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Health Network Communications, London
8-11 February 2011
Pre-conference workshop - Tuesday 8 February 2011
9am Registration and coffee
9.30am Introduction to the day and workshop leader Sanjiv Kanwar,Managing Director, Polaris BioPharma Consulting Ltd
9.35am Trends in clinical outsourcing in Asia • What is pushing pharma to invest in Asia? • Why is Asia now such an attractive location? • Key trends in clinical outsourcing to this region • Players in the region: niche vs domestic vs multinational companies conducting - sponsors vs service providers • Asia in clinical trials strategies more and more, who is active in the region? • Overview of the outsourcing industry to this region: how is this changing?
Benefits and challenges of outsourcing in Asia • What are the direct benefits of running clinical trials in Asia and what challenges does the region bring?
11.05am Morning refreshments
11.35am Regional review • Focus on India - regulatory setting, cultural values, operational considerations and regional processes • Malaysia • Thailand
1.05pm Lunch
2.05pm Regional review • Philippines • Sri Lanka • South Korea • Taiwan
2.35pm Panel discussion and delegate Q&A
3.05pm Close of workshop and afternoon refreshments
Day One - Wednesday 9 February 2011
8am Registration & refreshments
CLINICAL OUTSOURCING INDUSTRY DRIVERS AND SOLUTIONS
9am Chair’s opening discussion: challenges and oportunities facing clinical outsourcing industry today • The changing structure of pharma and biotech companies • Including "value" in addition to "efficacy and safety" in clinicaltrials • The impact of personalised medicine on clinical trial protocols • The rapidly changing geography of pharmaceutical marketsand its implication for location of clinical trials • Audience feedback: what challenges do you face in yourclinical outsourcing today? Professor Trevor M Jones CBE,Former Director-General of the ABPI, ABPI
9.30am KEY NOTE: Driving breakthrough results in challenging times • Our goal in drug development is to develop innovative new medicines that improve the quality and safe lives of patients. The industry faces unprecedented challenges including resource constraints and productivity improvements • How can we working with our strategic partners deliver against these challenges in such a way that we fundamentally transform the way we work? What does it take to do this successfully and how easy will it be for us to make this both best and common practice? • Using real examples of transformation in ways of working, the key ingredients for achieving some breakthrough results will be explored Paula Gildert,Head Strategic Sourcing Development, Novartis Pharma AG
10am Why strategic clinical trial outsourcing yields good medicine • Reliable delivery with quality, on time and on budget through strategic sourcing partnerships • Deliverables based - functional sourcing vs. project sourcing • CROs must be a partner not a vendor....a big paradigm change • What has worked in the past won't work in the future Jeffrey Kasher,Vice President and COO Global Clinical Development, Eli Lilly and Company
10.30am Speed Networking followed by morning refreshments
11.45am Strategic resourcing models: blending outsourcing, in sourcing and FTE • Different resourcing options and their main characters • What are the main drivers of the "blended" resourcing strategy • Advantages and disadvantages of the "blended" resourcing strategy Pasi Piitulainen,Senior Director Business and Science Affairs, Actelion Pharmaceuticals Ltd.
12pm Panel Session: What are the challenges of outsourcing faced by small/midsized manufacturers and what can be learnt from big pharma? Dr Wolfgang Eglmeier,Head Clinical Operations Germany, Grünenthal GmbH Deborah Profit,MS, Associate Director - Alliance Managment, Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization
1pmLunch
Day One - STREAM 1: CLINICAL OUTSOURCING IN THE GLOBAL ENVIRONMENT
2pm Opening remarks from chair
2.10pmConsiderations for ensuring effective management of a multinational outsourcing project • How to start building bridges between the in-house and CRO teams already in the contract negotiation phaseUnderstanding the cultural differences and their impact in the contractsMitigating possible problems in conducting a multinational project by preparing the contract well Anne Maria Ylisaari,Head of In and Outsourcing, Orion Pharma
2.40pm Advantages, risks and key factors in conducting successful clinical trials in Latin America • General and clinical research information on Latin AmericaThe regulatory environmentRecommendations Dr Silvio Klimovsky,Head of Clinical Research Argentina and Uruguay, Pfizer
