Conference on Amorphous Pharmaceutical Materials

Amorphous Pharmaceutical Materials
Assessing emerging applications, methodologies, techniques and challenges.
24th - 25th January 2011, BSG Conference Centre, London, UK

Key Speakers:

Ljiljana Harding, Inhalation & Devices Centre of Emphasis, Pfizer,
Franco Sartor, Principal scientist , GlaxoSmithKline,
Sigrid Stokbroekx, Research Fellow, Johnson & Johnson Pharmaceutical R&D,
Dr. Rolf Hilfiker, Vice President Head of Department Solid-State Development, Solvias,
Roger Parker, Senior Scientist, Food Structure and Health Programme, Institute of Food Research,
Dr. Simon Gaisford, Senior Lecturer in Pharmaceutics, The School of Pharmacy, University of London
Mark Saunders, Owner, co-founder and Development Director, Kuecept,
Robert Whittock, IP/IT Practice Group, Freshfields Bruckhaus Deringer LLP,
Wouter Pors, Attorney, Bird & Bird,
Michael Gamlen, Managing Director, Pharmaceutical Development Services,
Prof. Graham Buckton, Chief Executive Officer, Pharmaterials,
Dr. Andreas Kordikowski, R&D Director, Activery Biotech,
Dr. Filipe Gaspar, Head of Particle Design, Hovione
Bertrand Gellie, Director of Organic Chemistry, European Patent Office.

Conference Introduction,
Amorphous Pharmaceutical Materials,
24th - 25th January 2011, London, UK.

With the continuous increase in the number of insoluble developmental drug molecules and growing regulatory scrutiny over pharmaceutical solids, the use of amorphous solids is steadily rising in the pharmaceutical companies. This conference combines presentations on the approaches to amorphous detection and quantitation within GSK, and clinical advice and practical tips from Pfizer and Johnson & Johnson. The biopharmaceutical implications for development of amorphous solid solution intermediates will be discussed and strategies to protect and commercialise innovations in amorphous materials will be presented.During the two days you will be exposed to several analytical strategies to protect and commercialise innovations in amorphous materials. Amorphous Pharmaceutical conference will provide an enlightening and thought-provoking forum with a series of case studies ranging from amorphous formulation to novel amorphous microparticle technology.

Reasons to register today:
• Understand the use of isothermal calorimetry to characterise stability of amorphous pharmaceuticals.
• Implement the latest technological developments.
• Discuss the best approaches to control and stabilise amorphous drug forms.
• Examine the quantifi cation of amorphous content.
• Gain a clearer insight on amorphous food materials.
• Seize this opportunity to network with leaders from pharma-biotech, healthcare and regulatory agencies.

Who should attend?

VPs, Directors, Heads and Managers of:
• Stability / Stability testing
• Pre-formulation
• Solid State Chemistry
• Formulation
• Crystallisation • Drug Discovery
• Drug Delivery
• Analytical methods / development
• API Development • Validation
• Pharmacokinetics • Quality Control
• R&D
• Product Submission
• Research and Development • Materials Science
• Technical Operations
• Statistical Sciences
• Manufacturing Science
• Regulatory affairs
• Particle Engineering
• Product Design
• Business Development

Day 1
Amorphous Pharmaceutical Materials,
Monday 24th January 2011, London, UK

09:30 Registration and refreshments,

10:00 Opening address from the chair

10:10 Amorphous content: Quantification in drug substance and drug product.
• Ways to trace amorphous content in crystalline solids.
• Ways to trace amorphous content in formulated products.
• Micronisation and amorphisation.
• Impact on drug substance properties.

Dr Rolf Hilfiker,
Vice President, Head of Department Solid-State Development, Solvias.

10:50 Biopharmaceutical implications for development of amorphous solid solution intermediates.
• Why amorphous solid dispersions / solutions.
• Current in vitro testing strategies.
• Physiology of the gastrointestinal tract and its relevance to oral delivery of poorly soluble compounds.
• Case Study: novel amorphous microparticle technology for targeted drug delivery.

Mark Saunders,
Owner, co-founder and Development Director, Kuecept.

11:30 Morning refreshments

11:50 Approach to amorphous detection and quantitation within GSK,
• Internal strategy, methods and techniques.
• Case study A: detection and quantitation of amorphous for micronised material.
• Case study B: dealing with amorphous formation in a Liquid Deposited Formulation.

Franco Sartor,
Principal scientist, GlaxoSmithKline,

12:30 Amorphous food materials – Some lessons from food research,
• Hot melt extruded flavour encapsulation systems, a vitrified emulsion.
• Small molecules: solvent, plasticiser, both or neither?
• Protein stability in the glass state: physical, chemical and biological.
• Brian Arthur’s “The Nature of Technology”: so what’s new?

