1. Clinical Trial
Logistics & Supply
Anticipating and overcoming management and delivery challenges
29th - 30th September 2011, Visiongain Conference Centre, London, UK BOOK NOW!
Key Speakers
Vladimir Anisimov, Senior Director, Research Statistics Unit, QSci, GlaxoSmithKline
Martin Simán, Clinical Information Science Director, AstraZeneca
Uwe Gudat, Medical Director, Office of the Chief Medical Officer, Merck Serono
Gary Cunnington, Global Head of Clinical Trial Supplies Respiratory, Boehringer-Ingelheim
Georgi Georgiev, Clinical Research Manager, Head of Office, Bulgaria, AstraZeneca
Justin Doel, Clinical Supplies Manager, Novartis Vaccines & Diagnostics,
Global Clinical Research & Development
Penny Ward, Senior Director, Experimental Medicine, UCB
Sean Smith, Vice President, Clinical Supply Chain, Fisher Clinical Services
Bassam Hallis, Project Manager, Health Protection Agency
Annegret van der Aa, Clinical Trial Manager, Galápagos
Sascha Holzmann, Manager, Clinical Logistics, PAREXEL
Stuart McGuire, Executive Director Global Business Development, Chiltern
Angus Cameron, Director & Senior Vice President, Business Development, Pharma International
Lewis Cameron, Chief Executive Officer, Clearstone Laboratory
Driving the Industry Forward | www.futurepharmaus.com
Media Partners Organised By
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/ctls

2. Conference Introduction
Clinical Trial Logistics & Supply
29th - 30th September 2011, London, UK
Dear Colleague, Media Partners:
utting overheads and improving supply chains in today’s market is as pressing a need as
C PharmiWeb.com is the leading industry-sponsored portal for
ever. With the whole drug development process heavily dependant on clinical trial efficiency, the pharmaceutical sector. Supported by most of the leading
logistic and supply chain optimisation are now integral to cost saving. pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news,
ffectively transporting clinical trial materials to investigator sites, and patient samples back
E features, events listings and international jobs to industry professionals across Europe
to central laboratories are critical if a product is to be launched on time and within budget. and the US.
In a world where time is money, even a week’s delay can potentially cost millions. For further information please email: corporate@pharmiweb.com
oreover, the relentless pressure to bring drugs to market quickly and cheaply means many
M
studies are now outsourced to Eastern European and other emerging markets. With each BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY
country having unique guidelines, understanding the complexities of shipping materials to a WORLD. It is based and located in Warsaw, Poland.
variety of destinations is crucial. Opportunities for strategic and adaptive planning include: Biotechnology World was founded in 2007 to provide the world’s biotech and pharma
regulatory compliance, multi-language labeling, risk-based modelling, and secure, co- information and market to make it universally accessible and useful for scientific
ordinated distribution. Whichever stage you’re at, maximising value demands an integrated and business processes. Its first step to fulfilling that mission was building the
and well organised supply chain. BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in
different channels. BIOTECHNOLOGY EUROPE offers companies completed internet
Visiongain’s Clinical Trial Logistics and Supply conference addresses
public relations, publication and marketing solutions. One of the mains goals of
your concerns, enabling you to efficiently resolve challenges at BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to
regional, national and international levels. In addition to providing global biotechnology, pharmaceutical and life science activities.
the latest developments in security, forecasting, partnering and For further information please visit: www.biotechnology-europe.com
outsourcing, you will also leave empowered to: Driving the Industry Forward | www.futurepharmaus.com
Future Pharmaceuticals has forged powerful relationships
• Optimise drug pooling for clinical trial supplies with key industry leaders to provide a platform for successful
• Ensure bioequivalence when undertaking comparative trials brand recognition, and for senior decision-makers to have the means to procure and
• Integrate national regulatory requirements into protocol design plan implementation strategies based on the topics covered. Positioned to be an
• Improve patient management for studies conducted in emerging markets authoritative resource within top pharma companies as well as small, specialty, and
• Label investigational medicinal products country-specifically to meet customs approval biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into
• Forecast supply demand to eliminate wastage a highly targeted and responsive audience, bridging the gap between the industries’
• Optimise sample management top issues and the solutions top-tier vendors can provide.
