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 quantification 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
Pfizer, GE Healthcare, Novartis Pharma and Boehringer-Ingelheim Pharma Confir...
Amorphous Pharmaceutical Materials 2010
1. Amorphous
Pharmaceutical Materials
Assessing emerging applications, methodologies, techniques and challenges
14th - 15th June 2010, BSG Conference Centre, London, UK BOOK NOW!
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
Driving the Industry Forward | www.futurepharmaus.com
Media Partners Organised
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/amorphouspharma
2. Conference Introduction
Amorphous Pharmaceutical Materials
14th – 15th June 2010, London, UK
Dear Colleague, Media Partners:
With the continuous increase in the number of insoluble developmental drug
PharmiWeb.com is the leading industry-sponsored portal for
molecules and growing regulatory scrutiny over pharmaceutical solids, the use of the pharmaceutical sector. Supported by most of the leading
amorphous solids is steadily rising in the pharmaceutical companies. pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features,
This conference combines presentations on the approaches to amorphous events listings and international jobs to industry professionals across Europe and the US.
detection and quantitation within GSK, and clinical advice and practical tips For further information please email: corporate@pharmiweb.com
from Pfizer and Johnson & Johnson. The biopharmaceutical implications for
BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD.
development of amorphous solid solution intermediates will be discussed and It is based and located in Warsaw, Poland. Biotechnology World was
strategies to protect and commercialise innovations in amorphous materials will founded in 2007 to provide the world’s biotech and pharma information and market to
be presented. make it universally accessible and useful for scientific and business processes. Its first step
During the two days you will be exposed to several analytical strategies to protect to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will
and commercialise innovations in amorphous materials. Visiongain’s Amorphous allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers
Pharmaceutical conference will provide an enlightening and thought-provoking companies completed internet public relations, publication and marketing solutions. One of
forum with a series of case studies ranging from amorphous formulation to novel the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector
amorphous microparticle technology. in Europe to global biotechnology, pharmaceutical and life science activities.
For further information please visit www.biotechnology-europe.com
Reasons to register today:
Future Pharmaceuticals has forged powerful relationships with
Driving the Industry Forward | www.futurepharmaus.com
• Understand the use of isothermal calorimetry to characterise stability of key industry leaders to provide a platform for successful brand
amorphous pharmaceuticals recognition, and for senior decision-makers to have the means to procure and plan
• Implement the latest technological developments implementation strategies based on the topics covered. Positioned to be an authoritative
resource within top pharma companies as well as small, specialty, and biotech, Future
• Discuss the best approaches to control and stabilise amorphous drug forms
Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted
• Examine the quantification of amorphous content and responsive audience, bridging the gap between the industries’ top issues and the
• Gain a clearer insight on amorphous food materials solutions top-tier vendors can provide.
• Seize this opportunity to network with leaders from pharma-biotech, For further information please visit: www.futurepharmaus.com
healthcare and regulatory agencies InPharm is the online platform for exclusive pharmaceutical news,
I look forward to meeting you at the conference comment, contracts, services, jobs and events and is home to
InPharmjobs.com, Pharmafile and Pharmafocus.
Best regards
For further information please visit: www.In-Pharm.com
‘Pharma Connections Worldwide® is the leading professional
business networking website focused in the Pharmaceutical,
Pranita Nangia Biotechnology and Life Sciences research industry. Our goal is to provide a conduit for
Conference Producer delivery of premiere content coupled with the right clientele in order to facilitate business
development opportunities among industry professionals responsible for making key
decisions in a global marketplace. ‘
For further information please visit: www.pharmaconnections.com
Who should attend?
VPs, Directors, Heads and Managers of:
About Visiongain:
Visiongain is a specialist business information company focused on providing cutting edge
• Stability / Stability testing
products and services across the Pharmaceutical/Biotech, Telecommunications, Defence
• Pre-formulation and Finance sectors, which include reports, conferences, online daily news and offline
• Solid State Chemistry news analysis and bespoke consultancy. With a commitment to innovation and excellence,
visiongain offers flexible solutions to meet our clients’ business intelligence needs, providing
• Formulation the right information at the right time to facilitate the commercial decision-making process. Our
• Crystallisation pharmaceutical products include Pharma Business Daily, the leading daily email newsletter for
the pharmaceutical, biotech and healthcare industries, and a range of independent, high-quality,
• Drug Discovery
in-depth reports covering focused and topical areas of concern. Our pharmaceutical conferences
• Drug Delivery address the hottest commercial, regulatory and technical topics and provide an ideal forum for
• Analytical methods / development debate and networking for pharmaceutical professionals from around the world.
For further information, please visit: www.visiongain.com
• API Development
• Validation
• Pharmacokinetics Sponsorship and exhibition opportunities:
• Quality Control This event offers a unique opportunity to meet and do business with some
• R&D of the key players in the pharmaceutical and biotech industries. If you have a
service or product to promote, you can do so at this event by:
• Product Submission
• Hosting a networking drinks reception
• Research and Development • Taking an exhibition space at the conference
• Materials Science • Advertising in the delegate documentation pack
• Technical Operations • Providing branded bags, pens, gifts, etc.
