March 30-Apr 1, 2011 - ICON plc

AGENDA AT A GLANCEWednesday March 30, 20118:00 Workshop Registration & Morning Coffee, Sponsored by9:00 Workshops Begin10:30 Networking Break12:00Luncheon for Workshop Participants & Main Conference Registration1:00 Main Conference Opens – Chairpersons’ Opening Remarks1:30 Regulatory Keynote: Clinical Partnerships at a Crossroad-The Intersection of Quality and Oversight2:15 A Sponsor Outsourcing Dilemma: Reducing Micro-Management of CROs while Maintaining Effective Quality Oversight3:00 Grand Opening of the Partnerships Hall- Networking Break3:30 Pharmerging Markets Launch the Evolution – Identify the Growth Opportunities for the Global Pharmaceutical Sector3:55 Global Partnerships Meeting Highlights – Europe, APAC, and Latin America4:20 Stakeholders Debate Operational Long Term Strategies for Profitability and Growth in Global Clinical Trials5:15 This is Emerging Market Jeopardy!6:00 Opening Day Reception in the Partnerships HallThursday March 31, 20118:00-8:45 Market Insight Roundtable Discussions & Morning Coffee in the Partnerships Hall9:00 Chairpersons’ Recap of Day One9:15 An Action Plan for Business Growth – Implement Changes to Adapt to the Increased Cost of Drug Development9:45 Fast Money Showdown – Debate Pipeline Trends and Investment Opportunities10:30 Networking Break in the Partnerships Hall11:00 SCORE Track Sessions and Market Insight RoundtablesS trategic Sourcing11:00-11:45 Wall Street Outlook- 2011Forecast and Analysis ofOutsourcing Trends11:45-12:30 Sponsors & CROs Unplugged-Assess the Impact of M&A on YourOutsourcing StrategyC ost & ContractManagementContract Approach andDevelopment – Key NegotiationStrategies to Help You BetterManage Your Clinical TrialsStructure Delivery Expectations inEmerging Markets – Responsibility,Liability, and Accountability12:30-1:30 Luncheon in the Partnerships Hall1:30 SCORE Tracks Continue1:30-2:15 Shared Risk Partnerships Spotlight Streamline Resource Management– How Sponsors Track ResourceUtilization in Development AcrossTheir Operational and ScientificFunctions2:15-3:00 Virtual Drug Development in aResource-Challenged Environment3:00-3:45 The Value of Strategic Alliancesvs. Transactional CRO-SponsorRelationshipsReconfigure Payment andContracting Strategies in Lightof Fair Market ValuePositively Influence Study TimeCompletion in Global Trials3:45 Networking Break in the Partnerships Hall4:15 Past Present and Future of Clinical Trial Outsourcing5:00 Create and Manage Transformational Change – How Do We Make the Switch?6:00 20th Partnerships Celebration – Featuring a Special Guest Performance, brought to you byO perational ExcellenceBest Practices for How to ManageYour Global Teams and RetainValue While OutsourcingAssess the Impact of IndustryConsolidations on ChangeManagement and Your OutsourcingOperational ModelClinical Trial Feasibility –Roadmap to Achieving Value andReturn on InvestmentStrategic Sponsor-Site PartnershipModels – Improve Site Selectionand Recruiting in a CollaborativeEnvironmentOutsourcing Phase IVObservational Studies: A DifferentAnimal?R egulatory Compliance& Quality OversightProactive GCP Compliance andQuality Management Systems –Ensure Quality is Stepping Up andStaff is Stepping BackThrough the Eyes of a Site: WhatDoes Quality Mean to Me?Globalize Regulations for ClinicalData Collection and SubmissionInspection Readiness Strategy inan Era of Heightened Scrutiny ofForeign Clinical Trials – PrepareYour Company and CRO forFDA Inspections, Auditing andMonitoring of the SiteAchieve Compliance with theSunshine Legislation Act on YourStandardized Disclosure PracticesE -Clinical TechnologiesUtilize Electronic Health Recordsin Clinical Research and DrugDevelopmentAchieve Closer Integrationof Clinical Operations Data(EDC, IVRS, CTMS) to ImproveQuality and Optimize ClinicalOutcomesUnderstand How to EffectivelyLeverage Technology to OptimizeYour Outsourcing StrategiesThe Evolution of CROs –Convergence of Serviceand Technology ProvidersBuild Strategic Partnerships byLeveraging Data ManagementProvider Experiences to ImproveOnboarding, Training, Governance,and ContractsFriday April 1, 20117:00-8:00 Stand Up 2 Cancer Morning Yoga8:00-8:45 Market Insight Roundtable Discussions & Morning Coffee in the Partnerships Hall9:00 Chairpersons’ Recap of Day Two9:15 Inspirational Patient Advocate Perspective with MLB Legend Curt Schilling9:45 Leverage the Value of Your Technology – Explore How the Patient will be the Game Changer for Clinical Drug Development10:30 Networking Break in the Partnerships Hall11:00-12:30 SCORE Track Sessions and Market Insight RoundtablesS trategic SourcingC ost & ContractManagementO perational ExcellenceR egulatory Compliance& Quality OversightE -Clinical Technologies11:00-11:45 Committing to Two Partners –A Look at the BMS IntegratedStrategic Sourcing InitiativeNegotiation Strategies – How toBest Define Responsibilitiesbetween Sponsors, Sites, andCROs to Avoid AccountabilityDisputesThe Changing Role of Central Labsand Implications for Outsourcing– Major Developments, FutureTrends, and Global ConsiderationsImplement a ComprehensiveClinical Trial Drug Safety Programand Improve Quality from ClinicalDevelopment to Post-ApprovalOptimize the Vendor-SponsorRelationship with ePRO11:45-12:30 Co-Development Between Sponsorand CRO: Transformational orConflict of Interest?Key Legal Considerations in GlobalOutsourcing – Use Critical Tacticsto Create Effective ContractsBest Practices for PatientRecruitment and Retention inClinical TrialsNext Generation Post-MarketingResearch (PMR) – Meet RegulatoryStandards and Enhance PatientSafety – Risk Maps, Registries,and REMSProactive Medical Monitoring –Planning for Success throughBetter Safety, Design, andEnrollment12:30-1:30 Luncheon in the Partnerships Hall1:30 Strategy is Innovation: Solving the Execution Challenge2:15 Industry Future – C-Suite Fireside Chat3:00 Partnerships Hall of Fame Awards Ceremony3:20 Main Conference Concludes3:30-5:00 Post-Conference Intensives4Register Now! Call +1 888.670.8200 US; +1 941.951.7885 Int’l • E-mail register@iirusa.com

