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Pharmaceutical Medical Devices

Dry Powder Inhalers: Annual Conference

There are no dates confirmed for this course yet. Please contact us for further information.

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Course Overview

Key annual conference for Pharmaceutical and Medical Device Professionals in the DPI Market

Speakers to include:

Dr Elizabeth Baker, Group Manager, Licensing Group 1 and Drug/Device Enquiries, MHRA
Peter Daley-Yates, Director, Clinical Pharmacology, GSK
Dr David Lewis, Head of Laboratory, Chippenham Research Centre, Chiesi

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KEY TOPICS TO BE COVERED INCLUDE

  • Generic DPIs – The Future
  • Human Factors in the Development of DPIs
  • Qualcomm Life: Connecting Inhalers Globally
  • Addressing the Needs of the Elderly Patient Requiring Orally Inhaled Therapy at Home – Focus on Dry Powder Inhalers
  • Aiming for the Lungs – Formulation Strategies for Delivery of Inhaled Biologics
  • Why are there Surprises When Correlating IVIV?
  • Regulatory Perspective on Inhalation Products
  • Oral versus Inhaled Drug Delivery for Respiratory Pharmacotherapy
  • Simplicity in Inhaler Design
  • Integrated Development and Scale-up of Combination Products
  • The In-Vivo Behaviour of Particles in the Extra Fine Region
  • Formulating Powder-Device Combinations for DPI Products
  • Mannitol as an Alternative to Lactose Dry Powder Inhalation

Sponsorship available

Why you should attend

  • Hear the latest technology in DPI formulation and development
  • Establish where the DPI market is going and the innovations being applied for patient compliance
  • Network with your peers and increase your business partnership potential

Who should attend

Those involved in

  • Respiratory drug development
  • Inhalation product development
  • Device engineering
  • Formulation Development
  • Scientific research
  • Medical marketing
  • Marketing and Business development

Programme Day One

09.30 Chairman’s Welcome and Introduction
Dr Steve Nichols, Director, OINDP Consultancy, UK

09.40 Review of DPI Developments over the Last Year
Dr Steve Nichols, Director, OINDP Consultancy, UK

10.20 Generic DPIs – The Future

  • What is happening?
  • Where is it going?
  • Future market opportunities
  • Influence of the East on the West

Philippe Rogueda, Executive Director, Aedestra, UK

10.50 Discussion

11.00 Refreshments

11.30 Human Factors in the Development of DPIs

  • Examples of how human factors can help you to develop a better DPI
  • Generic versus originator brand DPIs – human factors and the switch proposition

Richard Featherstone, Managing Director, Medical Device Usability, UK

12.10 Qualcomm Life: Connecting Inhalers Globally
Novartis case study on how Qualcomm Life´s Internet of Medical Things technology connects millions of inhalers

Thomas J. Olesen, Commercial Director, Qualcomm Life, Europe, Germany

12.50 Discussion

13.00 Lunch

14.10 Addressing the Needs of the Elderly Patient Requiring Orally Inhaled Therapy at Home – Focus on Dry Powder Inhalers

  • Introducing the elderly patient needing chronic inhaled therapy at home
  • The likely disease scenario: asthma, COPD, asthma-COPD overlap
    syndrome, other respiratory diseases, comorbidity, polypharmacy
  • Cognition or lack thereof: importance of intuitive patient interface for the patient/care-giver
  • Manual dexterity: can the patient operate the device
  • Instructions for Use: Are they useful to the patient/caregiver?
  • Importance of human factors analysis in the design of dry powder inhalers for the elderly: ISO 20072: 2009 – importance of the device functionality profile
  • How do we improve the elderly patient/care-giver experience

Jolyon Mitchell, Owner and CEO, Jolyon Mitchell Inhaler Consulting Services Inc., USA

14.50 Aiming for the Lungs – Formulation Strategies for Delivery of Inhaled Biologics

  • Formulation and delivery of biologic molecules via dry powder inhalation
  • Opportunities and challenges in the field.

Charlotte Yates, Team Leader – Pharmaceutical Development, Vectura, UK

15.30 Discussion

15.40 Refreshments

16.10 Why are there Surprises When Correlating IVIV?

  • Current approaches
  • Case studies showing unexpected IVIVC
  • Is a risk-based approach helpful?

