1. Clinical Trial Logistics & Supply Anticipating and overcoming management and delivery challenges29th - 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.comMedia 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, UKDear 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: firstname.lastname@example.org 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.comoutsourcing, 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: email@example.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 visiongains Clinical Trial Logistics & Supply • Quality Assurance Conference, please contact us: • Research Statistics Ronald Magali, +44 (0)20 7549 9934 • Regulatory Affairs firstname.lastname@example.org
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 201109:00 Registration and refreshments 12:40 Networking lunch09:30 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 Smith09:40 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 PAREXEL10:20 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 chain11:00 Morning refreshments • Integrated feedback processes11:20 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 practice12:00 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 email@example.com.
5. Registration Form Clinical Trial Logistics & Supply 29th - 30th September 2011, London, UK Angel Conf. code FB Pentonville Road Clinical Trial Logistics CiStandard Prices ty & Supply Ro adConference only Fee: £1299 VAT: £259.80 Total: £1558.80 29th - 30th September 2011 Old StreetNumber of bookings: Total cost: Location: Visiongain Conference Centre Old Street Address: 230 City RoadPromotional Literature Distribution City Road LondonDistribution of your company’s promotional literature to all conference attendees EC1V 2TT UK Fee: £999 VAT: £199.80 Total: £1198.80Details How to bookForename: Surname: Email: firstname.lastname@example.org Web: http://www.visiongain.com/ctls Job Title: Company: UK Office: Tel: +44(0) 20 7336 6100 Fax: +44(0) 20 7549 9932 Main Switchboard Number: Visiongain Ltd BSG HouseAddress: 226-236 City Road London EC1V 2QY UKCountry: Postcode: General information Venue: Venue: Directions: Visiongain Conference Centre 230 City Road, London, EC1V 2TT. United Phone: Fax: Kingdom. Closest tube station is Old Street (Northern Line). Accommodation: Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, Phone: 0871 376 9004 / +44 845 305 8304, Fax: 0871 376 9104 / +44 845 305 8343Email: http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.html Travelodge London City Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207 Signature: 628 2503, http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340 Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain I confirm that I have read and agree to the terms and conditions of booking Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may be requested if payment has not been received in full before the event. 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Delegates may be able to recover VAT Security number (last 3 digits on back of credit card): incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, email@example.com. Eurocash specialise in recovering cross-border VAT.Signature: How we will contact you: Visiongain Ltd’s preferred method of communication is by email and 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 News updates with your payment. You will receive speaker talks in PDFs two weeks after the event.Please tick if you do not want to receive email news updates in the future Yes, please send me speaker talks Price£550 VAT:£110 Total:£660 www.visiongain.com/ctls