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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
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