This document provides information about an upcoming conference on amorphous materials to be held on May 18-19, 2010 in Ljubljana, Slovenia. The conference will explore fundamentals of amorphous forms and how to optimize commercial success with amorphous materials. Speakers will include experts from universities and pharmaceutical companies. Topics will include predicting stability, classification of materials, methods for accessing stability, and manufacturing processes. Attendees can learn practical solutions for developing amorphous drugs and gain insights from industries like biologics and food. The pre-conference workshop on May 17 will focus on analytical techniques for measuring amorphous content.

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Exploring the fundamentals of the amorphous form to
optimise your commercial success
18 -19 May 2010 | Hotel Lev | Ljubljana | Slovenia
This year’s amorphous experts include: Benefits of Attending:
• Guy van den Mooter, University of • Learn how to predict the stability of your
Leuven, Belgium amorphous material by understanding molecular
• Peter van Hoof, Schering Plough, dynamics
The Netherlands
• Geert Verreck, Johnson & Johnson • Explore the classification of materials according
Pharmaceutical R & D, Belgium to their ability to become amorphous
• Pernille Hemmingsen, Egalet a/s, • Understand methods for accessing and
Denmark
maintaining the stability of amorphous materials
• Staffan Schantz, AstraZeneca R&D,
Sweden • Determine the appropriate manufacturing process
• Denny Mahlin, Uppsala University, for your API
Sweden
• Gain practical advice from the biologics industry
• Sarah Nicholson, Bristol-Myers
Squibb, UK • Discover the application of the amorphous form
• Yaroslav Khimyak, University of in the food industry and share lessons learnt
Liverpool, UK
• Obtain practical solutions to the scale-up process
• Jerry Heng, Imperial College, UK
• Frank Thielmann, Novartis Horsham • Hear updates on the patenting environment
Research Centre, UK concerning amorphous materials
Plus don’t miss:
Monday 17 May 2010: Pre-conference workshop
Quantifying amorphous content: Best practice analytical techniques for your API
Led by: Paul Royall, Lecturer, Pharmaceutics Department, King’s College London, UK
Why you should attend:
• Obtain a deeper insight into analytical techniques and have your questions answered
• Discover novel applications of existing analytical techniques
• Explore the pertinent properties that are essential to measure
Media Partners
The course is CPD accredited,
gaining you formal recognition
for your attendance
To Register Please Tel: +44 (0) 20 7017 7481
Web: www.informa-ls.com/amorphous
Fax: +44 (0) 20 7017 7823 Email: registrations@informa-ls.com Please quote CQ5118

2. “Very good summary of the amorphous pharmaceuticals field”
Principal Scientist | Johnson and Johnson
Pre-conference workshop – Monday 17 May 2010
Quantifying amorphous content: Best practice analytical techniques for your API
Led by: Paul Royall, Lecturer, Pharmaceutics Department, King’s College London, UK
Registration is at 9.30 for a 10.00 start. The workshop will finish no later than 17.00. Lunch, refreshments and workshop material will be provided.
Amorphous materials, whether encountered to meet a drug delivery This workshop will:
need or as an unwanted side effect of processing the pure API, are • Explore the pertinent properties that are essential to measure
becoming increasingly prominent within pharmaceutical literature,
regulatory guidance and in the design of novel formulations. • Introduce novel approaches to the quantitative analysis of the
Whichever your situation, a broad library of analytical tools is content of amorphous materials
required to measure the properties of amorphous or semi-amorphous • Discuss new applications of established analytical methods
materials.
