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Europe's leading industry update for all clinical development outsourcing professionals9th AnnualPharmaceutical companiescurrently spend approximately30% of their totalR&D budget onoutsourcing - how areyou optimisingyour spend?Congress and Exhibition 2010Practical models for successful strategic partnerships16-19 November 2010, Reed Messe, Vienna, AustriaKEYNOTE ECONOMIST:Quentin Peel,Associate Editor,The Financial TimesINSPIRATIONAL PATIENTPERSPECTIVE:Charles Sabine,Emmy-award winningNBC Journalist,War Correspondent,and Huntington'sDisease patientPROJECT MANAGEMENT EXPERT:Stephen Carver,Project ManagementSpecialist and Lecturer atCranfield UniversityCONFERENCE CHAIR:Richard Barker,Director General,Association of theBritish PharmaceuticalIndustry (ABPI)INDUSTRY KEYNOTE SPEAKERS INCLUDE:Dalvir Gill,President, Late StageDevelopment,PharmaNetMatthias R. Evers Ph.D.,Principal,McKinsey & CompanyDr Rabinder Buttar,President & CEO,ClinTec International GroupJane Clarke, FormerlyAssistant Vice President,Clinical Development Support,WyethHarris Koffer, Pharm.D,President and ChiefOperating Officer,ReSearch PharmaceuticalServices (RPS)Sebastian Pacios,Senior Vice President,Clinical Development, Europe,Middle East and Africa,PPD, Inc.Dave GilloglyGlobal Head, ClinicalContracting & CategoryManagement,Novartis PharmaceuticalsCorporationGareth Down Ph.D.,Head of European Healthcare,William Blair InternationalWarren Myers,Formerly Head of R&DStrategic Sourcing,AmgenVasco M. Grilo,Vice-President GlobalPharmaceutical R&DSourcing (GPS)Johnson & JohnsonPharmaceutical Research& Development, L. L. C.OUT OF INDUSTRY PERSPECTIVEAlan Crane CBE,Vice President, CharteredInstitute of Buildingand former ChiefExecutive OfficerBovis InternationalWHAT WILL YOU ACHIEVE ATPARTNERSHIPS IN CLINICAL TRIALS 2010? Gain unprecedented access to the largest ever expert speaker panel –150+ presenters including largest ever group of Vice Presidents,Directors and Heads of clinical outsourcing Meet all you clinical outsourcing contacts in one place - 800+ attendees Tailor make your programme with our largest and most comprehensive agendaever - 94+ hours of independently researched, content-driven presentations Understand how other sponsors and providers have created successful,strategic clinical partnerships - 70+ brand new case studies Network with the highest ever number of senior outsourcingrepresentatives across 15+ hours Have more choice than ever through 14 intensive break-out streamsNEW FOR 2010: EIGHT brand new streams including:• Vendor oversight• Global footprint for your trials• Early clinical development • Relationship management• Project management• Small Pharma/biotech outsourcing• Strategic clinical outsourcing • Maximising resources FOUR intensive half day workshops:• Performance management: tools for measuring the performance of serviceproviders and sponsors• Focus on new regulatory expectations for vendor oversight• Managing the project management and contract challenges of workingwith functional service providers• Honing your CRO cost and contract negotiation skills“Outstandingnetworking,wonderfulopportunity to getan update on theoutsourcing space”Product Development Director,Futura Medical Development LtdAssociate SponsorsSupporting Sponsorswww.ct-partnerships.comTo register: Call: +44 (0) 20 7017 7481 Fax: +44 (0) 20 7017 7823Email: registrations@informa-ls.com


9th Annual Partnerships in Clinical Trials Congress and Exhibition 201016-19 November 2010, Reed Messe, Vienna, AustriaAdvisory BoardThe Partnerships in Clinical Trials team would like to express their thanks to the members of the advisory board who have been invaluable in helping to create this year’s programme:Graham P Belgrave, Vice President, Head Global Clinical Development Operations (Interim), GCD, Grunenthal GmbHGraduating from Warwick University In 1984, Graham began his career in Pharmaceuticals with Sterling Winthrop first as a CRAand then Study Manager Phases I-III, moving to Lorex-Synthelabo for another six years as a Clinical Project Manager then finally asHead of Clinical Trials with responsibility for all Phase I-IV studies. Changing direction in 1997 by moving out of Clinical Researchinto Contracts and Outsourcing, firstly with GW, later GSK, for seven years moving through several roles to finally becoming GlobalHead of Outsourcing and Contract Management. In 2003 he moved to Pfizer Global R&D to develop a new role as Director of VendorRelationship Management within the C&O group, a strategic global role which facilitated the effective delivery of business criticalprojects and programs. In 2006 he started working as a Pharmaceutical Consultant taking an Interim role in Global Studies Leadership, Oncology,at Hoffman-La Roche, Basel. Following this came a permanent position as Director, Global Outsourcing and Contract Management andsubsequently as Vice President, Clinical Operations at Vernalis R&D, a specialist Bio-Pharmaceutical Company. In late 2007 he re-started hisConsultancy business working for many sponsors Pharma. Biotech and CRO and most recently May 2010 has started as the Vice President, HeadGlobal Clinical Development Operations (Interim) at Grunenthal in Aachen Germany. He is a Professional Member of the Institute of ClinicalResearch, The Hon. Secretary of the Society of Pharmaceutical Medicine and a Fellow of the Royal Society of Medicine.Dr Rabinder Buttar, President & CEO, ClinTec International GroupDr. Rabinder Buttar is the Founder, President and CEO of ClinTec International, a global clinical research organizationestablished in 1997 and present in over 40 countries worldwide. Included in Real Business’ List of Britain’s 100 MostEntrepreneurial Women, Dr Buttar is the recipient of several business awards including the Lloyds TSB Business andCommercial Excellence Jewel Award. With two doctorate degrees and management qualifications from British Universities, DrButtar has spent 20 years within the pharmaceutical and CRO industry in leading companies such as GSK, Astellas and Wyeth.Under Dr Buttar's leadership ClinTec has grown from inception to a global organization with a strong presence in all major andemerging markets including the Middle East and Africa. The company now provides innovative clinical research services to 11 of the top25 pharmaceutical companies in the world and has established its Global Academy of Clinical Research Excellence (ACRE). Dr Buttarserved previously on the Board of the Institute of Clinical Research and currently serves on the Editorial Board of Scrip Clinical Researchand Journal of Clinical Studies. She is a Fellow of the Royal Society of Medicine, and Regional Director of the Year (Glasgow & West ofScotland) at Institute of Directors, UK. The Scottish Parliament has congratulated Dr Buttar and ClinTec for their contribution to life sciencesand provision of clinical research teams across the globe.Vanessa Cooke, Global Head External Supplier Management, Pharmaceutical Division, Bayer HealthCareVanessa is based in London UK. A graduate in Pharmacology & Physiology, she joined the Pharmaceutical industry in 1986 asa CRA and worked for Bristol Myers and Wellcome before joining her CRO in 1990 as a Project Manager. She has worked for3 global CROs and spent a total of 11 years in the CRO business and gained experience at a senior level in both global operationsand global business management. Vanessa joined Bayer in 2001 to head - up the newly formed Global External SupplierManagement Group. Her team is responsible for all international global outsourcing for phases II – IV, as well as providing adhoq support to the other divisions within Bayer HealthCare. They manage all types of vendor outsourcing and are activelyinvolved in ongoing relationship management between the vendor and Bayer throughout the life of a project.David Davies, Product Development Director, Futura Medical <strong>plc</strong>David manages the research and development functions within Futura Medical Developments Ltd., a wholly owned subsidiaryof Futura Medical <strong>plc</strong>, of which he is an Executive Director. Futura Medical <strong>plc</strong> develops novel, topical pharmaceutical drugsand medical devices, which are out-licensed to global pharmaceutical companies prior to regulatory approval. David joinedFutura in 2001, building the development function from scratch to create a high performing virtual team of approximately 30individuals and with all development work outsourced. He is inspired by the constant challenge to achieve successful delivery(and therefore ROI) through effective Project Management and Outsourcing. David holds a degree in Microbiology and researchexperience at Porton Down, Bristol University and Glaxo Group Research Ltd, from which he has published several refereed papers. Hissubsequent pharmaceutical career spans 23 years, during which time he has pursued increasingly senior roles in Clinical Research and ProjectManagement in both pharmaceutical companies (Wellcome Foundation, Zambon) and global contract research organizations (Pharmaco,PPD, Clintrials). He holds an MBA from the Open University. Externally David is a committee member of PCMG (pharmaceutical contractmanagement group), is on the Informa Partnerships in Clinical Trials advisory board and is a member of the Institute of Directors. He haspresented at - and chaired - numerous events, notably speaking on performance metrics and outsourcing in a virtual company.Jean Edwards, European Procurement Manager, Eli Lilly and Co. Ltd.Jean joined the Procurement Team at Eli Lilly in October 2002 and is responsible for the coordination of clinical outsourcingacross Europe and ensuring that Lilly gets best value from their clinical suppliers. Prior to joining Lilly Jean spent most of hercareer with Bayer working in Clinical Research, Quality Management and Contract Resource Management Groups. In her last18 months at Bayer, Jean was part of the Global External Supplier Management Team responsible for Europe & Overseas.Carl Emerson, Senior Manager, Clinical Procurement, GSKBio LtdA graduate in Pharmacology and Chemistry from Sheffield University, Carl spent most of his working life at the same company.Starting as a bench chemist for Glaxo, a succession of varied posts in the medical area followed as the company merged and grew.As well as working at the clinical front end collecting the GCP documentation in the early days of such requirements, he has alsospent time in various technical roles with databases, programming and training featuring as the role demanded. With experience insmall biotech as well as large Pharma, Carl now leads the clinical procurement process for GSK's vaccine business out of BelgiumJacqui Gatehouse, PhD, Director, Outsourcing & Contract Management, Genmab A/SJacqui Gatehouse, PhD – with 13 years experience in various roles related to clinical development, Jacqui is currently leading theoutsourcing and contract management function at Genmab A/S, a biotechnology company that creates and develops humanantibodies for the treatment of life-threatening and debilitating diseases. Previously Jacqui was Head of Outsourcing at NycomedDanmark Aps and also spent more than four years leading the global sales team at a centralized imaging CRO. She also hasoperational experience of both planning and executing clinical trials from both the Pharma and Investigator site perspectives. Jacquihas a PhD in Radiological Sciences (King’s College, London) and a First in Human Physiology (University of East London).Julianne Hull, Senior Director, Global Development Data Operations, WyethJulianne was born in Antrim, Northern Ireland. Her primary degree was in Biochemistry, which she achieved in 1980 fromQueens University, Belfast. In 1982 she achieved an MSc in virology and then undertook postgraduate research at North WesternUniversity in Chicago. In 1988 she moved to England where she has gradually built up experience in all aspects of clinical trialoperations particularly clinical data management, project management and to a lesser extent monitoring. In May 1998 sheaccepted the new position of Associate Director globally responsible for all outsourcing of Clinical Data Management for WyethThis role encompassed development of strategy, selection of vendors, development of contracts and oversight of contractdelivery. In this she was responsible for the strategic development and implementation of unique, quality and cost effective methods ofoutsourcing of Clinical Data Management. This eventually led to the establishment of the Wyeth Accenture strategic alliance in 2003.Julianne currently has business and operational oversight of the Wyeth/Accenture alliance. She is also responsible for identifying, escalatingand assuring resolution of any issues, which may impact delivery of the many Wyeth clinical trials. Julianne is an active member of the DIAand currently one of the co-chairs of the DIA European Clinical forum.Roger Joby, Director, 1to1to1Roger has been involved in the pharmaceutical industry for over 30 years. He has experience in Clinical operations, ProjectManagement, Proposal generation and sub contractor contracts at all levels including senior director. Roger qualified as aBiochemist and has a Certificate in Management and is a Member of the Association for Project Management. Roger has workedhas worked either full time or as a consultant for several Pharmaceutical Companies (including Glaxo Research, Pfizer, CambridgeAntibody Technology), and Clinical Research Organisations e.g. Quintiles, Pharmaco, MDS Pharma Services and CroMedica.Roger is currently working as a senior project management consultant for 1to1to1. Roger is also involved in project managementresearch looking at the impact of Earned Value in clinical research, with Dr. David Bryde of Liverpool JM University (Faculty of Businessand Law). Apart from Earned Value Roger is also interested in Risk Analysis, Project Pricing, Forecasting, and Stakeholder analysis.Susanne Kihlblom, Outsourcing Director, Clinical Outsourcing, AstraZeneca R&DSusanne is working as a Strategic Sourcing Leader within AstraZeneca’s Clinical Development organization and is responsible tohelp assess, plan and forecast external service provider requirements when outsourcing clinical trials and supporting services forneuroscience and respiratory/infection. In her role Susanne recommends sourcing options to all Clinical Project Teams withinthose therapy areas. Prior to that Susanne was leading a global “External Provider Management Team” for phase I outsourcedclinical trials. This group of 30 members was implementing AstraZeneca’s new outsourcing strategy. Susanne has also beenresponsible for global account and relationship management of phase I CROs and lead the allocation of outsourced phase I trialsglobally for AstraZeneca. She has an MSc in Pharmacy from Uppsala University, Sweden, and received a Diploma in Clinical Trials from theSwedish Pharmaceutical Society. Susanne started her career in the Pharmaceutical Industry in 1992 and has pursued increasingly senior rolesin clinical research at Roche and also Amgen´s European R&D headquarters in Cambridge. Since 2001 Susanne has worked with outsourcingin different global roles at AstraZeneca and is located in Sweden.Cliff Leat, Senior Outsourcing Manager, Celgene InternationalCliff started his early career within the in-vitro diagnostics industry where he worked at various companies including J&J OrthoClinicalDiagnostics as a Project Leader. Cliff moved to the Pharmaceutical industry in 1999 joining Roche Products as a Project Data Manager. Hesubsequently moved to Wyeth and GSK working in the Contracting and Outsourcing departments. Cliff now works at Celgene Internationaland is based in the UK office as a Senior Outsourcing Manager having responsibilities for the outsourcing of European and global studies.Cliff has been the treasurer of the PCMG for four years.Steve Martindill, PhD, Senior Director, Head of Clinical Development, Kyowa Hakko UK LtdSteve Martindill is currently Senior Director and Head of Clinical Development at Kyowa Hakko Kirin UK Ltd, the Europeanaffiliate office of Kyowa Hakko Kirin Co, Ltd - one of Japan’s largest biopharmaceutical companies. Prior to joining Kyowa asa Project Manager in 2000, Steve achieved a 1st class honours degree in Applied Science and a PhD in Toxicology beforegaining 5 years experience in a variety of positions within an international CRO, working in UK and S.E Asia. In his currentposition Steve has overall responsibility for Kyowa’s clinical development activities in Europe, which is a varied role involvinggeneral and personnel management as well as outsourcing and oversight of operational and project management teams workingon the development of novel small molecules and biologicals in a range of therapeutic areas. Steve has presented and acted as session chairat several international conferences and is a Chartered Scientist (CSci) and Biologist (CBiol), a Member of the Society of Biology (MSB)and the Institute of Clinical Research (MICR) and a fellow of the Royal Society of Medicine. He has been a member of the PharmaceuticalContract Management Group for over eight years and was co-opted onto the Committee in 2007.Content and Programme:Siobhan Corry, Research Director, Partnerships in Clinical TrialsTel: +44 (0)20 7017 7135 Email: siobhan.corry@informa.comSponsorship and Exhibition:Kirianne Marshall, Commercial Director, Partnerships in Clinical TrialsTel: +44 (0)20 7017 7129 Email: Kirianne.marshall@informa.comDelegate Registration:Simon Lau, Team Manager – Delegate Sales, Partnerships in Clinical TrialsTel: 44 (0) 207 017 7165 Email: simon.lau@informa.comTHE PARTNERSHIPS IN CLINICAL TRIALS TEAMAnna Matranga, PhD MBA, Head of Global Purchasing & Outsourcing, Galderma R&DAnna M.C. Matranga holds a PhD in microbiology (Bristol University, UK) and an MBA in general management (HenleyManagement College, UK). She joined the pharmaceutical industry at Eli Lilly (Surrey, UK) where she held various roles inclinical and was an international project manager for Phase I to IV projects. She moved company & country and went to work forAllergan, an American eye-care company, with offices in France (Sophia Antipolis) where she held roles as a Clinical ProgrammeLeader, Head of Benchmarking and Training and finally Head of Contracts, Benchmarking & Training. Having created andestablished the CRO/contracts management team (in parallel to completing an MBA – hard work but enjoyable!), she then movedonto Galderma (Sophia Antipolis). Galderma is a Swiss pharmaceutical company specialising in dermatology and a joint venture betweenL’Oreal and Nestlé. Currently, she is responsible globally for optimising the in- and out- sourcing strategies across the entire R&D division(from discovery to development plus site support) as well as managing the purchasing department. She lectures in Organisational Behaviour,conducts research into Emotional Intelligence, is an active member of PCMG (having held the Chairperson & Treasurer’s role) and considersherself multicultural (speaks English, French, Italian & “rusty” German)Elisabeth Overend, Sr. Global Brand Manager, Clinical Development, CovanceElisabeth joined Covance in 2005 and oversees clinical development global marketing including strategic planning, growth- andtargeting initiatives, commercial tactics and liaising with other departments. Prior to entering the CRO industry, she obtained anMPhil from the University of Cambridge, and transferred to the US in 1998 to join Datamonitor, the market research company.She specialised in the pharmaceutical and biotechnology vertical, ultimately serving as the head of marketing for the US.Elisabeth is involved in several industry organisations including Massachusetts Biotech Council and New York Pharma Forum,and also is a member of the advisory board for IIR Partnerships' US sister event.Barry Overton PhD., Director of Clinical Research Operations, MedImmuneBarry manages the Cambridge based staff of the Clinical Operations department of MedImmune, the worldwide biologics businessfor AstraZeneca. Barry joined the company when it was Cambridge Antibody Technology, to establish the clinical operationscapability. Following the merger with MedImmune in 2007, he has been working to integrate and expand the Cambridge office aspart of MedImmune’s global clinical operation. Barry’s pharmaceutical career started in 1986 at Sterling Winthrop. After gainingfurther experience in pharma at Yamanouchi and Schering Plough, Barry joined the medium-sized, UK based CRO, Data Analysisand Research (DAR). In 1996, after 6 years with DAR, he left to join Cambridge Antibody Technology. Barry has been anenthusiastic member, and former Chairman, of the Pharmaceutical Contract Management Group (PCMG). PCMG is a forum for the discussionof all issues relating to outsourcing and draws its membership from pharmaceutical and biotechnology companies across Europe.Andy Parrett, Senior Outsourcing Manager, MedImmuneAndy manages the European clinical development outsourcing work for MedImmune; AstraZeneca's worldwide biologicsbusiness unit. He has a degree in genetics and a background in clinical science and medical research gained as an embryologistat Bourn Hall Clinic and a neuroscientist at the Royal London Hospital. Andy has been with MedImmune since March 2009 andprior to that spent 5 years building a renowned outsourcing team at Mundipharma and 4 years working in contracts, proposalsand finance teams at various CROs - most notably MDS, PRA and Parexel. In addition, Andy has been an active committeemember of the PCMG since early 2004 and Chairperson since January 2009. Andy is an enthusiastic innovator around theapplication of project management methodologies within clinical development outsourcing teams and has presented some well respectedwork in this field in recent years – including contributions on relational contracting models, the Forecast Earned Value & Invoice Tracker(FEVIT) system and the first reported stakeholder analysis for an outsourced multicentre trial.Richard D Pompe, Group R&D Purchasing Director, Mylan IncRichard Pompe has worked in the Pharmaceutical Industry for more than 16 years with experience covering a number of functional areas.His early experiences in the industry encompass working in the sales, marketing and training departments of Roche Pharmaceuticals andMerck-Lipha. After nearly 10 years Richard has moved into the contract research arena in business development working for one of theleading global contract research organisations. Recently he has moved back into the Pharmaceutical Industry as Group R&D PurchasingManager for the Mylan Inc. Richard holds a BSc in Neuroscience and a Masters in Business and Administration.Michael Ryan BSc, BSc, MBA, Vice-President, Business Development, PharmaNetMike Ryan is currently Vice president of Business development at PharmaNet Development Group International. During his11.5 years at PharmaNet, Mike has collaborated with a number of large international Pharmaceutical companies and a series ofbiotechnology organisations as well as collaborating with a number of Venture capital companies. He has worked throughoutEurope, North America and Asia-Pacific. Prior to joining Pharmanet, Mike work in both the proposal development and clientrelationship groups at PAREXEL. Mike is married with two children.Norbert Seguin, Group Head Europe, Global Outsourcing & Alliances, GlaxoSmithKlineNorbert graduated as a Doctor in Pharmacy from the University of Lyon in 1995. He started as a Clinical Research Associatefor Servier Laboratories in Paris while completing a postgraduate degree in Medical Biostatistics at the University of Paris.Shortly after completing his post graduate degree, Norbert was transferred to the UK and appointed Project Manager. In 1998,Norbert joined PAREXEL International as a Global Project Manager where he managed a large pivotal phase III trial. In 2000,he joined GSK where he has held a number of positions in Contracts Operations and Management. He was especially involvedin business improvement initiatives which aim to improve outsourcing productivity and optimize GSK Research & Developmentexternal spent. Since 2006, he has taken on new responsibilities and currently manages a team of Contracts Analyst/ManagerSamir Shah, Vice President, Strategic Development, ReSearch Pharmaceutical Services, Inc. (RPS)Mr. Samir D. Shah is the Vice President, Strategic Development for RPS, ReSearch Pharmaceutical Services. In this role for thelast 10 years, he oversees business development, has responsibilities for corporate expansion and is a member of the RPSExecutive Team. RPS, with corporate headquarters in Fort Washington, PA, USA, is the industry’s first Next Generation CROproviding innovative and customized global solutions to assist companies with the management and execution of their clinicaldrug programs. Prior to RPS, Mr. Shah spent seven years in the pharmaceutical, biotech and CRO industries in various roles inboth clinical research and business operations. Mr. Shah began his career in the Department of Psychiatry/Pharmacology at theUniversity of Pennsylvania Medical Center where he served as a Research Scientist for four years.Peter Summerfield, Vice President, Product Development, PPD, IncTrained as an anaesthetist, he has worked for 31 years in the pharmaceutical industry (including Boehringer Ingleheim, Cyanamid(Lederle), Glaxo, Roche and Biogen). His roles have been strategic and operational covering drug development and medico-marketingactivities. His therapeutic expertise spans all major therapeutic areas. Within PPD, his responsibilities include Strategic Consulting forProduct Development in CNS and Immunology, support to Business Development, and consulting on Risk Management including sittingas an independent expert on the Safety Monitoring Board for a client’s product development portfolio. He also acts as an EducationalSupervisor for the Royal College of Physicians’ Higher Professional Training in Pharmaceutical Medicine Course.Sigrid Viergutz, Senior Director International R&D Outsourcing, NycomedSigrid Viergutz has over 20 years of experience in both the pharmaceutical industry and CRO, and has held a variety of positionsin drug development. She has achieved her MSc in Statistics with minors in economics and business development at theUniversity of Munich, Germany. After working as a Research Scientist at the University of Munich and post-graduate studiesin computer science with minor in theoretical medicine she started her career in clinical development. After having held severalpositions in Statistics, Health-/Pharmacoeconomics, Business Development, International Study Management and Outsourcingshe started in 2001 the function of Clinical Development Outsourcing at ALTANA Pharma. She headed up the department ofcorporate External Provider Management, responsible for phase I-IV, at ALTANA Pharma’s headquarters in Germany for several years untilshe has been appointed as Head of International R&D Outsourcing at Nycomed in March 2007. In this position she is globally responsiblefor all outsourcing activities in Research & Development as part of the strategic role of outsourcing within the R&D Operating Model ofNycomed. During the last 3years she successfully managed the shift from tactical to strategic outsourcing at Nycomed. She is managing ateam including 8 Outsourcing professionals across Germany and Denmark.Dave Webber, Associate Director Clinical and Financial Operations, Biogen IdecDavid Webber has a BSc in Biological Sciences and a PhD in Bone Metabolism from the University of Manchester. After apostdoctoral fellowship at Washington University in St Louis and an MRC fellowship again at Manchester he joined thepharmaceutical industry with Procter and Gamble in Newcastle in 1991. Specialising primarily in managing clinical trials inosteoporosis he held a number of positions in the Clinical Research department. In August 1997, he joined the phase II group ofCovance in Maidenhead as a Clinical Research Manager working in areas such as Head and Neck Cancer, Rheumatoid Arthritisand CNS. He re-joined Procter and Gamble Pharmaceuticals in December 1998 as Section Head of European Cardiovascularstudies. In January 2002 he became European Outsourcing Manager handling the placement of a number of bone, cardiovascular and GI trials.David then took on the role of Vice President of Business Development for <strong>ICON</strong> clinical Research in June of 2007 responsible for sales targetsin Europe, and subsequently joined Biogen Idec in May 2008 as Associate Director of Clinical Business Operations. He has been an activeparticipant and committee member of the Pharmaceutical Contract Management Group for several years and served as Chairman from January2006 until June 2007. David is particularly interested in strategic outsourcing and supplier relationship management.Rikke Winther, Divisional Director, Outsourcing Management R&D, LundbeckRikke Winther has worked in the CRO and Pharmaceutical industry for the past 16 years and has experience from Clinical R&D,Business Development and Contract/Outsourcing Management. During the last nine years she has built up, and is now heading upthe Outsourcing Management function primarily within all pre-clinical and clinical functions at Lundbeck. Rikke is involved in theentire process from CRO selection through RFP development, negotiations and finalisation of contracts and Work Orders.Furthermore, Rikke is contributing to the development of Lundbeck’s future outsourcing strategies and is highly focused on Vendormanagement and optimised relationships. Prior to her employment at Lundbeck, Rikke worked for five years within analyticalresearch and Clinical Development in hospital settings and the pharmaceutical industry, respectively. This was followed by four year ofemployment in an International CRO where she held positions as International Project Manager in Europe followed by setting up the first SouthEast Asia office working as Business Development Manager and local Manager. Rikke is a member of the Pharmaceutical Contract ManagementGroup (PCMG) in Europe. She is a contributing author of the book: “Outsourcing Clinical Development, Gower Publishing Limited”.Anne Maria Ylisaari, Head of In- and Outsourcing, ORION PHARMAAnne Maria (Amy) joined Orion Pharma R&D Clinical Department 1995. She started as a CRA, moving on soon to the marketingdepartment where she worked a couple of years in different roles in marketing of analgesics, CNS drugs and cancer drugs. 1998 shereturned to clinical research to lead international, fully outsourced phase III studies conducted by global CROs. During the years workingwith global CROs she got more interested in outsourcing and its many aspects, finally ending up working in the In- and Outsourcing Unitat Orion Pharma Clinical R&D. At the same time she also joined the Pharmaceutical Contract Management Group (PCMG), anassociation for European contract managers, and has been a member of the PCMG committee since January 2008. For the past few yearsshe has led the In- and Outsourcing unit at Orion Pharma, and continues developing the general outsourcing processes and networks with her team.Exhibition, Conference & Venue Logistics:Amy Capel, Logistics Manager, Partnerships in Clinical TrialsTel: +44 (0) 207 017 4830 Email: amy.capel@informa.comMarketing and Promotions:Marie Paul, Marketing Director, Partnerships in Clinical TrialsTel: +44 (0) 207 017 7126 Email: marie.paul@informa.com


