This document provides information about an upcoming clinical trial logistics and supply conference taking place in London from September 29-30, 2011. The conference will address challenges in managing and delivering clinical trial materials and samples. Key speakers will include representatives from major pharmaceutical companies such as GSK, AstraZeneca, Merck Serono, and Boehringer-Ingelheim. Attendees will learn how to optimize drug pooling, ensure bioequivalence in comparative trials, integrate regulatory requirements, improve patient management in emerging markets, and implement secure cold chain strategies to reduce temperature deviations during shipping. The conference aims to help attendees resolve supply chain issues and maximize the value of clinical trial logistics.

1. Clinical Trial
Logistics & Supply
Anticipating and overcoming management and delivery challenges
29th - 30th September 2011, Thistle City Barbican, 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
Maria Eugenia Giribets Parra, Clinical Supply Chain Coordinator, Boehringer-Ingelheim Pharma
Justin Doel, Clinical Supplies Manager, Novartis Vaccines & Diagnostics,
Global Clinical Research & Development
Penelope Ward, Senior Director, Experimental Medicine, UCB New Medicines
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
Stuart McGuire, Executive Director Global Business Development, Chiltern
Angus Cameron, Director & Senior Vice President, Business Development, Pharmarama International
Lewis Cameron, Chief Executive Officer, Clearstone Laboratories
Silver Sponsors
Associate Sponsors
Diagnostics Clinical Clinical Pharma Sciences
Technologies Services Services
Organised By
Driving the Industry Forward | www.futurepharmaus.com
Media Partners
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/clinical-trial-logistics-and-supply

2. Conference Introduction
Clinical Trial Logistics & Supply
29th - 30th September 2011, London, UK
Silver Sponsors:
Dear Colleague, Incorporated in 1998, DGP Intelsius specializes in the design,
utting overheads and improving supply chains in today’s market is as pressing a need as
C manufacture and supply of temperature-controlled packaging and
ever. With the whole drug development process heavily dependant on clinical trial efficiency, regulatory-compliant sample transport solutions. With a strong focus
logistic and supply chain optimisation are now integral to cost saving. on developing environmentally sustainable products and procedures, we offer clients an eco-friendly
ffectively transporting clinical trial materials to investigator sites, and patient samples back
E way to ensure the integrity of their products. DGP Intelsius has a growing global presence, with
manufacturing facilities, distribution hubs and local offices situated throughout the world, including
to central laboratories are critical if a product is to be launched on time and within budget. North America, Europe and Asia. We are dedicated to protecting life’s most precious cargo.
In a world where time is money, even a week’s delay can potentially cost millions.
For further information please visit: www.intelsius.com
oreover, the relentless pressure to bring drugs to market quickly and cheaply means many
M
Durbin is a global leader in clinical trail supply, specialising in Comparators, Standard of Care
studies are now outsourced to Eastern European and other emerging markets. With each medications and Ancillary supplies. Based on its foundations, heritage and experience Durbin
country having unique guidelines, understanding the complexities of shipping materials to a brings a difference for the Clinical Trial supply market. This difference – The Durbin Difference – can
variety of destinations is crucial. Opportunities for strategic and adaptive planning include: be summarised as 1) Global sourcing capability – frequently sourcing from over 100 countries,
regulatory compliance, multi-language labeling, risk-based modelling, and secure, co- 2) Global custom distribution – custom distribution solutions to 180 countries 3) Transparent
ordinated distribution. Whichever stage you’re at, maximising value demands an integrated pricing – full disclosure of all purchase costs and invoices. For more information please contact
and well organised supply chain. clinicaltrialsupply@durbin.co.uk or +44 208 869 6517. Proven reliability. It’s in our DNA.
