March 30-Apr 1, 2011 - ICON plc

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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
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March 30-Apr 1, 2011 - ICON plc

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