Nasal Drug Delivery

This conference gives a comprehensive review within the field of nasal drug delivery while reviewing interesting new data and innovative technologies.

12-13 Apr 2018

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 9 Feb

Book now

Course overview

How difficult is it to bring all these products to market? 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? This conference seeks to explore these and other questions within the field of nasal drug delivery while reviewing interesting new data and innovative technologies. 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, the conference will discuss nasal delivery to the sinuses and interesting case histories.

Your next step is to call us now on +44 (0)20 7749 4730 or email us at info@management.forum.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Who should attend

Managing directors, medical directors, head of regulatory affairs and quality assurance, senior executives in research and development, registration, marketing and all departments that may be involved in nasal drug delivery, or who wish to understand the potential of this alternative therapeutic route. 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 conference is an excellent route to understanding all aspects from the basic physiology through to launching a successful product.

Three reasons to attend

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.

Programme - Day one

Chairman’s welcome and introduction

Dr Julie Suman, President, Next Breath, USA
Dr René Bommer, General Manager, pharmAccel Consulting, Germany

Nasal drugs to treat nasal disorders: a comprehensive review

  • Anatomy and physiology
  • Nasal disorders
  • Treatment options and future prospects to treat allergic and non-allergic Rhinitis
  • Rhinosinusitis and Polyps

Professor Michael S. Benninger, _Chairman, The Head and Neck Institute, Professor of Surgery, Lerner College of Medicine, The Cleveland Clinic, USA_

Discussion

Nasal drug delivery challenges

  • Discuss ideal attributes of a nasal spray formulation
  • Present strategies to optimise deposition
  • Highlight excipients to facilitate absorption
  • Present technology for delivery and formulation characterisation

Dr Julie Suman, President, Next Breath, USA

Formulation, deposition and effect of nasal medications

  • Formulation aspects of liquid and dry powder systems
  • Nasal deposition of liquid and dry powder systems
  • Techniques to determine nasal deposition
  • Interplay of therapeutic targets and nasal deposition

Dr Regina Scherliess, Christian Albrecht University of Kiel, Department of Pharmaceutics and Biopharmaceutics, Germany

Discussion

Nose to brain drug delivery of Oxytocin

  • Where do we need to deposit drug in order to have a chance at effective N2B delivery of Oxytocin
  • Importance of delivery device in reaching the area of the nasal cavity
  • Oxytocin in healthy men – Cognitive outcomes and fMRI results with IV comparator
  • Oxytocin in Autism patients – Cognitive outcomes in cross-over placebo controlled study

Dr Per Gisle Djupesland, CSO, OptiNose, Norway

Repurposing CNS drugs: opportunities and challenges via the nose

  • What are the opportunities for re-purposing CNS drugs?
  • The challenges – drugs/formulations – delivery devices – regulatory approach

Gerallt Williams, Director Scientific Affairs, Aptar Pharma, France

Discussion

Intranasal Insulin for the treatment of Alzheimer’s disease

Paul Jenkins, Business Development, Impel Neuropharma, UK

Topical delivery in chronic Rhinosinusitis with nasal polyps

  • Typical origin and location of nasal polyps and clinical implications
  • In-vitro deposition methods – advantages and limitations
  • In-vitro assessment of nasal spray products for topical action
  • Can in-vitro studies be a bridge to, or replace in-vitro studies

Dr Per Gisle Djupesland, CSO, OptiNose, Norway

Discussion and close

Networking drinks reception for delegates and speakers

Programme - Day two

Review of day one

Dr Julie Suman, President, Next Breath, USA
Dr René Bommer, General Manager, pharmAccel Consulting, Germany

Review of nasal drug delivery devices

  • Trends in nasal delivery systems
  • Advances in device technologies
  • Nasal spray characteristics

Dr René Bommer, General Manager, pharmAccel Consulting, Germany

Applying FDA combination drug product guidance to nasal spray products

  • Review of recent combination product guidance – the basics
  • Developing regulatory strategies and balancing regulatory risk
  • Legacy v new nasal spray delivery systems
  • Human factors and combination products
  • Combo product – drug company and nasal spray delivery vendor: Case study

Badre Hammond, Associate Director, Market Development Aptar Pharma, USA Switzerland

Discussion

From eDevices to cDevices – connected health new paradigm

  • What forms of drug delivery have successfully evolved into technologically advanced communication devices?
  • What are the technical challenges involved?
  • What are the human factors requirements?
  • Why have nasal drug delivery devices stood still?
  • How do I set about designing a device for this new paradigm?

Tony Bedford, Senior Account Manager, Chiltern International, UK

Development path for nasal spray products

  • Device selection
  • Fill and finish strategies

Leif-Rune Skymoen, CEO, Curida, Norway and Joe Keenan, Director Sales & Business Development Healthcare – Americas, Westrock, USA

Discussion

Case study: Opioid overdose – Developments in intranasal Naloxone Speaker, (invited)

*Benefit brought from latest dry powders v liquid formulations

Dr Jag Shur, Director, Nanopharma, UK

What are Chemisimilars and what’s the problem?