AGENDA AT A GLANCEThree Co-Located EventsMedical Device ClinicalTrials ForumMedical Device Clinical Trials Forum is the only eventdesigned specifi cally for medical device clinical trialprofessionals to improve clinical strategy development anddeliver high quality clinical trial monitoring, data management,and project management to guarantee fi rst time marketaccess.Who Should Attend: CEO, CMO, CFO, CTO, Engineers,VP of R&D, Directors/ VPs of Clinical Affairs, Directors/VPSRegulatory Affairspartnerships inSitesA brand new co-located event specifi cally designed for sitemanagement professionals looking for strategies to improvetrial management with CROs and Sponsors.Who Should Attend: Physician Investigators (PI), StudyCoordinators, Site Managers, Directors of Site Services,Clinical Project Managers, Managers of Site Identifi cation,Clinical Operations ExecutivesClinical biotech Forum WestA unique co-located event specifi cally designed for seniorbiotech executives looking for the tools needed to execute fast,effective and compliant clinical trials to maintain funding andensure regulatory approval.Who Should Attend: CEOs, CSOs, CFOs, CTOs, Directors, VPsof Clinical and Outsourcing Executives, and Operations fromBiotech CompaniesClinical Trial Leadership Forum – Where Strategy Meets TacticsForum ModeratorSteve Whittaker, President,pHARMApM COnSuLTinG, LLC;former COO, Sr. Director, CV/Acute Care Platform, ELi LiLLyAnD COMpAnyDuring this forum, participants engage in an open exchange among peers to discuss current shared challengesand feed off each other’s ideas for solutions to optimize clinical trials. Each discussion topic will be led by 4-6leading industry experts who will facilitate a discussion around your most pressing issues.Who Should Attend: EVPs and VPs of Clinical Development, R&D and Outsourcing*This Leadership Forum is a participant-driven format open to registered and paid pharmaceutical and biotech executives whohave attended Partnerships for three or more years. If you are interested in participating, please email dburakoff@iirusa.com.invitationOnlyWednesday March 30, 20119:00am-12:00pm Closed Door Trial Sponsor Only Session: The intersection of Quality and Oversight –A Sponsor Outsourcing Dilemma: Reducing Micro-Management of CROs while Maintaining Effective Quality Oversight12:00-1:00pmLuncheon1:00-6:00pm partnerships General Session and Regulatory and Globalization keynotes6:00-7:00pmPartnerships Opening Day ReceptionThursday March 31, 20119:00-10:15am partnerships General Session and Financial keynotes10:15-11:00am11:00am-12:30pm12:30-1:30pm1:45pm2:30pm4:15-6:00pm6:00pmNetworking Break in Partnerships HallTopic i: Design Trials in a More Meaningful and Cost-Effective Manner – The interface between Science and Study Management andStrategic OutsourcingHear the 10 year evolution of partnerships in clinical outsourcing examining models such as Preferred Provider Relationships, Functional Service Provider Relationships,Offshore Modeling, CRO Investments in Pharma, and “Strategic Alliances”. Discuss the future business modeling within service providers to meet the needs of tomorrow’sbiopharmaceutical organizations. Panelists characterize the disruptive change biopharmaceutical companies are forced to make in order to survive in today’s environmentand the origin / transformation of today’s new business models driven by:• Increasing cost pressures and need for enhanced effi ciencies• Increasing complexity of industry needs driven by tougher regulatory environment• Increasing globalization of clinical trialsRalf Kohnen PhD, ScD, Prof Executive Vice-President & Head, Global Scientifi c Affairs, RpS, inC.LuncheonTopic ii: Participants will be surveyed in advance of the meeting to include the topic of their choice for discussion.(Globalization, Patient Recruitment, Site Management, Impact of M&A on Trial Management)Topic iii: Participants will be surveyed in advance of the meeting to include the topic of their choice for discussion.partnerships General Session and Change Management keynotespartnerships 20th Anniversary Celebration and ConcertFriday April 1, 20119:00-10:30ampartnerships General Session and Technology keynotes10:30-11:00am11:00am-12:30pm12:30-1:30pm1:30-3:30pmNetworking Break in the Partnerships HallTopic iv: next Generation Clinical Operations Technology in Clinical TrialsAs the life science industry continues to battle with escalating costs, executives are naturally looking for ways to increase effi ciency in the most expensive phase of drugdevelopment- the clinical trial. This session examines the evolution of technology for the use of clinical trials and how changes are infl uencing data capture, quality,integration, and management to improve the effi cacy of trials. Discuss where the emerging technology is headed and how to prepare for what clinical research might looklike in 2015.• Discuss how the new government funds for the Offi ce of Comparative Effectiveness might transform the clinical trials community• Explore the use of open source software in clinical trials• Implement procedures today to prepare for the futureLuncheonpartnerships General Session and innovation keynotesTentative Schedule (Check the Website for Updates)www.clinicaltrialpartnerships.com5