• mplement a secure cold chain strategy and reduce temperature deviation and delivery
I For further information please visit: www.futurepharmaus.com
time during shipping
InPharm is the online platform for exclusive pharmaceutical
• valuate improved GPS and RFID temperature-monitoring devices to minimize risk during
E
news, comment, contracts, services, jobs and events and is
transportation
home to InPharmjobs.com, Pharmafile and Pharmafocus.
• Maximise your depot supply and distribution practices
For further information please visit: www.In-Pharm.com
• Implement lessons gleaned from case studies from Eastern Europe, the Far East and Asia
• Utilise IVR and IWR to save time and money
I look forward to meeting you at the conference
Best regards Poster Presentation
At a busy conference it is hard to make sure everyone who shares your interests
knows what you are doing. Maximise your time at Visiongain’s Clinical Trial Logistics
& Supply meeting by sharing your results in a poster presentation. With a plethora of
John Shah key decision makers, take advantage of this senior networking opportunity.
Senior Conference Producer Please send your 200 word abstract, in English, to: info@visiongainglobal.com
for approval. The deadline for submissions is Thursday 22nd September, 2011. Please
include contact details for the corresponding author(s).
Academic institutions will not be charged a fee if booked as full-price delegates.
Posters submitted by pharmaceutical and biotechnology firms will be charged a fee
Who should attend? of £199.
Presidents, Chief Executive Officers, VPs, Global Heads, Chief Scientific Posters submitted by service providers / vendors are welcome and will be subject
Officers, Directors, Principal Scientists, Franchise Heads and Investigators in: to evaluation. Upon approval a fee of £500 will apply. Two delegates from your
• Clinical Research organisation must be booked at full price to present a poster.
• Clinical Operations Please note that all posters will be displayed at the discretion of Visiongain Ltd and
• Clinical Logistics Planning/Distribution
are subject to approval. Due to limited space, please register your interest early.
• Clinical Trial Process Implementation
• Drug Formulation
• Chemistry, Manufacturing & Controls
Sponsorship and exhibition opportunities
• Drug Supply Planning/Management
This event offers a unique opportunity to meet and do business with some
• Clinical Trial Support
of the key players in the pharmaceutical and biotech industries. If you have
• Global Clinical Outsourcing a service or product to promote, you can do so at this event by:
• Clinical Packaging
• Hosting a networking drinks reception
• Labelling • Taking an exhibition space at the conference
• Supply Chain Management/Integrity • Advertising in the delegate documentation pack
• Cold Chain Technology • Providing branded bags, pens, gifts, etc.
• Transportation Operations If you would like more information on the range of sponsorship or
• Business Development exhibition possibilities for visiongain's Clinical Trial Logistics & Supply
• Quality Assurance Conference, please contact us:
• Research Statistics Ronald Magali, +44 (0)20 7549 9934
• Regulatory Affairs ronald.magali@visiongainglobal.com

3. Day 1
Clinical Trial Logistics & Supply
Thursday 29th September 2011
09:00 Registration and refreshments 13:40 Predictive drug supply modelling in clinical trials
(statistical methodology and software)
• ain uncertainties and risks in CT supply chain processes
M
09:30 Opening address from the Chair
• redictive patient recruitment and risk-based supply modelling tools
P
• Software tools for drug supply modelling
09:40 Designing a clinical programme
Vladimir Anisimov
• Understanding corporate and clinical research goals
Senior Director, Research Statistics Unit, QSci
• Planning and implementing a suitable programme GlaxoSmithKline
• Case study examples
Uwe Gudat 14:20 Bioequivalence and strategic comparator sourcing
Medical Director, Office of the Chief Medical Officer
• Bioequivalence is the key and how to perform such studies
Merck Serono
• hanging regulatory requirements and the BioPharmaceutics
C
Classification System
• Working with the FDA, and drug costs in the US vs. EU
10:20 Coordinating complex clinical information flow
phase III Angus Cameron
Director and Senior Vice President
• Aligning clinical information from multiple CROs and big pharma Pharmarama
CASE STUDY
• Managing challenges to evolve into success
• Lessons learned from an alliance phase III development programme 15:00 Afternoon refreshments
Martin Simán
Clinical Information Science Director
AstraZeneca 15:20 Drug pooling as a clinical supply strategy
Gary Cunnington
Global Head of Clinical Trial Supplies Respiratory
Boehringer-Ingelheim
11:00 Morning refreshments
16:00 Assay development and sample management
11:20 Quality considerations for audit compliance
• Sample handling
• verseeing trial progress and ensuring it meets GCP guidelines and
O
• Sample logging and tracking through the analysis cycle
sponsor SOPs
• Reducing uncertainty through quality assurance
• he roles of the sponsor of a clinical investigation, the IRB, or
T
independent ethics committee Bassam Hallis
Project Manager
• he roles and responsibilities of the clinical trial investigator
T
Health Protection Agency
Lesley Chaplin
Consultant
LC Biotech 16:40 Closing remarks from the Chair
12:00 Patient management: project priorities
• ecruiting and retaining patients in clinical studies
R 16:50 Networking drinks
• electing participating countries for multinational Phase III
S
Take your discussions further and build new
studies- recent updates
relationships in a relaxed and informal setting.