Roger Parker,
Senior Scientist, Food Structure and Health Programme, BBSRC Institute of Food Research.

14:30 Stable amorphous dispersions – science, formulation and manufacturing method,
• Methods of manufacture and the importance for stability.
• Relaxation of bulk and surface.
• Intentional and accidental amorphous materials.
• Use of NIR, IGC, and thermal methods.
• The value of Raman mapping.

Prof. Graham Buckton,
Chief Executive Officer, Pharmaterials

15:10 Amorphisation as Tool for Product Life Cycle Management,
• Phases and critical steps in LCM.
• Solid form roles in LCM.
• Activery the amorphisation company.
• Current and future products.
• Amorphous combinations, single drug products and nanoparticles.

Dr. Andreas Kordikowski.
R&D Director, Activery Biotech.

15:30 Afternoon refreshments.

15:50 Patents - amorphous materials & formulations.
• Satisfying patentability requirements.
• Practical advice to drafting strong claims.
• Assessing infringement.
• Reviewing recent case law examples.

Robert Whittock,
IP/IT, Practice Group, Freshfields Bruckhaus Deringer.

16:30 Strategies to protect and commercialise innovations in amorphous materials.
• How to draft for existing active ingredients.
• Create a return on investments and maintain market position.
• Effective enforcement.

Wouter Pors,
Attorney at law, Bird & Bird,

17:10 Closing remarks from the chair.

17:20 Networking drinks.

Take your discussions further and build new relationships in a relaxed and informal setting.

Day 2
Amorphous Pharmaceutical Materials
Tuesday 25th January 2011, London, UK

09:30 Registration and refreshments.

10:00 Opening address from the chair.

10:10 Partially amorphous materials: In-situ monitoring of the recrystallisation process at the nanoscale using heated tip AFM.
• Process-induced disorder and its importance in pharmaceutical industry
• The use of Atomic Force Microscopy (AFM) and related techniques for detection and characterisation of process-induced changes in pharmaceutical materials, incl. several examples from the literature.
• Novel Nano-thermal analysis approach to characterisation of partially amorphous materials at the nanoscale, incl. examples of in-situ monitoring of the recrystallisation process.

Ljiljana Harding
Inhalation & Devices Centre of Emphasis, Pfizer.

10:50 Automated solid dispersion screening: A useful tool to design amorphous systems.
• The approach to automate and miniaturize the search for precipitation inhibitors.
• Preparation of amorphous films.
• Evaluation of amorphous systems.

Sigrid Stokbroekx,
Research Fellow, Johnson & Johnson Pharmaceutical R&D.

11:30 Morning refreshments.

11:50 Stability assessment of amorphous pharmaceuticals with calorimetry.
• Instrument considerations and experimental design.
- Scanning calorimetry and isothermal calorimetry.
• Determination of relaxation rates.
• Examples of applications.
- Measurement of glass transitions with DSC.
- Stability of glassy pharmaceuticals.
- Oral fast-dissolving films.

Dr Simon Gaisford,
Senior Lecturer in Pharmaceutics, The School of Pharmacy, University of London.

12:30 Patenting amorphous forms - EPO views.
• What distinguishes amorphous forms from other patentable products?
• How to claim amorphous forms properly?
• How to disclose amorphous forms and support this disclosure properly?
• Case law of interest.

Bertrand Gellie,
Director of Organic Chemistry, European Patent Office.

13:10 Networking lunch.

14:30 Formulating materials to retain amorphous character –ensuring you get what you pay for,
• Amorphous materials are highly active in their nature and need careful processing to ensure they retain their amorphous character.
• Many amorphous materials also have low bulk density and present handling problems.
• Formulation development to ensure the products retain their amorphous character, otherwise the desirable properties will be lost.
• Enabling the small scale manufacture of products containing amorphous materials for use in preclinical and Phase 1 testing while retaining their amorphous character and overcoming bulk density problems.
• Reviewing the possible impact of common pharmaceutical processes on amorphous character.

Michael Gamlen,
Managing Director, Pharmaceutical Development Services.

15:10 Developing solid dispersions by spray drying.
• The role of solid dispersions.
• Methods to produce solids dispersions.
• O Spray drying of solid dispersions.

Dr. Filipe Gaspar
Head of Particle Design, Hovione.

15:40 Afternoon refreshments.
16:10 Process analytical techniques during amorphisation by hot melt extrusion.
• Hot melt extrusion: generation of amorphous and co-crystal forms.
• Process Analytical Technique (PAT) in melt extrusion: Online rheology and NIR measurement.

Prof. Anant Paradkar PhD.
Professor of Pharmaceutical Engineering, Interdisciplinary Chair in Pharmaceutical Engineering Science, University of Bradford.

16:50 Chair’s closing remarks.

17:00 End of Conference.

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