Friday | April 1st, 2011 | General SessionTechnology7:00 Stand up 2 Cancer Morning yogaBring your gear to work up a sweat during some morning stretches that will keepyou energized throughout the day! RPS will generously make a donation for allparticipants. Yoga will be held at the Sheraton Phoenix Downtown Hotel. Sign up inadvance at the RPS booth.8:00-8:45 Market insight Roundtable Discussions (see page 14 for details)8:00-9:00 Morning Coffee in the Partnerships Hall9:00 Chairpersons RecapJohn W. Hubbard, PhD, FCP,Senior Vice President, Headof Worldwide DevelopmentOperations Worldwide R&D,pFizER, inC.Harris Koffer, PharmDPresident and COORpS, inC.9:45 Leverage the value of your Technology – Explore How the patientwill be the Game Changer for Clinical Drug DevelopmentScience and medicine journalist and acclaimed author, Thomas Goetz, shares insightsfrom his new book “The Decision Tree” and how it applies to the pharmaceuticalmarketplace. This lively discussion identifi es trends on how consumers engage withtechnology in the healthcare space.• Explore how consumers interact with data, and how variables are broken downinto metrics, analyzed, and factored into health decisions• Learn how data-crunching tools and bioinformatics infl uence the knowledgeof how diseases work in the body and the discovery of new drug targets thatimpact the future of clinical drug development• Hear about the latest tools patients use to share their health experienceand manage disease• Identify specifi c trends and approaches that help patients selectively useinformation to elevate sound science in a relevant, personalized wayThomas Goetz, MPHExecutive Editor, WiRED MAGAzinEAuthor, The Decision Tree9:15 inspirational patient Advocate perspective with MLb LegendCurt SchillingCurt Schilling shares the story of his son’s Asperger’s syndrome and how it changedhis family’s journey. As an active patient advocate for amyotrophic lateral sclerosis(ALS) sufferers, Schilling’s organization, Curt’s Pitch for ALS, allows fans andorganizations to sponsor him and donate to the ALS Association for every strikeouthe throws. In 2007, Schilling released a charity wine called Schilling Schardonnaywith 100% of the proceeds supporting Curt’s Pitch for ALS. He also supports his wifeShonda’s personal charity, The Shade Foundation of America, an organization devotedto eradicating melanoma through the education of children and the community inthe prevention and detection of skin cancer and the promotion of skin safety. Comehear Schilling draw on his personal and professional experiences to teach leadershiplessons to help save lives.Curt Schilling, Former Major League Baseball Pitcher and 3 Time World SeriesChampion; Founder and Chairman, 38 Studios and Founder, Curt’s pitch for ALS10:30 Networking Break and photo opportunity with Curt Schillingin the Partnerships Hall11:00-12:30 S C O R E tracks and Market insight RoundtableDiscussions (see pages 14-15)12:30-1:30 Networking Luncheon in the Partnerships HallGreat introductions, good ability to drill down in tracks,and fun after hours sponsored activities.– Jane Brennan, Associate Contracts Manager, Corporate Purchasing,GENZYME CORP“”Innovation1:30 Strategy is innovation: Solving the Execution ChallengeWe live in an era of almost constant change. First, new technologies continueto emerge at an ever-more rapid pace. Second, globalization brings with it newmarkets, new customers, nontraditional competitors, and new challenges. Third, theInternet has created much greater transparency to any company’s strategy, actions,and performance. As a result of these forces, companies fi nd that their strategiesneed almost constant redefi nition – either because the old assumptions are nolonger valid, or because the previous strategy has been imitated and neutralizedby competitors, or because technological developments and globalization offerunanticipated opportunities. Rooted in these premises, the strategic challenges fororganizations become: How do we identify the market discontinuities that couldtransform our industry? How do we analyze the opportunities and risks as a result ofour understanding of market discontinuities? How can we create new growth platformswith a view to exploit the market discontinuities? What are our core competencies andhow can we leverage them in the growth platforms? How do we allocate resources tosupport growth? What kind of organizational DNA must we have in order to anticipateand respond to changes on a continual basis? How do you execute breakthroughstrategies? Develop a framework to answer the following questions:• Why do companies need to continuously innovate strategically?• How can fi rms identify market discontinuities that shape the future evolutionof the industry?• How can fi rms exploit accelerating global opportunities as a result of thediscontinuous shifts in the marketplace?• How can fi rms build the requisite organizational DNA to create the future whilemanaging the present?