• anaging protocol compliance
M
Penny Ward
Senior Director, Experimental Medicine
UCB
12:40 Networking lunch
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
Clinical Trial Logistics & Supply
Friday 30th September 2011
09:00 Registration and refreshments 12:40 Networking lunch
09:30 Opening address from the Chair 13:40 Managing time and temperature sensitive
Justin Doel supply chains
Clinical Supplies Manager • Planning in advance: from depot to site
Novartis Vaccines & Diagnostics, Global Clinical
Research & Development • Understanding local distribution infrastructure
• Customs and regulatory compliance
Sean Smith
09:40 Customs requirements in Eastern Europe Vice President, Clinical Supply Chain
Fisher Clinical Services
• Setting quality agreements
• Deciding contractual partners
• Essential GMP/GDP contents 14:20 Monitoring a drug’s environment through the
Georgi Georgiev supply chain using RFID
Clinical Research Manager, Head of Office, Bulgaria
• Principles of RFID enabled temperature monitoring
AstraZeneca
• Impacts on clinical trial supply chain security
Sascha Holzmann
Manager, Clinical Logistics
PAREXEL
10:20 Essential steps towards successful clinical trial
supplies in Eastern European countries - case study
• Rationale for conducting studies in EEU countries
15:00 Afternoon refreshments
CASE STUDY
• Additional regulatory challenges in EEU countries
• Case study: real-life experience & lessons learned
Annegret van der Aa
Clinical Trial Manager, Development 15:20 Minimising risk in low-temperature
Galapagos maintenance
CASE STUDY
• Ensuring integrity of packaging containers
• Risk assessment techniques in the supply chain
11:00 Morning refreshments • Integrated feedback processes
11:20 Presentation to be announced
16:00 Challenging the cold chain with distribution to rural
Stuart McGuire
Executive Director Global Business Development and remote locations
Chiltern • Transportation hurdles for vaccines to rural and remote locations
Lewis Cameron • armonizing guidance for storage and transport of temperature-
H
Chief Executive Officer sensitive biologics
Clearstone Laboratory
• An international guide to good practice
12:00 Panel discussion: Supply challenges in 16:40 Chair’s closing remarks
emerging markets
P
anelists will discuss strategies to optimize management and distribution,
and co-ordinating delivery with third parties. Ensuring accurate multi- 16:50 End of conference
language labelling, and meeting national inspection, regulatory and QA
standards will also be covered. Please email your questions for the panel to
john.shah@visiongainglobal.com.

5. Registration Form
Clinical Trial Logistics & Supply
29th - 30th September 2011, London, UK
Angel
Conf. code FB Pentonville Road
Clinical Trial Logistics
Ci
Standard Prices
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& Supply
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ad
Conference only Fee: £1299 VAT: £259.80 Total: £1558.80
29th - 30th September 2011
Old Street
Number of bookings: Total cost: Location: Visiongain Conference Centre Old Street
Address:
230 City Road
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Distribution of your company’s promotional literature to all conference attendees EC1V 2TT
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Fee: £999 VAT: £199.80 Total: £1198.80
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