing large CMO plants producing aerosol, liquids, creams in the personal beauty, pharmaceutical and home care market segments. He has a bachelor of science in mechanical engineering and is a six-sigma black belt.
Céline Petitcolas holds Materials engineer degree from the National School of Chemic and Physic of Bordeaux (France). Her current position is Customer Technical Support for nasal range at Nemera. Following a first R&D experience in automotive industry, Céline joined Nemera in 2012 to develop pharmaceutical device and especially for nasal spray area. Her new role consists in helping and assisting customers from a technical point of view in their development for nasal spray and more specifically on Bioequivalence topics.
Andrew Wood, Associate Director Regulatory Affairs, Aptar Pharma. Originally a graduate in Chemistry, Andrew has worked with Aptar Pharma for 10 years managing their Regulatory Affairs team. Having previously held posts with GlaxoSmithKline and Bespak in technical project management and quality assurance roles, Andrew has amassed more than 30 years experience in development of nasal and inhalation products and drug delivery devices.
Christopher Fuller, Associate Director of Engineering, Impel NeuroPharma
Christopher has worked at Impel since 2012, developing Impel’s patented POD technology. He has a background in physics and applied mathematics completing both graduate and undergraduate work at the University of Washington. His current role is focused on new product introduction, developing and launching Impel assets across Migraine, Parkinson’s Disease, and acute agitation.
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.