For further information please visit: www.durbin.co.uk
Visiongain’s Clinical Trial Logistics and Supply conference addresses
your concerns, enabling you to efficiently resolve challenges at The Haupt Pharma Group is one of the largest, fully integrated contract
development and manufacturing organisations in Europe with nine
regional, national and international levels. In addition to providing production sites in Germany, France, Italy and Japan. Our services cover the
the latest developments in security, forecasting, partnering and complete process chain from lab scale formulation development via process
outsourcing, you will also leave empowered to: development and validation tocommercial scale production. A portfolio of standard pharmaceutical
• Optimise drug pooling for clinical trial supplies dosage forms is rounded off by lyophilized formulations. In addition to conventional APIs, Haupt
• Ensure bioequivalence when undertaking comparative trials Phama handles cytotoxics, hormones and controlled drugs. Our corporate development organisation
provides a single customer interface for development, analytics and clinical trial supplies.
• Integrate national regulatory requirements into protocol design
• Improve patient management for studies conducted in emerging markets For further information please visit: www.haupt-pharma.de
• Label investigational medicinal products country-specifically to meet customs approval Associate Sponsors:
• Forecast supply demand to eliminate wastage Sofrigam, cold chain expert. Rely on Sofrigam’s expertise, packaging and services
• Optimise sample management to warranty your cold chain security. Sofrigam designs and qualifies isothermal
• mplement a secure cold chain strategy and reduce temperature deviation and delivery
I and refrigerated packaging enabling the transport of heat sensitive products (fresh
time during shipping or frozen) in non-refrigerated vehicles. The materials used associated with the expertise of our engineers
and our partnership with Ater Metrologie Laboratory, means our products are suitable for sectors that are
• valuate improved GPS and RFID temperature-monitoring devices to minimize risk during
E
VERY demanding with regard to quality and safety, such as the pharmaceutical, chemical, biotechnology
transportation industries. We offer our clients a range of standard or made-to-measure products and services enabling
• Maximise your depot supply and distribution practices them to establish secure, economical and ecological cold chain logistics.
• Implement lessons gleaned from case studies from Eastern Europe, the Far East and Asia For further information please visit: www.sofrigam.com
• Utilise IVR and IWR to save time and money
Based in France, Euromedex is an experienced partner for CROs and promoters
I look forward to meeting you at the conference involved in clinical trials. Euromedex organizes and follows all the logistics of
Best regards clinical trials, from manufacturing to delivery of the drug to the investigators.
Services provided are in strict compliance to laws and regulatory; Euromedex has a Quality Assurance
System allowing to fulfill most demanding pharmaceutical requirements and especially GMP/GDP.
Euromedex offers services of a logistic centre and a central pharmacy for all logistic operations : reception,
checking, storage and delivery under different temperature conditions. We propose short delivery time to
John Shah the sites (for France in one day).Goods flows are traced and follow up is available.
Senior Conference Producer For further information please visit: www.euromedex.com
Almac Clinical Services, part of the Almac Group, has over 20 years experience
delivering a full range of global clinical trial supply and innovative technology solutions
Clinical Clinical Pharma
Diagnostics Sciences
to Pharmaceutical and Biotech Companies worldwide. We are the most trusted and
Technologies Services Services
Who should attend? stable name in the clinical supply marketplace. We are differentiated by our exceptional client service powered
Presidents, Chief Executive Officers, VPs, Global Heads, Chief Scientific by experienced and knowledge based Project Management. Our clinical supply services include: Global
Officers, Directors, Principal Scientists, Franchise Heads and Investigators in: comparator sourcing, Blinding and over-encapsulation, Packaging and labelling of trial supplies, Online Label
• Clinical Research Approval System, Global distribution and depot network ,Shipping Temperature Monitoring (STEMS), Project
• Clinical Operations Management and Qualified Person consulting, range of analytical services and drug supply management.
• Clinical Logistics Planning/Distribution For further information please visit: www.almacgroup.com
• Clinical Trial Process Implementation
• Drug Formulation Media Partners:
• Chemistry, Manufacturing & Controls PharmiWeb.com is the leading industry-sponsored portal for the
pharmaceutical sector. Supported by most of the leading pharmaceutical
• Drug Supply Planning/Management corporations, PharmiWeb.com provides dynamic real-time news, features,
• Clinical Trial Support events listings and international jobs to industry professionals across Europe and the US.