• Facilitate the decision of the best practice method for your API,
This interactive workshop will feature presentations, scenarios and including analytical techniques to find short range order
problem solving exercises, with an emphasis on applying and
transferring the knowledge discussed. • Review software packages for analysis
Day One: Tuesday 18 May 2010
08.30 Registration • Determining changes in surface properties (surface
energetics and surface roughness) of amorphous/
09.00 Opening remarks from the Chair crystalline solids as a function of temperature, % relative
humidity and time
Understanding the Fundamentals of • Practical applications in drug delivery (e.g. Solubility)
Amorphous Materials Jerry Heng, Lecturer, Department of Chemical Engineering,
Imperial College, UK
09.10 Taming the beast that is amorphous
• Unique properties of amorphous materials 12.35 Lunch
• Key challenges and benefits of working with amorphous
materials 13.45 Relevance of relaxation of the amorphous state for solid
• History of the use of amorphous materials dosage form development
• New amorphous drug substances • Micronisation and post micronisation treatment of API's and
Pernille Hemmingsen, Director Formulation Development, excipients
Egalet a/s, Denmark • Physical stability of drug substance and drug product upon
storage
09.45 Assessing molecular dynamics and mobility of the • Physical properties to characterise the amorphous state
amorphous form • Relaxation mechanisms and measurement
• Gaining and using molecular level information Frank Thielmann, Senior Fellow, Novartis Horsham Research
• Characterising and regulating molecular information Centre, UK
• Relating molecular level to global characteristics
Yaroslav Khimyak, Lecturer, Department of Chemistry, 14.20 Lessons learned from the food industry and practical
University of Liverpool, UK solutions for nutraceuticals and biopharmaceuticals
• Developing the “Food Polymer Science” framework of Slade
10.20 Managing the viscous nature of amorphous materials and Levine
• Characterising amorphous materials • Progress towards the rational development of amorphous
• Stability mechanisms food systems for delivering functionality
• Techniques for measuring ‘stickiness’ • Microscale and nanoscale structuring of oral delivery
• Processing viscous materials systems
Staffan Schantz, Principal Scientist, AstraZeneca R&D, Roger Parker, Senior Scientist, Food Structure and Health
Sweden Programme, Institute of Food Research, Norwich, UK
10.55 Morning coffee 14.55 Speed networking and afternoon tea
• SPEED NETWORKING – the perfect opportunity to leave
Early Stage, Formulation and Design Considerations with a pocket full of business cards and numerous new
for Amorphous Materials professional contacts
• Network with industry peers one-on-one, a few minutes at a
11.25 Predicting the ability of organic compounds to be amorphous time
• Which compounds can benefit from being transformed into • Make initial contacts to continue networking at the end of the
the amorphous form? conference day, while admiring the beautiful streets of
• Can sorting tools be used to judge an organic compound’s Ljubljana
propensity to form stable amorphous materials?
• Increasing dissolution by amorphization - is it worth the 15.35 The use of porous Silica as a formulation strategy for poorly
effort? soluble drugs
Denny Mahlin, Assistant Professor, Department of Pharmacy, • Overview of the methodology
Uppsala University, Sweden • Pros and cons of the technique
• Ability to stabilise the amorphous form
12.00 The effects of powder processing on amorphous content of • Examples
pharmaceutical solids Guy van den Mooter, Full Professor, Department of
• Particle engineering - effects of milling and drying on Pharmaceutical Sciences, Laboratory of Pharmacotechnology
pharmaceutical solids and Biopharmacy, University of Leuven, Belgium
To Register
Please Tel: +44 (0) 20 7017 7481 Fax: +44 (0) 20 7017 7823
Email: registrations@informa-ls.com Web: www.informa-ls.com/amorphous Please quote CQ5118

3. “Nice conference with good presentations and good atmosphere”
Pharmaceutical Scientist | Solvay Pharmaceuticals
16.10 Third generation solid dispersion 17.00 Complimentary guided walking tour of Ljubljana
• Benefits of using solid dispersion
• Solid dispersion classification Unique opportunity to see the
• Considerations in solid dispersion formation beautiful sights of Slovenia
• Case study Relax and unwind after day one with a
Teófilo Vasconcelos, Formulation Scientist, Laboratory of
Pharmaceutical Development, BIAL, Portugal (awaiting final complimentary guided walking tour of
