1. 4th Annual
Stability Testing
Examining current challenges and exploring more cost-effective strategies
22nd – 23rd November 2010, BSG Conference Centre, London, UK BOOK NOW!
Key Speakers
Garry Scrivens, Senior Principal Scientist, Pfizer
David Elder, Externalization Director, GlaxoSmithKline
Ahmed Yasin, BioPharm Analytical & Formulation Research, GlaxoSmithKline
Dagmar Mohr, Group Head Analytical R&D and QC Biotech Products, Roche
Simona Bohanec, Head of Regulatory Analytics, Sandoz
Duu-Gong Wu, Executive Director, PharmaNet
Jan Jiskra, Project leader, Synthon
Jane Robinson, Principal Scientist, Biotherapeutics, National Institute for Biological Standards and Control
Driving the Industry Forward | www.futurepharmaus.com
Media Partners Organised By

2. Conference Introduction
4th Annual Stability Testing
22nd - 23rd November 2010, London, UK
Media Partners:
Dear Colleague,
ailing to conduct a proper stability testing can be very time consuming and
F PharmiWeb.com is the leading industry-sponsored portal for
costly for companies, and damaging to their reputation. The cost of taking NCE the pharmaceutical sector. Supported by most of the leading
pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news,
through the development stages can range anywhere between $800 million to
features, events listings and international jobs to industry professionals across Europe
$1.2 billion (source: Springer, 2009). It is therefore, important for companies to
and the US.
understand key factors affecting the stability profile of a potential product, and
carry out an effective stability program. For further information please email: corporate@pharmiweb.com
BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY
isiongain’s 4th Annual Stability Testing Conference will feature key industry
V
WORLD. It is based and located in Warsaw, Poland. Biotechnology
experts who will aim to share their experiences and explore key themes, including
World was founded in 2007 to provide the world’s biotech and pharma information
criteria for product stability, challenges associated with specific product types
and market to make it universally accessible and useful for scientific and business
(including biotechnology products). Attendees will gain latest insights into the processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY
regulations, risk management, as well as the application and limitations of EUROPE platform that will allow a quick spread of information in different channels.
stability test procedures. BIOTECHNOLOGY EUROPE offers companies completed internet public relations,
publication and marketing solutions. One of the mains goals of BIOTECHNOLOGY
Why you should attend this conference: EUROPE is to integrate the Biotech and Pharma Sector in Europe to global
• Understand strategies to design and implement a compliant stability program biotechnology, pharmaceutical and life science activities.
For further information please visit: www.biotechnology-europe.com
• Hear the latest regulations guidelines, including FDA and ICH requirements
Future Pharmaceuticals has forged powerful relationships
Driving the Industry Forward | www.futurepharmaus.com
• Examine when it is best to perform stability tests: at what stage in the lifecycle? with key industry leaders to provide a platform for successful
• Debate the best approaches for data management of statistical data 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
• Understand the importance of risk assessment authoritative resource within top pharma companies as well as small, specialty, and
biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into
• Review current methods used to reduce costs a highly targeted and responsive audience, bridging the gap between the industries’
• Explore the benefits of outsourcing
top issues and the solutions top-tier vendors can provide.
For further information please visit: www.futurepharmaus.com
• Discuss challenges associated with specific product testing
InPharm is the online platform for exclusive pharmaceutical news,
• Use this opportunity as a platform for future collaborations comment, contracts, services, jobs and events and is home to
InPharmjobs.com, Pharmafile and Pharmafocus.
I look forward to meeting you at the conference
For further information please visit: www.In-Pharm.com
Best regards
Pharma Connections Worldwide® is the leading professional
business networking website focused in the Pharmaceutical,
Biotechnology and Life Sciences research industry. Our goal is to provide a conduit
for delivery of premiere content coupled with the right clientele in order to facilitate
business development opportunities among industry professionals responsible for
Koos Mohammed
making key decisions in a global marketplace.
Conference Producer
For further information please visit: www.pharmaconnections.com
Who should attend this conference?
Senior VPs, VPs, Chief Scientific Officers, Directors, Managers,
Sponsorship and exhibition opportunities:
Professors, and Principal Investigators in: This event offers a unique opportunity to meet and do business with some
• Stability/ Stability Testing of the key players in the pharmaceutical and biotech industries. If you have a
• Analytical Laboratory service or product to promote, you can do so at this event by:
• Formulation Development
• Hosting a networking drinks reception
• Contract Laboratory
• R&D • Taking an exhibition space at the conference
• Quality Assurance • Advertising in the delegate documentation pack
• Quality Control
• Analytical Development
• Providing branded bags, pens, gifts, etc.
