Inhalation Drug Development: Emerging Trends and Markets 28 - 29 September 2010, Ambassadors Bloomsbury
1. www.informa-ls.com/inhalation A breath of fresh air: New trends
and solutions for your
Inhalation Drug inhalation drug
development
programmes
Development: Featuring Inhalation
Specialists from the USA
• Robert Baughman, Vice President -
Experimental Pharmacology,
Emerging Trends
Mannkind, USA
• John Patton, President and CEO,
Dance Pharmaceuticals, USA
• Sarvajna Dwivedi, Executive Vice President,
R&D and Co-Founder, Pearl Therapeutics, USA
and Markets
• Robert Sievers, Professor, Department of
Chemistry and Biochemistry and Centre for
Pharmaceutical Biotechnology,
University of Colorado, USA
Exploring the future of inhalation drug delivery and showcasing European Industry Leaders
• Frank Chambers, Senior Scientist Inhalation
advances in inhalation drug formulation and development R&T, AstraZeneca, UK
28 – 29 September 2010 • Ambassadors Bloomsbury Hotel • London • UK • Peter Barnes, Head of Respiratory Medicine,
Imperial College London, UK
Benefits of Attending in 2010: • Jussi Haikarainen, Development Manager
Inhalation Technology, Orion, Finland
• Gain a comprehensive understanding of regulatory requirements for • Michael Goller, Associate Director
inhalation drug development in Europe and USA Respiratory R&D, Teva Pharmachemie, The
• Explore novel developments in inhalation drug development, including Netherlands
• Birte Jensen, Principle Scientist, Respiratory
inhaled insulin, inhaled vaccines and new targets for COPD
Drug Delivery, Boehringer Ingelheim
• Learn techniques to be more efficient in measuring particle size Pharma, Germany
distribution, including an overview of the AIM concept • Anders Fuglsang, Clinical and Regulatory
• Discover applications and limitations of methods in improving Strategy Manager, Aeropharm GmbH,
bioequivalence and bioavailability of inhaled drugs Germany
• Frank Thielmann, Senior Fellow, Novartis
• Assess the impact of particle morphology on aerosol performance
Horsham Research Centre, UK
• Understand the influence of formulation and excipients on product • Andrew Brown, Head of Manufacturing,
stability and performance Oriel Therapeutics, UK
Monday 27 September 2010: Pre-conference workshop • Norbert Rasenack, Fellow, Pharmaceutical
Development, Novartis Pharma AG,
CRUCIAL PRE-CONFERENCE INTRODUCTION TO THOSE NEW TO THE Switzerland
INHALATION INDUSTRY • Peter Daley-Yates, Director Clinical
Inhalation Drug Delivery Device Technology Masterclass: Pharmacology, GlaxoSmithKline, UK
A comprehensive guide to successfully developing inhalation products • Claus-Michael Lehr, Helmholtz Institute of
Led by: Ola Nerbrink, Independent Consultant, Respiron Consulting, Sweden and Pharmaceutical Research, Saarland
David Howlett, Owner, Pharma Delivery Solutions Ltd, UK University, Saarbrücken, Germany
Tuesday 29 June 2010: Meet and greet breakfast seminar • Francesca Buttini, Post-doc Research Fellow,
FREE Department of Pharmacy, University of
Maximise your networking time while ‘ensuring collaborations Parma, Italy
Breakfast
enhance rather than stifle exploitation of new technology’
Seminar Media partner
Led by: Craig Thomson, Attorney, Murgitroyd & Company, UK
Tuesday 29 June 2010: Evening seminar
Establishing equivalence in line-extension and generic inhalation drug
development
Led by: Anders Fuglsang, Clinical and Regulatory Strategy Manager, Aeropharm GmbH, Germany
To Register Please Tel: +44 (0) 20 7017 7481 Fax: +44 (0) 20 7017 7823
Email: registrations@informa-ls.com Please Quote CQ5122
3. Optimise the success of your inhalation drug development programmes
• Case study examples of bioequivalence evaluation 17.05 What happens after landings?: Modulating absorption and clearance
• Comparisons of in vitro, pharmacokinetic, pharmacodynamic and efficacy processes in the lung by inhalation nanomedicines
endpoints • How do drugs and particles get across the air-blood barrier – insights from
• Utility and limitations of pharmacokinetic methods new in vitro models
Peter Daley-Yates, Director Clinical Pharmacology, GlaxoSmithKline, UK • Can mucociliary and macrophage clearance be avoided?
• Cellular targeting and delivery of inhaled nanomedicines - new
16.30 Bioavailability of inhaled drugs perspectives to treat lung cancer
• Correlation between particle size and in vivo behaviour Claus-Michael Lehr, Professor and Head of Department Drug Delivery,
• Relieving the burden of doing large clinical trials – how well does Helmholtz Institute of Pharmaceutical Research, Saarland University,
laboratory data translate to the patient? Saarbrücken, Germany
• Relevance of systemic bioavailability for local therapy
• Exploring bioavailability of inhaled medicines to disease lesions 17.40 Closing remarks from the Chair
John Patton, President and CEO, Dance Pharmaceuticals, USA
17.45 End of day one
Evening seminar – Tuesday 28 September 2010
Establishing equivalence in line-extension and generic inhalation drug development
Led by: Anders Fuglsang, Clinical and Regulatory Strategy Manager, Aeropharm GmbH, Germany
Discussion Panel will include John Patton, President and CEO, Dance Pharmaceuticals, USA
18.00 for 18.15 start. The seminar will finish no later than 21.30. This seminar will include documentation and evening meal.