• How do you execute breakthrough strategies in the pharmaceutical industry?Vijay Govindarajan, Founding Director of the Center for Global Leadership at the TuckSchool of Business, DARTMOuTH COLLEGE, Co-author, The Other Side of Innovation:Solving the Execution Challenge“As we struggle with the pressure of doing more with less in ourmotivation to develop new therapies for patients in need, Partnershipsprovides a forum to hear leading sponsors and providers discussthe challenges, present creative solutions and permits interactivedialogue that I find unlike another meeting in our industry– Larry Blankstein, Senior Director, Clinical Research, GENZYME”2:15 industry Future – C-Suite Fireside ChatFor the past several years, an economic recession, mergers and acquisitions, patentcliffs, product pipeline rationalizations, and changes in the way pharmaceuticalcompanies invest in R&D have been impacting the healthcare industry. This sessionlooks at macroeconomic trends, strategies, and practices as well as analogies drawnfrom other R&D intensive industries to project where sponsor-CRO relationships areheaded. Discuss some of the recent factors driving change in the industry and explorenew business paradigms for partnering with clients to enhance value and expeditedrug development. Panelists explore the following issues:• What will Pharma look like in 5 years time and how will we get there?• How will comparative effectiveness research impact the industry with strategies forclinical trial designs and drug development?• What are the projected changes in discovery, preclinical, early clinical, and laterstage clinical outsourcing?• How do you improve the organizational effi ciency as a part of the newvalue equation?• How do you expect the CRO-Sponsor relationship to change in the next decade?Vijay Govindarajan, Founding Director of the Center for Global Leadership at the TuckSchool of Business, DARTMOuTH COLLEGE, Co-author, The Other Side of Innovation:Solving the Execution Challenge (Moderator)James T. Ogle, CEO, inC RESEARCHJeffrey P. McMullen, CEO, pHARMAnET3:00 partnerships Hall of Fame Awards CeremonyAn awards ceremony will honor and celebrate Partnership MVPs throughout thepast 20 years. Come celebrate the achievements of your colleagues! Winners forthe following categories will be announced: Technology and Innovation, LifetimeAchievement Award, Operational Excellence, Change Management, Most ValuableAttendee, and more.3:30 Main Conference Concludes3:30-5:00 post Conference intensivesThese 90 minute intensives take a deep dive into some specialized topicareas in the industry. See page 15 for a list of sessions offered. Please visitour website for updates.www.clinicaltrialpartnerships.com9

Thursday | March 31st, 2011 | S C O R E TracksS TRATEGIC SOURCINGC OST & CONTRACTOChairperson: Frances Grote, Senior Director, StrategicSourcing, Millennium: The Takeda Oncology CompanyMANAGEMENTPERATIONAL EXCELLENCEChairperson: Jessica Bowler, Associate DirectorProcurement, Pfizer, Inc.Who Should Attend: Senior Executives including VPsof Global Outsourcing, Clinical Operations, Clinical R&D,R&D Finance, Strategic Sourcing, and Strategic PlanningDescription: Discover business drivers for small,medium, and large companies in model selection and theoutsourcing of specific functional areas. Discuss obstaclespreventing the formation of effective partnerships andthe incidence and growth of new emerging collaborationmodels. Engage in discussions around global outsourcingof clinical trials. Discover how to survive in this economicenvironment and the future outlook for the CRO industry.Who Should Attend: Clinical Contract Management,Clinical Budgeting and Finance, Contract Analysis,Procurement and Purchasing, Grant ManagementDescription: Greater scrutiny of financial ties toclinical investigators coupled with increased focus onaccountability and drug safety puts more pressure oncontracting executives to clearly outline responsibilitiesfrom the start. This track provides clinical trial budgetand contracting executives with the tools to streamlineprocesses and better define accountability andresponsibilities.Who Should Attend: Professionals responsible for ClinicalOperations, Project Management, Patient Recruitment,Clinical Affairs, Clinical Site Management, ProtocolDevelopment, Clinical Trial Monitors/CRAs, Site MonitoringDescription: Build and maintain alliances with internalstakeholders so you are continuously up to date witheach other’s needs towards your common goal. Leverageproject management methodology and build quality intothe process to leverage and manage outsourced work.11:00 Wall Street Outlook – 2011 Forecast andAnalysis of Outsourcing TrendsWall Street offers an assessment of the outsourcingenvironment from 2010-2011 as well as an outlook forthe next few years. Our presenters each offer a briefcommentary to kick off this very interactive session thatwelcomes audience questions and comments. Specialfocus is given to the following issues, with a Wall Streetview on:• Determine the standards by which you calculate riskand measure investment value• Examine the trade-offs of being a public vs.a private company• Prepare your firm’s strategy for 2011 and identify howthe drivers will differ from 2010John Lewis, Vice President for Public Affairs, ACRO(Moderator)Stephen Unger, Director, Senior Analyst, Life SciencesSector, Lazard Capital MarketsDavid Windley, CFA, CPA, Managing Director, HealthcareEquity, Jefferies & companyEric Coldwell, Managing Director, Healthcare Distributionand Services Equity Research, Robert W. BairdContract Approach and Development –Key Negotiation Strategies to Help youBetter Manage your Clinical Trials in an Eraof Increased ConsolidationThe tumultuous state of the drug manufacturing industryimpacts every line of business, but perhaps is feltstrongest in clinical trials. More than ever, it is critical forclinical trial executives to forecast correctly and adaptto their changing surroundings. In