• Global Clinical Outsourcing For further information please email: corporate@pharmiweb.com
• Clinical Packaging BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and
• Labelling located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide
• Supply Chain Management/Integrity the world’s biotech and pharma information and market to make it universally
• Cold Chain Technology accessible and useful for scientific and business processes. Its first step to fulfilling that mission was
• Transportation Operations building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different
• Business Development channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and
marketing solutions. One of the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and
• Quality Assurance Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities.
• Research Statistics
• Regulatory Affairs
For further information please visit: www.biotechnology-europe.com
Future Pharmaceuticals has forged powerful relationships with key
Driving the Industry Forward | www.futurepharmaus.com
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
Sponsorship and exhibition opportunities within top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals
This event offers a unique opportunity to meet and do business with some of the key magazine is geared to create a deep penetration into a highly targeted and responsive audience,
bridging the gap between the industries’ top issues and the solutions top-tier vendors can provide.
players in the pharmaceutical and biotech industries. If you have a service or product
to promote, you can do so at this event by: For further information please visit: www.futurepharmaus.com
InPharm is the online platform for exclusive pharmaceutical news,
• Hosting a networking drinks reception comment, contracts, services, jobs and events and is home to InPharmjobs.
• Taking an exhibition space at the conference com, Pharmafile and Pharmafocus.
• Advertising in the delegate documentation pack For further information please visit: www.inpharm.com
• Providing branded bags, pens, gifts, etc.
Welcome to Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical
If you would like more information on the range of sponsorship or exhibition possibilities and biopharmaceutical contract services. With regular sections on contract
for visiongain's Clinical Trial Logistics & Supply Conference, please contact us: manufacturing, contract research, contract packaging, formulation/development
services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most
Damian Gorman, +44 (0)20 7549 9934 complete coverage of trends and issues in the industry to our 15,000 readers in North America.
damian.gorman@visiongainglobal.com For further information please visit: http://pharmoutsourcing.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
14:20 Presentation to be announced
Uwe Gudat
Medical Director, Office of the Chief Medical Officer Robert Donnell
Merck Serono Business Development Manager
Durbin
14:40 Bioequivalence and strategic comparator sourcing
10:20 Coordinating complex clinical information
flow phase III • Benefits of a single comparator for a worldwide trial
• Aligning clinical information from multiple CROs and big pharma • Bioequivalence: if it walks like a duck and quacks like a duck…
CASE STUDY
• Managing challenges to evolve into success • FDA Waivers
Angus Cameron
• Lessons learned from an alliance phase III development programme
Director and Senior Vice President
Martin Simán Pharmarama International
Clinical Information Science Director
AstraZeneca
15:20 Afternoon refreshments
15:40 Drug pooling as a clinical supply strategy
11:00 Morning refreshments
• Definition and regulatory background of drug pooling
• Possible drug pooling approaches, benefits and challenges
11:20 Quality considerations for audit compliance
• Case study: pooling at sites across studies
• verseeing trial progress and ensuring it meets GCP guidelines and
O Maria Eugenia Giribets Parra
sponsor SOPs Clinical Supply Chain Coordinator
• he roles of the sponsor of a clinical investigation, the IRB, or
T Boehringer-Ingelheim Pharma
independent ethics committee
• he roles and responsibilities of the clinical trial investigator
T 16:20 Assay development and sample management
• Sample handling
12:00 Strategic considerations for patient recruitment, • Sample logging and tracking through the analysis cycle
retention and compliance in multinational trials • Reducing uncertainty through quality assurance
• Recruitment practices across cultures; the good, the bad and the ugly Bassam Hallis
Project Manager
• Minimising drop out; enhancing patient retention
Health Protection Agency
• Violations and deviations; strategies to improve compliance
Penelope Ward 17:00 Closing remarks from the Chair
Senior Director, Experimental Medicine
UCB New Medicines
17:10 Networking drinks
12:40 Networking lunch
Take your discussions further and build new
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, 2011

4. Day 2
Clinical Trial Logistics & Supply
Friday 30th September 2011
09:00 Registration and refreshments
13:40 Management and supply challenges in
09:30 Opening address from the Chair emerging markets
PANEL DISCUSSION
Justin Doel O
ptimising procurement, distribution and third-party deliveries are among
Clinical Supplies Manager the many challenges encountered when running trials in BRICK and EEU
Novartis Vaccines & Diagnostics, Global Clinical countries. Panelists will discuss strategies to overcome these and other
Research & Development hurdles, as well as complying with regulatory, QA standards and labelling
guidelines, choosing and supplying investigator sites, and meeting national
inspection standards. Selecting the right transport strategy and realistic
09:40 Personalised medicine – it’s always about YOU, isn’t it?
