Inhaled Drug Delivery Summit 2019 - Kongress / Konferenz von Qepler s.r.o.

Assess and harness novel approaches to the development of inhaled drug products for enhanced patient care.

Inhalte

CONFERENCE OVERVIEW:

The recent years have witnessed major growth in the inhaled drugs market driven by rising prevalence of chronic pulmonary diseases, the evolution of inhaled therapies and technological advancements in device development.

Challenges still remain to ensure safe and efficient respiratory drug delivery - including device and drug integration, particle engineering and formulation technologies, clinical studies and regulatory pathways.

Our meeting facilitates hands-on experience sharing of successful development of inhaled drug products for enhanced patient care.

 

CONFERENCE PROGRAM:

Day 1st | Thursday, 23 May 2019

08:30 - Registration and Welcome Coffee 09:00 - Opening Address from the Chairman

PART 1: REGULATORY UPDATES

09:10 - Clash of the cultures: Requirements for inhalation bioequivalence – contrasts between US, EU, Australia, Japan, Brazil.

  • Which regulations exist in US, EU and other countries?
  • What are the differences between US and EU requirements for bioequivalence of inhalation products?
  • Why are there such differences?
  • Is harmonization possible?

Dr. Stefan Leiner,Chemical-Pharmaceutical Expert, Boehringer Ingelheim, Germany

09:50 - Speed ​​Networking

PART 2: INNOVATIVE TECHNOLOGIES

10:30 - Applying the TRIZ Methodology to Medical Device Innovations.

  • What is TRIZ?
  • Five Stage TRIZ Model for Medical Device Innovations
  • Case study of TRIZ to Auto-injector Designs

Dr. René Dathe,Head Medical Devices Quality Dev. Sandoz & LCM, Novartis, Germany

11:10 - Morning coffee and networking break

11:40 - The pMDI, issues, opportunities and the future for the current generation of products.

  • The ideal inhaled product QTPP
  • Issues with the pMDI:
  • Adherence
  • Patient User errors
  • Quality aspects
  • Environment
  • Opportunities:
  • Enhancements to address adherence
  • Enhancements to address user errors
  • Replacement:
  • Alternative delivery platforms
  • Reformulated pMDI

Paul Johnson Director, Paul Johnson Consulting Limited, United Kingdom

12:20 - Development of a generic triple combination product – hurdles and opportunities.

  • Why triple combinations to treat asthma and COPD? What are the clinical benefits?
  • API combinations on the market or in the clinical pipeline
  • Formulation challenges with triple combination
  • Special device requirements and availability
  • Hurdles and opportunities for generic companies

Dr. Orest Lastow,CEO, Iconovo AB, Sweden

13:00 -  Business lunch

14:00 - Nebulized therapy: advantages, innovations and new advances. Nebulisers development.

John Pritchard Independent Business Owner, Inspiring Strategies, United Kingdom

PART 3: FORMULATION, DEVELOPMENT & DESIGN

14:40 - MDI IVIVR.

Alex Slowey, Formulation Specialist, 3M United Kingdom PLC, United Kingdom

15:20 -  Afternoon coffee and networking break

15:50 - Development of an in vitro high content analysis screen to assess new compounds and formulations for adverse alveolar macrophage effects.

  • Macrophage responses in non-clinical safety studies for oral inhaled products
  • Description of an in vitro high content analysis screening assay to identify and characterise compound effects on macrophages
  • Effects of different drug classes on macrophages: Beta-agonists, corticosteroids, antimuscarinics, antibiotics, etc
  • The impact of species differences on assay results
  • Future development work

Prof. Dr. Lea Ann Dailey,Head of the Biopharmacy group, Martin Luther University, Germany

16:30 - Rethinking DPI packaging environment. Using integrated three-phase Activ-polymer to control moisture ingress and improve performance.

Badre Hammond, MBA, Director, Market Development, Aptar Pharma, USA

17:10 - Panel Discussion

17:40 - Chairman's closing remarks and end of day one 19:00 - Business dinner

 

Day 2nd | Friday, 24 May 2019

08:30 -  Registration and Welcome Coffee 09:00 -  Opening Address from the Chairman

PART 4: FORMULATION, DEVELOPMENT & DESIGN

09:10 - Engineering particles to deliver high dosed and sensitive drugs to the lung using standard inhaler systems.

  • The changing portfolio of development compounds and challenges for pulmonary delivery
  • Formulation technologies for DPI to address these emerging challenges
  • Considerations for technology selection
  • Application of spray drying in DPI formulation
  • Case study

Sven Stegemann, Professor for Patient Centric Drug Development and Manufacturing, Graz University of Technology,  Austria

09:50 - Dosing and process control technologies to cover the wide variety of Dry Powder Inhalers.

Dosing systems to fill DPI have to be adapted to the type of containment to be filled, the dosing range and the powder properties.

The functional principle of the different technologies, the integration into production machines and the requirements regarding powder properties will be described.

To mitigate the risk for under-filling during production, not being detected by statistical in-process controls, systems for the 100% in-line verification of fill weights have been developed.

Three different approaches will be presented.