“An excellent event to learn about new paradigms in clinical research partnerships”Director, Clinical Operations, Helix Biopharma CorpDear Clinical Development Partner,Never before has clinical development relied so heavily on strong, strategic partnerships. Low R&D productivity, rising costs, and the looming patent cliff for blockbusterdrugs have resulted in consolidation and staff reductions across the industry. All pharmaceutical and biotech companies are looking at radical ways to reduce fixed costs,while still delivering high quality trials on time and on budget.So how can you save money and increase productivity through practical, successful strategic partnerships?What you will achieve at Partnerships in Clinical Trials 2010:• Gain unprecedented access to the largest ever expert speaker panel – 150+ presenters including largest ever group of Vice Presidents, Directors and Heads of Clinical Outsourcing• Meet all your clinical outsourcing contacts in one place - 800+ attendees• Tailor make your programme with our largest and most comprehensive agenda ever - 94+ hours of independently researched, content-driven presentations• Understand how other sponsors and providers have created successful, strategic clinical partnerships - 70+ brand new case studies• Network with the highest ever number of senior outsourcing representatives across 15+ hours• Take advantage of more programme choice than ever through 14 intensive break-out streamsNEW FOR 2010• INSPIRATIONAL PATIENT PERSPECTIVE: Charles Sabine, Emmy-award winning NBC Journalist, War Correspondent and Huntington’s Disease Patient- Charles will talk with passion about what it means to feel fear over his many years reporting from war torn countries and natural disasters. He will also talk frompersonal experience about the crucial importance of clinical research, and his personal mission to find a cure for Huntington's disease.• OUT OF INDUSTRY CLOSING KEYNOTE ADDRESS: Alan Crane CBE, Vice President, Chartered Institute of Building, and former Chief Executive Officer,Bovis International, Travers Morgan Consulting Group and Christiani & Nielsen Group- Alan Crane was responsible for the construction of Canary Wharf and Euro Disney, and understands the crucial importance of strategic partnering for project delivery.He was awarded a CBE for services to the construction industry, and speaks here on ‘Rethinking Construction - How did the construction industry outsourcing haveto radically change to survive difficult times?’• Out-of-industry case studies with top lessons learned for Pharma• Project management solutions clinic where YOU set the agenda and have your questions answered• Interactive panel discussions on the hottest industry topics, including:- Tactical versus strategic sourcing: how should your company size influence your approach?- How can CROs perform their best at bid-defence meetings?- What is a true preferred provider agreement and how do sponsors and service providers get to that point?- How hands off can or should the sponsor be when partnering with a CRO in a strategic or full service outsourcing model?• EIGHT brand new break out streams• FIVE brand new break out symposia• FOUR intensive half day workshops before and after the main conference:- Performance management: tools for measuring the performance of service providers and sponsors - Focus on new regulatory expectations for vendor oversight- Managing the project management and contact challenges of working with functional service providers - Honing your CRO cost and contract negotiation skillsBACK BY POPULAR DEMAND• John Micklethwait, Editor-in-Chief, The Economist- Delegates from Partnership 2007 in Amsterdam will remember how John predicted the global economic crisis. In 2010 he returns to address the timely topic‘How has the world been changed by the recession?’• Stephen Carver, Project Management Specialist and Lecturer at Cranfield University, one of Europe's top business schools- In 2009, Stephen received the highest ever speaker scores in the history of Partnerships in Clinical trials. In 2010 he will address the topic ‘Agile Project Managementand the Battle of Britain; the lessons for Clinical Development Partnerships’- Delegate responses from 2009: ‘excellent!’ (Lilly UK), ‘absolutely brilliant!’ (Mundipharma)Your breakout streams for 2010:• Maximising resources through flexible clinical outsourcing NEW FOR 2010• Improving project management in your clinical partnerships NEW FOR 2010• Partnering solutions for small Pharma and Biotech BACK BY POPULAR DEMAND• Innovative approaches to strategic clinical outsourcing NEW FOR 2010• Developing and maintaining successful partnerships in early clinical developmentNEW FOR 2010• How to achieve effective vendor oversight in clinical partnerships NEW FOR 2010• International landscape for clinical outsourcing – getting a global footprint foryour trials NEW FOR 2010• Relationship management – your key to successful project delivery BACK BYPOPULAR DEMANDYour intensive pre and post-conference symposia• Successful cost and contract management BACK BY POPULAR DEMAND• Implementing and maintaining continuous improvement in clinical partnershipsNEW FOR 2010• Developing outcomes-based strategic partnerships NEW FOR 2010• Using partnerships to improve the operational delivery of your trial NEW FOR 2010• Ensuring appropriate vendor oversight within partnerships NEW FOR 2010• Establishing and improving preferred provider relationships NEW FOR 2010I look forward to welcoming you to Vienna for your best networking opportunity of 2010.Kind regards,Siobhan CorryResearch Director9th Annual Partnerships in Clinical Trials Congress and Exhibition 2010, Vienna, Austriat: +44 (0) 20 7017 7481 f: +44 (0) 20 7017 7823 w: www.ct-partnerships.com