  • Pre-1984 and the whole dossier approach
  • Post 1986 and the pharmacokinetic approach
  • Chemisimilars that have no, or limited, PK data
  • Assay sensitivity and the best models to test for similarity

Dr John Warren, Director, Medicines Assessment, UK

Concluding remarks

Close of conference and refreshments

Presenters

John Warren

Prior to establishing a pharmaceutical consultancy in 2011 John held a position of an Expert Medical Assessor with the UK Medicines Healthcare products Regulatory Agency (MHRA) for 15 years. Having joined the European Scientific Advice Working Party in 2003 he contributed to the EU guidance on Asthma, COPD and ARDS.
John Warren holds a triple specialist accreditation in the UK, has authored over 100 publications in international journals and a book on the Endothelium.
He is also an Executive Editor for British J Clinical Pharmacology.

Rene Bommer

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.

Julie Suman

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.

Michael Benninger

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.

Georges Bouille

Georges Bouille started his career in internationally renowned companies in finance and packaging industries after graduating in economics in 1987. Ever since 1991 he succeeded in international introduction of an innovative dispensing technology called BOV, which was acquired by Aptar Group in 2005.
As a VP Sales Marketing and subsequently a VP Business Development at Consumer Healthcare Division of Aptar Pharma, Georges steered nasal saline & woundcare application fields on international level.
Currently Georges is a CEO of ADWATIS SA, a Swiss based company specialising in ionized water technology as well as an independent consultant for business & dispensing solutions at Lindal Group company, a major international and leading player in aerosol business.

Pascale Farjas

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).

Tom Grinnan

Thomas Grinnan,Senior Commercial Director, Healthcare, Europe, Asia, Africa & Middle East, Silgan Dispensing Systems, France.

Wim Vos

Dr. Vos received an MSc degree in aerospace engineering from Delft University of Technology, The Netherlands and a PhD degree in physics from the University of Antwerp, Belgium. He was responsible for the development of functional respiratory imaging (FRI) as a tool to better describe a disease progression, as well as a response to treatment.
Dr. Vos is the author of many papers in international journals and received several awards for his research. Since 2010 Dr. Vos has been Chief Operating Officer at FLUIDDA.

Jean-Michel Verjus

Jean-Michel Verjus is a PhD Pharmacist and has been active in the management and the development of food supplements, cosmetic and medical devices. Previously he held a position of Head of Wholesale at a pharmaceutical distributor in Geneva area. He was also involved in the development of a medium size pharmaceutical company specialising in saline and natural ingredients for Nasal and Ear wash products.

Laurent Vecellio

Laurent Vecellio is 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.

Cecilie Vo

Cecilie Vo is a pharmacist with a keen interest in health economy. She earned her Master’s at the University of Oslo in 2012 and proceeded to work as a Drug Safety consultant for Pharmalex (former Lindeq).
Subsequently Cecilie moved into a challenging role as the Qualified Person for Novartis Norway with responsibility for product release and handling of all quality related tasks. Currently Cecilie has a position within Quality and Business Development at Curida. Her role is to support identification of new business areas and defining actions within quality assurance.

Sai Shankar

Sai Shankar is Director, Business Development – Connected Devices, Aptar Pharma.

David Exline

David Exline has over 25 years of experience in managing and administering analytical laboratory and consulting services. As a President of Gateway Analytical, he oversees the company’s day-to-day operations, business growth and service areas. His current areas of focus in the pharmaceutical industry are particle characterization methodologies, device testing as well as drug product characterization including identification, sizing and counting of formulation and device components.

Yannis Paloyelis

Professor Yannis Paloyelis, Lecturer in Neuroscience and Psychology, Neuroimaging Department, Kings
College, UK

Book now

12-13 Apr 2018
12-13 Apr 2018 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 9 Feb
Enrol now

Previous customers include...

  • Abbott Healthcare Products BV
  • Advanced Medical Institute Inc.
  • Bespak Europe Ltd
  • Catalent Pharma Solutions
  • CLINITRIALS BIO RESEARCH LTD
  • CSL LTD
  • DCA Design International
  • Department of Health & Human Services
  • DnE
  • Ever Neuro Pharma GmbH
  • FAES Pharma SA
  • Federal Institut for Drug and Medical Devices
  • GlaxoSmithKline
  • Jenson R+ Ltd
  • LEK Pharmaceuticals d.d.
  • LTS Lohmann Therapie-Systeme AG
  • M&P Pharma AG
  • Novo Nordisk A/S
  • Office for Registration of Medicinal Products, Medical Devices & Biocides
  • OPTINOSE U K LTD
  • PALATIN TECHNOLOGIES
  • Pfeiffer GmbH
  • Quotient Clinical Ltd
  • STRIDES ARCOLAB LIMITED
  • Sulzer Mixpac AG
  • Takeda GmbH
  • Teva Czech Industries S R O
  • University of Kiel
  • Ursatec GmbH
  • Virginia Commonwealth University