Dr. Karlheinz Seyfang,Principal Consultant Pharmaceutical Technology, Harro Höfliger Verpackungsmaschinen GmbH, Germany

10:30 -  Morning coffee and networking break

11:00 - Experimental investigation of inhaled nanoparticles in the respiratory tract.

His presentation provides an overview on experimental studies of the deposition of inhaled nanoparticles in the respiratory tract.

It also describes some possible benefits of using nanoparticles in medical inhalation applications.

Finally, a new method is presented for detection of respiratory disease based on the deposition of nanoparticles.

Jakob Löndahl, Associate Professor, Lund University, Sweden

11:40 - Nano-structured Microparticles for pulmonary application.

  • Microparticles composed out of nanoparticles
  • Preparation and flying properties of such particles
  • Microparticle matrix for stabilization of such particles
  • Functional aspects of the microparticle matrix

Prof. Dr. Marc Schneider,Full Professor (W3) Chair Biopharmaceutics and Pharmaceutical Technology, Saarland University, Germany

12:20 -  Business lunch

PART 5: ANALYTICAL APPROACHES & SPECIFICATIONS

12:05 - Using mathematical modeling to address many of the challenges associated with the estimation of local lung concentration after inhaled drug delivery.

  • Multiscale mechanism-based integrated computational platform developed to provide mechanistic insights into key complex species-specific physiological-based processes associated with pulmonary drug delivery.
  • Model qualification using existing lung and systemic data from the literature.
  • Effect of breathing patterns on lung deposition and PK.
  • Translation of systemic and lung PK from preclinical species to humans using in-silico lung platform.
  • Effect of physicochemical properties on lung selectivity.

Dr. Antonio Cabal,Principal Scientist, Merck Research Labs, USA

14:00 - Material selection for OINDPs (orally inhaled and nasal drug products).

  • Types of materials
  • Priorities for selecting materials
  • Physical vs chemical vs chemical vs change management
  • Risk Management for materials and components

Andrew Feilden, Technical director, Smithers Rapra Ltd., United Kingdom

14:40 - Afternoon coffee and networking break

15:10 - New lung disposition software: Derisking inhaled product changes using predictive models.

  • Prediction of bioavalability/bioequivalence
  • Device/formulation changes during development
  • Generic development
  • New software for prediction of lung deposition and PK: Mimetikos Preludium
  • Key performance attributes using clinically relevant test methods
  • Examples

Bo Olsson, PhD, Senior Inhalation Consultant, Emmace Consulting AB, Sweden

PART 6: INHALATION & THERAPEUTICS

15:50 - Inhaled antimicrobials: Current strategies and future challenges.

  • Evaluation of inhaled antimicrobials in CF, bronchiectasis, COPD and VAP
  • Available drugs and compounds in the pipeline
  • Formulations and and devices for inhaled antimicrobial delivery

Dr. Carsten Ehrhardt,Professor in Pharmaceutics and Biopharmaceutics, Trinity College Dublin, Ireland

16:30 -  Panel Discussion17:00 -  Chairman's closing remarks and end of summit

Lernziele

THE FEATURED TALKS ON:

  • Regulatory pathways in global respiratory market
  • Future needs for inhaled delivery systems
  • Safe and intuitive solutions for home care treatments
  • Human factor design and connecting technologies
  • Integrated development program for inhaled products
  • Next generation of molecules for pulmonary delivery
  • Preclinical inhalation drug development
  • Challenges of developing a generic inhalation product
  • Particle engineering for pulmonary drug delivery
  • Bioequivalence of inhalation products
  • Analytical tools for inhaled medicines
  • Manufacturing processes and selection of the right parameters

Zielgruppen

INDUSTRIES:

  • Pharmaceutical
  • Biotechnology
  • Medical Devices
  • Plastics
  • Chemicals
  • CMO/ CDMO
  • CRO
  • NOP

DIVISIONS:

  • Aerosols
  • Asthma
  • Combination Products
  • Connective Health
  • COPD
  • Cystic Fibrosis
  • Device Development & Engineering
  • Drug Development & Delivery
  • Dry Powder Inhalers
  • E-Health
  • Formulation Development
  • Generics
  • Inhalation Delivery
  • Inhalation Product Development
  • Inhalation Products
  • Inhaled Dosage Forms
  • Medical Devices
  • Metered Dose Inhalers
  • Nasal Delivery
  • New Materials
  • Particle Characterisation
  • Process Development
  • Pulmonary Delivery
  • Pulmonary Diseases
  • R&D
  • Regulatory Affairs
  • Respiratory Delivery
  • Respiratory Drug Delivery & Development
  • Respiratory Supply Chain
  • Respiratory Therapeutics
  • Respiratory Pharmacology
  • Scientific Research
  • Marketing & Business Development

Termine und Orte

Datum Uhrzeit Dauer Preis
Berlin, DE
23.05.2019 - 24.05.2019 08:30 - 17:00 Uhr 16 h Jetzt buchen ›

SG-Seminar-Nr.: 5210043

Anbieter-Seminar-Nr.: qinhaled19

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  • 23.05.2019 - 24.05.2019

    Berlin, DE

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Datum Uhrzeit Dauer Preis
Berlin, DE
23.05.2019 - 24.05.2019 08:30 - 17:00 Uhr 16 h Jetzt buchen ›