Establishing equivalence in line-extension and generic inhalation drug By means of presentation and group discussions, participants will:
development • Gain practical advice to design efficient studies for the demonstration of
Do you have problems understanding what is comparable and understanding the equivalence
degree of sameness? This participative evening seminar will cover: ways to measure • Understand the scientific bottlenecks in inhalation drug development
equivalence, including in vitro, pharmacokinetic and pharmacodynamic equivalence; • Learn to navigate the murky waters of regulatory requirements for inhalation
how to prove your product is the same in terms of quality and efficacy; and the drug development
parameters required to prove comparability to regulatory authorities.
Formulation Considerations and Drug Stability
Day Two: Wednesday 29 September 2010
13.30 Influence of particle morphology on aerosol performance
09.00 Opening remarks from the Chair • Micronisation and particle engineering: Opportunities, pros and cons
Frank Thielmann, Senior Fellow, Novartis Horsham Research Centre, UK • Effect of manufacturing technique on particle morphology and drug
product performance
Advances in Analytical and Characterisation Techniques • Opportunities of a seamless drug substance-drug product interface
• Influence of morphology factors, e.g. surface characteristics, particle
9.10 Advances in physico-chemical characterisation techniques charge, shape, on aerosol performance
• Requirements with respect to physico-chemical parameters • Impact of particle characteristics on aerosol efficacy
• Methods for determining glass transition, amorphous content and Norbert Rasenack, Fellow, Pharmaceutical Development, Novartis Pharma
crystalline structure AG, Switzerland
• Electrical properties and triboelectrification
• Active centres and energy distribution - new methods for characterisation 14.05 Novel developments and applications in formulation preparation techniques
Frank Thielmann, Senior Fellow, Novartis Horsham Research Centre, UK • High shear versus low shear blending of dry powders
– Challenges of combining high lung deposition with low dose variability
9.45 Measuring particle size distribution: Can we reduce the analytical – Importance of ensuring a robust final manufacturing process
burden? Michael Goller, Associate Director Respiratory R&D, Teva Pharmachemie,
• How the AIM concept is being used for rapid screening of formulations The Netherlands
• Overview of the 2-stage impactor – benefits and challenges
• Accuracy in predicting functionality 14.40 Afternoon tea and networking
Frank Chambers, Senior Scientist Inhalation R&T, AstraZeneca, UK
15.10 Optimising dry powder inhaler performance through formulation
10.20 Morning coffee and networking • Current challenges in dry powder formulations
• Impact of excipients on product performance
10.50 Characterisation by dissolution testing • Interactions between the device and the formulation
• Is dissolution testing feasible for inhalation products? • Manufacturing considerations
• Challenges/benefits of dissolution testing for inhalables Andrew Brown, Head of Manufacturing, Oriel Therapeutics, UK
• Comparison of different dissolution test methods
Birte Jensen, Principle Scientist, Respiratory Drug Delivery, Boehringer 15.45 Managing excipients in inhalation drug development: DPI options
Ingelheim Pharma, Germany • Requirements for excipients and regulatory aspects (liquid/powder)
• Excipient surface characteristics on DPI performance: How to manipulate this
11.25 Advances in analytical techniques for drug substance/drug product • Influence of excipients on performance and stability
characterisation Francesca Buttini, Post-doc Research Fellow, Department of Pharmacy,
• Application of QbD in inhalation drug development University of Parma, Italy
• Laser diffraction for micronised drug substance
• Dynamic particle engineering for lactose carriers 16.20 Combination inhaled products: Key challenges for product development
Rachel Brody, Principal Scientist, Pfizer, UK • Benefits of combination products
• Considerations for different inhalation device platforms
12.00 SPOTLIGHT SESSION • Novel approaches to combination product development
Raise your corporate profile by sponsoring or exhibiting at the 2nd Annual Nayna Govind, Team Manager, AstraZeneca, UK
Inhalation Drug Development conference. For details on speaking in this
session or other sponsorship opportunities at this conference please contact: 16.55 Discussion of issues arising from the conference and closing remarks from
Ben Edwards, Tel: +44 (0)207 017 4447, Email: ben.edwards@informa.com the Chair
12.30 Lunch 17.30 End of day two
PROMOTIONAL OPPORTUNITIES
Raise your corporate profile by sponsoring or exhibiting at the 3rd Annual Genotoxic Impurities conference. For details on promotional
opportunities at this conference please contact: Sukhvir Hayre, Tel: +44 (0)207 017 7131, Email: sukhvir.hayre@informa.com
To Register Please Tel: +44 (0) 20 7017 7481 Fax: +44 (0) 20 7017 7823
Book online: www.informa-ls.com/inhalation Email: registrations@informa-ls.com
Please Quote CQ5122
4. Inhalation Drug Development Conference Code: CQ5122C
28 – 29 September 2010, Ambassadors Bloomsbury, London, UK Pre-Conf Workshop Code: CQ5122X
www.informa-ls.com/inhalation Evening seminar code: CQ5122Y
5 Easy ways to Register
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Full Pass: Conference + pre-conf CQ5122CXY 27-29 Sept £2497+ VAT@17.5% ????? £2597+ VAT@17.5% ????? £2697+ VAT@17.5% ?????
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