Dry Powder Inhalers: Annual Conference

The second generation of DPIs have become either established on the market or are a signifcant way along the approval process, these have been a great success story in improving inhaled drug delivery. However, we now have to tackle the technical and regulatory issues with ‘generic’ inhalers and their approval. The development of triple therapies is well underway, these bring about their own challenges of formulation and bioequivalence. Amazingly, new DPIs are still being created, with some moving in to development programs. Further, one of the areas where much study and recent guidance has been applied is in considering the patient use, compliance and human factors associated with DPIs. These linked topics are creating a whole new area that requires better understanding during product development and associated studies.

This annual conference aims to: address many of the issues around generic inhalers, provide case studies of bioequivalence testing, focus on the diffcult formulation challenges and the strategies used so that they may be overcome and to discuss in-depth patient and human factor issues when developing a DPI to gain regulatory approval.

• How to develop a generic DPI: from scratch to market
• Designing drugs for inhalation – achieving solutions
• How much does it cost to develop a generic DPI inhaler?
• Easyhaler device and performance under simulated real-life conditions
• Clinical Bioequivalence of latest drugs
• Asthma UK’s 2016 Annual Report
• The AOS add-on device as a novel tool to improve powder dispersion
• Parameters infuencing the performance of interactive blends for inhalation
• Challenges of industrialisation of a novel user friendly DPI
• Case study: comparing usability of two inhalers with the same drug but differen

Media partners

Exhibitors

Those involved in

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

9.00 Registration and refreshments

9.30 Chairman’s welcome and introduction

Dr Steve Nichols, Director, OINDP Consultancy, UK

09.40 Dry Powder Inhalers – the wrong hammer

• Deagglomeration in passive DPIs is like taking a sledgehammer to a walnut – but finding it doesn’t work
• So what is the “right” energy?
• What can we learn from this for future inhaler development…?

David Harris, Leading Respiratory Drug Delivery, PA Consulting Group, UK

10.20 How to develop a generic DPI: from scratch to market

• ICOres DPI platform case study
• Setting up the requirement specication for a generic DPI platform
• Quality by design development of key features
• Customer special adaptations
• Integration and optimisation with the formulation

Dr Orest Lastow, CEO, ICONOVO, Sweden

10.50 Discussion followed by refreshments

11.30 Designing drugs for inhalation – achieving solutions

• This presentation will attempt to overview the over lapping and sometimes competing molecular design parameters for novel inhaled candidates
• Examples will be described of how projects can seek to include physical form and formulation requirements in the fowchart for new candidate discovery

Steve Collingwood, Head of Chemistry, RespiVert, Ltd, The London Bioscience Innovation Centre, UK

12.10 Formulation of biologics for inhaled delivery

• Introduction and discussion of the current market
• Manufacturing process review and discussion of key manufacturing and formulation challenges
• Review of formulation strategies for biologics including discussion of current examples
• Overview of the testing approaches and differences for biologics compared to small molecules and how these interact with the development strategy

Mark Parry, Technical Director, Intertek Melbourn, UK

12.50 Discussion followed by Lunch

14.10 MRX001 and MRX003: how to get generic inhalers right

• Understanding the reference product and matching the target
• Perfect match v bio-equivalence
• IP hurdles and smokescreens: what routes for a 505j substitutable DPI device?
• The economics of a generic DP devices: reduce costs, reducing risks
• Avoid the route to disaster: don’t invest $MM on a filling line and skimp on the device

Phillipe Rogueda, Director and co-Founder, Merxin Ltd, France

14.50 Strategies for an efficient development of a Generic DPI Carrier Based Formulation

Lars Asking Vice President MVIC

15.30 Discussion followed by refreshments

16.10 Easyhaler device and performance under simulated real-life conditions

• Design, operating principles and user ergonomics
• Device and formulation integration
• Product performance under simulated real life conditions

Jussi Haikarainen, Senior Development Manager, Pharmaceutical Sciences Platform, Orion Corporation – Orion Pharma, Finland

