March 30-Apr 1, 2011 - ICON plc

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