Pre-Conference SymposiaTuesday 16th November 20109:20 Coffee and RegistrationCQ3005MPre-conference Symposium MSUCCESSFUL COST ANDCONTRACT MANAGEMENT10:00 Opening remarks from the ChairGraham Belgrave, Vice President, Head Global ClinicalDevelopment Operations (Interim), GCD, Grunenthal GmbHCQ3005NPre-conference Symposium NIMPLEMENTING AND MAINTAININGCONTINUOUS IMPROVEMENT INCLINICAL PARTNERSHIPS10:00 Opening remarks from the ChairRichard Barrett, Contract & Outsourcing Services LtdCQ3005OPre-conference Symposium ODEVELOPING OUTCOMES BASEDSTRATEGIC PARTNERSHIPS10:00 Opening remarks from the ChairDianne Kikta, PhD, MBA, (previously) Vice President,Global Clinical Strategic Resourcing, Wyeth10:10 Panel discussion: How can CROs perform their best atbid-defence meetings?Despite the strength of a proposal and the CRO’s experience, so much cancome down to the bid-defence meeting.In this session sponsors and CROs will get together to discuss: Tips for CROs to maximise time and money spent preparing for andpresenting at bid defence meeting Presentation styles that keep the sponsors attention What is the difference between a capabilities presentation and a bid defence? How can the CRO demonstrate they understand the brief and scope of work Gaining sponsor confidence and winning the workGraham Belgrave, Vice President, Head Global ClinicalDevelopment Operations (Interim), GCD, Grunenthal GmbHLesley Mathews, Strategic Sourcing Manager, Bayer <strong>plc</strong>, UKPaul Bouten, Free-lance Consultant/Interim-Manager, PharmconmedBarry Overton PhD., Director of Clinical Research Operations,MedImmune10:55 Debate: Reverse Auctions Are No Longer Useful in ClinicalOutsourcing – Discuss How much are service provider margins currently being squeezed? What types of services do reverse auctions work for best? What do service providers really think of this model? Do reverse auctions give a true representation of the appropriate partner?Michael Betke-Hornfeck, Head of Global Sourcing Medical,Boehringer Ingelheim Pharma GmbH & Co. KG, GermanyGraham Belgrave, Vice President, Head Global ClinicalDevelopment Operations (Interim), GCD, Grunenthal GmbH10:1010:10 Developing robust metrics for improving relationshipmanagement Can chemistry ever be measured? Defining objectives and outcome of the relationship Metrics apply to both parties Developing metrics to cover the relationship at all stakeholders levels Capturing and using the emotional inputs and outputs Using cost, quality and productivity metrics as measures ofrelationship progress The importance of the support of Board level management in maintaining arelationship when the metrics don't look good. The use of metrics in divorce proceedingsRichard Barrett, Contract & Outsourcing Services Ltd10:50-10:55 5 minute change over10:55 Standardisation and innovation are they mutually exclusive? Understand how standardisation can free up innovation in other parts ofthe business Utilising best practices to reduce cycle time Innovation techniques to enable better operational planning The role of innovation in strategic planningGary Aldam, Director, Life Sciences, Harpum Consulting Ltd10:10 Case study: Overcoming the challenges of two pharmacompanies managing one single Global CROMs Estrella Garcia, Head of Global Clinical Operations& Strategic Resourcing, AlmirallAndUlo Palm, Vice President, Clinical operations, Forest Laboratories10:55 Case Study: Working in Partnership Towards MutualPerformance Management Overview of the traditional tools used by pharma to measure service providers Understanding how service providers measure their own performance How can pharma companies measure themselves in performance delivery? How Wyeth developed an on-going process for performance management Performance management: tools for measuring the performance of serviceprovider and sponsorDianne Kikta, PhD, MBA, (previously) Vice President,Global Clinical Strategic Resourcing, Wyeth11:55 Panel discussion: Effective investigator contract negotiationand site agreements How can sponsors and CROs work together to achieve compliance inthis area? Deciding with your partner on fair market value for investigator grants Negotiating the investigator contract How to assess if your investigator is making reasonable requests? Overcoming the top challenges of negotiating a contract with an investigator Common pitfalls in clinical trial agreements with regional investigatorsAnna Apicella, Outsourcing Analyst,Takeda Global R&D Centre Europe Ltd11:35 - 11:55 Morning coffee11:55 Reducing R&D expenditure and increasing quality –can specific sourcing methods help to achieve this? Overview of key types of sourcing Review of benefits and weaknesses of each method Introduction to Business Process Outsourcing (BPO) Using different regions to optimize cost vs quality Ways to help reduce cycle times and increase quality throughtransformation strategies Case studies showing how BPO can be used in different typesof organizationsDaniel Chapple, PhD. General Manager, Life Sciences BPO,Cognizant11:55 Clinical Operations Perspective: What are the Challengesand Advantages of Working in an FSP Model? How supported do operations feel by the outsourcing department? How do operations maximise the knowledge, quality and training oftheir suppliers? How can outsourcing further support the operations department? Defining responsibility and accountability with the functionalservice providers Streamlining the handling of a trial master file Ensuring operations define scope of work for process optimisationPeter DiBiaso, Clinical Development Operations,Vertex Pharmaceuticals12:40 Site contract outsourcing: An overview The importance of planning in the site contracting process / the relevance ofthe Clinical Trial Agreement in site selection Capturing site contracting units and tasks in the CRO contract How to optimise the working relationship between Sponsor and CRO Adherence towards country legal request, GCP, Compliance andSponsor/CRO policiesInmaculada Gcia-Colavidas, LLM, FCIArb, Contracts Manager,Biogen Idec, UK12:35 - 12:40 5 minute change over12:40 Achieving successful governance in process andquality oversight The structure and scope of a steering committee framework Implementation of project oversight meetings and KPIs Exploring how to achieve process transparency and harmonisation Example of a quality risk management strategy Examining a real life case studyAlmut Heuner, Head of Global Outsourcing Specialists,Bayer Schering Pharma AG, Germany&Louise Anderson, Business Support Manager,Bayer Healthcare, UK12:40 Exploring the point at which the partnership goes fromclinical team level to upper management Examining the situations in which the partnership goes to upper management Assessing the differences between clinical team level partnerships and uppermanagement partnerships Strategies for effective communication between the clinical team andupper management Overcoming the challenge of ensuring that the service provider is aware ofinternal structureAnders Persson, PhD, Director, Capacity Management,MedImmune LLC, USA13:20 - 14:20 Lunch14:20 Case study: Danone’s Experience of Pharma and CROSetting the Budget Together Why were unit prices included in the master service agreement? How were the unit prices decided? Who was involved in the process? How this model created a different type of negotiation What impact did this model have on change of scopesSebastien Marque, PhD, Director of Global BiometricsDepartment, Danone Research, France14:20 Governance and Supplier Relationship Management Cross-Industry, Supplier Relationship Management Overview Developing a consensus on SRM within Biopharmaceutical industry:“best practices & keys to success”Warren Myers, Formerly Head of R&D Strategic Sourcing,Amgen14:20 Improving your vendor selection process – why does oneservice provider get the job over another? Key considerations in balancing perception and reality of a vendor’s skills Making sure that gut reaction is balanced by quantitative assessment tools Employing effective measurement tools in bid defence meetings What part should money play in the selection criteria? What value does formal vendor selection processes give to Pharma Winning strategies for becoming a partner and sponsor of choiceAnita Meulengracht Dahl, R&D Outsourcing Manager,LEO Pharma A/St: +44 (0) 20 7017 7481 f: +44 (0) 20 7017 7823 w: www.ct-partnerships.com


Europe's leading industry update for all clinical development outsourcing professionalsCQ3005M (continued)15:05 Bridging the gap between outsourcing and clinical projectteams for improved budget forecasting What is the gap? Who are the key players? How can we bridge the gap?Carolyn Garrood, European R&D Outsourcing Manager,Mundipharma Research Ltd16:05 Minimising the Potential for Disputes in Site Agreements Whose template should be used when handling site agreements: sponsor,CRO or site? Eliminating confusion on site agreements Reducing delays in getting site agreements in place How involved should a CRO be in the legal review of a site agreement?Helena Haramis, European R&D Outsourcing Associate,Mundipharma16:50 Evaluating the difficulties faced by the sponsors comparingdifferent cost proposals Reviewing the variables Tools to help or hinder How can we avoid the problem?Jennifer Valsler, European R&D Outsourcing Associate,Mundipharma Research LtdCQ3005N (continued)15:00 - 15:05 5 minute change over15:05 Case study: Working alongside preferred providers forcontinuous improvement What process improvement initiatives can be implemented within a preferredprovider relationship? Ways of working together to improve cycle times Reducing duplication of workload through streamlined handovers Why should sponsors get away from imposing certain SOPs on the provider How did the sponsor learn from the CROs processes? At what level was risk shared in this preferred provider arrangement?Stig Møller Christensen, International Planning & CROManager, ALK-Abello, Denmark15:45 - 16:05 Afternoon tea16:05 Importance of Vendor Governance within Clinical Development How does commitment to a large volume of work affect vendor governance? At what point does the partnership go from clinical team level toupper management? How to manage vendor governance across multiple therapeutic areas How vendor governance moves from master service agreement, throughlegal frameworks to strategic partnership How does vendor governance affect the relationship and the sharingof information? To what extent should CROs have an interest in the outcome of the trial?Richard Scaife, Deputy General Manager, Vendor Management,Mitsubishi Pharma Europe Ltd.16:45 - 16:50 5 minute change over16:50 Implementing a new CRO partnership model in support ofimproved cycle times Selection of country footprint Vendor selection process to optimise success Establishing a new operating model – practical considerations Service delivery structure Ensuring quality and compliance - Governance and oversight considerations Progress and challenges to dateGareth Lewis, Global Sourcing Lead, Pfizer, UKCQ3005O (continued)15:05 How to handle difficult people - a comprehensiveinteractive session Three ways to approach a relationship problem Prime targets for change Steps for handling difficult people Principles of behaviour to keep in mind Techniques for handling anger (when people become difficult)For more information please visit www.howtohandledifficultpeople.infoEurofins MedinetJaap Bron, Director, Bron & Partners B.V.16:05 How to handle difficult people (session continued)Eurofins MedinetJaap Bron, Director, Bron & Partners B.V.16:50 Outcomes-Based Contracts and other New ContractingModels with CROs Involving CROs in deciding payment schedules and bonus/penalty payments Advantages of planning payments according to project delivery dates What are the operational freedoms created by a fixed budget and greaterCRO responsibility? To what extent does this model drive a true partnership? How realistic is it to cap CRO costs at the start of a project?Alex Leech, Head of Operations, Solace17:30 End of pre-conference symposiaPre-conference half day workshops13:00 - 17:00 Tuesday 16th NovemberNote: All delegates registered for pre-conference symposia are allowed to attend either of the pre-conference workshops. Please email registrations@informa-ls.com to ensure your place is reservedCQ3005WPre-conference workshop WPERFORMANCE MANAGEMENT:TOOLS FOR MEASURING THE PERFORMANCEOF SERVICE PROVIDERS AND SPONSORSSection 1: Dealing with Uncertainty Managing uncertainty and being able to recognise what is beyond your control. How good are CRO pricing models, and how realistic are the initial time lines? What can we do to improve theseestimates with tools like risk and PERT analysis. Are the traditional ways of judging CRO performance Quality , Cost and Time the only way to measure performance.Section 2: Monitoring the day to day running of the project What are project managers expected to do. What is the function of the sponsor PM if the CRO PM is managing the project? How do you measure the day to day performance of the project a Pharma and CRO view?- Metric.- Milestones.- Earned Value Analysis. How to measure the effectiveness of project management.Section 3: Introducing Performance based payment schedules What types of contracts are we using now? Deliverable based payment schedules v milestone payments. Free for service models with built in incentives.Section 4: What are the factors leading to successful projects? Understanding what the success criteria are. High levels of collaboration. Medium levels of structure. Preferred providers and preferred customers. Process improvement agreements.Workshop leader: Roger Joby, Director, 1to1to1.For more information about Roger Joby, visit www.ct-partnerships.comCQ3005XPre-conference workshop XFOCUS ON NEW REGULATORYEXPECTATIONS FOR VENDOR OVERSIGHTFocus on New EMEA Regulatory Requirements for Vendor Oversight What is vendor oversight? Who is responsible for it? Panelists’ recent experiences on regulatory queries from European agencies What are the European regulators currently asking for on outsourced clinical trials? When would a regulator create a filing or litigation on an outsourced trial? On a fully-outsourced trial how much vendor oversight is required? What are legacy findings and what level of detail needs to be provided? What recommendations are made on the definition and communication of change in SOPs? What are the requirements of CROs and Sponsor obligations using third parties? To what extent is Pharma expected to“check”/know about the subcontractor contracts? What proof of governance structure must you present to the inspector? What level of detail are they looking for in terms of qualifying and re-qualifying partners? What is focussed on in terms of Data Management What documentation do inspectors expect of your vendor oversight? What are the different models available?This workshop will also cover how vendor oversight needs to be implemented into: Your overall outsourcing strategy Selection of CRO and negotiation of contracts clinical project management Development of outsourcing processes and systems Competency development Clinical Process Improvement and development Process Development; including writing SOP Quality Management Evaluation and due diligence of CROs Supplier Selection, assessment and monitoringWorkshop leader: Jane Winter, Director, Pharma Business Solutions LtdFor more information about Jane Winter, visit www.ct-partnerships.comt: +44 (0) 20 7017 7481 f: +44 (0) 20 7017 7823 w: www.ct-partnerships.com


7:30 Coffee and registrationHOW HAVE ORGANISATIONSTRANSFORMED TO SURVIVE THE STORM?8:50 Opening remarks from the ChairRichard Barker,Director General,Association of the British PharmaceuticalIndustry (ABPI)9:00 A Comprehensive Review of CRO Activity in 2010 Which parts of the CRO industry has seen a drop in revenue over the pasttwelve months? To what degree has pharma consolidation affected CRO revenues in 2010? An examination of private equity activity in CROs Critically assessing the service provider pipeline in 2011 How did overall R&D spend change in 2010? What’s the market outlook for niche CROs in 2011? Which phases have created the highest volume of business for CROs? Where has growth occurred in RFP activity?Gareth Down Ph.D.,Head of European Healthcare,William Blair International9:30 Surviving Difficult Times: How Much Has the RecessionReally Affected Clinical Outsourcing and how does theindustry need to change? Has there been a reduction in internal fixed costs, an overall cut in R & Dinvestment, or both? Have there been job losses or job shifts from pharma to CROs? In what ways have the financial pressures created opportunities for pharma? What are the other drivers for change in the way we run clinical trials andhow much is actually changing? The trend towards emerging markets – is the industry really prepared for this? How did the recession affect the length of the studies across the industry? To what extent is there a paradigm shift in the way partners now share risk? What are the strategies that Pharma needs to employ to survive? How have the small biotechs and virtuals fared during the recession? What is coming out as the light at the end of the tunnel? Impact on changes to payment terms and contract budget models (i.e. fixed,unit based, milestone-types etc)Dalvir Gill,President, Late Stage Development,PharmaNetMAXIMISING RESOURCESTHROUGH FLEXIBLECLINICAL OUTSOURCINGChair: Simon Higginbotham, Senior VicePresident and Chief Marketing Officer, Kendle14.50 Getting the most out of Functional serviceprovider model How do they manage resources? How do they develop transparency? Challenges around developing and retracting How do you provide overall business continuity? How do you manage talent with the sponsor team andprovider team? What are the lead times required for getting the bestpeople on your project? How do you manage the contracts? In particular ifseveral vendor-deliverables are linked to each other?Linda Christmas, Executive Vice President,Resourcing Solutions, ChilternDr Chris Eastwood, Senior Regional AreaManager, GB R&D Europe, Allergan UK15.25 Examining the Practicalities andAdvantages of an "In-Sourced" Model How can an in-sourced model assist in proactivelymanaging resources? What project types lendthemselves best to in-sourcing? What does in-sourcing offer beyond 'renting alab coat'? What is the reality of 'in-sourced' reporting structures? Firsthand examples of building Quality into thein-sourced model, e.g. identification of trainingneeds and proactive issue resolutionDiane Lewis, PhD, Senior Director, CoSource,Clinical Development Services, Covance“Still the best Outsourcing and Networking event”CONFERENCE DAY ONE: Wednesday 17th November 201010:00 Keynote Address: How has the world been changed bythe recession? What is the current landscape for globalisation? Where next for potential markets? What are the implications for the big business? Will Europe be the loser in a world divided between Asia and America? How did the emerging economies fare during the recession and what is theexpected growth for the next five years? Long-term effect on the global and local economy as a result of naturaldisasters (island volcano, tsunami)Quentin Peel,Associate Editor,The Financial Times10:40 Morning coffee and exhibition - sponsored by S-Clinica11:20 Creating winning strategic partnerships:ClinTec – Merck Sharp & Dohme Global experience ClinTec expansion and growth into 17 new countries in 2009 Aligning the global insourcing & outsourcing model dependant on geography Successful ClinTec global delivery through the MSD/Schering mergerStefania Sordoni,Global Procurement Country Lead, EMEA,MSDandDr Rabinder Buttar,President & CEO,ClinTec International Group11:50 Keynote panel discussion: Getting true strategic value fromclinical partnerships – how have sponsors and providersresponded to increased cost pressures?Never before has clinical development relied so heavily on strong, strategicpartnerships. Low R&D productivity, rising costs, and the looming patent clifffor blockbuster drugs have resulted in consolidation and staff reductions acrossthe industry. All pharmaceutical and biotech companies are looking at radicalways to reduce fixed costs, while still delivering high quality trials on time andon budget. This keynote panel will discuss: Reviewing recent consolidation activity within pharma – is the industryresponding to cost-pressure or actually changing its model? What does consolidation actually mean for the service provider market? What innovative approaches are sponsors and CROs taking to deliver drugsin a more efficient way? What does it mean to be a well-managed service provider in 2010 –how to bear through the storm What will clinical outsourcing look like five years from now (and how dopartnerships need to change to achieve this)?Quentin Peel,Associate Editor,The Financial TimesWarren Myers,Formerly Head ofR&D Strategic Sourcing,AmgenVasco M. Grilo,Vice-President GlobalPharmaceutical R&DSourcing (GPS),Johnson & JohnsonPharmaceutical Research& Development, L. L. C.12:20 Agile Project Management and the Battle of Britain;the lessons for Clinical Development Partnerships Identifying the demands of a highly complex projects If a clinical project were the Battle of Britain, who are the fighter pilots andwho are the air traffic controllers? The crucial importance of leadership and trust in outsourced projectsStephen Carver,Project Management Specialist and Lecturer,Cranfield University, One of Europe's top business schoolsSTREAM A STREAM B STREAM C STREAM DIMPROVING PROJECTMANAGEMENT IN YOURCLINICAL PARTNERSHIPSChair: Susan C. Stansfield, Ph.D, ExecutiveVice President, Product Registration – Europe,Africa and Asia-Pacific, PRAPARTNERING SOLUTIONSFOR SMALL PHARMAAND BIOTECHChair: Daniel Spasic, Chief Executive Officer,TFS14.50 Interactive session: refreshing the way that wemeasure our service providers' performance How important is quality in the time-cost qualitymatrix? Is there a better way of measuring this matrix? Why timelines are not the most important way ofmeasuring a CRO Measuring a CRO on quality of information ratherthan cost Engaging rather than managing stakeholders todeliver quality What makes a quality supplier? Taking out the guessworkRoger Joby, Director, 1to1to1“A good insight on the subject even forthe ones not familiar with the field”Director of Biostatistics & Programming,Nerviano Medical Sciences15.25 Extended Project Management ClinicThis is your opportunity to ask the panel about yourspecific Project Management issues or just to find outwhat you didn’t know about project management.The panel of Stephen Carver, Keith Rodgers and RogerJoby has been chosen to give the delegates the widestpossible experience to tap into.Stephen is and experienced practitioner in severaldifferent industries including pharmaceuticals,petrochemicals, banking and a well respected academic.Both Keith and Roger have a wealth of experience in clinicalresearch, Keith predominantly in Pharma and Rogerpredominantly in CROs. So we have covered all of the bases.We hope that the agenda will be driven by you we dohave a contingency plan in the form of a vox pop survey.Ipsen Ltd“Good conferences andnetworking opportunities”Account Manger, Eurofins Medinet13:10 - 14:50Lunch and exhibition - sponsored by Esoterix15:20-15:25 5 minute change over14.50 Biotech Keynote: Learning to let go and relyon your providers: what Can Large PharmaLearn from Biotech about outsourcing? Examining the hard metrics of Biotech’s external costs How do Biotechs overcome the constraints of externalclinical development? How do Biotechs develop process-driven qualityplatforms on limited resources? What are the elements of large pharma that make themuncompetitive? How do biotechs remain hands-off whilst maintainingultimate responsibility? What measurements can pharma and CROs put in placeto let go of micro management? Defining responsibilities and accountability to the CRO:how do biotechs do this successfully?Fredrik Sjovall, Managing Director, Lipopeptide AB15.25 Clinical Development In A New TherapeuticArea: The Challenges for Small Companies Renovo background and history The impact of scarring in the skin Clinical development challenges of new therapeutic areas Outsourcing strategy: In house expertise versusoutsourced resource CRO selection: Selection process, selection criteria,deciding factors- Contractor management: Quality- Contractor management: Financial- Contractor management: Timescale- Conclusions and recommendationsMark Cooper, Senior VP, Clinical Operations,RenovoMatthias R. Evers,Principal, McKinsey& CompanyJane Clarke,Formerly AssistantVice President,Clinical DevelopmentSupport, WyethDave Gillogly,Global Head, ClinicalContracting & CategoryManagement, NovartisPharmaceuticalsCorporationINNOVATIVE APPROACHESTO STRATEGIC CLINICALOUTSOURCINGChair: Janet L. Brennan, Executive Vice President& Chief International Affairs Officer, RPS14.50 Moving Beyond a Tactical FSP/InsourcingModel and Truly Sharing the Skin in theGame: Examining True Risk/RewardModels in Integrated (Embedded)Outsourced PartnershipsThe industry has realized that while cost-effective,FSP/Insourcing/Resourcing Solutions are often tacticalin nature and limited in providing long-term strategicvalue. This session characterizes robust integrated(embedded) partnerships designed to not only reducecosts but more importantly to improve quality andexpedite drug development processes. This operatingmodel involves engagements that are long-term, spanentire development pipelines, involve strong governanceoversight, and require significant trust on both thesponsor and partner’s end. This session will concentrateon how sponsor companies, in partnership withproviders, are able to employ true risk/reward modelsthat yield long-term value tied to measurable dimensionsof quality, innovation, speed, productivity, and cost.Biopharmaceutical Industry panelists will discuss: Identifying key drivers and elements of a shared riskmodel that are tied to critical corporate objectives Developing risk/reward models that bring the greatestvalue across the dimensions of quality, innovation,speed, productivity, and cost Empowering teams to implement risk/reward strategy Process of continuously aligning risk/reward modelswith evolving corporate strategy and objectivesModerator: Samir Shah, Vice President, RPS, IncPanelists include:Jennifer Goodfellow, Senior Director & GlobalHead, Clinical Outsourcing, sanofi pasteur15.25 Successful Approaches to Partnering inpost-marketing Studies How to work in partnership to meet both regulatoryrequirements and commercial needs How to work in partnership in the development andexecution of patient registries Exploring the vendor landscape in Phase IV Connecting your Phase IV trial to potential marketsthrough health economics and outcomes research What is different operationally in a Phase IV partnership? Closing the gap between Clinical Development andSales/MarketingJeff Trotter, Executive Vice President, Phase IVDevelopment, PharmaNett: +44 (0) 20 7017 7481 f: +44 (0) 20 7017 7823 w: www.ct-partnerships.com