the highly regulatedpharmaceutical sector, understanding the key pointsof negotiation and drafting a proper contract can bechallenging, especially when you don’t have a law degree.As clinical outsourcing managers lead negotiations, draftand manage key contracts on a daily basis, it is essentialto have a firm grasp of tactics for creating effectivecontracts.Anthony Carita, Director, Clinical Outsourcing, OtsukaPharmaceutical Development & CommercializationBest Practices for How to ManageYour Global Teams and Retain ValueWhile OutsourcingThe global economic climate is changing in terms ofreinforcing the need for greater throughput and greatertracking. How do you handle things that are not donein your own shop? This session provides best practicesfor managing team members in different regions andadapting to a changed economic landscape.• Manage virtual teams across the globe from anoperational standpoint• Create new ways to propagate the pipeline through riskmanagement techniques• Understand differences in cultural expectations toenable better working relationships• Integrate country requirements, guidance, and work ofteam members for multiple emerging markets into theU.S. core teamEurona Tilley, Managing Editor, PHARMSOURCE(Moderator)Kent Thoelke, Senior Vice President, Scientific & MedicalAffairs, PRA InternationalAusten Eddy, Director of Clinical Operations,Avi Biopharma11:45 Sponsors & CROs Unplugged – Assess theImpact of M&A On Your Outsourcing StrategyExplore the best practices in rapid renegotiation strategies,and how to shift control from one company to another ina post M&A environment to maximize ROI. Listen in asexecutives of various size companies share their insightsand outlook for the future of the CRO industry.• Identify critical considerations when considering amerger or acquisition of a company• How have companies who come together consolidatedtheir sourcing strategy?• What do you need to compare and evaluate?Frances Grote, Senior Director, Strategic Sourcing,Millennium: The Takeda Oncology Company(Moderator)David Grange, CEO, PPDLawrence Florin, Section Director, U.S. ClinicalOutsourcing, AstrazenecaStephen Cutler, PhD, Senior Vice President and ChiefOperating Officer, KendleStructure Delivery Expectations in EmergingMarkets – Responsibility, Liability, andAccountabilityAs more companies ramp up their clinical operationsin new markets, contract and budgeting executives arefaced with the task of adjusting to a new set of rules. Thissession explores the challenges in structuring deliveryexpectations in emerging markets and reviews countryspecificrequirements and best practices for contractingglobal agreements.• Pinpoint key differences in accountability when workingwith CROs and sites in emerging markets• Observe local norms regarding fair market value toavoid complications• Obtain negotiation strategies to ensure globalresponsibilities and liabilities match your U.S. contracts• Learn how to create templates that work with differentpolicies, regulations, and data pointsPeter Pitts, President, Center for Medicine in thePublic Interest (Moderator)James Tsui, Contracts and Outsourcing Manager,Roche Product Development in Asia and PacificRobert J. Davie, PhD, Vice President & General ManagerEurope, Clinical Development Services, CovanceAssess the Impact of Industry Consolidationon Change Management and YourOutsourcing Operational ModelWith the uptake of more mergers and acquisitions in theindustry, there is the need for clearly defined roles andresponsibilities to harmonize the language and culture oftwo offices. How are companies restructuring themselvesinternally? How are they managing that operationalchange? During this roundtable discussion, you address:• How to determine which projects to keep movingforward in a post-merger stage• Critical cultural factors within an organization that willaffect the transitions of staff• How to make integration and work flow easier• Proactive risk management approaches• New strategic approaches for your vendor management• Review implementation techniques across differentdelivery modelsThomas Lawler, Senior Director, Clinical ProjectManagement, AstraZeneca (Moderator)Mike Collins, Vice President, Development Operations,Pfizer, Inc.Lauren Meyers, Alliance Leader, Product DevelopmentStrategic Outsourcing (PDAS), Genentech12:30 Luncheon in Partnerships HallContinued on pg 12-138:00-8:45 Market Insight Roundtable DiscussionsHIPAA Compliance for Sponsors and CROsJeremy Stoloff, Associate General Counsel, Banner HealthImpact of Reform on Biosimilar Drug DevelopmentGregory Skalicky, Senior Vice President, Worldwide Business Development,PHARMANET, LLCDalvir Gill, President, Late Stage Development, PHARMANET LLCVirtual Sponsor Team OutsourcingChristina S. DiArcangelo, CEO, Armonia Clinical Research, LLCPrepare for FDA Clinical Trial InspectionsSandra L. Shire, DMD, MPA, Director, MS in Regulatory Science and Health SafetyProgram, Arizona State University10Register Now! Call +1 888.670.8200 US; +1 941.951.7885 Int’l • E-mail register@iirusa.com

