Conference on Amorphous Pharmaceutical Materials

Venue: BSG House, London, UK

Location: London, United Kingdom

Event Date/Time: Jun 14, 2010 End Date/Time: Jun 15, 2010
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Key Speakers

Ljiljana Harding, Inhalation & Devices Centre of Emphasis, Pfi zer
Franco Sartor, Principal scientist , GlaxoSmithKline
Sigrid Stokbroekx, Research Fellow, Johnson & Johnson Pharmaceutical R&D
Dr. Rolf Hilfi ker, 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, Synectix Pharmaceutical Solutions
Robert Whittock, IP/IT Practice Group, Freshfi elds Bruckhaus Deringer LLP
Wouter Pors, Attorney, Bird & Bird
Michael Gamlen, Managing Director, Pharmaceutical Development Services
Senior Representative, Solid Form Solutions

Due to the continuous increase in the number of insoluble developmental drug
molecules and growing regulatory scrutiny over pharmaceutical solids, amorphous
pharmaceutical materials have gained importance in the last few years.
With the help of interactive discussions and leading presentations, participants
will gain a comprehensive outlook of the current market trends, discover the
latest technological developments.
During this two day event, a wide range of case studies will be presented, covering areas of amorphous formulation to novel amorphous microparticle

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
I look forward to meeting you at the conference.

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 14th June 2010, 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
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
Synectix Pharmaceutical Solutions
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

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?

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

13:10 Networking lunch
14:30 Presentation to be announced
Senior Representative
Solid Form Solutions
15:10 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
15:50 Afternoon refreshments
16:10 Patents - amorphous materials & formulations
• Satisfying patentability requirements
• Practical advice to drafting strong claims
• Assessing infringement
• Recent case law examples

Robert Whittock
IP/IT Practice Group
Freshfields Bruckhaus Deringer
16:50 Presentation to be announced
17:30 Closing remarks from the chair
17:40 Networking drinks

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

Day 2

Amorphous Pharmaceutical Materials
Tuesday 15th June 2010, 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
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 Presentation to be announced
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 Assessing the amorphous drug stability in drug formulations
• Discus different methods for preparing amorphous formulation
• Comparison of different techniques
• Analyse formulation designs
15:50 Afternoon refreshments
16:10 Examining methods for formulation, development, stability of amorphous materials
• Use of freeze-drying
• Spray drying process
• Key challenges
16:50 Chair’s closing remarks
17:00 End of Conference