9th Annual Partnerships in Clinical Trials Congress and Exhibition 201016-19 November Reed Messe, ViennaSTREAM A (continued) STREAM B (continued) STREAM C (continued) STREAM D (continued)16.00 Understanding the practicalities of flexibleclinical resourcing Reviewing the fundamentals of flexible vs. functionalresourcing. What does it actually mean? How can this model be appropriate for small tomedium pharma in reducing fixed costs? What are the key challenges of flexible andfunctional resourcing? Examining the benefits for large pharma whenrestructuring internally? What are the differences between fixed versusflexible costs? Managing resourcing challenges – developing andkeeping the talent poolDr John Hubbard, Group President ClinicalResearch Services, Icon“Good opportunity to discuss/seewhat others are doing”Clinical Program Manager, CSL Ltd16.00 Project Management Clinical ContinuedAnticipated topics: What are PMs supposed to do? What is the difference between a Programme Managerand a Project Manager? What is lean and agile project management? Hard skills Planning – is it worth the effort? Project Uncertainty and risk management Stakeholder engagement Problem solving Issue management Scope management Scheduling Earned value management Softer skills Communication Teamwork Leadership Conflict management and negotiationThe agenda is down to you.Panelists:Stephen Carver, Lecturer at Cranfield UniversityRoger Joby, Director, 1to1to1Keith Rodgers, CEO, Bodiam Consulting Limited15:55 – 16:00 5 minute change over16.00 A Review of Virtual Drug Developmentmodels: two decades of perspective The Distributed Partnering Model for Drug Discoveryand Development; is this the salvation of Big Pharma’sor the last gasp of a dying dinosaur Virtual Drug Development: Examples of wildlysuccessful and failure to launch companies Shared Risk Shared Reward models: Winnersand losers Chorus: Autonomous Experiment drug unit: Lilly’ssuccessful paradigm Hudson Bay fur trapper model vs. the Colonialist Modelin China CRO’s as drug development partners and stake holders;conflict of interest or motivated strategic moveR. Stephen Porter, Pharm,D. CEO Chairman,VDDI Pharmaceuticals16:30 - 17:10 Afternoon Tea and Exhibition - sponsored by Medidata GmbH16.00 Overcoming Industry Challenges throughStrategic Outsourcing and Partnering It's not one size fits all: explore different models forpartnering, their relative advantages and limitations After the honeymoon: joint review of a matureoutsourcing partnership Best practices and lessons learnedDiane Lewis, PhD, Senior Director, CoSource,Clinical Development Services, CovanceLiz Rogers, Executive Director, WW Head ofStudy Management, Pfizer17.10 Case study: working with your partner tomake the most of flexible resourcing How did this project work from the sponsor perspective? What challenges were faced and overcome for theservice provider? How did they ensure quality in your in-sourcing? Permanent v Contractors - What fits with the clientsneeds best? What would be done differently next time?Garrath Read, Director Global BusinessDevelopment, ClinTec International Group17.45 EDC vendor CRO certification forincreased sponsors outsourcing confidence What is it and why is it required? What should it involve and what should it not involve?Where are the boundaries? What are the benefits for the Sponsor, the CRO and theEDC vendor?Graham Bunn, Ph.D., Vice President, Partnerships& Alliances, Medidata Solutions, Inc.17.10 Engaging with internal customers in asponsor company to provide a morestrategic way of outsourcing and workingwith a provider How to plan better so that providers are aware of yourportfolio in advance in order to operate more effectively The need to influence when decisions are made How this can help manage risk in a better waySusanne Kihlblom, Outsourcing Director,Clinical Outsourcing, AstraZeneca R&D17.45 Relationship management: Your key tosuccessful project delivery How to increase productivity and efficacy Exploring how to shorten start up activities Best practice in maintaining a high quality level Exploring the new concept of trial allocation Internal & external FU activities Understanding how to strengthen talentTali Schaffer, MPA, GMO, CRA GroupHead Oncology, Novartis Pharma ServicesAG, Israel17:40 – 17:45 5 minute change over18:15 – 18:20 5 minute change over17.10 Panel discussion: Top lessons from biotechson how to work smarter and truly let gowhen outsourcing Exploring the pros and cons of involving a CRO atprotocol stage Measuring and optimising internal hours spent onvendor oversight Critically assessing how much internal resource isrequired for outsourcing How much regulatory compliance does the sponsorcompany need to ensure when outsourcing? Looking at the possibility for joint terms to optimizeinternal spend Why hands-off partnering requires creative paymentschedules Small to Medium size Biotech compared to Medium toLarge Pharma with regards to outsourcing How do CROs market to virtuals? How does a CRO price for virtual companies?Peter DiBiaso, Clinical DevelopmentOperations, Vertex PharmaceuticalsTerri Hinkley, RN, BScN, MBA, CCRC,Director, Clinical Operations, Helix BioPharmaCorp, USAR. Stephen Porter, Pharm,D. CEO Chairman,VDDI Pharmaceuticals17.45 Project management IS the core competencerequired to deliver drugs to market: lessonsfrom construction Understand the similarity with construction: the totalreliance on high quality project management to ensureproject objectives are achieved. Review the implications of a fully outsourced approachto delivering drug projects, using the constructionindustry as a comparison. The organisational capabilities needed to manageprojects in such an environment Review the pitfalls from the development of high levelsof projectization in the construction industry and lessonslearned to help life science organisations effectivelymeet these challengesPeter Harpum, Managing Director,Harpum Consulting Ltd17.10 Case Study: Robust KPIs to Measure If YourStrategic Partnership is Really Working Reviewing exactly how much internal resource hasbeen saved by the partnership Quality: what is it and how do you know you are getting it? Assessing the strength of the project management teams Lessons learned and areas for improvement What do you measure, how do you collect it and howdo you use it moving forward? Has outsourcing really achieved decreased costs andimproved quality or is it just keeping down headcount?Todd M. Esporas, JD, MBA, ExecutiveDirector, Contracts & Functional Services,INC ResearchandFred Naids, PhD, Senior Strategic Director,Clinical Development Operations andBiometrics, Shire Pharmaceuticals17.45 Challenges when running Clinical trialsin emerging countries - how to ensureacceptance by international regulatoryauthorities like EMA and FDA What is the EMA perspective on how foreign data maybe extrapolated to Europe? Ensuring GCP standards are met on site The level of vendor oversight when working withlocal CROs Certification of clinical trial site Demonstrating training and education of clinicalresearch staff Managing the risks of the quality and validity of the result Managing expectations – what are the challenges forpharma companies going into these areas?Heinrich Klech, MD, PhD, Professor of MedicineCEO and Executive Vice President,Vienna School of Clinical ResearchDr. Marcus Müllner, Head, AGES PharMed,Austrian Medicines and Medical Devices Agency18.20 Working in partnership with ECG corelabs to delivery better science and lowercost: the potential of centralised cardiacsafety studies Findings of the recent Tufts report True cost of collecting ECG data local versuscentralised What Economies of scale and process can be achievedwith centralising cardiac safety data What is the dynamic between clinical outsourcing andproject teams in making this decision Reference to successful case studies How to approach this strategicallyJohn Blakeley, EVP, Sales and Marketing,ERT18.20 Panel discussion: What is the added valueof project management? To what extent is project delivery the main added valueof project management Are you paying for the experience of your serviceprovider in managing a project? Making sure sponsor and providers’ expectations ofproject management are the same How do you contract for effective projectmanagement?Susanne Kihlblom, Outsourcing Director,Clinical Outsourcing, AstraZeneca R&DTali Schaffer, MPA, GMO, CRA Group HeadOncology, Novartis Pharma Services AG, IsraelAlex Leech, Head of Operations, Solace18.20 How to ensure CRO accountability: SmallPharma-Biotech Perspective How can we achieve better collaboration between SmallPharma-Biotech and CRO Who are the experts conducting clinical trials? How can we assure study budgets we can rely on andavoid too many Change Orders and increasing budgets? Why is it important to discuss Risk Management beforefinalizing a contract with CRO How can we capture increased CRO accountability inthe contractAnnika Ekelöw, Outsourcing Manager, ClinicalOperations, Biovitrum AB, Sweden18.20 Managing change: How have leaders inother industries transformed throughdifficult times and what can Clinicalorganisations learn from it? Making it happen: Understanding the strategy,structure, style, staff and shared values of changeMatthias Evers, Ph.D., Principal,McKinsey & Company, Inc.18:50 End of conference day one followed by Cocktail Reception - sponsored by Cognizantt: +44 (0) 20 7017 7481 f: +44 (0) 20 7017 7823 w: www.ct-partnerships.com


9th Annual Partnerships in Clinical Trials Congress and Exhibition 201016-19 November Reed Messe, ViennaCONFERENCE DAY TWO: Thursday 18th November 20109:00 Opening remarks from the ChairR. Stephen Porter, Pharm,D,CEO Chairman,VDDI Pharmaceuticals9:10 Ensuring Effective Clinical Trial Compliance in anEnvironment of Increasing Oversight and Scrutiny:Building Strong QC and QA Processes within yourStrategic CollaborationsIt is clear that there is an increasing level of scrutiny by regulatory agencieson sponsors, providers and investigative sites regarding obligations to ensureadequate oversight and compliance of clinical trials. Regardless of theoutsourcing model utilized, the Sponsor retains the ultimate obligation toensure effective oversight of all internal and external activities related tothe conduct of their clinical trial programs. Without an effective qualitymanagement process, the potential for good clinical practice (GCP) breachesthat impact new drug approvals will continue to exist. This keynote sessionwill examine the complexities that exist in establishing shared quality systemsacross strategic partnerships and the organizational designs, systems andprocesses needed for building and sustaining quality operating models.The keynote panel will be comprised of a cross-section of small, mid-sizeand large biopharmaceutical regulatory compliance and operational expertsand will address the following key elements: The key drivers of increasing regulatory oversight and scrutiny of globalclinical trial conduct Application of Various QC and QA processes in different outsourcedoperating models ranging from integrated to hybrid to full-service models Risk management strategies and degrees of sponsor oversight ranging fromdirect oversight to limited transfer of obligations to full transfer of obligations Interdependencies between Training, QC and QA processes Continuous improvement methodologies including application of qualityKPIs, error detection and prevention strategies, and audit preparedness andperformance strategiesModerator:Harris Koffer, Pharm D,President and COO,RPS, Inc9:40 Preferred Provider Relationships: What Are They and HowDo You Get There?Efficiency and productivity. Biopharmaceutical companies are transformingtheir relationships with service providers in order to gain the greatestefficiencies and make the best use of limited resources. The preferredprovider outsourcing model is one solution that has gained ground. How do tactical, preferred provider and strategic outsourcing models differ? What are the key elements of Millenium’s preferred provider model? What are the benefits of this model to Millenium and PPD? What was the selection criteria and what was involved in theselection process? What happened after the contract was signed? How is the relationship maintained?Sebastian Pacios,Senior Vice President, Clinical Development, Europe,Middle East and Africa,PPD, Inc.Lynn McGovern,Director, Strategic SourcingMillenium Pharmaceuticals, IncFran Grote,Senior Director, Clinical Sourcing,Millenium Pharmaceuticals, Inc.10:10 – 10:20 Delegates separate into streamsSTREAM A STREAM B STREAM C STREAM DDEVELOPING ANDMAINTAININGSUCCESSFULPARTNERSHIPS IN EARLYCLINICAL DEVELOPMENTChair: Jean Edwards, UK Affiliate & RegionalLRL Procurement Manager, Lilly UK10:20 Case Study: How Partnering inEarly Clinical Development CanEncourage Innovation Real life examples of how to work with your partner toextract more data early How to drive flexibility in the placement of your earlyclinical development studies Practical ways for providers to assist in characterisingmolecules more quickly Examining the landscape for AMS (Accelerated MassSpectrometry), biomarker selection and validation,ADME and Proof of Concept How can partnering enhance the translatability betweenpre-clinical and clinical? How partnerships may help increase chances of successin Phase IIIRolf Pokorny MD, MSc, Executive Director,Head of Clinical Research, Basel ClinicalResearch Unit, CovanceHOW TO ACHIEVEEFFECTIVE VENDOROVERSIGHT IN CLINICALPARTNERSHIPSChair: Robert Davie, PhD, Vice President &General Manager, Europe, ClinicalDevelopment Services, Covance10:20 Critical success factors in testing thefinancial stability of your service provider Understanding the basics of reading a financial report What are the different models for evaluating thefinancial health of a vendor? How often do you needto do this? How can you evaluate the financial risk of a CRO? What information do you need to ask for from aprivately-owned service provider? How important is it to carry out financial assessmentsof existing providers?John Gate, Procurement Executive,Eli Lilly, UK“One of the main places to getinfo about the industry trend”Business Development Director, Farmasoft LLCINTERNATIONALLANDSCAPE FORCLINICAL OUTSOURCING– GETTING A GLOBALFOOTPRINT FOR YOURTRIALSChair: Gerard Ong, Portfolio Director,Project Management, PAREXEL International10:20 The Changing Role of Central Labs andthe Implications for Outsourcing: MajorDevelopments, Future Trends andGlobal Considerations Reviewing major developments in the central lab market How can central labs assist in the validation ofbiomarker assays? How are central labs reducing sponsor costs in theoperational delivery of a trial? How can central lab partnerships evolve fromcommoditized to strategic?Lewis Cameron, Chief Executive Officer,Clearstone Central LaboratoriesRELATIONSHIPMANAGEMENT – YOURKEY TO SUCCESSFULPROJECT DELIVERYChair: Louise Eggleton, Vice President,European Operations, Paragon Biomedical,Ltd.10:20 Panel discussion: Trust – what does itmean to you? Relevance of trust in the sponsor-vendor relationship Definition and theoretical development of trust Benefits and value of trust Trust in the real world of clinical development What happens when trust is not there or declining?Micromanagement?Rabinder Buttar, President and CEO,ClinTec International GroupAnna Matranga, PhD MBA, Head of GlobalPurchasing & Outsourcing, Galderma R&DYvonne Ulrich, Development StrategicSourcing, Head of Sourcing Alliances & ActiveBenchmarking, Novartis, SwitzerlandRene Sluijter, Global Head AllianceManagement, Abbott Healthcare Products B.V.10:50 – 11:30 Morning coffee and Exhibition - sponsored by ERT11.30 Partnering to Overcome the Challengesof Biosimilar Development Understanding how the development of biosimilarsdiffer from other generics Reviewing the key regulatory hurdles forbiosimilars in the US and Europe Challenges proving comparability in pre-clinicaldevelopment of biosimilars Establishing a specific clinical development planfor biosimilars- Is demonstration of comparable efficacy necessaryfor each separate indication? An appreciation of how efficacy studies forbiosimilars may differ in the following areas:- Statistical approaches- Immunogenicity- Safety and PharmacovigilanceDr. Pablo Fernandez, LMS, FFPM, SeniorVice President, Medical Affairs, PharmaNet11.30 An Industry-wide Effort to Developand Implement Standardized ClinicalTrial Performance Metrics to DriveProcess Improvement & EnhancePartnership Performance Gaining knowledge about Sponsor and CROindustry efforts to develop and implementstandardized performance metrics with a goal ofimproving efficiency and delivery of clinicaltrial operations Building an industry benchmarking database forclinical trial metrics Using new approaches to measuring the quality ofsite selection, protocol writing and other clinical trialactivities: is this the wave of the future?Guy Mascaro, President, Metrics ChampionConsortium, USADave Zuckerman, President, MetricsChampion Consortium, USA11.30 To what extent is Turkey prepared totake on Clinical Trials? Metrics on the volume of clinical trials currentlytaking place in Turkey What is the profile of the sites? Recent regulatory changes and challenges What GCP standards can be expected? Tips on running a successful trial in TurkeyDr. Lale Ozturanli, International ClinicalBusiness Development Manager, ZEINCRO11.30 How can you avoid these Change Orders? When was last time your pivotal study completed onor ahead of schedule? How can you be sure that the CRO will keep itsenrollment promises? How can you enforce guarantees in a CRO contract?These and other key CRO performance questionswill be answered by Iain Gordon, Senior DirectorBD at PSIIain Gordon, Senior Director, BusinessDevelopment, PSI“It is good to see a lot of partners in theone place. New contacts and meetings”Project Manager, Farmasoft LLCt: +44 (0) 20 7017 7481 f: +44 (0) 20 7017 7823 w: www.ct-partnerships.com


