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Pharmaceutical Medical Devices

Nasal Drug Delivery

12-13 Apr 2018

GBP EUR USD
Standard 1499 2099 2338
Excluding VAT @ 20.00%

Venue: Rembrandt Hotel, London

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Bespoke training

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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.

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

Previous customers include...

  • Acino Pharma AG
  • Aptar Pharma
  • ARADIGM CORPORATION
  • Archimedes Pharma UK Limited
  • CDC
  • Charles River Laboratories
  • Clinic of Allergy & Asthma
  • Copley Scientific Limited
  • CSL LTD
  • Danish University of Pharmaceutical Sciences
  • Ferring Middle East
  • Harro Hoefliger Verpackungsmaschinen Gmbh
  • Hoffmann Neopac AG
  • Impel NeuroPharma
  • J Uriach Y Compania
  • LTS Lohmann Therapie-Systeme AG
  • MeadWestvaco Calmar GmbH
  • Nolato Medical Business Area
  • PALATIN TECHNOLOGIES
  • ReGen Therapeutics Plc
  • Sanivo Pharma AS
  • STRIDES ARCOLAB LIMITED
  • Sulzer Mixpac AG
  • Synthon Biopharmaceuticals BV
  • Takeda Pharma A/S
  • Teva Branded Pharmaceutical Products R&D, Inc
  • Valois Dispray SA
  • Virginia Commonwealth University
  • WORLD HEALTH ORGANISATION
  • Zentiva Group AS