3.10pm Afternoon break
3.40pm Clinical trial outsourcing landscape & development in Asia • Rapid changes of the clinical trial outsourcing environment in China & Asia-Pacific Regulatory environment, processes and requirements for outsourcing clinical trials to the region James Tsui,Contracts & Outsourcing Manager, Roche Product Development in Asia and Pacific
4.10pm Recruiting trained CRAs and investigators in a competitive Indian market · Finding the most qualified professionals as the number of trials increase · Setting the criteria for staff recruitment to ensure appropriate levels of experience and expertise · Working with clinical trial training institutes to supply qualified professionals · Staff retention in the face of intense competition between trial sponsors · Making the most of the professionalisation in the industry to reduce trial errors · The long term clinical trial strategy for emerging countries Anish Desai,Medical Director, Bayer HealthCare, Bayer Schering Pharma India
4.40pm Panel Session: What are the strengths and weaknesses of using locally based CROs in a region specific project? Lan Bandara, Associate Director, Global Head Clinical Outsourcing, Eisai Product Creation Systems, Eisai Limited David Kim, Head, Vendor Strategy & Management, Merck Ltd
5.10pm Evening drinks reception
Day One - STREAM 2: OPERATIONAL FACTORS IN CLINICAL OUTSOURCING
2pm Opening remarks from chair
2.10pm Optimization of the sponsor provider relationship by employing a highly effective lessons learned process · Understand the key characteristics of high performing sponsor-provider teams · Identification of the factors that enhance team performance · Implementation of a lessons learned process to maximize team performance Dr Larry Blankstein,Senior Director of Clinical Research, Genzyme
2.40pm Are you managing your contract staff efficiently? It is estimated that 90% of companies currently utilize contract staffing services. Managing employees to their full potential is a constant challenge, in today’s organizations managers must effectively manage internal employees along with contract staff. It is more and more important for organizations to incorporate contract staff with internal staff to meet study deadlines. How can contract staff performance be optimized? Resource Planning Recruit contract staff which compliment existing staff Utilize your staffing provider to manage the contract employees Reduce staff turnover Determine Performance Metrics Create a clear governance structure, to assure responsibilities and avoid co-employment issues Sabine Hutchison,Vice President, Global Business Development Clinical & Medical, DOCS International
3.10pm Afternoon break
3.40pm Panel Session: What are the major operational challenges faced in clinical outsourcing Panelists include a selection of the days speakers
4.10pm Operational excellence in outsourced early clinical development • Selecting the right model and right partnerChoosing and implementing the right governance processQuality risk management – measuring performance Dr Isobel Lakatos,Senior Clinical Research and Exploratory Development Operations Leader, F. Hoffmann-La Roche AG
4.40pm Clinical outsourcing in late phase research - obstacles and pitfalls · Current trends in late phase outsourcing · Differencies to earlier phases and managing changing mutual expectations · Proper planning and overcoming obstacles Dr Wolfgang Eglmeier,Head Clinical Operations Germany, Grünenthal GmbH
5.10pm Evening drinks reception
Day Two - Thursday 10 February 2011
8am Refreshments
9am Opening remarks from the chair
9.15am The pharma industry is undergoing extensive changes with M&A, streamlining of departments and changing working strategies. What role is outsourcing playing in the current environment?
STRATEGIC RELATIONSHIPS
9.45am Outsourcing through the FSP model: one year post implementation • General on the model chosen • Governance • Managing deliverables and Metrics • Quality oversight Dr Elspeth Carnan,Executive Director Head Global Clinical Site Management, Global Development Operations, Amgen
10.15am Case Study: A sponsor and CRO collaboration: building from ground zero • Establishing a collaboration - executive and operational • considerations • Creating effective communication - implementing tactics that reach • all levels of the collaboration • Building work streams that provide for streamlined and efficient • processes • Balancing partnering and regulatory oversight • Change management activities/planning Deborah Profit,MS, Associate Director - Alliance Managment, Global Clinical Development, Otsuka Pharmaceutical Development & CommercializationKaren Graham,Senior Director, Alliance Management, Covance Inc.