timelines for obtaining import licenses will also be considered. Please
• Importance of stratification email your questions for the panel to john.shah@visiongainglobal.com.
• Impact on clinical trials Chair: Angus Cameron, Director and Senior Vice President,
Pharmarama International
• A glimpse of the future
Annegret Van der Aa, Clinical Trial Manager,
Angus Cameron
Development, Galápagos
Director and Senior Vice President
Pharmarama International Stuart McGuire, Executive Director Global Business
Development, Chiltern
10:20 Customs requirements in Eastern Europe Lewis Cameron, Chief Executive Officer, Clearstone
• Setting quality agreements Laboratories
• Deciding contractual partners Robert Donnell, Business Development Manager, Durbin
• Essential GMP/GDP contents
14:20 Managing time and temperature sensitive
11:00 Morning refreshments supply chains
• Planning in advance: from depot to site
• Understanding local distribution infrastructure
11:20 Essential steps towards successful clinical trial • Customs and regulatory compliance
supplies in Eastern European countries - case study Sean Smith
• Rationale for conducting studies in EEU countries Vice President, Clinical Supply Chain
CASE STUDY
Fisher Clinical Services
• Additional regulatory challenges in EEU countries
• Case study: real-life experience & lessons learned 15:00 Afternoon refreshments
Annegret Van der Aa
Clinical Trial Manager, Development 15:20 Piloting RF-enabled technology for temperature
Galápagos monitoring in clinical trails
• Potential of RF enabled technology for temperature monitoring
• Piloting experience (setup, conduct, data analysis)
12:00 Presentation to be announced • onsiderations when implementing RF-technology for
C
• dentifying the right transport strategy for your clinical trial
I temperature monitoring
with focus on central lab
• Managing risks on clinical trial sample transportation
16:00 Minimising risk in
CASE STUDY
• Rightsizing your batch shipment frequency low-temperature maintenance
Stuart McGuire • Ensuring integrity of packaging containers
Executive Director Global Business Development
• Risk assessment techniques in the supply chain
Chiltern
• Integrated feedback processes
Lewis Cameron
Chief Executive Officer
Clearstone Laboratories
16:40 Chair’s closing remarks
12:40 Networking lunch
16:50 End of conference

5. Registration Form
Clinical Trial Logistics & Supply
29th - 30th September 2011, London, UK
Conf. code PP
Clinical Trial Logistics
Standard Prices & Supply
Conference only Fee: £1299 VAT: £259.80 Total: £1558.80
29th - 30th September 2011
Number of bookings: Total cost: Location: Thistle City Barbican
Address:
Central Street, Clerkenwell
Promotional Literature Distribution London
Distribution of your company’s promotional literature to all conference attendees EC1V 8DS
UK
Fee: £999 VAT: £199.80 Total: £1198.80
Details How to book
Forename: Surname: Email: piyush.patel@visiongain.com
Web: http://www.visiongain.com/clinical-trial-logistics-and-supply
Job Title: Company: UK Office:
Tel: +44(0) 20 7549 9961
Fax: +44(0) 20 7549 9932
Main Switchboard Number:
Visiongain Ltd
BSG House
Address: 226-236 City Road
London
EC1V 2QY
UK
Country: Postcode: General information
Venue: Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, Phone: 0871 376 9004 /
Phone: Fax: +44 845 305 8304, Fax: 0871 376 9104 / +44 845 305 8343
http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.html
Guests should quote the booking reference number VISW290911_006 by 15/09/2011 when making
Email: their booking in order to guarantee they receive the group rate. UK Telephone Number: 0871 977 0218,
International Telephone Number: +44845 073 7154, E-mailing: groupsadmin.citybarbican@thistle.co.uk
Signature: Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain
Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may
I confirm that I have read and agree to the terms and conditions of booking be requested if payment has not been received in full before the event. Visiongain Ltd reserves the
right to charge interest on unpaid invoices.
