This document announces the 5th Annual Stability Testing Conference to be held November 3-4, 2011 in London. The conference will bring together experts from pharmaceutical companies like Pfizer, GSK, Novartis, and others to discuss multiple facets of stability testing. Topics will include updates on guidelines, effective planning, methods, evaluation of results, challenges in biologics stability testing, and analytical testing methods.

1. 5th Annual
Stability Testing
Bringing together the multiple facets of stability testing for improved efficacy and end product quality
3rd – 4th November 2011, Visiongain Conference Centre, London, UK BOOK NOW!
Key Speakers
Dr Garry Scrivens, Senior Principal Scientist, Pfizer
Dr Glen Hodge, Senior Principal Scientist, Pfizer
Dr Simon Hicks, Senior Scientific Investigator, GlaxoSmithKline
Dr Bernhard Helk, Section Head, Technology department, Novartis
Dr Abigaill Moran, Deputy Manager and Pharmaceutical Asessor, Licencing Division, MHRA
Dr Leonardo Allain, Research Fellow, Merck
Dr Brett Cooper, Research Fellow, Merck
Dr Alexander Pontius, Laboratory Head, Bayer Schering Pharma
Sarah Hayter, Analytical Scientist, AstraZeneca
Professor Pauline Rudd, Principal Investigator, National Institute for Bioprocessing Research and Training
Dr Paul Matejtschuk, Principal Scientist, National Institute of Biological Standards and Control
Dr Simon Gaisford, Senior Lecturer in Pharmaceutics, The School of Pharmacy, University of London
Dr Paul Royall, Lecturer in Pharmaceutics, Kings College London
Associate Sponsor
Organised By
Driving the Industry Forward | www.futurepharmaus.com
Media Partners
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/stabilitytesting

2. Conference Introduction
5th Annual Stability Testing
3rd - 4th November 2011, London, UK
Dear Colleague, Associate Sponsor:
harmaceutical companies are under intense pressure to provide safe, effective
P Epichem offers a range of impurity and degradant standards for
medicines for patient consumption while also maintaining adherence to stringent APIs and excipients, particularly for OTC and generic drugs. Many of
regulatory and quality requirements. Stability testing is a highly integral part of these standards are hard to find or exclusive to Epichem and can be
pharmaceutical product development which constitutes one of the fastest growing
markets in the pharmaceutical and biotechnology sectors. supplied in multi-gram quantities to enable you to rapidly and cost
effectively undertake stability testing for product development. Epichem’s laboratory
n a state of affairs where the outcome of stability testing can have substantial
I
medical and financial implications it is important to consider the most comprehensive and systems have passed audits by four of the world’s top pharmaceutical companies
and cost-effective approach to successful stability testing. and all standards are supplied with CoA and MSDS. Epichem also has considerable
isiongain’s 5th Annual Stability Testing Conference will look at the stability of the
V experience in the identification and synthesis of new impurities and degradants, and
ingredients and overall product during different phases of the product lifecycle. can advise on methods to minimise their formation.
By attending this event you will gain insight into the various aspects of stability
testing ranging from updates on current guidelines, effective planning, methods For further information please visit: www.epichem.com.au
and regulatory requirements to evaluation of results, the case of biologics and the Media Partners:
industry-hospital interface. Our conference will provide you with current essential
information on the key issues surrounding stability testing via our expert speakers. PharmiWeb.com is the leading industry-sponsored portal for
the pharmaceutical sector. Supported by most of the leading
Reasons to register today: pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news,
• Receive an update on the WHO and ICH stability guidelines features, events listings and international jobs to industry professionals across Europe
• earn strategies for effective planned stability testing at different stages of the
L and the US.
product life cycle For further information please email: corporate@pharmiweb.com
• dapt your forced degradation studies: predicting stability rate data
A
BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY
• xamine Quality by Design in the context of stability testing
E WORLD. It is based and located in Warsaw, Poland.
• onsider compliance of pharmaceutical product with regulatory requirements
C Biotechnology World was founded in 2007 to provide the world’s biotech and pharma
• ssess challenges in the stability testing of biologics: aggregation, denaturation,
A information and market to make it universally accessible and useful for scientific
oxidation and de-amination and business processes. Its first step to fulfilling that mission was building the
• xplore analytical testing methods and specifications: focus on HPLC
E BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in
• iscuss how to effectively evaluate stability results
D different channels. BIOTECHNOLOGY EUROPE offers companies completed internet
• ain further insights in to outsourcing: the pros and cons
G public relations, publication and marketing solutions. One of the mains goals of
• nvestigate the pharma industry-hospital interface: what are the stability issues?
I BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to
• tilise networking opportunities with diverse leaders
U global biotechnology, pharmaceutical and life science activities.
I look forward to meeting you at the conference For further information please visit: www.biotechnology-europe.com
Future Pharmaceuticals has forged powerful relationships
Driving the Industry Forward | www.futurepharmaus.com
Best regards
with key industry leaders to provide a platform for successful
brand recognition, and for senior decision-makers to have the means to procure and
plan implementation strategies based on the topics covered. Positioned to be an
authoritative resource within top pharma companies as well as small, specialty, and
Nima Farah biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into
a highly targeted and responsive audience, bridging the gap between the industries’
Conference Producer
top issues and the solutions top-tier vendors can provide.
For further information please visit: www.futurepharmaus.com
InPharm is the online platform for exclusive pharmaceutical
news, comment, contracts, services, jobs and events and is
Who should attend this conference? home to InPharmjobs.com, Pharmafile and Pharmafocus.
Presidents, Vice Presidents, Directors, Chief Executive Officers, Chief Scientific
For further information please visit: www.inpharm.com
Officers, Heads, Managers, Team Leaders, Researchers and Consultants of:
• Stability Testing
• Quality Assurance
• Quality Control
• Regulatory affairs
• Research and Development Sponsorship and exhibition opportunities
• Analytical Chemistry
• Analytical Development This event offers a unique opportunity to meet and do business with some
• Analytical Laboratory
of the key players in the pharmaceutical and biotech industries. If you have
• Contract Laboratory
• Forced Degradation Studies a service or product to promote, you can do so at this event by:
• Formulation Studies
• Formulation Development • Hosting a networking drinks reception
• Product Submission
• Validation • Taking an exhibition space at the conference
• Documentation and Technical writing • Advertising in the delegate documentation pack
• Business Development
• Project Management • Providing branded bags, pens, gifts, etc.
• Product Development
• Pharmaceutical & Biopharmaceutical Production If you would like more information on the range of sponsorship or
• Product Lifecycle Management
• Biologics
exhibition possibilities for visiongain's 5th Annual Stability Testing
• Biosimilars Conference, please contact us:
• Technical Operations
Branded and Generic Pharmaceutical Companies,Contract Research
Damian Gorman, +44 (0)20 7549 9934
Organisations/ Contract Manufacturing Organisations Drug Regulators, damian.gorman@visiongainglobal.com
Academics & Government Bodies

