t - ICON plc

Post-Conference SymposiaFriday 19th NovemberCQ3005PPost-conference Symposium PUSING PARTNERSHIPS TO IMPROVE THEOPERATIONAL DELIVERY OF YOUR TRIAL9:10 What does it take to make a successful study? Scientific expertise and decision criteria for the assessment and selectionof providers Impact on process and data review when managing multiple providers. What isthe best approach? Identifying core competencies. Importance of keeping “in-house expertise” Understanding the importance of balance between trust and control Real-life examples of successful management strategies Summary and conclusion: maintaining the balance between external resourcingand in-house expertiseMaria Solonets, Senior Clinical Research Physician, ClinicalScience, Actelion Pharmaceuticals Ltd, Switzerland8:20 Coffee and RegistrationCQ3005QPost-conference Symposium QENSURING APPROPRIATE VENDOROVERSIGHT WITHIN PARTNERSHIPS9:00 – 9:10 Opening remarks from the ChairsChair: Julianne Hull, Senior Director, Global Development DataOperations, Wyeth9:10 Regulators’ requirements for vendor oversight of outsourcedtrials: what is state-of-the art from an industry perspective? What do inspectors define as adequate vendor oversight? How is adequate vendor oversight demonstrated? Common pitfalls in EMA and FDA MAAs? What level of contact will the regulator have directly with yourservice provider? What is their view of clinical partnerships? What interface do they expect between CRO and sponsor?Christian Biberger, Director Clinical Trial Management,NycomedCQ3005RPost-conference Symposium RESTABLISHING AND IMPROVINGPREFERRED PROVIDER RELATIONSHIPS9:10 Do sponsors know the price of everything and the valueof nothing? The value of values in sponsor-vendorrelationship managementOften people talk about pharma/biotech being focused on helping patients,while CROs are just out to make money. Those opinions are based on the factthat people perceive ‘helping people’ to be a key value for pharma/biotechcompanies while ‘money’ is a key value for CROs. This speaker disagreeswith that and actually thinks both pharma/biotech and CROs have money nearthe top of their values hierarchy, whether they are willing to admit it or not.This session will examine: What are values? Why are values important? How do you know what your values are? Corporate values of sponsor vs. CRO Corporate vs. personal vs. group values What happens when values conflict? How do you align values between sponsor and vendor? The benefits of aligning values to achieve maximum results09:55 Strong partnerships between Pharma, CRO andinvestigator sites: Managing the Key Challengesof Monitoring International Investigator Sites How can CROs and sponsor work together in site selection? Understanding the specialities of the sites together How the language barrier can sometimes cause consternation and confusion Examining the common misunderstandings in monitoring reports What internal processes can help improve the quality of clinical monitoring? Ensuring your international sites are meeting GCPPaul Quinn BSc, PhD, Senior Clinical Programs Director,Shire Pharmaceuticals Ltd10:55 Working in Partnership for Effective Trial MasterFile Compilation Why is trial master file compilation so often overlooked until late in the project? Can it be done by a clinical CRO, or are specialists better value? What are the pros and cons of working with both? Ensuring streamlined compilation for better project delivery Electronic versus paper TMF – logistics, requirements of the CRO,confidentiality when working with multiple CROs on same study?Maria Öhlander, Principal Project Manager Eprotirome, DirectorClinical Operations, Karo Bio AB, Sweden11:40 Panel Discussion: How Outsourcing Departments CanSupport Project Management and Delivery How robust are pharma companies’ SOPs for the following areas:- Invoicing - Outsourcing - GCP - Project delivery - Timelines How closely are outsourcing and operational departments working together toachieve these SOPs? How regularly are pharma companies reviewing and revising SOPs forproject delivery Purchasing versus development/clinical based outsourcing groups?Bea Sauerhoff, Associate Director, Outsourcing Management, NovartisMichael Zoerer, Global Therapeutic Area Operations ManagerHemophilia, Baxter BioScienceMaria Öhlander, Principal Project Manager Eprotirome, DirectorClinical Operations, Karo Bio AB, Sweden13:20 Regulatory and Operational Challenges of Site Activation How feasibility can facilitate quicker site activation Examining the pain points for sponsors and CROs in activating a new site What are the common regulatory delays in site activation? Strategies for making your site productive quicklyMichael Zoerer, Global Therapeutic Area Operations ManagerHemophilia, Baxter BioScience14:05 Panel discussion: Clinical Trial Insurance and Its Role inClinical Partnering To what extent are prices rising from insurance costs? Where should insurance sit within your clinical organisation? Examining the types of insurance options available in a clinical partnership? What is involved in risk-transfer insurance? Examining international anomalies in required clinical trial insurance What are the parameters for distribution of liability between Sponsor/CRO How should insurance be shared within a strategic partnership?Anna Apicella, Outsourcing Analyst,Takeda Global R&D Centre Europe Ltd09:50 - 09:55 5 minute change over09:55 Outsourcing to a number of smaller providers -how does the pharma ensure that communicationbetween all subcontractors works effectively? Using a number of niche providers versus one large global provider Managing vendor and study budgets - methods for staying on top of the costof changeThierry Escudier, Head of Clinical Operations, Pierre Fabre10:35 - 10:55 Morning Tea10:55 Real-life case study on how compliance issues impact theoutsourcing strategy for Late Phase studies To what extent should service providers be monitored to ensure that they arecomplying with regulatory requirements in Late Phase studies? Overcoming the challenge of compliance in multinational studies – ensuringthat CROs comply with regulations across