16.50 Clinical bioequivalence of OT329 SOLIS and ADVAIR DISKUS

• Hurdles in bringing a AB-rated generic ICS/LABA combination product to market in the US are both technical and regulatory in nature
• Product-specific FDA guidance now require large clinical endpoint studies to support invitro and PK equivalence endings for orally-inhaled products
• Oriel has completed a clinical endpoint study demonstrating clinical lung function equivalence of OT329 SOLIS and ADVAIR DISKUS at Day 1 and week 4 of treatment

Malinda Longphre, Director, Clinical Research, Oriel Therapeutics, a Novartis Company, USA

Discussion followed by close of day one

17.45 – 18.45 Drinks reception for delegates and speakers

09.15 Review of day one

Mike Holroyd, Senior Director, Mylan, UK

09.30 Asthma UK’s 2016 Annual Survey

• What proportion of people with asthma are not receiving basic care?
• How does asthma affect people’s work, education and free time?
• How do prescription payments influence the lives of people with asthma?

Cat Broadbent, Senior Insight Analyst, Asthma UK

100.10 The AOS (Axial Oscillating Sphere) add-on device as a novel tool to improve powder dispersion

• Two version of RS01 device were tested with or without AOS
• Two laboratories at different altitudes performed the study
• Formoterol fumarate lactose blend was used
• Aerosol quality (dispersion) and effect of altitude/atmospheric pressure were evaluated

Francesca Buttini, Assistant Professor, University of Parma, Italy and Visiting Professor-King’s College London, UK

10.50 Discussion followed by refreshments

11.30 Parameters influencing the performance of interactive blends for inhalation

• Different types of interactive blends
• Micronised and particle engineered API
• Different carrier materials (lactose, mannitol and particle engineered materials)
  • Influence of fines in interactive blends
  • Influence of blending parameters

Dr Regina Scherliess, _Department of Pharmaceutical and Biopharmaceutics,
Christian-Albrecht University, Kiel, Germany_

12.10 Particle engineering using a novel dry coating technology – opportunities for DPI formulations

• Principle of dry coating for particle surface modification
• Particle engineering using dry coating for dry powder inhalers
• Flowability, content uniformity and in vitro evaluation of DPI dry coated particles
• Reverse engineering of particles to optimise dosage form performance

Professor Afzal R Mohammed, Director, Aston Particle Technologies, UK

12.50 Discussion followed by Lunch

14.10 Is dissolution a critical attribute for inhaled products?

• Dissolution methodologies for inhaled products
• Biorelevant techniques for studying dissolution
• The impact of dissolution on inhaled drug PK

Professor Ben Forbes, Professor of Pharmaceutics, King’s College London

14.50 Challenges of industrialisation of a novel user friendly DPI – a DPI case study on Presspart’s new PowdAir Plus

• Introduction on DPIs
• Understanding market and user needs
• Regulatory and quality requirements
• From design to product
• Production of a medical device

Dr. Anselm Ebert, _Global Business Development Manager, H&T Presspart, Germany*

15.30 Case study: comparing usability of two inhalers with the same drug but different user steps

• Defining the outcomes
• Identifying and comparing the use steps
• Deciding which use errors are important
• Comparing usability outcomes
• Usability and substitutability

Richard Featherstone, Managing Director, Medical Device Usability, UK

16.10 Discussion and Chairman’s closing remarks

16.30 Close of forum and refreshments

• Aptar France SAS
• Aptuit (Edinburgh) Ltd
• Bang & Olufsen Medicom AS
• Bespak Europe Ltd
• Bitop AG
• Boehringer Ingelheim Animal Health GmbH
• Capsugel - France
• CELLTECH
• Chiesi Farmaceutici S.p.A.
• Consultant
• DFE Pharma
• Exco InTouch Ltd
• Ferring Pharmaceuticals A/S
• Glenmark Pharmaceuticals Europe R&F Ltd
• Hovione Capital
• Kamada Ltd
• Laboratorios Linconsa S.A.
• Mikron SA Boudry
• NDA Regulatory Science Ltd
• Novartis Vaccines & Diagnostics AG
• Nypro Healthcare
• PERLOS LTD
• PH&T SpA
• Presspart Manufacturing Ltd
• SARTORIUS AG
• Siegfried Ltd
• Siegfried Pharma Development GmbH
• Takeda GmbH
• Technology Partnership Plc
• Unilever R&D Vlaardingen