Thursday | March 31st, 2011 | S C O R E TracksSTRATEGIC SOURCING1:30 Shared Risk Partnerships SpotlightOver the past few years we have seen pharma/CROpartnerships move beyond traditional outsourcingagreements to those that share risk to a much greaterdegree. The presenter focuses on partnerships involvingcapital at-risk transactions where third party capitalpartners take on risk for the ultimate outcomes of theproducts either in the development or commercial areas.In discussing case studies of shared-risk partnershipswith pharmaceutical companies including Eisai, Eli Lilly& Co and Solvay Pharmaceuticals, our speaker highlightsthe financial commitment Quintiles has made to itspartnerships and how this has been adapted to suit theneeds of partnerships with biotech and large pharmaclients. The case studies will be explored within thecontext of current changes in the industry, the drivers forthese changes, and the progress of the industry.• Evaluate risk and assess return mechanisms in theseshared-risk partnerships• Review how and why Quintiles moved intoshared-risk partnerships and their operationaland governance elements• Discuss how to split up financial commitmentsPeter Payne, VP, Corporate Development,NOVAQUEST, The Investment Arm of QuintilesTransnational Corp2:15 Virtual Drug Development in a Resource-Challenged EnvironmentVirtual companies essentially outsource every componentof development. These new companies are being formedby those who are recognizing that the big Pharma modelis losing its sustainability. Now the model is beginningto move into a construct where there is a whole portfolioof products being managed virtually. This session willfocus on the virtual pharma model and their strategicpartnerships with CMOs, CROs and consultants. CROsdiscuss innovative ways to accommodate the virtualpharma model by having a real stake in the success of theclient with risk-sharing models of rising interest.• Is the rise of virtual pharma a fad or a permanentchange in the industry?• Define virtual pharma’s expectation of the CRO• Hear lessons learned from virtual companies that canbenefit big pharma• How to manage virtual development in a small company• Is there a happy medium- semi-virtual?Tomasz Sablinski, MD, Managing Director, Head ofDevelopment, Celtic TherapeuticsCOST & CONTRACTMANAGEMENTStreamline Resource Management – HowSponsors Track Resource Utilization inDevelopment across their Operational andScientific FunctionsThis session looks at the evaluation and assessmentof internal resource requirements for in-house andoutsourced studies across functions. Panelists discusstheir methods for using data to understand what thedifferent resources across organizations are contributingin order to identify opportunity areas for improvementactivities.• Get enough money to sustain a robust portfolio• Maximize your resources, whether it’s your internalFPEs or out of pocket dollars• How to be a lean project manager when facing pressureto succeed with limited resourcesChrista A. Maurer, Director Outsourcing and ContractManagement, Bristol-Myers SquibbMichael Cox, Manager, Resource PerformanceManagement, MedimmuneReconfigure Payment and ContractingStrategies in Light of Fair Market Value(FMV)As the FDA and global regulatory bodies becomeincreasingly involved with Fair Market Value, drug anddevice sponsors need a clear direction on how to proceedwith both domestic and international clinical trials,physician disclosure issues and proper documentation.Understand what FMV means to sponsor-site relationshipand establish a protocol for setting up payments andcontracts with new CROs and sites.• Learn what information is required to be reported• Avoid penalties for infractions designated by the DOJand comply with latest FDA guidelines to preventserious negative implications to your clinical trial• Learn how private and public manufacturers arerequired to report physician involvement in clinical trials• Deal with and report for the various state regulationsabout investigator compensationMark Milberg, Sr. Contract manager, Clinical Contractsand Alliance Management, MEDTRONICCory Gutterman, Independent Pharmaceutical ConsultantO PERATIONAL EXCELLENCEClinical Trial Feasibility – Roadmap toAchieving Value and Return on InvestmentMany pharmaceutical companies have begunimplementing lessons learned from past trials throughoutthe industry with proactive feasibility studies. Feasibilityanalyses can help mitigate risk to the success of the trialeven before it begins. Done correctly, feasibility allowssponsors to transform clinical development planning bytaking extra time in advance, saving time and money inthe long run through better trial design. Hear from bothsponsor and provider perspectives on an internal andexternal approach to clinical trial feasibility:• Explore the value in bringing a CRO in early• Develop protocols, site feasibility and selection,documentation, and site activation• Obtain best practices for finding the best clinicaltrial investigators and managing clinical investigatorcompliancePeter Dibasio, Clinical Development Operations,Vertex PharmaceuticalsKatherine Tranotti, VP Clinical Operations,ICON Clinical ResearchJay Turpen, Advisor, Clinical Project Management,Eli Lilly and CompanyStrategic Sponsor-Site Partnership Models–Improve Site Selection and Recruiting in aCollaborative EnvironmentThis session focuses on new collaboration models thatsponsors, CROs and investigative sites are entering intoin response to rising drug development inefficienciesand cost. Results from original research will shed lighton obstacles preventing the formation of effectivepartnerships and the incidence and growth of newemerging sponsor-site collaboration models. Strategicobjectives and structural components of these partnershipmodels will be discussed and their advantages anddisadvantages explored. Collaborative models drawn fromother research-intensive industries will also be discussedand applied to sponsor-site partnerships.