3. Day 1
5th Annual Stability Testing
Thursday 3rd November 2011
09:00 Registration and refreshments 12:40 Networking lunch
09:30 Opening address from the chair
Dr Garry Scrivens
Senior Principal Scientist
13:40 Quality by design applied to a stability
Pfizer sensitive compound
• Quality by design within pharmaceutical sciences
09:40 Forced degradation to develop stability • Target product profiles
CASE STUDY
indicating methods • Risk analysis at various stages of development
• Overview of regulatory guidance • Formulation variables and effect on quality attributes
• What are the appropriate conditions • Case study demonstration on a stability sensitive compound
• Pitfalls of using excessive conditions
Dr Brett Cooper
• Making the link between forced degradation studies and stability data
Research Fellow, Pharmaceutical Sciences
Dr Simon Hicks
Merck
Senior Scientific Investigator
GlaxoSmithKline
10:20 Increasing the reliability of shelf-life predictions 14:20 Prediction of aggregation propensities of
from accelerated stability studies therapeutic proteins
• hort (e.g. 2 week) accelerated stability studies can be used to predict
S • Review of methods for in silico prediction of aggregation propensities
shelf life much more than conventional approaches • ntroduction to the SAP (spatial aggregation propensity) technology, a
I
• Focuses on solid-state degradation – e.g. API, tablets and capsules (etc.) new technology developed at Novartis and MIT
• rovides quantitative information on the temperature and humidity
P • dentification hot-spots for aggregation based on the dynamic exposure
I
dependence of chemical degradation reactions of spatially-adjacent hydrophobic amino acids
• an predict degradation rates in packaging such as blisters and bottles
C
• anking of monoclonal antibodies by SAP scoring and comparison of the
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with and without dessicant as well as unpackaged products
results with characterisation and long-term stability data
• his approach has proven useful in a number of applications, e.g. setting
T
shelf-life, selecting packaging, assessing new formulations, excipient • emonstration of the utility of the SAP technology in protein engineering
D
compatibility studies, assessing stability impact of changes to API synthetic and in the design of antibody drug conjugates
route, demonstrating equivalence between batches of API and drug product, Dr Bernhard Helk
understanding impact of processing changes as part of QbD studies, Section Head, Technology Department
inclusion in registration documentation as supportive data to minimalize Novartis
stability commitment and as a post-approval change stability protocol
• This approach is convenient, inexpensive and rapidly carried out 15:00 Afternoon refreshments
Dr Garry Scrivens
Senior Principal Scientist
Pfizer
15:20 Sponsor Spotlight Session
11:00 Morning refreshments T
ake this unique opportunity to be a part of the conference
theme, network, share ideas and provide an overview of your
11:20 Novel thermal methods for stability testing of product/services to the audience. For more information please contact
damian.gorman@visiongainglobal.com
amorphous drugs and drug products
• Relaxation rates of amorphous glasses
• Crystallisation kinetics of glasses
• tability testing of amorphous drug products (solid dispersions and oral films)
S 16:00 Stability testing in early phase clinical studies
• Amorphous content quantification • Considerations when assessing pre-clinical solution stability data
• ach section with a focus on instrument selection and experimental best practice
E
• Assessing stability for simple, early phase clinical formulations
Dr Simon Gaisford
• reas for future improvement: predictive science and/or high
A
Senior Lecturer in Pharmaceutics
throughput testing
The School of Pharmacy, University of London
Sarah Hayter
12:00 Stability studies: physical stability and extreme Senior Scientist
Astrazeneca
storage temperatures
• Overview of physical stability:
16:40 Closing remarks from the chair
- Physical process
- Factors affecting stability across the product lifecycle
• Extreme storage temperature-impact on stability testing
• Summary 16:50 Networking drinks
Dr Paul Royalll Take your discussions further and build new
Lecturer in Pharmaceutics
relationships in a relaxed and informal setting
Kings College London
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011

