Nasal Drug Delivery

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

14-15 May 2020

GBP 1,499
EUR 2,099
USD 2,338

Book now

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 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.

Media Partner

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Newly updated programme for 2020 will be avialable in due course, please revisit this web page soon!

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 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 seminar 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

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
    Professor Valerie Lund

Discussion session

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

Nasal formulation of drugs

  • Formulation aspects of liquid systems
  • Carrier-based and matrix dry powder formulations for nasal delivery
  • (Nano)particulate drug carriers for nasal administration
  • Interplay of therapeutic targets and nasal deposition
    Dr Regina Scherliess

Discussion session

Developing next generation powder nasal delivery using POD technology

  • Device development efforts
  • Formulation development efforts
  • Unique challenges to powder delivery
    Christopher Fuller

Rethinking nasal packaging environment

  • Using integrated three-phase activ-polymer to control moisture ingress
  • Extend shelf life
  • Improve performance
    Lee Lucas

Discussion session

Key insights for a successful device development to achieve nasal bioequivalence requirements

  • Design and testing techniques for nasal spray devices
  • In-Vitro BioEquivalence (IVBE) requirements and region-specific regulatory strategies
  • Statistical tools and new alternative approach applied to nasal sprays
  • Key success factors for nasal spray development projects
    Pascale Farjas and Céline Petitcola

The unique challenges of nasal drug delivery to treat chronic rhinosinusitis (CRS); considerations before and after sinus surgery

  • Medical therapy in CRS – goals and challenges
  • Endoscopic sinus surgery – implications for drug deposition
  • Nasal delivery methods – advantages and limitations
    Per Djupesland

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 associated with BE/TE for nasal products

  • Average BE versus population BE
  • End point right, outcome wrong: why?
  • Getting the sample size right
  • Lessons learned from inhaled aerosol products
    Anders Fuglsang

US/FDA regulatory guidance on combination products

  • Origin and objective of the regulations
  • The regulation and guidance documents
  • Requirements and expectations of FDA
    Andrew Wood

Discussion session

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

Investigations regarding the developability of nasal metered dose inhalers

  • Findings
  • Opportunities
    Dr Jag Shur

What are chemisimilars and what’s the problem?

  • Standardisation
  • EU guidance
  • FDA guidance
  • Assay sensitivity and the best models to test for similarity
    Dr John Warren

Discussion session

Concluding remarks

Close of conference and refreshments

Presenters

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.

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.

Book now

14-15 May 2020
14-15 May 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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  • Abbott Healthcare Products BV
  • Alkermes Pharma Ireland Ltd
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  • ChemImage Corporation
  • Copley Scientific Limited
  • Elan Pharma International Ltd
  • F. Hoffmann-La Roche Ltd
  • Federal Institut for Drug and Medical Devices
  • Hoffmann-La Roche Incorporated
  • Indivior UK Limited
  • J Uriach Y Compania
  • Marinomed Biotechnologie GmbH
  • Munit SA
  • NASTECH PHARMACEUTICALS
  • Patheon UK Ltd
  • PFIZER PGRD
  • Raumedic UK Ltd
  • Research and Markets
  • Schwarz BioSciences GmbH
  • SOCRATEC R&D GmbH
  • Spital - Pharmazie
  • Strategic Pharmaceutical Advisors
  • Takeda Pharma A/S
  • Team Consulting Ltd
  • Teva Czech Industries S R O
  • Teva Pharmaceutical Industry Limited
  • UNIVERSITY OF AMSTERDAM
  • University of York
  • VIRSOL

I was able to take away relevant information from each presentation. Perhaps as I grow my knowledge, I was able to achieve my goal of getting a better understanding of the current status of N2B delivery and the CMOs that operate in this space. Great networking and worth the cost and time of international travel.

Michelle Sparks, Head of Product Development, Zafgen

Well organised, good agenda!

Michiharu Kageyama, Manager, Teijin Pharma Limited

Very well organised, good speakers.

Ana Campo Rodrigo, Postdoctoral Research Fellow, University of York

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

A great collection of knowledgable speakers

Matthew Burton, Jenson R+ Ltd

Excellent

Nicola Hardman, Jenson R+ Ltd