9th Annual Partnerships in Clinical Trials Congress and Exhibition 201016-19 November Reed Messe, ViennaSTREAM A (continued) STREAM B (continued) STREAM C (continued) STREAM D (continued)12:00 – 12:05 5 minute change over12.05 Outsourcing responsibilities of keyroles in early clinical development:an innovative type of strategicpartnership for Eli Lilly and Aepodia Key attributes of the model for this innovativedelegation of responsibilities (accountabilities,metrics, performance) Keys to success: skills and drug developmentexperience of external staff; clear delegation ofresponsibilities; timing for transition; optimizationof joint operating processes; and definition of rolesand responsibilities Benefits for both Lilly and AepodiaKen Carlson, Manager, Global Sourcing -Early Phase, Eli Lilly & CompanyandDominique Demolle, CEO, Aepodia12.05 Regulatory findings against CROs:what impact is this having on clinicalpartnership dynamics? How has the partnering dynamic shifted followingrecent FDA findings against CROs? Trend towards more outcomes based relationships How is contracting affected by recent findings? Change management consequences for both CROsand sponsorsJulian Remnant, Partner & R&D Lead(UK/CH) | Operations Excellence |Consulting, Deloitte MCS Limited12.05 Panel discussion: Preparing for thechallenges of conducting clinical trialsin ChinaChina presents unique challenges and opportunities tothe pharmaceutical and biotechnology industry and anexperienced partner can help companies navigate thosechallenges and gain the most benefits from this market.Hear from a leading global CRO, on how they’vesuccessfully met the challenges they’ve experiencedconducting local and global studies in China. Overcoming language issues Managing lengthy regulatory timelines Addressing issues with IT infrastructure, EDC Importing clinical supplies and exportingbiological samples Retaining staff in a competitive marketSimon Britton, Vice President, ClinicalDevelopment, Asia Pacific, PPDR. Stephen Porter, Pharm,D. CEOChairman, VDDI Pharmaceuticals12.05 Panel discussion: How hands off can orshould the sponsor be when partnering witha CRO in a strategic outsourcing modelNik East, Senior Clinical OutsourcingManager, AstraZenecaNadia Turner, Clinical Project ManagementDirector, AstraZenecaLars Sandell, Senior Clinical OutsourcingManager, AstraZenecaYvonne Ulrich, Development StrategicSourcing, Head of Sourcing Alliances & ActiveBenchmarking, Novartis, SwitzerlandMaria Schwarzenhofer, Clinical OperationsManager, AMERASIA (Africa, Middle East,Russia and Asia), Eli Lilly, AustriaErasmo Messina, Director, AllianceManagement & Project Operations,Clearstone Central Laboratories12:35 – 12:40 5 minute change over12.40 Panel discussion: First-in-human studies –essential considerations when outsourcing What should be included in a Phase I RFP? What is required of your Phase I unit? How much therapeutic expertise can and shouldyou expect from your Early phase provider? How to engage with the Phase I marketplace toimprove vendor selection How to plan a more strategic Phase I outsourcingstrategy based on sounds commercial objectivesAnna Petroccione, Director of Biostatistics& Program, Milano International OncologySally Hughes BSc., FRQA, Senior Director,Clinical Pharmacology and ClinicalDiagnostic Services, Lilly, UK12.40 How to build upon existing relationships:Customized Safety System Setup as anentrance point Collaboration in setting up a customized integratedsafety system for Clinical Trials Integrated support for submission to the EMAincluding preparation of Risk Management Plan &Detailed Description of Pharmacovigilance System Strategic partnership for a successful transitionbetween pre and post-authorization safety in the EU Future areas to expand the relationship in extendedterritory and activitiesVeronique Basch, Executive Director, SafetyEurope, United BioSource CorporationGiuseppe Alvaro, MD, VP, Drug Safety& Pharmacovigilance, SantheraPharmaceuticals (Switzerland) Ltd.12.40 Case Study of Outsourcing in Japan:Understanding Mentality and Culture What are the main cultural factors to be aware of? Cost drivers in Japan and what they will do to yourstudy budgets Operational models for inclusion of Japan inglobal studies Interpretation of JGCP - a possibility? And is it at alldifferent from ICH GCP?Morten B. Norgaard, Outsourcing Manager,Lundbeck12.40 Case study: True Risk/reward clinicaldevelopment through deliverable-basedpartnerships Finally it’s happening – no longer just theory!A thorough examination of risk-sharing modelcurrently being used How can a service provider share risk by influencingprotocol design? How far can risks be shared between Pharmaand CRO?Yariv Hefez, Director Global BusinessDevelopment and Alliance Management,Merck Serono S.A.andAlan Morgan, Group President - EarlyClinical Research and Laboratory Services,<strong>ICON</strong>13.10-14.40 Lunch and Exhibition‘Meet the experts’ round tablesR. Stephen Porter, Chairman, President and CEO, VDDI PharmaceuticalsGuy Mascaro, President, Metrics Champion Consortium, USA14:40 Inspirational Patient perspective:Charles Sabine,Emmy-award winning NBC Journalist, WarCorrespondent, and Huntington's Disease patientCharles Sabine has worked for the US Network NBC for 26 years.That career took him, via 12 wars, six revolutions and four earthquakes,to most of the news events of Europe, The Middle East, Africa and Asia.He learnt first hand the extraordinary limits that the human spirit is capableof reaching, in the face of tragedy inflicted by both nature and mankind.In 2008, he decided to put the lessons of those experiences to a different use,when he became a pioneering spokesman for freedom of scientific research,Dementia, and, in particular, Huntington’s Disease, which has ravagedhis family.Here he talks about the crucial importance of clinical research.15:20 The Descent of Management - the psychology of teammanagement and its impact on outsourcing & partnershipsCharles Darwin first published his theory of evolution in The Origin ofSpecies, but it wasn’t until his follow up book, The Descent of Man, thathe presented the consequences for humans and our relationships. In hispresentation, Andy Parrett will explore the further implications of Darwin’stheory on workplace behaviours and how evolutionary psychology lies atthe heart of all our interactions in cross-functional teams and partneringorganisations. Topics addressed will include: The selfish gene and group selection The tragedy of the commons Reciprocal altruism and trust Game theory and the prisoners dilemma The logic of emotion Motivation – what makes a modern ape happy? Culture and memeticsAndy ParrettPCMG Chairman and European OutsourcingManager at MedImmune,AstraZeneca’s worldwide biologics business unit15:50 OUT OF INDUSTRY PERSPECTIVEChange management keynote: Rethinking Construction -How did the construction industry have to radically changeto survive difficult times? What part does outsourcing play in the construction industry and how did thischange over the last 20 years? How did consolidation affect strategic partnerships in construction? How can companies be flexible enough to manage the change? Understanding the strategy, structure, style, staff and shared values of changewithin an organisation How to maintain flexibility whilst striving for efficiency What is the future of partnering?Alan Crane CBE , Vice President, Chartered Instituteof Building, and former Chief Executive Officer,Bovis International, Travers Morgan ConsultingGroup and Christiani & Nielsen Group16:45 End of conference day twoBack by popular demand:networking with 'Spotme' device“Superb networking opportunity. Spotme was a superb resource”Vitalograph & MESM LtdIntroduced last year the Spotme networking device was a huge success. Register onsite for Spotmeat no extra charge and get the very most out of the networking opportunities over the two day period.The Spotme tool enables you to;Contact anybody at anytime. Useexisting mail templates to arrangea meeting with another person.Find out who is near you right nowby “scanning” your neighborhood.Respond to surveys. Activate real-timevoting during interactive sessions.Learn more about the otherparticipants. Find specific peopleyou want to meet.Check your agenda for the event.Display details for each schedule item.Exchange business cards via infrared andreceive a personalized post-event e-mailcontaining all your contacts automatically.


Post-Conference SymposiaFriday 19th NovemberCQ3005PPost-conference Symposium PUSING PARTNERSHIPS TO IMPROVE THEOPERATIONAL DELIVERY OF YOUR TRIAL9:10 What does it take to make a successful study? Scientific expertise and decision criteria for the assessment and selectionof providers Impact on process and data review when managing multiple providers. What isthe best approach? Identifying core competencies. Importance of keeping “in-house expertise” Understanding the importance of balance between trust and control Real-life examples of successful management strategies Summary and conclusion: maintaining the balance between external resourcingand in-house expertiseMaria Solonets, Senior Clinical Research Physician, ClinicalScience, Actelion Pharmaceuticals Ltd, Switzerland8:20 Coffee and RegistrationCQ3005QPost-conference Symposium QENSURING APPROPRIATE VENDOROVERSIGHT WITHIN PARTNERSHIPS9:00 – 9:10 Opening remarks from the ChairsChair: Julianne Hull, Senior Director, Global Development DataOperations, Wyeth9:10 Regulators’ requirements for vendor oversight of outsourcedtrials: what is state-of-the art from an industry perspective? What do inspectors define as adequate vendor oversight? How is adequate vendor oversight demonstrated? Common pitfalls in EMA and FDA MAAs? What level of contact will the regulator have directly with yourservice provider? What is their view of clinical partnerships? What interface do they expect between CRO and sponsor?Christian Biberger, Director Clinical Trial Management,NycomedCQ3005RPost-conference Symposium RESTABLISHING AND IMPROVINGPREFERRED PROVIDER RELATIONSHIPS9:10 Do sponsors know the price of everything and the valueof nothing? The value of values in sponsor-vendorrelationship managementOften people talk about pharma/biotech being focused on helping patients,while CROs are just out to make money. Those opinions are based on the factthat people perceive ‘helping people’ to be a key value for pharma/biotechcompanies while ‘money’ is a key value for CROs. This speaker disagreeswith that and actually thinks both pharma/biotech and CROs have money nearthe top of their values hierarchy, whether they are willing to admit it or not.This session will examine: What are values? Why are values important? How do you know what your values are? Corporate values of sponsor vs. CRO Corporate vs. personal vs. group values What happens when values conflict? How do you align values between sponsor and vendor? The benefits of aligning values to achieve maximum results09:55 Strong partnerships between Pharma, CRO andinvestigator sites: Managing the Key Challengesof Monitoring International Investigator Sites How can CROs and sponsor work together in site selection? Understanding the specialities of the sites together How the language barrier can sometimes cause consternation and confusion Examining the common misunderstandings in monitoring reports What internal processes can help improve the quality of clinical monitoring? Ensuring your international sites are meeting GCPPaul Quinn BSc, PhD, Senior Clinical Programs Director,Shire Pharmaceuticals Ltd10:55 Working in Partnership for Effective Trial MasterFile Compilation Why is trial master file compilation so often overlooked until late in the project? Can it be done by a clinical CRO, or are specialists better value? What are the pros and cons of working with both? Ensuring streamlined compilation for better project delivery Electronic versus paper TMF – logistics, requirements of the CRO,confidentiality when working with multiple CROs on same study?Maria Öhlander, Principal Project Manager Eprotirome, DirectorClinical Operations, Karo Bio AB, Sweden11:40 Panel Discussion: How Outsourcing Departments CanSupport Project Management and Delivery How robust are pharma companies’ SOPs for the following areas:- Invoicing - Outsourcing - GCP - Project delivery - Timelines How closely are outsourcing and operational departments working together toachieve these SOPs? How regularly are pharma companies reviewing and revising SOPs forproject delivery Purchasing versus development/clinical based outsourcing groups?Bea Sauerhoff, Associate Director, Outsourcing Management, NovartisMichael Zoerer, Global Therapeutic Area Operations ManagerHemophilia, Baxter BioScienceMaria Öhlander, Principal Project Manager Eprotirome, DirectorClinical Operations, Karo Bio AB, Sweden13:20 Regulatory and Operational Challenges of Site Activation How feasibility can facilitate quicker site activation Examining the pain points for sponsors and CROs in activating a new site What are the common regulatory delays in site activation? Strategies for making your site productive quicklyMichael Zoerer, Global Therapeutic Area Operations ManagerHemophilia, Baxter BioScience14:05 Panel discussion: Clinical Trial Insurance and Its Role inClinical Partnering To what extent are prices rising from insurance costs? Where should insurance sit within your clinical organisation? Examining the types of insurance options available in a clinical partnership? What is involved in risk-transfer insurance? Examining international anomalies in required clinical trial insurance What are the parameters for distribution of liability between Sponsor/CRO How should insurance be shared within a strategic partnership?Anna Apicella, Outsourcing Analyst,Takeda Global R&D Centre Europe Ltd09:50 - 09:55 5 minute change over09:55 Outsourcing to a number of smaller providers -how does the pharma ensure that communicationbetween all subcontractors works effectively? Using a number of niche providers versus one large global provider Managing vendor and study budgets - methods for staying on top of the costof changeThierry Escudier, Head of Clinical Operations, Pierre Fabre10:35 - 10:55 Morning Tea10:55 Real-life case study on how compliance issues impact theoutsourcing strategy for Late Phase studies To what extent should service providers be monitored to ensure that they arecomplying with regulatory requirements in Late Phase studies? Overcoming the challenge of compliance in multinational studies – ensuringthat CROs comply with regulations across different countries How the increasingly strict compliance rules will affect the outsourcing strategy Examples of increasingly sophisticated ways to deal with more complicatedregulatory requirements Ensuring that service providers will deal effectively with the EFPIA Code(European Federation of Pharmaceutical Industries and Associations) oncontracts between pharma and healthcare professionals Effective communication to the service provider: Ensuring transparency withheadquarter recommendations and what the country affiliates carry out in practiceBoris Pfeiffer, M.Sc., Head R&D, Medical Affairs,Merck Serono GmbH11:35 - 11:40 5 minute change over11:40 Debate: To what extent should a sponsor audit a vendor? Why are you auditing? What should you focus on? How can a CRO’s QA be measured by pharma? How can pharma audit without annoying the CRO? Who is reading your SOPs? Should you be auditing sub-contractors? At what time do you audit? What documentation should the pharma company be requesting? Qualification audits Following up on changes and assessing continuation of qualityBirgit Ruhfus, Head GCP Study Audit Management - EuropeBerlin, Bayer Schering Pharma AG, GermanyChristian Biberger, Director Clinical Trial Management, NycomedThierry Escudier, Head of Clinical Operations, Pierre FabreBoris Pfeiffer, M.Sc., Head R&D, Medical Affairs,Merck Serono GmbH12:20 - 13:20 Lunch13:20 Real-life case study on moving into a new set-up for sponsoroversight of clinical CROs Overview of the clinical CRO oversight set-up, including the main advantages Identifying the main challenges with clinical CRO oversight, and how toovercome them How to decide who is responsible for clinical CRO oversight Understanding how to work effectively with the clinical CRO to make itsimple for Leo Pharma To what extent is oversight required on a fully outsourced trial?Susan Sforzini, Head of Section, Clinical Operations,LEO Pharma A/S, Denmark14:00 - 14:05 5 minute change over14:05 Panel discussion: How Do Pharma and CROs IncreaseQuality of Work by Sharing Information on Quality Aspects? How to Include Quality Metrics in a Contract While traditional milestones have included hard metrics on patient deliveryand monitoring visits, how do you measure for quality and incorporate thatinto the contract? What models for quality measurement are CROs currently seeing in negotiations? During a bid defence meeting how are quality aspects reflected in thepayment schedule? How open should pharma and CROs be on the findings made in internal audits? Quality should be included in the CRO overhead: discuss Ensuring due diligence around the information obtained in a clinical trialBirgit Ruhfus, Head GCP Study Audit Management - EuropeBerlin, Bayer Schering Pharma AG, GermanyArthur Hecht, Head of QM Medicine and Regulatory WesternEurope South, Boehringer Ingelheim Pharma GmbH & Co. KG09:55 Case Study: Next Steps in the Evolution of aStrategic Partnership Four years into a strategic partnership, how is it managed day-to-day? How to demonstrate value that the sponsor derives from the long-term partnership Challenges in moving from strategic intent to strategic delivery How the contract changed to support the objectives of the partnership What is the progression in terms of what partnerships can deliver? Lessons learned and process improvement over timeMark Blanchard, Global Account Manager, AstraZeneca, UK10:55 Evaluating the risk of preferred providers versus newsuppliers: A GlaxoSmithKline perspective Real life examples of risks involved with preferred providers and withnew suppliers Assessing situations when it is appropriate to use new suppliers Building contingency plans to manage risk with preferred and new suppliers Best practice for communicating with service providers to minimise riskMichael Patten, Senior Contract Manager, Global Outsourcing& Supplier Governance, GSK11:40 Panel discussion: Striking the Right Balance betweenControl and Trust in a Preferred Provider Relationship How do we define micro-managing? Defining what trust actually means for both sponsor and provider How to solve delivery issues without micro-managing Developing robust metrics between sponsor and provider Managing communication between multiple CROs and locations Importance of complex outsourcing structure when managing full service andniche providers How to get buy-in from your internal pharma team What happens when a sponsor is dissatisfied with a preferred provider? How important is it for CROs to be transparent about cost structures in thecontext of a preferred relationship? How can partners work smarter to reduce duplication of work?Corinne Pala, Outsourcing and Contract Manager, Grunenthal GmbHMichael Patten, Senior Contract Manager, Global Outsourcing &Supplier Governance, GSKMark Blanchard, Global Account Manager, AstraZeneca, UK13:20 Successfully managing and improving the interface anddivision of responsibilities between Sponsor’s localMarketing Companies and CROs in outsourced studies How to optimise division of functional responsibilities between corporateand affiliate levels at both sponsor and CRO sides How to combine trial sponsor central and local compliance, e.g. anti briberyand anti corruption policies and local regulations with process efficiency. How to handle the complexity when many CRO study teams have tointeract with several Marketing Companies How to h andle potential competition situations between In-House andoutsourced studies.Brigitte Everding, Global EPMT Marketing Company LeadAlliance Manager, AstraZeneca AndBjörn Bältsjö, MSc E.E., Clinical Information Science Directorand Lean Sigma Black-Belt, AstraZeneca R&D14:05 Case Study: Outsourcing Strategy after the PfizerWyeth Acquisition The challenge: how do you take two different processes to create a hybridstrategic outsourcing strategy? What are the consequences for the existing clients of both companies? What decisions were made regarding the outsourcing of functional areas? Establishing the timelines on fully integrating both strategies How will the new operational platform work in practice?Thomas Verish, Senior Director, Development Operations, Pfizer