4. Day 2
5th Annual Stability Testing
Friday 4th November 2011
09:00 Registration and refreshments 12:00 Assessing and assuring stability of biological
reference materials
09:30 Opening address from the chair • Role of biological reference materials
• Freeze drying reference standards
Dr Paul Matejtschuk
• Impact of formulation & manufacture on stability
Principal Scientist, Standardisation Science
• Accelerated degradation testing & stability
National Institute of Biological Standards and Control
Dr Paul Matejtschuk
Principal Scientist, Standardisation Science
09:40 Impact of contaminants on the stability of
National Institute of Biological Standards and Control
pharmaceutical products
• Leachables: definition
12:40 Networking lunch
• Overview of major leachables
• Quality Problems 13:40 Relevance of in vitro dissolution testing for
• Toxicological risk evaluating stability effects on new formulations
Dr Leonardo Allain • Prerequisites for dissolution testing
Research Fellow • Selection of dissolution method parameters
Merck • Automated dissolution testing
• Evaluating manufacturing process
10:20 Potentially Genotoxic degradation products- • Evaluating effects during stability studies
strategies for control in clinical drug products • Monitoring modification changes during storage
• ey considerations for developing stability indicating methods for
K Alexander Pontius
potentially genotoxic degradation products Laboratory Head
• helf life predictions in drug substances and drug products using
S Bayer Schering Pharma
accelerated stability assessments
• Specification strategies for maximizing drug product shelf lives 14:20 A Regulator’s Perspective on Stability
• Relevant case study examples • Clarifying ICH and CHMP guidelines for stability
• dentifying common reasons for failure and for questions from
I
Dr Glen Hodge competent authorities
Senior Principal Scientist
• Outlining how to avoid problems with regulatory submissions
Pfizer
Dr Abigail Moran
Deputy Manager and Pharmaceutical Assessor, Licensing Division
11:00 Morning refreshments MHRA
11:20 A systematic approach to protein glycosylation 15:00 Afternoon refreshments
analysis: a path through the maze
• Basics of glycobiology
• oles for glycosylation in determining the efficacy, pharmacokinetics,
R
15:40 Sponsor Spotlight Session
stability and safety of biological drugs
T
ake this unique opportunity to be a part of the conference
• Factors that control glycosylation processing pathways theme, network, share ideas and provide an overview of your product/
• Rapid, detailed, quantitative glycan analysis at all stages of bioprocessing services to the audience. For more information please contact
• pproaches to glycan analysis include mass spectrometry, capillary
A damian.gorman@visiongainglobal.com
electrophoresis and various HPLC techniques. The appropriate strategy
depends on the information that is required
• generic robotics HPLC platform has been designed to be rugged in terms of
A
16:00 The pharma industry-hospital interface: what are
cost, reliability, data interpretation and operator training. Data can be coupled
the stability issues?
with software and data bases for computer assisted data interpretation
• Overview of challenges
• he system can be used as a front end to many separations technologies to
T
• Prominent issues
determine the factors that control glycosylation and glycoprotein integrity
• Clinicans perspective
Professor Pauline Rudd • Future: problem solving for patient benefit
Principal Investigator
National Institute for Bioprocessing,
16:40 Closing remarks from the chair
Research and Training
16:50 End of conference

5. Registration Form
5th Annual Stability Testing
3rd - 4th November 2011, London, UK
Angel
Conf. code PP Pentonville Road
5th Annual Stability
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Standard Prices
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Testing
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Conference only Fee: £1299 VAT: £259.80 Total: £1558.80 3rd - 4th November 2011 Old Street
Location: Visiongain Conference Centre Old Street
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