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Nasal Drug Delivery Training Course: face to face

A comprehensive review of the latest scientific developments, technology advances and regulatory guidance in the field of nasal drug delivery.

15-16 Apr 2021

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Details

Conference overview

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:

  • An essential update on the very latest scientific developments and advances in technology
  • An unrivalled panel of international expert speakers who will share their valuable knowledge and insight
  • An excellent networking opportunity to build business relationships with fellow professionals

Media Partner

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Who should attend?

  • Managing directors
  • Medical directors
  • Heads of regulatory affairs
  • Quality assurance managers
  • Senior executives in research and development
  • Registration associates
  • Marketing managers
  • All departments that are already involved in nasal drug delivery or who wish to understand the potential of this alternative therapeutic route

Programme – day one

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
  • CRS with and without nasal polyps
    Michael S Benninger

Discussion session

Nasal drug delivery challenges

  • Ideal attributes of a nasal spray formulation
  • Strategies to optimise deposition
  • Excipients to facilitate absorption
  • Technology for delivery and formulation characterisation
    Dr Julie Suman

Effects of excipients in nasal powder formulations

  • Definition and characteristics of nasal powders
  • Formulation options for nasal powders
  • Excipients in nasal powders
  • (Side) effects of excipients in nasal powders
  • Delivery aspects of nasal powders
    Regina Scherliess

Discussion session

Advanced characterisation and formulation strategies for nasal drug delivery systems

  • Enhancing nasal absorption
  • Improving solubility and permeability
  • Successful treatment using the nasal route
    Dr Jag Shur

In-vitro assessment of sinonasal drug delivery – appropriate as substitute for in-vivo studies?

  • Cadaver studies
  • Nasal cast studies
  • Computer simulation studies (CFD)
    Per Djupesland

Discussion session

Characterisation of nasal devices for delivery of insulin to the brain

  • Nose to brain delivery
  • Nasal spray characterisation
  • Functional magnetic resonance imaging in human volunteers
  • Delivery of insulin to the brain by nasal administration
    Ben Forbes

RetroNose: breakthrough technology for nasal drug delivery by oral route using an aerosol

  • RetroNose technology
  • Proof of concept with nebuliser
  • Proof of concept with pMDI
  • Differences of nasal deposition distribution between oral and nasalroutes
    Laurent Vecellio and Alain Regard

Programme – day two

Review of day one
Dr Julie Suman and Dr René Bommer

Review of nasal drug delivery devices

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

Requirements concerning bioequivalence of nasal drug products from an authority’s point of view

  • Bioequivalence of nasal products
  • The evaluation of the monograph for nasal products in the European Pharmacopoeia will be outlined
    Dr Cornelia Nopitsch-Mai

Discussion session

Regulatory science for abridged nasal products

  • The guideline situation
  • PBE versus ABE
  • Elvis is alive: ‘Weight of evidence’
    Anders Fuglsang

Human factors (HF) studies – a hype or a must-do?

  • Legal and regulatory guidelines covering human factors for pharmaceutical products
  • HF and risk management
  • HF and clinical trials
  • Generic combination products – ANDAs and HF
  • Questions and challenges
    Richard Featherstone

Discussion session

Development of three anatomical nasal models for more predictive in-vitro testing of nasal sprays

  • Construction of 20 nasal casts
  • Cast depositions for two nasal spray products
  • Correlations between cast geometry and nasal deposition
  • Approaches for selecting a small, medium and large nasal cast
    Dennis Sandell

Qualification of new nasal drug delivery systems for existing drugs

  • Formulation analysis
  • System and compatibility
  • Stability testing
  • Performance testing
  • Production line and efficiency optimisation
    Thomas Grinnan

Nanotechnology for nasal drug delivery

  • Nanotechnology treatment methods
  • Design, characterisation and products
  • Application of nanoscale drug delivery systems
    Dr Satyanarayana Somavarapu

Discussion session

Concluding remarks

Presenters

Rene Bommer (More...)

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 (More...)

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 (More...)

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 (More...)

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 (More...)

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.

Ben Forbes (More...)

Ben Forbes is a Professor of 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).

Profesor 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 Professor 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.

Richard Featherstone (More...)

Richard Featherstone, Human Factors 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, MDU has grown rapidly to become Europe’s largest specialist medical HF consultancy with clients around the world. 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.

Regina Scherließ (More...)

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.

Tom Grinnan (More...)

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.

Cornelia Nopitsch-Mai (More...)

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.

Book now

Book now

15-16 Apr 2021
Face-to-face, (venue not yet confirmed)
15-16 Apr 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 4 Mar 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • AlgiPharma AS
  • Aptar Pharma
  • ARADIGM CORPORATION
  • Becton Dickinson
  • BOC Medical
  • Britannia Pharmaceuticals Ltd
  • CLINITRIALS BIO RESEARCH LTD
  • EBEWE Neuro Pharma GmbH
  • Emergent BioSolutions
  • Fortitude
  • Harro Hoefliger Verpackungsmaschinen Gmbh
  • Indivior UK Limited
  • Interdos Pharma bv
  • M+P Pharma AG
  • Merck Sharp & Dohme
  • Next Breath
  • Novo Nordisk A/S
  • Pfeiffer GmbH
  • Pfizer Limited
  • Pharmacosmos A/S
  • Raumedic UK Ltd
  • Rexam Healthcare
  • Rexam Healthcare La Verpilliere
  • SAINT-GOBAIN CALMAR
  • Sanivo Pharma AS
  • Spital - Pharmazie
  • Strategic Pharmaceutical Advisors
  • Team Consulting Ltd
  • Virginia Commonwealth University
  • Z F UNIA

I was able to take away relevant information from each presentation. Great networking and worth the cost and time of international travel.

Michelle Sparks, Head of Product Development, Zafgen, Apr 19

Well organised, good agenda!

Michiharu Kageyama, Manager, Teijin Pharma Limited, Apr 18

Very well organised, good speakers.

Ana Campo Rodrigo, Postdoctoral Research Fellow, University of York, Apr 18

The speakers were all very well spoken and gave a good overview of the background to their research/product before going into detail. It was a very well organised programme with a variety of interesting topics delivered by experts within the field.

Gillian Hutcheon, Reader, Liverpool John Moores University, Apr 18

The speakers were enthusiastic and highly knowledgeable and there was plenty of opportunity for discussion and a really good in-depth exploration of the subject. Excellent.

Nicola Hardman, Jenson R+ Ltd, Apr 17

A great collection of knowledgable speakers.

Matthew Burton, Jenson R+ Ltd, Apr 17