9th Annual Partnerships in Clinical Trials Congress and Exhibition 201016-19 November Reed Messe, ViennaCQ3004P (continued) CQ3004Q (continued) CQ3004R (continued)14:45 - 15:05 Afternoon Tea15:05 Successfully Positioning EDC within an Outsourced Trial Critically assessing the EDC based on the scale of your project Choosing the right EDC provider to create a strong partnership withyour CRO How an EDC-CRO partnership can support data management andknowledge sharing How to ensure EDC-CRO work more effectively together Lessons learned in translating EDC data into a usable form Achieving real time integration interfaces so data may be used instantly Integrating EDC into the existing R&D workflow How are investigators handling EDC? Is it a help or a hindrance? Convergence in eclinical systemsGregor Spiekermann, PhD, Global R&D InformationSystems Section Head Clinical Information Systems,Merz Pharmaceuticals GmbH15:05 Partnering with your QA department for qualityrisk assessment How your QA department can assist in identifying areas of concern Working with QA to prepare for an inspection What level of contact should your QA have with your CRO? Processes for managing and tracking quality issues How the issues can be reconciledErsen Gokser, Clinical Operations Manager,Abbott Laboratories, Turkey15:05 Panel discussion: Tactical versus strategic sourcing:how should your company size influence your approach? Spotme question: How much of the audience believe they are engaged intactical outsourcing? Examining the sharing of rewards in a strategic partnership The balance between choosing one-stop-shop and functional services Large strategic partnerships vs. single trial transactions - are the returns oninvestment real?Jane Clarke, Formerly Assistant Vice President, ClinicalDevelopment Support, WyethThomas Verish, Senior Director, Development Operations, PfizerCorinne Pala, Outsourcing and Contract Manager,Grunenthal GmbH15:45 - 15:50 5 minute change over15:50 Impact of training and education of clinical research staff What training and education is mandatory and what is just ‘nice to have’?What do the regulations say? Can one size fit all? Should the individual decide if they need the training? What is the most effective methodology for training – what geographic andcontent variations to consider? Has eClinical improved levels of training or added complexity, duplicationand cost? How does one rate the effectiveness of training? What should be measured?Jane Clarke, Assistant Vice President, Global ClinicalDevelopment Support, Pfizer15:50 Debate: To what extent should sponsor involve themselvesin reviewing CRO quality assurance activities? How can a CRO’s QA be measured by pharma? How can pharma keep oversight without annoying the CRO? What documentation should the pharma company be requesting? How can partners work smarter to reduce duplication of work?Arthur Hecht, Head of QM Medicine and Regulatory WesternEurope South, Boehringer Ingelheim Pharma GmbH & Co. KGProf. Hoda Tawfik, Director Global Clinical Operations,MediGene AGPasi Piitulainen, Senior Director, Business & Science Affairs,Actelion Pharmaceuticals, Switzerland“Outstanding networking, wonderfulopportunity to get an update on theoutsourcing space”Senior Director, Futura Medical Development Ltd16:30 End of symposia15:50 Panel debate: what is a true preferred provideragreement and how do sponsors and service providersget to that point? Definition of what preferred provider actually means What do service providers have to do to get on the list? What does it take to become a preferred provider? What is involved in the selection process? And how does this differ betweendifferent sized companies? How important are oversight committees? Managing the disconnect between what sponsors and providers are lookingfor in a preferred provider relationship Examining the most effective selection processes Can you choose a preferred provider that you haven’t used before? What are sponsors looking for in a best in class provider? Does the decision on preferred providers come from head office or should itcome from the ground up? Importance of defining volume of work in order to negotiate on price Examining the various models available for preferred provider relationships How important is visibility of the pipeline for the service provider? What is the CROs favourite partnerships with Pharma? What is a valuable partner? CRO perspectiveStephanie Kamp, Grunenthal GmbHMartina Müller, Global Sourcing Medical,Boehringer Ingelheim Pharma GmbH & Co. KG, GermanyPost-conference half day workshops9:00 - 13:00 - Friday 19th NovemberNote: All delegates registered for post-conference symposia are allowed to attend either of the post-conference workshops. Please email registrations@informa-ls.com to ensure your place is reservedCQ3005YPost-conference workshop YFriday 19th November, 9:00 - 13:00MANAGING THE PROJECT MANAGEMENT ANDCONTRACT CHALLENGES OF WORKING WITHFUNCTIONAL SERVICE PROVIDERSSection 1: How do CROs manage resource within this model? What are the challenges faced? Importance of transparency in this model? How do Pharma deliver business continuity within the FSP model?Section 2: Successful scope management within PartnershipsScope management is that discipline representing the proper consideration, tracking and communication of scope change and itsconsequences throughout a project. Applied effectively scope management can be the core process of a clinical developmentoutsourcing function and the presentation will therefore describe: The link between scope management and contract management The link between scope management and budget management The link between scope management and relationship management Feedback mechanisms of scope management into vendor selection processesSection 3: Reducing the risks when working with Sub-Contractors? Should a sponsor allow a large CRO to assess the niche provider? What are the indemnity implications of the CRO sub-contracting? Assessing the quality perspective of this issue Where does the sub-contractor sit within the overall strategic partnership? How involved should the sponsor get on this?Section 4: How Outsourcing Departments Can Support Project Management and Delivery How robust are pharma companies’ SOPs for the following areas: - Invoicing - Outsourcing - GCP - Project delivery – Timelines How closely are outsourcing and operational departments working together to achieve these SOPs? How regularly are pharma companies reviewing and revising SOPs for project delivery Purchasing versus development/clinical based outsourcing groups?Section 5: Outcomes-Based Contracts and other New Contracting Models with CROs How to introduce this model with existing preferred providers How to increase vendor responsibility and risk sharing while maintaining vendor oversight Challenges for training and adjusting internal staffWorkshop leader: Peter Harpum, Managing Director, Harpum Consulting Limited.and Dr John Bennett B.Sc. Ph.D., Independent Pharmaceutical ConsultantFor more information about Peter Harpum and Dr John Bennett B.Sc. Ph.D., visit www.ct-partnerships.comCQ3005ZPost-conference workshop ZFriday 19th November, 9:00 - 13:00HONING YOUR CRO COST AND CONTRACTNEGOTIATION SKILLSSection 1: What should be included in an initial cost proposal? How to negotiate hard without making it too difficult for your service provider to deliver Understanding which areas/margins can be pushed on an outsourcing project Establishing the parameters for negotiation on timelines Negotiating discounts based on volume of work How far can a good relationship take you in negotiations? How realistic is it to expect your CROs to quote in a way that is comparable? Master Service Agreements Examining different discount models The financial contracting that goes on in negotiation Importance of defining volume of work in order to negotiate on price What models for quality measurement are CROs currently seeing in negotiations?Section 2: Are We Pushing Suppliers’ Time Lines Too Hard and Forcing Them to Make Mistakes? Which areas of supply negotiation can be exploited and which should be more circumspect? Ensuring a focus of process rather than money in the development of clinical trials Trusting your CRO’s ability to manage resources A consideration of:- IVRS - EDC - Patient Recruitment - Monitoring - Data BaseSection 3: Discussion session: How does a contract work in relation to a partnership?A contract puts a fence up around a relationship that you already have. But what about the negotiation? What have you already said? Does this make it easier or harder? Contracts won’t cover every risk. It may help manage them, but it doesn’t handle them all? How do you get the relationships to help with this?Section 4: Developing Real Metrics on Internal Versus External Costs What are successful methods for measuring internal costs? How does pharma break down costs differently from service providers? Measuring the total cost of delivery versus CRO costs Methods for focusing on fixed internal costs Redefining the difference between fixed and variable costs in an outsourced studyWorkshop leader: Richard Barrett, Contract & Outsourcing Services Ltd.For more information about Richard Barrett, visit www.ct-partnerships.comt: +44 (0) 20 7017 7481 f: +44 (0) 20 7017 7823 w: www.ct-partnerships.com