• Illustrate new approaches to structure sponsor, CRO-siterelationships to better leverage the partnership• Highlight obstacles preventing the formation of moreeffective sponsor-site interactions and collaborations• Convey trends in the adoptions and usage of varioussponsor-site relationship structuresJoseph Kim, MBA, Clinical Operations Director,Shire Pharmaceuticals Ltd3:00 The Value of Strategic Alliances vs.Transactional CRO-Sponsor RelationshipsAs drug development and outsourcing industries continueto mature and as cost pressures continue to increase,progressive players are starting to look for more value intheir relationships. This session explores the definitionof clinical delivery alliances and the value these alliancepartnership models bring to the drug development processfrom both the sponsor and CRO perspective. Per theseindustry movements, this session answers the followingquestions:• How do more strategic relationships positively affectperformance and outcomes?• When do alliance partnerships make sense for asponsor or a CRO?• What alliance partnership models are emerging?• Lessons learned from current clinical delivery alliancemodels – what works and what doesn’t?• How can both large pharma and biotechs benefit fromcreative partnership structures and a process drivenmethodology for managing strategic developmentprograms?David Gillogly, Global Head, Clinical Contracting andCategory Management, NovartisTim Dietlin, VP Alliance Development, INC ResearchPositively Influence Study Time Completionin Global TrialsDrawing upon extensive industry data from the costbenchmarking databases and extensive industry clinicaltrial performance data from the Centre for MedicinesResearch (CMR), this analysis draws on 20 year’s worth ofdata from both pharma companies and CROs on the costsand time it takes to complete clinical trials. The researchwill help you identify the most influential variables in studytime completion and why some clinical trials finish fasterthan others across therapeutic areas and regions.The database contains extensive cost data at theProcedure, Cost Per Visit, and Cost Per Patient levels fromNorth America, Europe, Asia, Latin America and otherimportant countries involved in drug testing.• Learn about the trends and comparative costs of clinicaltrials around the world• Assess the elements of study design that have thebiggest impact on study completion times, includinginclusion/exclusion criteria, protocol design and thecountries involved• Determine the impact of the use of CROs on study costsand study completion times• Examine how payment levels to CROs and sitesinfluence study completion times and data qualityHarold E. Glass, MD, Research Professor of Health Policy& Adjunct Professor, Pharmaceutical and HealthcareBusiness, University of the SciencesPhiladelphiaOutsourcing Phase IV Observational Studies:A Different Animal?This session presents strategic issues underlyingpost-approval observational research as a foundationfor considering different operational approaches inoutsourcing. New findings from a multi-disciplinary surveyprovide insights into industry needs, expectations, andapproaches to their design and operational factors. Hearsponsor and CRO perspectives on the mechanics ofoutsourcing Phase IV to gain clarity on strategies neededto optimize the relationship between CROs and researchsponsors.• Examine the role of comparative effectiveness researchin Phase IV strategic initiatives• Obtain less costly approaches that yield high quality,on-time results• Determine critical considerations that need to be givento selection and training of individuals supporting PhaseIV studies• Get guidance for Phase IV protocol development andoperational planningJeffrey Trotter, Executive VP, Phase IV Development,PharmanetColleen McCoy, Associate Director, PDAOR Contracts andOutsourcing, Genentech Inc. (invited)Return to General Session pg 812Register Now! Call +1 888.670.8200 US; +1 941.951.7885 Int’l • E-mail register@iirusa.com

PARTNERSHIPS HALL2011 Partnerships in Clinical TrialsADVISORY BOARDDaniel Amatulli, Outsourcing Manager,CelgeneSolomon Babani, Sr. Director, Outsourcingand Alliance Management, CelticTherapeutics DevelopmentDeirdre BeVard, Vice President,Clinical Operations & Data Management,Endo pharmaceuticalsLarry Blankstein, PhD, Senior Director,Clinical Research, Genzyme pharmaceuticalsChristina Bodurow, PhD, Senior Director,External Sourcing, Development Center ofExcellence, Eli Lilly and CompanyJessica Bowler, Associate Director, WorldwideProcurement, pfi zer, inc.Marisa Bower, Contracts & Outsourcing,pfi zer, inc.Christina S. DiArcangelo, Chief ExecutiveOffi cer, Armonia Clinical Research, LLCPeter DiBiaso, Senior Director, ClinicalPlanning & Performance, vertexpharmaceuticalsLarry Florin, Section Director, U.S.,Clinical Outsourcing, AstrazenecaElisabeth Overend-Freeman, Global BrandManager, Clinical Development Services,Covance incFrances Grote, Senior Director, StrategicSourcing, Millennium pharmaceuticalsErica Hill, Senior Manager, Marketing,iCOn Clinical ResearchKevin L. Keim, PhD, MSc, Chief DevelopmentOffi cer, inC ResearchMary Rose Keller, Vice President, ClinicalDevelopment and Operations, prometheusTherapeutics and DiagnosticsJack Lawler, Director Clinical Operations,CephalonJonathan Lee, Vice President, DevelopmentOperations, CerexaLauren Meyers, Strategic RelationshipManager, Product Development Operations,Strategic Outsourcing, GenentechTheresa Musser, Vice President,Development Operations, RigelpharmaceuticalsFredrick Naids, PhD, Senior Director,Clinical Operations, Shire pharmaceuticalsDavid Reasner, PhD, Senior Vice President,Biostatistics, Data Management, and