Dr. Herbert Wachtel, Analytical Development, Boehringer Ingelheim Pharma GmbH & Co. KG

16.50 Regulatory Perspective on Inhalation Products
Dr Elizabeth Baker, Group Manager, Licensing Group 1 and Drug/Device Enquiries, MHRA, UK

17.30 Discussion

17.45 End of Day One

17.45 – 18.45 Drinks reception for Delegates and Speakers

Programme Day Two

09.15 Review of Day One
Mike Holroyd, Senior Director, Mylan

09.30 Oral versus Inhaled Drug Delivery for Respiratory Pharmacotherapy

  • Oral and inhaled drugs approved and in development
  • The pros and cons of the inhaled versus the oral route of administration
  • The pros and cons of dual and triple inhaled therapies versus monotherapies
    and oral drugs

Peter Daley-Yates, Director, Clinical Pharmacology, GSK, UK

10.10 Simplicity in Inhaler Design

  • The making of PowdAir: how simple inhalers drive success in human factors studies
  • Scaling up TwinCaps DPI delivered dose four-fold

João Ventura, Business Development Manager, Hovione Technology Ltd, Portugal

10.50 Discussion

11.00 Refreshments

11.30 Integrated Development and Scale-up of Combination Products
Smaller and smarter combination products to support the trend toward patient-administered drug delivery

  • Integrating HFE and DFM/DFA as foundations of the combination product development process
  • Early manufacturing involvement to speed up time-to-market and reduce risk by “getting it right the first time”
  • Development of a manufacturing scale-up strategy, concurrent with the development process

Bill Welch, Chief Technology Officer, Phillips-Medisize Corporation, USA

12.10 Case Study: New Combination DPI
Yorick Kamlag, Head of Pharmaceutical Development, Zentiva Inhalationsprodukte, GmbH

12.50 Discussion

13.00 Lunch

14.10 The In-Vivo Behaviour of Particles in the Extra Fine Region: Exploring the Potential Advantages of Extra Fine Particle Delivery and the Technology that can Help to Achieve it

  • The potential advantages of extra fine inhaled drug delivery: a number of studies have shown that there may be important clinical advantages to using extra fine drug delivery to, for example, enhance deposition in the peripheral airways and to control the consistency of drug delivery in the face of device use by different patients, with different inhalation profiles
  • Formulating with extra fine particles: although many formulations already contain extra fine particles they are difficult to detect and study. Effective formulation with extra fine particles may require the refinement of certain measurement strategies to provide the data needed to progress
  • The practicalities of delivery: effective dispersion of a DPI dose is always a prime area of concern when developing a new product. Dispersion into the extra fine region intensifies the challenge but there is device technology that can help

Dr David Lewis, Head of Laboratory, Chippenham Research Centre, Chiesi, UK

14.50 Formulating Powder-Device Combinations for DPI Products

  • The role of the device in formulation development
  • The impact of different powder and device parameters on product performance • Robust formulation development best practices

Mark Parry, Technical Director, Intertek Melbourn, UK

15.30 Mannitol as an Alternative to Lactose Dry Powder Inhalation

  • General requirements for carriers in dry powder inhalation
  • Properties and advantages of mannitol in comparison to lactose
  • Case studies of mannitol in dry powder inhalation

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

Discussion

Chairman’s Closing Remarks

Close of Conference and Refreshments

Previous customers include...

  • 3M Healthcare Ltd
  • Aarti Industries Ltd
  • Almirall S.A.
  • Aptar France SAS
  • Ballington Hall Associates
  • BIOGEN IDEC FRANCE SA
  • Catalent Pharma Solutions
  • Celanese Emulsions BV
  • CSP Technologies
  • F. Hoffmann-La Roche Ltd
  • Farmaprojects S.A.
  • Ferring Pharmaceuticals A/S
  • Fraunhofer ITEM
  • Gerresheimer Regensburg GmbH
  • Glenmark Pharmaceuticals Europe R&F Ltd
  • IGS Gebojagema
  • Kamada Ltd
  • Laboratoires SMB
  • Laboratorio Dosa SA
  • LICONSA
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Merck Pharmaceuticals Limited
  • Molkerei MEGGLE Wasserburg GmbH & Co KG
  • PERLOS LTD
  • Polpharma SA
  • Ranbaxy Laboratories Ltd
  • RCC LTD
  • Rexam Healthcare La Verpilliere
  • Rexam Pharma GmbH
  • STADA Arzneimittel AG