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Clinical Outsourcing World Europe 2011

 
  October 21, 2010  
     
 
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

 
 
Organized by: Health Network Communications
Invited Speakers:
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
Partner, ALS Consultants
» 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
 
Deadline for Abstracts: N/A
 
Registration:

Register online at: https://secure.terrapinn.com/V5/rCalc.aspx?E=3892 or call Sabrina on +44 (0)207 608 7055

E-mail: skhamissa@healthnetworkcommunications.com
 
   
 
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