HealthOutcomes, SepracorMaryRedge Santos, Executive Director, StrategicAlliances, kendle internationalSamir Shah, Executive Vice President, GlobalStrategic Development, RpS, incGreg Skalicky, Senior Vice President,Strategic Global Business Development,pharmanetJay Turpen, Director, Clinical StrategicSourcing, Eli Lilly & CompanyAnn Wang, Vice President, ClinicalOperations, Human Genome SciencesSteve Whittaker, Former Chief OperationsOffi cer, Director of Project Management CV/Acute Care, Eli Lilly & Companypartnerships Hall TourWe know there are many solution providers that you would like to meet with and we will bearranging brief tours to navigate you through the large exhibit hall.Meet the 2011 Speakers and Advisory boardSpeakers and advisory board members will be on hand at the Partnerships Lounge at select timesthroughout the conference to discuss program sessions or other questions or ideas you may have.20th Anniversary Celebration – Featuring a Special Guest performance,sponsored byDon’t miss the 20th Anniversary Celebration of Partnerships. Each year, the Partnershipsnetworking reception offers a wonderful opportunity to meet with colleagues in a fun and informalsetting. This year promises to ROCK!The Clinical Expert is in the HallDuring breaks the Partnerships MVP speakers will be at the Partnerships lounge to meet, greetand take your questions on clinical development.Speed networkingBack by popular demand, the speed networking has been expanded to improve your face timewith new contacts in clinical development and your overall networking experience. Don’t forget tobring your business cards!Solution ShowcaseNew this year our sponsors and exhibitors will be providing presentations in the hall to help youevaluate and compare services of leading full service, specialized and ancillary service providers.Arizona biotech pavilionBack in Arizona for the fi rst time in a few years, we’ve partnered with the Arizona BiotechAssociation to show you the best of what Arizona has to offer. Be sure to visit the special area ofthe Partnerships Hall to visit the sites and providers ready to help execute your trials.E-Clinical pavilionIn addition to a brand new track on e-Clinical technologies, we are making it easier for you to fi ndthe e-Clinical providers in the hall this year. Just look for the e-Clinical logo on the fl oor plan and inthe company description to fi nd the services you are looking for.Market insight Roundtable DiscussionsMaximize your networking experience in a fun and relaxed setting as industry experts facilitatediscussions on top challenges to foster the sharing of experiences and best practices. Space willbe limited and registered conference attendees must sign up for the roundtables in advance of theconference. Visit us online for more details.Find the Clear Stonehosted byinternet HospotPartnering Events and HighlightsKeep in touch and check your email at our Wireless Internet Hotspot, hosted byGet Connected Before the Event!personalized Scheduling and pre-Event networking Tool – We have partneredwith a leading provider of event scheduling and networking software to provideyou with an easy way to schedule your time before the event and manage yourtime onsite through the mobile application.We’ve created the Partnerships group on linked in to encourage year-rounddiscussion, knowledge sharing, and idea generation. At time of print, the grouphas over 4,000 members!Join us on LinkedIn – partnerships with CROs or visit the Partnershipswebsite and click on the “Linkedin” iconJoin our partnerships in Clinical Trials Community Facebook group forupdates on regional events, dinners, and more!Meet the 2011Partnerships TeamDanya Burakoff, ProgramDirector, Biopharmaceuticaland Healthcare DivisionMegan Antonelli, ManagingDirector, Biopharmaceuticaland Healthcare DivisionAllison Rigels, SeniorMarketing ManagerPartnerships in Clinical Trials Blog –partnershipswithcros.blogspot.comAndrew Sinetar, SalesManager, PharmaceuticalsFollow us on twitter: @partnershipscros16Register Now! Call +1 888.670.8200 US; +1 941.951.7885 Int’l • E-mail register@iirusa.com

PARTNERSHIPS HALL2011 Partnerships in Clinical Trials Exhibitors (to date)Partnerships Hall Hours*Exhibit hours subject to changeWEDNESDAY, MARCH 30, 20116:00-7:00pmPartnerships OpeningDay ReceptionTHURSDAY, MARCH 31, 20118:00-8:45amMorning Coffee• Market Insight Roundtables• Partnering Meetings10:30-11:00am Networking Break• Speed Networking• The Clinical Expert is In the Hall• Solution Showcase12:30-1:30pmLuncheon3:45-4:15pmNetworking Break• Speed Networking• The Clinical Expert is In the Hall• Solution Showcase6:00-7:00pm20th AnniversaryPartnerships Celebration7:00-8:00pmSpecial Guest PerformanceSponsored byFRIDAY, APRIL 1, 20118:00-8:45amMorning Coffee (Market InsightRoundtables & PartneringMeetings)10:30-11:00am Networking Break• Speed Networking• The Clinical Expert is In the Hall• Solution Showcase12:30-1:30pmLuncheon1:45pmHall Closes3:20pmConference Concludesreserve your booth –space is limitedJoin a wide range of US-based and global CROs,central labs, core labs, e-technology providers,clinical staffing companies, patient recruitmentproviders, and more, already confirmed to be inthe exhibit hall.The 20th Annual Partnerships in Clinical Trialsoffers you an excellent opportunity to promoteyour products and/or services in front of keydecision-makers.Please contact Andrew Sinetar atasinetar@iirusa.com for more information.Save the Date forPartnerships 2012!March 5-7, 2012Marriot World CenterORLANDO, FLORIDAwww.clinicaltrialpartnerships.com17