confirmation) Ljubljana. The tour will take you through
the picturesque city centre, including a
16.45 Closing remarks from the Chair
visit to the Ljubljana Castle – the perfect
16.50 End of day one photo opportunity. Don’t miss this chance to mix business with pleasure!
Day Two: Wednesday 19 May 2010
09.00 Opening remarks from the Chair 13.45 Lessons learnt from biologics
• Nature of biomolecules and comparisons to amorphous
Addressing the Instability of Amorphous Materials materials
• Overview of the lyophilisation technique: Pros and cons
09.10 Understanding the correlation between physical and chemical • Formulation of biomolecules and related solid state
properties and long term stability investigations
• Overview of the factors necessary for stability Holger Grohganz, Assistant Professor, Department of
• Effects of temperature and relative humidity Pharmaceutics and Analytical Chemistry, University of
• Conditions under which amorphous is converted to crystalline Copenhagen, Denmark
form
• How to assess long term stability in a short time frame 14.20 From pilot to production: Lessons from the scale-up process
Sarah Nicholson, Principal Scientist, Biopharmaceutics R&D, • Overview of the scale-up technique
Bristol-Myers Squibb, UK • Key challenges and successes
• Lessons learnt
09.45 How to stabilise and characterise the amorphous material in Geert Verreck, Principal Scientist, Johnson & Johnson
solid dosage forms Pharmaceutical R & D, Belgium
• Techniques to characterise amorphous material in tablet form
• How to identify when a product starts to crystallise in tablet 14.55 Afternoon tea
format
• How the amorphous material was kept stable Legal Environment
• How long the amorphous material was kept stable
• Long term storage of the solid dose form 15.25 Patents: Amorphous materials and formulations
Peter van Hoof, Director, Solid State Characterisation, Schering • Satisfying patentability requirements
Plough, The Netherlands • Practical advice to drafting strong claims
10.20 Morning coffee • Assessing infringement
• Recent case law example
10.50 Amorphous materials: The importance of formulation and Robert Whittock, IP/IT Practice Group, Freshfields Bruckhaus
method of manufacture on their stability Deringer LLP, UK
• How to make stable amorphous solid dispersions
• The significance of methods of manufacture (spray drying 16.00 Panel discussion: Will amorphous formulations be able to
and milling) spread across the market?
• Relaxation properties A panel discussion with industry experts debating various
Graham Buckton, Professor of Pharmaceutics, School of amorphous considerations such as long term stability, cost
Pharmacy, University of London, UK effectiveness, readiness of the market, formulation and
manufacturing nuances and regulatory and patenting concerns
11.25 SPOTLIGHT SESSION
Raise your corporate profile by sponsoring or exhibiting at the 16.25 Closing remarks from the Chair
3rd Annual Amorphous Materials conference.
For details on speaking in this session or other sponsorship 16.30 End of day two
opportunities at this conference please contact: Ben Edwards,
Tel: +44 (0)207 017 4447, Email: ben.edwards@informa.com PROMOTIONAL OPPORTUNITIES:
Raise your corporate profile by sponsoring, exhibiting or
12.00 Lunch presenting at Informa Life Sciences’ 3rd Annual Amorphous
Materials conference
Manufacturing Techniques and Scaling Up Demonstrate your products and services to our highly targeted
audience of decision makers from the pharmaceutical and biotech
13.10 Determining the appropriate manufacturing technique for industries.
your API
• A comprehensive overview of the spray drying, hot melt Become an event partner and experience the benefits of:
extrusion and freeze drying techniques comparing: • Forging new alliances and joint ventures
– Nature of the end product • Developing new client relationships and affirming existing ones
– Speed and efficiency of the technique • A captive audience to launch new products and promote existing
– Limitations of the technique ones
– Influence of varying the parameters on the results For more information on our wide-range of tailored sponsorship
– Novel applications of the techniques solutions, please contact: Ben Edwards,
David Elder, Director, Product Development, Tel: +44 (0)207 017 4447,Email: ben.edwards@informa.com
GlaxoSmithKline, UK
Due to unforeseen circumstances, the programme may change and Informa reserves the right to alter the venue and/or speakers © Copyright Informa BV, 2009
To Register
Please Tel: +44 (0) 20 7017 7481 Fax: +44 (0) 20 7017 7823
Email: registrations@informa-ls.com Web: www.informa-ls.com/amorphous Please quote CQ5118

4. Amorphous Materials 2010 Conference code: CQ5118C
18-19 May 2010, Hotel Lev, Ljubljana, Slovenia Pre-conference
www.informa-ls.com/amorphous Workshop code: CQ5118X
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