March 30-Apr 1, 2011 - ICON plc

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