• Analytical Chemistry If you would like more information on the range of sponsorship or exhibition
• Pharmaceutical & Biopharmaceutical Production
possibilities for visiongain's 4th Annual Stability Testing Conference, please
• Product Development
contact us:
• Product Submission
• Validation Ronald Magali, +44 (0)20 7549 9934
• Documentation and Technical Writing
ronald.magali@visiongainglobal.com
• Regulatory Affairs
• Project Management Christopher Clegg, +44 (0)20 7549 9964
• Technical Operations
christopher.clegg@visiongainglobal.com
• Regulatory Affairs

3. Day 1
4th Annual Stability Testing
Monday 22nd November 2010
09:00 Registration and refreshments 12:40 Networking lunch
09:30 Opening address from the chair 13:40 Stability challenges of amorphous compounds
• Chemical and physical stabilisation of amorphous API/drug product
09:40 US regulatory perspective on stability testing of
pharmaceutical products • orrelations between molecular mobility and chemical stability -
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Learnings from Ritonavir
• The objectives of stability studies during drug development
• Approaches to stabilise poorly soluble drugs, some case examples
• S regulatory requirements for stability testing of drug substances and
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drug products during different phases of drug development avid Elder
D
Externalization Director
• egulatory and scientific considerations on design of stability protocols
R
GlaxoSmithKline
• pecial issues on stability testing for drugs, biological products and
S
combination products
14:20 Role of thermal methods in stability testing
• Stability testing and Quality by Design (QbD)
• Application of DSC:
uu-Gong Wu
D
- olymorph screening and characterization application of isothermal
p
Executive Director
calorimetry
PharmaNet, USA
- amorphous content quantification
10:20 Early screening of key stability issues of - final product stability
biopharmaceuticals
imon Gaisford
S
• ey BioPhysical and PhysicoChemical properties of proteins that are key
K Senior Lecturer in Pharmaceutics
in stability testing The School of Pharmacy, University of London
• Characterisation of various pathways
• Stable Formulation options available for proteins 15:00 Afternoon Refreshments
• Stability options and a case study
15:20 Evaluation of stability data (Q1E ICH guideline)
• ETC
• Implementation of the Q1E guideline: Evaluation of Stability Data
hmed Yasin
A
BioPharm Analytical & Formulation Research - nderstanding and using linear regression analysis (intercept, slope,
U
GlaxoSmithKline confidence intervals)
- hy to test for poolability of batches?
W
11:00 Morning refreshments
- ow to test for poolability of batches?
H
11:20 Challenges in using bioassays in stability studies • sing calculations to predict shelf-life and release limits
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(Case studies 1–3)
• or most biopharmaceuticals, testing for potency by bioassay is a
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required part of stability studies • pplication of linear regression analysis to long-term data for climatic
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zones 3 and 4
• The bioassay used must be shown to be stability indicating
• he precision of the bioassay may limit its detection of small changes
T imona Bohanec
S
in potency Head of Regulatory Analytics
Sandoz
• nterpretation of changes in potency can be complicated and usually
I
requires complementary physicochemical data
16:00 Bracketing and matrixing (B&M)
ane Robinson
J
• Success in reducing stability testing
Principal Scientist, Biotherapeutics
National Institute for Biological Standards • Limitations of these procedures
and Control
• Applicability
12:00 Thinking smart about stability testing for post
16:40 Closing remarks from the chair
market products
• mplement stability programs to answer the specific needs: Change,
I
Ongoing, Deviation programs
• What is the risk to changing stability programs 16:50 Networking drinks
• How do we mitigate the risk to change Take your discussions further and build new
• Implementing the changes relationships in a relaxed and informal setting.
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
4th Annual Stability Testing
Tuesday 23rd November 2010
09:00 Registration and refreshments 12:40 Networking lunch
09:30 Opening address from the chair
13:40 Stability testing: the case for out-sourcing
09:40 Increasing the reliability of shelf-life predictions • Assessing the benefits
from accelerated stability studies • Factors to consider when considering outsourcing
• Description of ‘accelerated stability assessment program’
• Choosing the right partner
• ocus on the prediction of degradation rates in the solid-state, i.e.
F
degradation of API (active pharmaceutical ingredient) and solid-oral drug acinta George
J
products (e.g. tablets and capsules). Commercial Director
Reading Scientific Services
• rediction of degradation of packaged drug products, and how this tool
P
may be used for packaging selection
• ase studies are briefly described that demonstrate the potential power
C 14:20 Monitoring and evaluation of single amino acid
of this approach modifications of therapeutic monoclonal antibodies
arry Scrivens
G odifications of single amino acids may be observed during stability
M
Senior Principal Scientist testing differing in their extend and their impact on product quality.
Pfizer This talk comprises drivers, methodology and evaluation of the
following single amino acid modifications:
10:20 Statistical shelf life estimation from multiple batch - methionine oxidation
stability studies
- asparagine deamidation
• hat do the ICH guidelines have to say about the statistical methods I
W
should use? - N-terminal glutamine / glutamate cyclization
• hould I use a linear or non-linear model?
S agmar Mohr
D
• ow to select the right model and test for differences between batches
H Group Head Analytical R&D and QC Biotech Products
• o I need (to be) a statistician - or - to what extent can/should the
D Roche
analysis be automated?
atthew Coates
M 15:00 Afternoon refreshments
Senior Statistical/Technical Consultant
StatSoft
15:20 Photostability testing
11:00 Morning refreshments • trategies to design a compliant photostability program
S
• nalytical approaches for assessing photostability
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11:20 Developing fast chromatography methods
to support your stability programmes from • valuation of illumination sources used for photostability testing
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development through to registration
• Developing Fast UPLC/Non-UPLC stability indicating methods 16:00 Importance of risk management in predicting success
• avings that can be made by streamlining your development efforts early
S
• hy it is important to perform risk assessment at every stage
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in the drug development cycle
of development
• How does the future of stability analysis look?
• Methods for predicting success early on
ark Benger
M
Director
Aptuit 16:40 Chair’s closing remarks
12:00 Stability testing of generic medicines
16:50 End of conference
• nderstanding guidelines and regulatory requirements for
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generic products
• Stability testing programme for generic products
• Specific issues on filing generics worldwide and/or different regions
• Strategies to keep costs low, including bracketing and matrixing
• omparison of the generic product to the innovator, prove the
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similarity in stability through analytical testing
an Jiskra
J
Project leader
Synthon