Methods of payment Substitutions/name changes or cancellations: There is a 50% liability on all bookings once
made, whether by post, fax, email or web. There is a no refund policy for cancellations received on or
Payment must be made in sterling after one month before the start of the event. Should you decide to cancel after this date, the full invoice
must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places
By Mail: Complete and return your signed registration form together with your cheque payable between conferences. However, if you cannot attend the conference, you may make a substitution/name
to Visiongain Ltd and send to: visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY, UK change at any time, as long as we are informed in writing by email, fax or post. Name changes and
substitutions must be from the same company or organisation and are not transferable between
By Fax: Complete and fax your signed registration form with your credit card details countries. Please note that discounted delegates places at a visiongain event are non refundable.
to +44 (0) 20 7549 9932 Invoice alterations: There will be an administration charge of £50 for any changes to an invoice,
excluding substitutions/name changes, requested by the customer. This will be charged to the
By Phone: Call us on +44 (0) 20 7336 6100 with your credit card details customer by credit card prior to the changes being made.
By Credit Card: Fill in your card details below and fax back to +44 (0) 20 7549 9932 Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive
briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled
By Bank Transfer: due to unforeseen events beyond the control of visiongain Ltd. If such a situation arises, we will try
to reschedule the event. However, visiongain Ltd cannot be held responsible for any cost, damage or
Visiongain Ltd A/C: visiongain Ltd expenses, which may be incurred by the customer as a consequence of the event being postponed or
cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the
Barclays Bank Sort Code: 20-71-64
cost of the registration, travel and expenses.
Piccadilly Branch Account No: 6038 7118 Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data
48 Regent Street Swift Code: BARC GB22
Protection Act 1988. Your personal information contained in this form may be used to update you on
London, W1B 5RA IBAN: GB80 BARC 20716460387118 visiongain Ltd products and services via post, telephone, fax or email, unless you state otherwise. We
may also share your data with external companies offering complementary products or services. If you
Please debit my credit card: wish for your details to be amended, suppressed or not passed on to any external third party, please
send your request to the Database Manager, visiongain Ltd, BSG House, 226-236 City Road, London,
Access MasterCard Visa American Express EC1V 2QY. Alternatively, you can visit our website at www.visiongain.com and amend your details.
Please allow approximately 30 days for your removal or update request to be applied to our database.
Following your removal or update request, you may receive additional pieces of communication from
visiongain Ltd during the transitional period, whilst the changes are coming into effect.
Card number:
Fee: The conference fee includes lunch, refreshments and conference papers provided on the day.
This fee does not include travel, hotel accommodation, transfers or insurance, (which we strongly
recommend you obtain).
Expiry Date:
VAT: VAT will be charged at the local rate on each conference. Delegates may be able to recover VAT
incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, eurocash@eurocashvat.com.
Security number (last 3 digits on back of credit card): Eurocash specialise in recovering cross-border VAT.
How we will contact you: Visiongain Ltd’s preferred method of communication is by email and
Signature: phone. Please ensure that you complete the registration form in full so that we can contact you.
Cardholder’s name:
Unable to attend
Obviously nothing compares to being there but you need not miss out. Simply tick the box and send
with your payment. You will receive speaker talks in PDFs two weeks after the event.
News updates Yes, please send me speaker talks Price£550 VAT:£110 Total:£660
Please tick if you do not want to receive email news updates in the future
www.visiongain.com/clinical-trial-logistics-and-supply