Day Two – Wednesday 8th February 2012

last modified: 13 February '12

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9am

Opening Remarks from the Chair

Mr Trevor Jones

Professor Jones is a Director of Allergan Inc (USA) and R&D Director of Sigma-Tau S.p.A (Italy).He is Chairman of the UK stem cell biotech company ReNeuron plc , the International CRO Synexus Ltd, a member of the Boards of NextPharma Technologies ...

› Mr Trevor Jones, Former Director-General, ABPI

OUTSOURCING: WHAT CAN PHARMA LEARN FROM OTHER INDUSTRIES?

9.10am

Out of Industry Perspective: How IT Organizations Leverage Outsourcing to Drive Value

Cathy Forsyth at Clinical Outsourcing World Europe

› Cathy Forsyth, EVP, Consulting Services, Telwares

CLINICAL OUTSOURCING: BEST PRACTICE

9.40am

The need for change: developing a logical, global sourcing strategy

Lee Scheible

Lee Scheible, Sourcing Consultant, has been at Eli Lilly for 25 years of which 9 years were spent in the Lilly Research Laboratories focusing on various microbiological and then analytical chemistry projects. He then moved his focus to a clinical...

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• Why is a global sourcing strategy needed in these changing times
• Current clinical research trends
• Critical trial and vendor capability criteria
• Logical sourcing strategy format
• Proactive model for vendor-sponsor-site interactions
• Vendor value model

› Lee Scheible, Sourcing Consultant, Eli Lilly & Company

10.10am

Morning Refreshments

CLINICAL OUTSOURCING IN THE GLOBAL ENVIRONMENT

10.40am

New integrated CRO model for managing trials in Asia

Donald Russell

I currently have operational accountability for all clinical research conducted for Eli Lilly and Company within Latin America, India, Russia, Turkey, Africa, the Middle East, Asia and Australia. This included the strategic placement of trials and...

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• Challenges and opportunities in Asian clinical trials
• Outline/ overview of CRO model used
• Results to date

› Donald Russell, Senior Director, International Clinical Operations, Eli Lilly & Company

11.10am

Case study: The risks/opportunities of conducting trials in Latin America

Eduardo Motti

Graduated in Medicine from the University of Sao Paulo - Brazil, and specialized in Infectious Diseases. After working in academia, joined the pharmaceutical industry at Merck Sharp Dohme in Brazil in 1984, first in Medical Marketing, then in...

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› Eduardo Motti, Regional Head of Clinical Operations, Pfizer

11.40am

Case study: Clinical outsourcing in Japan

Ian Hodgson

Ian has 11 years experience in drug development during in which time he has worked for the UK Government, CROs and Pharmaceutical companies. His varied career includes positions such as laboratory scientist, CRA, Project Manager and Clinical...

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• Challenges faced by international pharma seeking to run studies in Japan
• Effective project management

› Ian Hodgson, Associate Director Clinical Programs, Shire Pharmaceuticals

12.40pm

Lunch

1.10pm

Approaches to Outsourcing for Clinical Testing Laboratories in Vaccine Immunology

Dr Roderick Cameron

Roderick Cameron is an Outsourcing professional who has served in the pharmaceutical and vaccines industry for over 10 years. Currently, he is Deputy Director of Outsourcing for Global Clinical Immunology group at Sanofi Pasteur. He manages a group...

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Discuss the background of clinical immunology testing
How to manage outsourcing to Key Opinion Leader's vs. Commercial Laboratories
Managing the quality standards in clinical immunology - GCLP

› Dr Roderick Cameron, Deputy Director GCI External Testing, Sanofi Pasteur

1.40pm

Is it possible for vendors and sponsors to work together to get perfect results every time?

Kathleen Dietz

Ms. Dietz is the category lead for R&D Clinical Research across the Johnson & Johnson Medical Device & Diagnostics (MD&D) sector. Her responsibilities include identifying and selecting preferred providers, developing outsourcing and functional...

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• Is it possible to work together effectively to meet targets, ensure quality, and make sure things are done within time constraints?
• What does it really mean to have a good working relationship between sponsors and CROs?