Keynote speakersQuentin Peel, Associate Editor, The Financial TimesFew people understand the dramas unfolding on the international stage better than QuentinPeel. He excels at relating politics and economics, with a bit of history and geography, toexplain the tensions at work in the world. Quentin has special depth on issues related to theevolution of the EU. He has been very well received as an analyst of the current economiccrisis. He also has focused on failed and failing states and countries in transition (fromdictatorship to democ racy, from poverty to prosperity). Having covered major world-changing events over thepast 30 years as an eye-witness reporter, he sees the social, political and economic forces shaping world affairswith historical perspective, personal knowledge and deep insight.Stephen Carver, Project Management Specialist and Lecturer,Cranfield University, One of Europe's top business schoolsStephen is rated as one of the top 3 lecturers at Europe’s top MBA Business Schools - Cranfield.He has a reputation of taking complex management concepts and being able to distil themdown, into highly informative and fun lectures - often using “storytelling” techniques. Hisattitude is “if you haven’t done it – you shouldn’t be teaching it!” Unusually, for an academic,he has actually has spent most of his working life in real business and still runs his own, highly successful,Project Management Company (his client list now reads like the FTSE/Dow top 100!). Stephen is an unusualblend of Academic, Businessman and Teller of Tales. He has taught in UK, US Holland, Germany, France,Portugal, Singapore, Hong Kong and Australia and has appeared on National Radio and TV. Stephen hasundertaken Project Management and Public Speaking assignments for many clients in the UK, Europe, theMiddle & Far East including: Goldman Sachs, BP, Morgan Stanley, Imperial, Linklaters, Merrill Lynch,Threadneedle, Sodexho, MOD, BAE.Charles Sabine, Emmy-award winning NBC Journalist, War Correspondent, and Huntington'sDisease patientCharles Sabine has worked for the US Network NBC for 26 years. That career took him, via 12wars, six revolutions and four earthquakes, to most of the news events of Europe, The MiddleEast, Africa and Asia. He learnt first hand the extraordinary limits that the human spirit iscapable of reaching, in the face of tragedy inflicted by both nature and mankind. In 2008, hedecided to put the lessons of those experiences to a different use, when he became a pioneering spokesman forfreedom of scientific research, Dementia, and, in particular, Huntington’s Disease, which has ravaged his family.Alan Crane CBE, Vice President, Chartered Institute of Building, and former ChiefExecutive Officer, Bovis International, Travers Morgan Consulting Group and Christiani& Nielsen GroupAlan has spent 40 years in the Construction Industry, including Chief Executive appointmentswith Bovis International, Travers Morgan Consulting Group and Christiani & Nielsen Group.He has had responsibility for a wide range of major projects including the Development &Construction of Canary Wharf in London, and Eurodisney. He has extensive international experience, throughoutEurope, Middle and Far East, Asia and Australia. He was a member of the Strategic Forum of the ConstructionIndustry, Chairman of the Institution of Civil Engineers Management Board, member of the ArchitectsRegistration Board and of a number of Government Task Forces, and currently Chair of CIOB Learning &Professional Practice Board. He provides consulting advice on Business Performance Improvement, Partnering,Supply Chain management and Value Management. He is the author of a number of industry and Task Forcereports and “How To” guidance documents. He established and chaired the group responsible for development ofthe UK industry Key Performance Indicators and Benchmark system. Following the issue of Sir John Egan's TaskForce Report ''Rethinking Construction'' in late 1998 he was asked by Government and Industry to establish andChair the Movement for Innovation (M4i) with the task of motivating industry to radically change the way inwhich it operates, and to adopt the recommendations and targets of the Egan report . In April 2002 he becameChairman of Rethinking Construction. With the merger of Rethinking Construction and the Construction BestPractice Programme he became a Director of the combined organisation, Constructing ExcellenceDalvir Gill, President, Late Stage Development, PharmaNetDr. Dalvir Gill is President of Late Stage Development for Pharmanet, a global, drugdevelopment services company, that provides a comprehensive range of services to thepharmaceutical, biotechnology, generic drug, and medical device industries. He has more than20 years of experience in international clinical research and in his current position; he hasoverall responsibility for all PharmaNet Phase ll to lV services. Prior to PharmaNet, Dr. Gillspent 9 years in various leadership roles at Rhone-Poulenc Rorer (RPR, now Sanofi Aventis) in the United Statesand Europe. During his tenure at RPR, he played a key role in the submission of a number of successfulregulatory filings and also held positions in Process Improvement, Health Economics and Corporate Marketing.Dr. Gill earned his Ph.D in Pathobiology from the Faculty of Medicine of the Royal Free Hospital School ofMedicine and has authored numerous peer reviewed publications in the fields of vascular diseases and diabetes.Dr Gill is also an elected fellow of the Royal Society of Medicine.Dr Rabinder Buttar, President and CEO, ClinTec International GroupDr. Rabinder Buttar is the Founder, President and CEO of ClinTec International, a globalclinical research organization established in 1997 and present in over 40 countries worldwide.Included in Real Business’ List of Britain’s 100 Most Entrepreneurial Women, Dr Buttar is therecipient of several business awards including the Lloyds TSB Business and CommercialExcellence Jewel Award. With two doctorate degrees and management qualifications fromBritish Universities, Dr Buttar has spent 20 years within the pharmaceutical and CRO industry in leadingcompanies such as GSK, Astellas and Wyeth. Under Dr Buttar's leadership ClinTec has grown from inceptionto a global organization with a strong presence in all major and emerging markets including the Middle East andAfrica. The company now provides innovative clinical research services to 11 of the top 25 pharmaceuticalcompanies in the world and has established its Global Academy of Clinical Research Excellence (ACRE).Dr Buttar served previously on the Board of the Institute of Clinical Research and currently serves on theEditorial Board of Scrip Clinical Research and Journal of Clinical Studies. She is a Fellow of the Royal Societyof Medicine, and Regional Director of the Year (Glasgow & West of Scotland) at Institute of Directors, UK.The Scottish Parliament has congratulated Dr Buttar and ClinTec for their contribution to life sciences andprovision of clinical research teams across the globe.Harris Koffer, Pharm.D, President and Chief Operating Officer,ReSearch Pharmaceutical Services (RPS)Dr. Harris Koffer is President and Chief Operating Officer for Research PharmaceuticalServices (RPS), a clinical research organization providing services to the Pharmaceutical andBiotechnology industries in support of clinical drug development. Prior to joining RPS, Dr.Koffer served as Vice President, Clinical Trials and Pharmaceutical Business Development, forQuest Diagnostics; Vice President and General Manager of Covance Clinical Services and President of CovancePeriapproval Services. In these roles, he was responsible for global central laboratory services as well as fullservice clinical research and development capabilities for Phases 1 through 4 of drug development. In additionto over 28 years of experience in clinical drug development, he has served as Adjunct Assistant Professor ofPharmacy in Medicine at the University of Pennsylvania School of Medicine and Clinical Associate Professorof Pharmacy at the Philadelphia College of Pharmacy and Science. Dr. Koffer has published and presentednumerous papers in the fields of cardiovascular clinical pharmacology and pharmacoeconomics. He earned botha BS in Pharmacy and a Doctor of Pharmacy degree from the Philadelphia College of Pharmacy and Scienceand completed a Fellowship in Clinical Pharmacology at Thomas Jefferson University Hospital in Philadelphia.Sebastian Pacios, Senior Vice President, Clinical Development, Europe, Middle East andAfrica, PPD, Inc.Sebastian Pacios joined PPD in January 2008 as senior vice president for clinical developmentof Europe, Middle East and Africa. He leads Phase II-IV operations in the well-establishedclinical research markets of Western and Central Europe, as well as some of our newest officesin developing regions for clinical research, such as Turkey, Russia and the Ukraine. Paciosprovides strategic direction to ensure delivery of international and global clinical research projects andcoordination of operational processes across all PPD offices in the region. Pacios brings extensive globaldevelopment experience, first as a co-founder of a regional contract research organization and then through anumber of senior management roles with a global CRO where he most recently served as vice presidentresponsible for clinical operations and project management in Europe, Africa and Asia-Pacific. He has taughtclinical trial management courses in Spain for a number of years at the University of Pamplona, the Universityof Barcelona, the University of Alcala de Henares and the University of Valencia, and is affiliated with theAssociation of Clinical Research Professionals. Pacios holds a medical degree from the Universidad Autónomade Madrid and is a licensed practical physician at the Colegio de Medicos de MadridAndy Parrett, PCMG Chairman and European Outsourcing Manager,MedImmune - AstraZeneca’s worldwide biologics business unitAndy manages the European clinical development outsourcing work for MedImmune;AstraZeneca’s worldwide biologics business unit. He has a degree in genetics and abackground in clinical science and medical research gained as an embryologist at Bourn HallClinic and a neuroscientist at The Royal London Hospital. Andy has been with MedImmunesince March 2009 and prior to that spent 6 years building the outsourcing team at Mundipharma and 4 yearsworking in contracts, proposals and project finance teams at various CROs – most notably MDS, PRA andParexel. In addition, Andy has been an active committee member of the PCMG since early 2004 and Chairmansince January 2009. Andy is an enthusiastic innovator around the application of project managementmethodologies within clinical development outsourcing teams and in recent years has published and presentedcontributions on relational contracting models, scope management systems, stakeholder analysis benefits andrelationship management strategies. More recently Andy’s external interests have returned to his first love –genetics – and the application of evolutionary psychology to models in organisational behaviour.Warren Myers, Formerly Head of R&D Strategic Sourcing, AmgenWarren Myers is a 25-year veteran of the biopharmaceutical industry whose backgroundincludes experience both as a scientist and R&D procurement leader. Following completion ofa bachelor’s degree in biology from the University of California, Santa Barbara in 1984, Warrenserved as a scientist in the biotechnology industry and academia. Warren’s research focused onapplications of cellular and molecular biology to the treatment of cancer. Warren joinedBayer’s biotechnology division in 1991 focusing his career on improving drug development efficiency. Whilecompleting a Master’s degree in Technology Management from Pepperdine University, Warren studied crossindustryoutsourcing best practices as applied to the biopharmaceutical industry. This research enabled Warrento lead the establishment of Bayer’s drug development outsourcing capability. Warren left Bayer to help Amgenestablish it’s strategic sourcing organization. During his ten years at Amgen, Warren held positions of increasingresponsibility culminating in the role of Global Head, Strategic Sourcing and Procurement for Research andDevelopment. Warren is noted for his contributions to the advancement of strategic sourcing and supplierrelationship management practices within the biopharmaceutical industry.Vasco M. Grilo, Vice-President Global Pharmaceutical R&D Sourcing (GPS),Johnson & Johnson Pharmaceutical Research & Development, L. L. C.Vasco has an Engineering degree in Metallurgy and Material Sciences from the TechnicalUniversity of Lisbon, Portugal. He subsequently received his MBA from SDA Bocconi in Milanand a Masters in Manufacturing Systems Engineering from Lehigh University in the US. Hestarted his career with Carrier Corporation in operations and has held assignments in the US,Europe and Latin America. Vasco joined Johnson & Johnson Consumer EMEA procurement organization in2003. In 2006 moved to Janssen-Cilag as Procurement Director for J&J's Southern European commercialcompanies. Vasco has served as Senior Director Non-Clinical within Global Pharmaceutical R&D Sourcing.Since March 1, 2009 he has been appointed as Vice President, Global Pharmaceutical R&D Sourcing.Matthias R. Evers, Principal, McKinsey & CompanyMatthias Evers is a Principal from the Hamburg Office in Germany. Matthias joined McKinsey& Company in April 2002. He has worked globally in the pharmaceutical industry, servingoriginators as well as generic players. His main interests are in the areas of R&D with specificfocus on the interface between development and commercial and strategy. Recent examples ofhis work are: • Transforming Development holistically for a top-10 originator to build excellencewith focus on overarching success drivers (e.g., team leadership models) as well as functional excellence invarious areas (e.g., Clinical Development / Operations, Regulatory, Biologics and CMC) • Supporting an EUbiotech player to define a sustainable business model and long-term strategy • Defining the R&D and M&Astrategy for a mid-sized pharmaceutical player • Building new R&D, Medical Affairs, and Pharmacovigilanceorganizations (strategy, structure, processes, people) in a European post-merger situation • Assessing investmentscenarios and planning implementation of mammalian cell culture manufacturing capacity expansion for a top-10 originator • Redefining entire R&D strategy and operating model (Research, Development, Regulatory) of amid-sized originator • Crafting a Medical Marketing strategy with implications on processes and organizationaldesign of country organizations for a major pharmaceutical player • Crafting an Research informatics strategy fora global pharma client • Launch preparation for two upcoming Primary Care Drugs across the European top-5markets for a global pharmaceutical player. Matthias, having a background as a biochemist, holds a Ph.D. inChemistry/Biochemistry from the University of Bochum. Before his career with McKinsey, he worked as aResearch Associate and Postdoctorate at a center for molecular neurobiology in Hamburg and authored severalarticles in the field of bioinformatics and molecular biology.Gareth Down Ph.D., Head of European Healthcare, William Blair InternationalGareth Down, Ph.D., vice president, joined William Blair International in 2000. Since joiningWilliam Blair International, he has worked on a variety of public and private merger-andacquisitiontransactions and is focused on the health care sector. Mr. Down has a B.S. in cellularand molecular biology from University College London and a Ph.D. in clinical biochemistryfrom Cambridge University.Jane Clarke, Formerly Assistant Vice President, Clinical Development Support, PfizerJane has over 20 years Clinical Research experience having worked for a number of US basedmulti-national Pharma companies. Fluent in French and Italian she initially worked as a CRA inthese countries before undertaking broader Clinical Programme Management responsibilities,allowing her to focus her interests in Clinical Process Design and Optimization. With the adventof ‘e’ Clinical Trials, Jane immediately recognized the potential benefits of these tools torecognize a step change in operational excellence and cost effectiveness in Clinical Research. She developed anew capability within Wyeth Research – an organization dedicated to the development, implementation andsupport of highly integrated IT systems designed for Clinical Research: CTMS, EDC, IVR, ePRO, TMF etc Usingthis group, Jane led a successful implementation of EDC at Wyeth, moving the organization from 9% to 90%uptake in 11 months and subsequently transitioned the organization from a custom built to commercial EDCsolution, enabling adaptive trial design and ePRO capabilities.Stefania Sordoni, Global Procurement Country Lead, EMEA, MSDDr Stefania Sordoni holds a Degree in Economics from the University La Sapienza, Rome. She complete herdissertation in Prices and Reimbursability of Drugs in the European Community and was further certified fromthe Bocconi University in Milan in Contract Management. She has served in positions of increasing responsibilityin Procurement, Site Services and Contract, Management for IRBM Site, a Basi Research site fully owned byMerck & Co. with a great focus on scientific outsourcing, in strong collaboration and partnership with the UScollegues. She was named in 2007 EMEA Lead for Research Prourement, being a key interface with senior Merckstakeholders in EMEA. She worked closely with Global Procurement colleagues to develop relationships and addvalue to major global and regional Merck Research Laboratories activities, as well as leading and co-ordinatingall EMEA activities within Research Procurement categories of spend. She launched in EMEA a full outsourcingof clinical trials. She is member of many Procurement and Scientific AssociationPre & Post-conference workshopsPre-conference workshop WTuesday 16th November 2010, 13:00 - 17:00PERFORMANCE MANAGEMENT: TOOLS FORMEASURING THE PERFORMANCE OF SERVICEPROVIDERS AND SPONSORSWorkshop leader: Roger Joby, Director, 1to1to1.Pre-conference workshop XTuesday 16th November 2010, 13:00 - 17:00FOCUS ON NEW REGULATORY EXPECTATIONSFOR VENDOR OVERSIGHTWorkshop leader: Jane Winter, Director,Pharma Business Solutions LtdPost-conference workshop YFriday 19th November, 9:00 - 13:00MANAGING THE PROJECT AND CONTRACTMANAGEMENT CHALLENGES OF WORKING WITHFUNCTIONAL SERVICE PROVIDERSWorkshop leader: Gary Aldam, Director Life Sciences,Harpum Consulting Limited.Post-conference workshop ZFriday 19th November, 9:00 - 13:00HONING YOUR CRO COST AND CONTRACTNEGOTIATION SKILLSWorkshop leader: Richard Barrett,Contract & Outsourcing Services Ltd.t: +44 (0) 20 7017 7481 f: +44 (0) 20 7017 7823 w: www.ct-partnerships.com


9th Annual Partnerships in Clinical Trials Congress and Exhibition 201016-19 November Reed Messe, ViennaMEDIA PARTNERS 2010OFFICIAL PREVIEW PUBLICATION“Excellentnetworking coupledwith some veryinteresting talks ”Head of ClinicalDevelopment,Kyowa Hakko UK LtdPart of the Scrip subscription service, Scrip Clinical Research (SCR) is the leading source of business news,features and analysis in the outsourced clinical trials market. Experienced journalists and analysts deliver anunrivalled range of market intelligence that informs decisions about best-practice and strategy within theoutsourced clinical trials arena. SCR reports on areas of vital importance which include: patient recruitmentstrategies, emerging markets, collaborative partnerships, trial design, technologies and services, regulatoryissues and professional development. Through the feature StartPoint, SCR reports trial starts and patientrecruitment by CRO. It also publishes daily news on new contracts, financial performance and businesscriticalinformation on the most important new clinical trials.OFFICIAL PUBLICATIONSCRfocus publishes authoritative articles to keep clinical research professionals up to date with best practice,and develop their careers. Members of The Institute of Clinical Research receive 10 issues per year, and canalso access news, podcasts, Editor's blog and Twitter feed via www.crfocus.org“Still the bestOutsourcingand Networking event ”Ipsen LtdInternational Clinical Trials (ICT) is a specialist journal designed to provide global coverage of key topicspertinent to the clinical trials sector. Published quarterly, the journal offers a platform of communication andinformation-sharing for executive and strategic decision-makers, seeking out new trends and marketingopportunities, as well as putting a spotlight on the latest innovations coming to market. Every issue, 10,500copies are distributed to our specially targeted readership of strategic decision-makers within pharmaceuticalcompanies and their contract partners, primarily in Europe, but increasingly to North America and the rest ofthe world. For further information please visit www.samedanltd.comThe European Pharmaceutical Contractor (EPC) continually provides a dedicated platform of communicationand information for the international pharmaceutical contract market. Edited by Dr Graham Hughes andestablished in 1997, each quarterly edition examines areas of importance – both economic and technical – tocontract research organisations, contract manufacturers, regulatory controllers, consultants and analysts. Everyissue, 10,500 copies of the magazine are distributed to our specially targeted readership across the world. Forfurther information please visit www.samedanltd.com“Very good opportunityfor networking, plusinteresting oralpresentationsurrounding this ”Associate Director,Ecron Acunova“Superb networkingopportunity. Spotmewas a superb resource”Vitalograph & MESM Ltd“The event is a verygood opportunityto update theoperationalknowledge andrefresh network ”MedigeneThe International Journal of Clinical Skills (IJOCS) is a peer reviewed International Journal, which promotesthe sharing of information and evidence based research, bringing together the international clinical skillscommunity. The IJOCS develops and maintains standards in research and practice, lays a platform for discussionand debate, and provides opportunity to present evidence based medicine and critical appraisal of research.Provision of this much needed resource for students, teachers and healthcare professionals not only enhancesglobal attempts to offer quality health services, but it also provides a vehicle for teaching and learning of clinicalskills. A diverse range of reviewers support the Editorial Board, all of whom are leaders in their respective fields.Aptly put by the Chairman of the Academy of Medical Royal Colleges United Kingdom, Professor Dame CarolBlack, “…the quality and safety of patient care depend upon the professionalism of people of many disciplineswho have a responsibility to deliver that care... The mission of the International Journal of Clinical Skills is tosupport and promote that professionalism.” For further information please visit www.ijocs.orgJournal for Clinical Studies – Your resource for Multisite Studies & Emerging Markets -is published bi-monthly. JCSis a unique peer reviewed journal, dedicated to providing information to the global pharmaceutical, biotechnology,medical devices and CROs, practical and theoretical operational procedures, challenges, validatory and regulatoryguidelines when conducting trials on a multisite basis and particularly within the emerging markets, naïve patientpopulation, and remote access areas. We give you country by country objectives on all disease study areas, but uniquelybring you experiences in developing country diseases such as Liver diseases, kidney diseases, insect borne diseases,malnutrition and under nutrition. Led by a strong editorial advisory board sourced out for their experiences, you will getthe most practical insight for your global studies. So join us, write for us, feature your experiences with us, advertise yourcapabilities with us, and ask our advisory board for suggestions and guidelines. Let us make health care available to all.IPI - International Pharmaceutical Industry “Supporting the Industry Through Communication” IPI was establishedto fill in the void for effective marketing and communication between all stakeholders in the life sciences sector globally.One of the main reasons why clients are using us is the extensive knowledge and reach we have built up over the yearswith our Editor, Editorial Advisory board and market research. We give you links into all areas of Biopharm, Medical,Pharmaceutical and Healthcare. We have established a strong presence in the Middle East, Latin America, EasternEurope, Asia and Africa which are becoming increasingly important to the way the industry is moving forwards in areasof Research and Development, Trials, manufacturing and Technology Transfer. Email: info@ipimedia.comSUPPORTING PARTNERSPharmaceutical Outsourcing Intelligence. Our expert pharmaceutical insights can help to enhance theresponsiveness and effectiveness of your clinical research strategies, with comprehensive therapy, strategy andcompany analysis, opinion, data and news combined in an intuitive online solution. Our Knowledge Centerplatform provides in-depth examinations of phase I – III pipelines, leading pharma/biotech company dynamics andthe latest trends shaping R&D including insights into the healthcare systems of emerging countries. Request a demotoday at demo@datamonitor.comThe PCMG is a best practice forum for pharma and biotech clinical development professionals routinelyengaged in working with vendor companies in their projects. Members include project managers and senioroperational stakeholders as well as contracts and outsourcing managers. The aim of the group is to afford aforum to inform its members on marketplace developments and best practice solutions for projects that requiresponsor-CRO collaboration. The directors of the PCMG are experienced outsourcing and operationsprofessionals who work voluntarily for the cause. The organisation is non-profit making and as such can layserious claim to being the best value networking group in clinical development; annually providing itsmembers with up to six full days of workshops and conference attendance as well as other benefits for aminimal fee. For more information please visit www.pcmg.org.uk2009 DELEGATES BY REGIONNorthern Europe 56%UK and Ireland 27%USA & Canada 7%Eastern Europe 6%Middle East 2%Africa 2%PTI is a global pharmaceutical training company with over 60 interactive courses focusing on Regulatory Affairs,R&D, Clinical Development, Manufacturing, Veterinary Medicine, Medical Devices, Biopharmaceuticals andAgrochemical best practices. Whether you are new to the industry or firmly established and looking for trainingto take you to the next level, you will receive practical information and comprehensive advice to meet the demandsof a challenging career in the Life Sciences industry. Our courses can also be delivered on-site, specificallytailored to place emphasis on your company’s own particular business objectives. For more information on PTI,please contact: Sophie Ahmed, Tel: +44 (0) 20 7017 7266 e-mail: sophie.ahmed@informa.comPOEM Clinical Trial Management System is the smart way to manage clinical trials. POEM has been developedwith experts in clinical trial management to enhance communication and collaboration, saving money so that youcan spend more on research. Online clinical trial management as it should be. www.poemctms.comInternet Café and Wi-Fi– sponsored byNew for 2010 – free Wi-Fi access in the exhibition area for all attendees. This year SGS is sponsoring Wi-Fiaccess as well as the Internet Café for the main two days of the event. To ensure that attending this event hasminimum impact on your work, SGS is ensuring that attendees are able to access the internet. The InternetCafé will be located in the Exhibition area.t: +44 (0) 20 7017 7481 f: +44 (0) 20 7017 7823 w: www.ct-partnerships.com