different countries How the increasingly strict compliance rules will affect the outsourcing strategy Examples of increasingly sophisticated ways to deal with more complicatedregulatory requirements Ensuring that service providers will deal effectively with the EFPIA Code(European Federation of Pharmaceutical Industries and Associations) oncontracts between pharma and healthcare professionals Effective communication to the service provider: Ensuring transparency withheadquarter recommendations and what the country affiliates carry out in practiceBoris Pfeiffer, M.Sc., Head R&D, Medical Affairs,Merck Serono GmbH11:35 - 11:40 5 minute change over11:40 Debate: To what extent should a sponsor audit a vendor? Why are you auditing? What should you focus on? How can a CRO’s QA be measured by pharma? How can pharma audit without annoying the CRO? Who is reading your SOPs? Should you be auditing sub-contractors? At what time do you audit? What documentation should the pharma company be requesting? Qualification audits Following up on changes and assessing continuation of qualityBirgit Ruhfus, Head GCP Study Audit Management - EuropeBerlin, Bayer Schering Pharma AG, GermanyChristian Biberger, Director Clinical Trial Management, NycomedThierry Escudier, Head of Clinical Operations, Pierre FabreBoris Pfeiffer, M.Sc., Head R&D, Medical Affairs,Merck Serono GmbH12:20 - 13:20 Lunch13:20 Real-life case study on moving into a new set-up for sponsoroversight of clinical CROs Overview of the clinical CRO oversight set-up, including the main advantages Identifying the main challenges with clinical CRO oversight, and how toovercome them How to decide who is responsible for clinical CRO oversight Understanding how to work effectively with the clinical CRO to make itsimple for Leo Pharma To what extent is oversight required on a fully outsourced trial?Susan Sforzini, Head of Section, Clinical Operations,LEO Pharma A/S, Denmark14:00 - 14:05 5 minute change over14:05 Panel discussion: How Do Pharma and CROs IncreaseQuality of Work by Sharing Information on Quality Aspects? How to Include Quality Metrics in a Contract While traditional milestones have included hard metrics on patient deliveryand monitoring visits, how do you measure for quality and incorporate thatinto the contract? What models for quality measurement are CROs currently seeing in negotiations? During a bid defence meeting how are quality aspects reflected in thepayment schedule? How open should pharma and CROs be on the findings made in internal audits? Quality should be included in the CRO overhead: discuss Ensuring due diligence around the information obtained in a clinical trialBirgit Ruhfus, Head GCP Study Audit Management - EuropeBerlin, Bayer Schering Pharma AG, GermanyArthur Hecht, Head of QM Medicine and Regulatory WesternEurope South, Boehringer Ingelheim Pharma GmbH & Co. KG09:55 Case Study: Next Steps in the Evolution of aStrategic Partnership Four years into a strategic partnership, how is it managed day-to-day? How to demonstrate value that the sponsor derives from the long-term partnership Challenges in moving from strategic intent to strategic delivery How the contract changed to support the objectives of the partnership What is the progression in terms of what partnerships can deliver? Lessons learned and process improvement over timeMark Blanchard, Global Account Manager, AstraZeneca, UK10:55 Evaluating the risk of preferred providers versus newsuppliers: A GlaxoSmithKline perspective Real life examples of risks involved with preferred providers and withnew suppliers Assessing situations when it is appropriate to use new suppliers Building contingency plans to manage risk with preferred and new suppliers Best practice for communicating with service providers to minimise riskMichael Patten, Senior Contract Manager, Global Outsourcing& Supplier Governance, GSK11:40 Panel discussion: Striking the Right Balance betweenControl and Trust in a Preferred Provider Relationship How do we define micro-managing? Defining what trust actually means for both sponsor and provider How to solve delivery issues without micro-managing Developing robust metrics between sponsor and provider Managing communication between multiple CROs and locations Importance of complex outsourcing structure when managing full service andniche providers How to get buy-in from your internal pharma team What happens when a sponsor is dissatisfied with a preferred provider? How important is it for CROs to be transparent about cost structures in thecontext of a preferred relationship? How can partners work smarter to reduce duplication of work?Corinne Pala, Outsourcing and Contract Manager, Grunenthal GmbHMichael Patten, Senior Contract Manager, Global Outsourcing &Supplier Governance, GSKMark Blanchard, Global Account Manager, AstraZeneca, UK13:20 Successfully managing and improving the interface anddivision of responsibilities between Sponsor’s localMarketing Companies and CROs in outsourced studies How to optimise division of functional responsibilities between corporateand affiliate levels at both sponsor and CRO sides How to combine trial sponsor central and local compliance, e.g. anti briberyand anti corruption policies and local regulations with process efficiency. How to handle the complexity when many CRO study teams have tointeract with several Marketing Companies How to h andle potential competition situations between In-House andoutsourced studies.Brigitte Everding, Global EPMT Marketing Company LeadAlliance Manager, AstraZeneca AndBjörn Bältsjö, MSc E.E., Clinical Information Science Directorand Lean Sigma Black-Belt, AstraZeneca R&D14:05 Case Study: Outsourcing Strategy after the PfizerWyeth Acquisition The challenge: how do you take two different processes to create a hybridstrategic outsourcing strategy? What are the consequences for the existing clients of both companies? What decisions were made regarding the outsourcing of functional areas? Establishing the timelines on fully integrating both strategies How will the new operational platform work in practice?Thomas Verish, Senior Director, Development Operations, Pfizer