10.45am Strategic partnerships: the key to success in clinical outsourcing • The role of strategic partnerships in driving productivity and cost-effectiveness • Benefits of a strategic partnership over a more traditional buy/ sell model • Challenges in achieving this • Are strategic partnerships now common place or do we have further to go? Yvonne Ulrich,Head of Operations, Development Strategic Sourcing, Novartis Meryl Wiernik,Director, Global Strategic Outsourcing Management, Teva Branded Pharmaceuticals R&D, Inc
11.15am Morning refreshments
REAL WORLD CASE STUDY SESSION
11.45am Case Study: A true operational risk sharing strategic partnership with CROs • The internal drivers for change • How to share operational risk in a win win way (risk and benefits) • The change management challenge on the way to success Yariv Hefez, Global Alliance Management, Business Development, Merck Serono
12.15pm Case Study: Pre-commercial outsourcing strategies: a case study of a vaccine project • Quicker to clinic is key, without sacrificing quality! We have recently concluded a major vaccine contract at a CMO, producing Phase III clinical supplies and successfully completing process validation. • We will recount the selection process for the CMO • the negotiations for Service and Quality Agreements • the complex technology transfer process for production processes and analytical test methods – what worked and what did not work – and why. Firelli Alonso-Caplen,Senior Director Biotherapeutics & Vaccines Outsourcing, Pfizer Inc
12.45pm Lunch
1.45pm Utilising technologies in clinical outsourcing • An overview of Bayer HealthCare's recent experience of applying technology to the outsourcing process. • Lessons learnt during on-line outsourcing workflow tool development, and eRFI / eRFP testing. • Application of technology in support of Supplier Relationship Management requirements (performance assessment tools, information exchange e-rooms etc). • Using technology to link study budget and assumption forecasting with supplier selection and actual performance. David Mantell,Regional Head (UK), Global Strategic Sourcing, Bayer PLC
2.15pm Relationship/performance metrics: how can we effectively measure the success of a partnership? Jennifer Holmes,Global Sourcing Relationship Manager, Medical Operations Global Medical Research and Development, Eli Lilly and Company
2.45pmKEY NOTE: Building the trust: high level partnering and governance• Developing a strategic partnership – when and how • Defining business responsibilities and purview -- range of authority and oversight Kathleen Dietz,Manager, Clinical Research Outsourcing, Cordis Corporation, a Johnson & Johnson Company
PROJECT MANAGEMENT FOR OUTSOURCED CLINICAL TRIALS
3.15pm Is our project management world class? In this live (and potentially lively) panel debate, a selection of experts will answer questions from the audience; this session will be facilitated by project and programme experts, with a wide cross section of experience in many industry sectors. • How does does the pharma sector benchmark itself, in project management? • Are there lessons to be learned from other business sectors? • How do we train, develop and support project managers in the industry? Steven Carver,Project Management Specialist and Lecturer, Cranfield University Trish Thurley,Partner, ALS Consultants John Gate, European Procurement Executive, Eli Lilly Klas Andersson, Global Alliance Project Manager, AstraZeneca Sabine Hutchison, Vice President, Global Business Development Clinical & Medical, DOCS International
4.15pm Closing remarks from the chair
4.25pm End of conference and afternoon refreshments
Post-conference workshop - Friday 11 February 2011
8.30am Registration and coffee9amIntroduction to the day and workshop leader Roger Joby,Managing Director and Senior Consultant, R. & N.R. Consulting Limited
9.05am Project uncertainty – an overview of project uncertainty and the importance of sharing knowledge and taking a joint approach to risk analysis • Knowledge • Untapped Knowledge • Risk: a brief overview of Project Risk Analysis and Management (PRAM) - Interactive session on Risk identification and Management - Demonstration of risk and Issue logs • Uncertainty
10.35am Morning refreshments
11.05amThe planning process • Why – The business case • What - Defining project success, scope of work, key performance indicators and metrics – Stakeholder satisfaction • How – Project strategy • How much – Project budget • When – Timelines • Where - Location
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Organized by:
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Health Network Communications |
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Invited Speakers:
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Senior Director Biotherapeutics & Vaccines Outsourcing, Pfizer Inc Global Alliance Project Manager, AstraZeneca Associate Director, Global Head Clinical Outsourcing, Eisai Product Creation Systems, Eisai Limited Senior Director of Clinical Research, Genzyme Executive Director Head Global Clinical Site Management, Global Development Operations, Amgen Project Management Specialist and Lecturer, Cranfield University Medical Director, Bayer HealthCare, Bayer Schering Pharma India Manager, Clinical Research Outsourcing, Cordis Corporation, a Johnson & Johnson Company Head Clinical Operations Germany, Grünenthal GmbH European Procurement Executive, Eli Lilly Head Strategic Sourcing Development, Novartis Pharma AG » Karen Graham, Senior Director, Alliance Management, Covance Inc. Global Sourcing Relationship Manager, Medical Operations Global Medical Research and Development, Eli Lilly and Company Vice President, Global Business Development Clinical & Medical, DOCS International Managing Director and Senior Consultant, R. & N.R. Consulting Limited Former Director-General of the ABPI, ABPI Managing Director, Polaris BioPharma Consulting Ltd Vice President and COO Global Clinical Development, Eli Lilly and Company » David Kim, Head, Vendor Strategy & Management, Merck Ltd Head of Clinical Research Argentina and Uruguay, Pfizer Senior Clinical Research and Exploratory Development Operations Leader, F. Hoffmann-La Roche AG Regional Head (UK), Global Strategic Sourcing, Bayer PLC Senior Director Business and Science Affairs, Actelion Pharmaceuticals Ltd. MS, Associate Director - Alliance Managment, Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization » James Tsui, Contracts & Outsourcing Manager, Roche Product Development in Asia and Pacific Head of Operations, Development Strategic Sourcing, Novartis Director, Global Strategic Outsourcing Management, Teva Branded Pharmaceuticals R&D, Inc Head of In and Outsourcing, Orion Pharma
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Deadline for Abstracts:
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N/A
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Registration:
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Register online at: https://secure.terrapinn.com/V5/rCalc.aspx?E=3892 or call Sabrina on +44 (0)207 608 7055
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E-mail:
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skhamissa@healthnetworkcommunications.com
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