9th Annual Partnerships in Clinical Trials Congress and Exhibition 201016-19 November Reed Messe, ViennaEXHIBITION FLOORPLANDESTINATION VIENNAVienna is located in the very heart of Europe and is a verygreen city – about half of the city is covered by forests,grassland, parks and gardens.Vienna‘s historic city centre ranks among the mostbeautiful historical cities in Europe. Numerous churches,palaces and parks contribute to the imperial flair ofVienna‘s Old Town. On the other hand, VienneseArt Nouveau (Jugendstil) has also brought forthunique places of interest. This mix of old and new,tradition and modernity is what gives Vienna itsextra special flair.Vienna is a paradise for art lovers. Over 120 museums and collections are open to the public,showcasing works of the highest calibre. They include the world’s largest collection of Bruegels at theKunsthistorisches Museum (Museum of Fine Arts) as well as the MuseumsQuartier Wien, one of the largestmuseum complexes in the world.Vienna is also renowned as the world’s capital of music. It has been home to “Waltz King” Johann Strauss,“Prince of Song” Franz Schubert, Haydn, Beethoven, Brahms, Schoenberg and Mahler, not to mentionWolfgang Amadeus Mozart. Enjoy an unrivalled selection of music – from opera and operettas to concertsand musicals – in Vienna, music is literally in the air!Vienna‘s outskirts are also especially attractive: romantic landscapes and picturesque villages invite you fora day‘s outing. www.wien.infoOnly 7stand unitsavailable –Don’t miss out!Travel Information to ViennaBy airVienna International Airport is located 16 km east of Vienna city centre.Presently, around 65 airlines offer more than 400 flights per week to40 destinations in Eastern Europe and another 130 destinations to allmetropolises in Western Europe, Asia, Australia and USA. The CityAirport Train (CAT) takes passengers in only 16 minutes non-stopfrom the Airport to the City Centre.www.viennaairport.comwww.cityairporttrain.comThe M.R.Stefanik Airport Bratislava is the principal international airportof Slovakia, with only a short 60 km distance to Vienna. Numerous trainsand buses run daily between Vienna city and Bratislava Airport. Thetransfer time lies between 75 and 120 minutes depending on traffic.www.airportbratislava.skKeyBooked StandsExhibition sites availableBy carAustria‘s expressway network extends right into Vienna, making it convenient and safe to reach the city by caror motor coach from anywhere on the European continent.Vienna can be reached by the following European Class A Roads:E49 Magdeburg – ViennaE58 Rostov-na-donu – ViennaE59 Praha – ZagrebE60 Brest – ConstantiaBy trainVienna occupies a hub position in Europe‘s international rail network. Intercity and international express trainsconnect the capital with all parts of Austria and with all major cities in Europe.There are two main train-stations in Vienna - Wien – West and Wien – Süd; both are located nearby the citycentre and all major hotels are located within easy reach.Company Stand Company Stand Company StandAccovion 318ACM Global Central Lab 414Aepodia 340Ascent Solutions 421Aspect 114Averion International 436B&C Group 120BARC 100BeCRO 122 & 124BioClinica 419Biomedical Systems 132Biostorage 443Biotrial 322Brecon Pharmaceuticals Ltd 140C3i 321Cardiocore 412Cardinal Systems 415Carefusion 110CEMO 417Charles River 123Chiltern 329Clearstone 232Clinical Reference Laboratory 423ClinTec International 107Cognizant 401Covance 225 & 324CRF Health 223Encorium 121eResearch (ERT) 336Esoterix 241Eurofins Medinet 333Focus 316Globex24 219Guy's and St Thomas' NHSFoundation Trust 441<strong>ICON</strong> 339,341,438Imperial ClinicalResearch Services, Inc 433INC Research 103InCROM 131Kendle 203LCG Bioscience 139Makrocare 447Marken 410Medidata GmbH 142Medidata Solutions Worldwide 325Medifacts International 315Medpace 432MESM 427MSOURCE 141Novella Clinical 112Ocasa Logistics Solutions 323OCT 310Omnicare Clinical Research 409Orion Clinical Services 136Oxford Outcomes 220Paragon Biomedical 309PAREXEL 237Perceptive Informatics 311PFC Pharma Focus 425Pharm-Olam International 239PharmaNet 129Phase Forward 217PHT Corporation 424Piramal Healthcare 331PPD 137PRA International 209Premier ResearchGroup Limited 307Pro Innovera 314Progenitor InternationalResearch 439PSI 207QED 211Quest Diagnostics 215QuickSTAT 133Quotient Bioresearch 422RadPharm, Inc 406RPS 303S-CLINICA 230SGS 125 & 224Simbec Research 445Syne qua non 119Synergy Research Group 418Tech Observer 222TFS 337The Clinical Trial Company 138Therapak 430TNT Express 306TransPerfect 319TTC 428United Biosource Corporation 302Unilabs 238Woodley Equipment Company 338World Courier 221Worldwide Clinical Trials 320ZeinCRO 420Quintiles - Hospitality Suite, locatedoutside the Exhibition Hall in theRegistration Areat: +44 (0) 20 7017 7481 f: +44 (0) 20 7017 7823 w: www.ct-partnerships.com


Our Sponsors and ExhibitorsASSOCIATE AND SUPPORTING SPONSORSCovance — one of the world's largest and most comprehensive drug development services companies — has the people, globalresources and problem-solving culture to respond to pharmaceutical and biotechnology clients' toughest drug developmentchallenges. We provide a portfolio of preclinical and clinical development and commercial service offerings — deliveredthrough industry-leading nonclinical testing services, the world's largest central laboratory network, and a global team of clinicaltrial professionals. www.covance.comRPS, a next generation CRO, provides comprehensive global Phase 1-4 clinical development solutions to the pharmaceutical,biotechnology and medical device industries. By combining an experienced clinical research operations infrastructure with the industry’slargest resourcing engines, RPS is uniquely positioned to offer our Clients both integrated and full service global outsourcing solutions.These solutions are powered by highly experienced and seasoned study teams providing innovative, cost-effective and high qualityservices. www.rpsweb.comPharmaNet Development Group, a global drug development services company, provides expertise to the pharmaceutical,biotechnology, generic drug, and medical device industries. PharmaNet companies offer clinical development solutions includingconsulting services, Phase I clinical studies, bioequivalency and pharmacodynamic studies, bioanalytical analyses, and Phase II, III,and IV clinical development programs. www.pharmanet.comClinTec International is a certified woman owned private global CRO with a strong presence in emerging markets including India and theMiddle East. With strong local country management and expertise, ClinTec offers high quality clinical services and insourced personnel acrossthe globe. As a fast, flexible and focussed organisation, ClinTec provides innovative clinical research solutions tailored precisely to meet theneeds of any client. www.clintec.comPPD is a leading global contract research organization, celebrating 25 years of providing drug discovery, development and lifecycle managementservices. With offices in 41 countries and more than 10,500 professionals worldwide, we are committed to helping our clients accelerate the deliveryof safe, effective therapeutics and maximize their R&D investments. www.ppdi.comSPONSORSEXHIBITORSt: +44 (0) 20 7017 7481 f: +44 (0) 20 7017 7823 w: www.ct-partnerships.com


9th AnnualCQ3005Step 1 Decide what you want to attend For more than one delegate please photocopy this form.Please register me for:Congress and Exhibition 2010Wednesday 17th –Thursday 18th November 2010 Conference CQ3005CTuesday 16th November Full day Pre-conference symposia Successful cost and contract management CQ3005M Implementing and maintaining continuousimprovement in clinical partnerships CQ3005N Developing outcomes based strategic partnerships CQ3005OTuesday 16th November half day pre-conference workshops16-19 November 2010, Reed Messe, Vienna, AustriaWhen and WhereReed Messe Wien GmbH - Congress Center Messeplatz 1, P.O.Box 277, A-1021 Vienna Te l: +43 (0) 1 727 20-0Fax: +43 (0)1 727 20-443 Email: info@messe.at Website: www.messecongress.at/en/index.htmlWorkshops Venue: Courtyard Vienna Messe, Trabrennstrasse 4, Vienna, Vienna 1020 AustriaTe l: +43 1 72730 Fax: +43 1 72730 355 Website: www.marriott.co.uk/hotels/travel/viefg-courtyard-vienna-messe/Partnerships in Clinical Trials, 17-18 November 2010, Reed Messe, Vienna, AustriaSymposiums and workshops - 16th and 19th November 2010, Courtyard Vienna Messe, Vienna, AustriaReduced rate accommodation: The price of accommodation is not included in the conference fee. In orderto book reduced rate accommodation, please visit the event website www.ct-partnerships.com, section "accommodation"where you will be able to choose different hotel options. Please book early to avoid disappointment.Nothing compares to being there? but you need not miss out! Simply tick the box, send it with paymentand your copy of the event documentation will be available 4 weeks after the event. CD Documentationat £499 (+ 17.5% VAT) Fax the form on +44 (0) 207 017 7823. Alternatively, call Customer Services on+44 (0) 207 017 7481 or email: registrations@informa-ls.com Docs only = £499 (+ 17.5% VAT)Your VIP number is on the address label. If there is no label, please quoteA B C D E F G H I J K L M N O P Q R S T U V W X Y ZFriday 19th November Full day Post-conference symposia Using Partnerships to improve the Operational Delivery of your Trial CQ3005P Ensuring Appropriate Vendor Oversight within Partnerships CQ3005Q Establishing and Improving Preferred Provider Relationships CQ3005RFriday 19th November half day post-conference workshops Managing the project management challengesof working with functional service providers CQ3005Y Honing your CRO cost and contract negotiation skills CQ3005Z Performance management: tools for measuring theperformance of service provider and sponsors CQ3005W Focus on new regulatory expectations for vendor oversight CQ3005XCall Simon Lau for GROUP BOOKING DISCOUNTS+44 (0) 207 017 7165 or simon.lau@informa.comStep 2 Work out the priceDays2 Days3 Days4 DaysPrice before 2nd July 2010 £1499 £2298 £2897SAVE£300£400£600Price from 2nd July to3rd Sept 2010 £1599 £2398 £2997SAVE£200£300£500Price from 3rd Sept to15th Oct 10 £1699 £2498 £3097SAVE£100£200£400Price after 15th Oct 2010£1799£2598£3197SAVE£100£300Supplier/Vendor Pricing before15th Oct 2010£1699£2498£3097Supplier/Vendor Pricing After15th Oct 2010£1799£2598£3197Informa Life Sciences will verify whether you are a vendor/supplier when your registration is processed.(The conference fee includes lunch, refreshments and course documentation. The fee does not include travel or hotel accommodation. Please photocopy this form for multiple bookings.)Personal details1st delegateDr/Mr/Mrs/Ms First Name Last Name Job Title Department2nd delegateTo assist us with future correspondence, please supply the following details:Head of Department:Booking Contact:Dr/Mr/Mrs/Ms First Name Last Name Job Title DepartmentCompany: ........................................................................................................ Address (if different from label above)......................................................................................................................................................................................................................................................................................................................................................... Postcode:......................................................Tel: .................................................................... Fax: ......................................................................... Email: .....................................................................................................................................No. of employees on your site: 1) 0-49 2) 50-249 3) 250-499 4) 500-999 5) 1000+ Nature of your company’s business:............................................................................................. YES! I would like to receive information about future events and services via email.Our statement of integrity can be found on our website at www.iir-conferences.com/feedback. Signature ........................................................................................................................................................................................................Step 3 Easy ways to pay All registrations must be paid in advance of the event.Billing address if different from above:■ Cheque. £ .............. Enclosed is our cheque in favour of IIR Ltd Please ensure that the Conference Code CQ3005 is written on the back of the cheque.■ Credit Card. Please debit my: ■ Visa ■ Amex ■ Eurocard ■ Mastercard Card No: .................................................................................................................................................................................CVV Number: ......................................(three digit number on the back of most credit cards/four digits on the front of American Express)Expiry Date: ........................................ Signature: ......................................................................................... Please note that cards will be debited within 7 days of your registration on to the conference Yes I agree to the terms and conditions as stated on this form. Delegates who do not pay with their booking are requested to provide a copy of bank transfer / credit card / cheque details to help payment allocation.Staff at the event will request a credit card guarantee for delegates without proof of payment.Step 4Five easy ways to registerTelephone: – +44 (0) 20 7017 7481 Please remember to quote CQ3005CE-Mail – registrations@informa-ls.comWeb – www.ct-partnerships.comBy Fax – Complete and send this registration form to: +44 (0)20 7017 7823Post – Complete and return the registration form together with payment to:The Bookings Department, Informa UK Ltd, PO Box 406, Byfleet. KT14 6WLConfirmation of your booking will only be sent when FULL PAYMENT is received. All posted registrationsmust be accompanied by a cheque or credit card details. Please treat this form as our request for payment.What happens if you have to cancel? Confirm your CANCELLATION in contact the Database Manager at the above address, Tel : +44 (0)20 7017 7077,writing (letter or fax) prior to 2nd November 2010 and receive a full refund of Fax: +44 (0)20 7017 7828 or email: integrity@informa.com. Occasionally yourthe total paid less a 10% service charge. Should you cancel between this date details may be obtained from, or made available to, external companies whoand a week prior to the event then, you will receive a refund less a 50% service wish to communicate with you offers related to your business activities. If youcharge. Regrettably, no refunds can be made for cancellations received less do not wish to receive these offers, please tick the box. than one week prior to the conference. A substitute delegate is welcome at no Incorrect Mailing: If you are receiving multiple mailings or you would likeextra charge. It may be necessary for reasons beyond the control of the us to change any details or remove your name from our database, pleaseorganiser to alter the content and timing of the programme or the identity of contact the Database Manager at the above address, Tel : +44 (0)20 7017the speakers. In the unfortunate event that an event is cancelled Informa are 7077, Fax: +44 (0)20 7017 7828 or email: integrity@informa.com - quoting thenot liable for any costs incurred by delegates in connection with their reference number printed on the mailing label.attendance. This contract is subject to English Law.Do you have any special requirements - please inform us if you have anyData Protection: The personal information shown on this form, and/or special requirements by calling customers services on +44 (0) 207017 7481provided by you, will be held on a database and may be shared with other ARE YOU REGISTERED?: You will always receive an acknowledgement ofcompanies in the Informa Group in the UK and internationally. If you do not your booking. If you do not receive anything, please call us onwish your details to be available to companies in the Informa Group please +44 (0) 20 7017 7481 to make sure we have received your booking.www.ct-partnerships.com Email: registrations@informa-ls.comEurope's leading industry update for all clinical development outsourcing professionals9th AnnualPharmaceutical companiescurrently spend approximately30% of their total R&Dbudget on outsourcing- how are youoptimisingyour spend?Congress and Exhibition 2010Practical models for successful strategic partnerships16-19 November 2010, Reed Messe, Vienna, AustriaKEYNOTE ECONOMIST: INSPIRATIONAL PATIENTPERSPECTIVE:Quentin Peel,Associate Editor,The Financial TimesCharles Sabine,Emmy-award winningNBC Journalist,War Correspondent,and Huntington’sDisease patientPROJECT MANAGEMENT EXPERT: CONFERENCE CHAIR:Stephen Carver,Project ManagementSpecialist and Lecturer atCranfield UniversityRichard Barker,Director General,Associationof the BritishPharmaceuticalIndustry (ABPI)NEW FOR 2010: EIGHT brand new streams including:• Vendor oversight• Early clinical development• Project management• Strategic clinical outsourcing• Global footprint for your trials• Relationship management• Small Pharma/Biotech outsourcing FOUR intensive half day workshops:• Performance management: tools for measuring the performance of service providers and sponsors• Focus on new regulatory expectations for vendor oversight• Managing the project management and contract challenges of working with functional service providers• Honing your CRO cost and contract negotiation skillsAssociate Sponsors“Outstandingnetworking,wonderfulopportunity to getan update on theoutsourcing space”Supporting SponsorsProduct Development Director,Futura Medical Development Ltdwww.ct-partnerships.comTo register: Call: +44 (0) 20 7017 7481 Fax: +44 (0) 20 7017 7823Email: registrations@informa-ls.com

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