If you would like more information on the range of sponsorship or exhibition
• Statistical Sciences
possibilities for visiongain's Amorphous Pharmaceutical Materials, please
• Manufacturing Science contact us:
• Regulatory affairs Ronald Magali, +44 (0)20 7549 9934
• Particle Engineering ronald.magali@visiongainglobal.com
• Product Design Emma Thomas, +44 (0) 20 7549 1943
• Business Development emma.thomas@visiongainglobal.com
3. Day 1
Amorphous Pharmaceutical Materials
Monday 14th June 2010, London, UK
09:30 Registration and refreshments 13:10 Networking lunch
10:00 Opening address from the chair 14:30 Stable amorphous dispersions – science, formulation
and manufacturing method
10:10 Amorphous content: Quantification in drug • Methods of manufacture and the importance for stability
substance and drug product • Relaxation of bulk and surface
• Ways to trace amorphous content in crystalline solids
• Intentional and accidental amorphous materials
• Ways to trace amorphous content in formulated products
• Use of NIR, IGC, and thermal methods
• Micronisation and amorphisation
• The value of Raman mapping
• Impact on drug substance properties
Prof. Graham Buckton
Dr Rolf Hilfiker
Chief Executive Officer
Vice President, Head of Department Solid-State Development
Pharmaterials
Solvias
15:10 Strategies to protect and commercialise innovations
10:50 Biopharmaceutical implications for development in amorphous materials
of amorphous solid solution intermediates
• How to draft for existing active ingredients
• Why amorphous solid dispersions / solutions
• Create a return on investments and maintain market position
• Current in vitro testing strategies
• Effective enforcement
• Physiology of the gastrointestinal tract and its relevance to oral delivery
of poorly soluble compounds Wouter Pors
• Case Study: novel amorphous microparticle technology for targeted Attorney at law
drug delivery Bird & Bird
Mark Saunders
Owner, co-founder and Development Director 15:50 Afternoon refreshments
Kuecept
16:10 Patents - amorphous materials & formulations
11:30 Morning refreshments • Satisfying patentability requirements
• Practical advice to drafting strong claims
11:50 Approach to amorphous detection and • Assessing infringement
quantitation within GSK
• Reviewing recent case law examples
• Internal strategy, methods and techniques
Robert Whittock
• Case study A: detection and quantitation of amorphous for IP/IT Practice Group
micronised material Freshfields Bruckhaus Deringer
• Case study B: dealing with amorphous formation in a Liquid
Deposited Formulation
16:50 Solid state method development
Franco Sartor
Principal scientist • Understand the importance of validation and development
GlaxoSmithKline • Discuss the stability issues in solid state
• Characterisation of solid forms
12:30 Amorphous food materials – Some lessons from
food research 17:30 Closing remarks from the chair
• 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 17:40 Networking drinks
• Brian Arthur’s “The Nature of Technology”: so what’s new? Take your discussions further and build new
Dr Roger Parker relationships in a relaxed and informal setting.
Senior Scientist, Food Structure and Health Programme
BBSRC Institute of Food Research
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2010
4. Day 2
Amorphous Pharmaceutical Materials
Tuesday 15th June 2010, London, UK
09:30 Registration and refreshments 12:30 Presentation to be announced
Bertrand Gellie
Director of Organic Chemistry
10:00 Opening address from the chair European Patent Office
10:10 Partially amorphous materials: In-situ monitoring of 13:10 Networking lunch
the recrystallisation process at the nanoscale using
heated tip AFM
• Process-induced disorder and its importance in pharmaceutical industry 14:30 Formulating materials to retain amorphous
character –ensuring you get what you pay for
• The use of Atomic Force Microscopy (AFM) and related techniques
for detection and characterisation of process-induced changes in • Amorphous materials are highly active in their nature and need careful
pharmaceutical materials, incl. several examples from the literature processing to ensure they retain their amorphous character
• Novel Nano-thermal analysis approach to characterisation of partially • Many amorphous materials also have low bulk density and present
amorphous materials at the nanoscale, incl. examples of in-situ handling problems
monitoring of the recrystallisation process
• Formulation development to ensure the products retain their amorphous
Ljiljana Harding character, otherwise the desirable properties will be lost
Inhalation & Devices Centre of Emphasis
• Enabling the small scale manufacture of products containing amorphous
Pfizer
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
10:50 Automated solid dispersion screening: A useful
amorphous character
tool to design amorphous systems
Michael Gamlen
• The approach to automate and miniaturize the search for
Managing Director
precipitation inhibitors
Pharmaceutical Development Services
• Preparation of amorphous films
• Evaluation of amorphous systems
15:10 Assessing the amorphous drug stability in drug
Sigrid Stokbroekx
formulations
Research Fellow
Johnson & Johnson Pharmaceutical R&D • Discus different methods for preparing amorphous formulation
• Comparison of different techniques
• Analyse formulation designs
11:30 Morning refreshments
15:50 Afternoon refreshments
11:50 Stability assessment of amorphous pharmaceuticals
with calorimetry
• Instrument considerations and experimental design
16:10 Examining methods for formulation, development,
- Scanning calorimetry and isothermal calorimetry stability of amorphous materials
• Determination of relaxation rates • Analysing the use of freeze-drying and spray drying
• Examples of applications • Assessing key challenges
- Measurement of glass transitions with DSC • Examining improved bioavailability and stability
- Stability of glassy pharmaceuticals
- Oral fast-dissolving films
16:50 Chair’s closing remarks
Dr Simon Gaisford
Senior Lecturer in Pharmaceutics
The School of Pharmacy, University of London
17:00 End of Conference
5. Registration Form
Amorphous Pharmaceutical Materials
14th – 15th June 2010, London, UK
Angel
For multiple bookings Pentonville Road
Photocopy this form Conf. code VG
Amorphous
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Pharmaceutical Materials
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Standard Prices
Conference only Fee: £1299 VAT: £227.33 Total: £1526.33
14th – 15th June 2010
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Location: BSG House Old Street
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