Day one- stream two: KEY OPERATIONAL CHALLENGES IN CLINICAL OUTSOURCING

last modified: 13 February '12

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2pm

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

2.10pm

New Horizons for Pharma, the Innovative Approach to Outsourcing

Judith Zwickel

Judith Zwickel, has 15+ years of experience in the clinical trials industry. Judith joined Teva Pharmaceuticals Ind. in 2003 and is the Global Strategic Outsourcing Manager at Teva's Global Innovative Research and Development. She previously also...

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› Judith Zwickel, Global Strategic Outsourcing Management, Teva Pharmaceuticals

2.40pm

Tracking budgets and budget control

Pasi Piitulainen

Pasi is working in Global Clinical Development Affairs at Actelion overseeing the Actelion’s clinical development finances globally. In his role Pasi believes that by implementing a clear outsourcing strategy by using different outsourcing models...

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• Different controlling methods
• Understanding the CRO contract
• Is automating the tracking and controlling an option?
• Example of an automated controlling tool

› Pasi Piitulainen, Senior Director, Business & Science Affairs, Actelion Pharmaceuticals Ltd

3.10pm

Successfully Managing the Proposal, Negotiation, and Contract Process – A Gilead International Case Study

Tarminder Bains

Tarminder Bains joined the pharmaceutical industry and outsourcing team at Glaxo Wellcome (GW) in 1999. Post merger under GlaxoSmithkline (GSK), he moved from a role of insourcing resources to outsourcing clinical services for development...

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• Developing Outsourcing Model
• Contracting Process
• CRO Costing Models and what they mean
• Dealing with Change Orders

› Tarminder Bains, Manager Clinical Contracts and finance, Gilead Sciences

3.40pm

Afternoon refreshments

4.10pm

Panel Session: Vendor selection process Is it Better to Rely on One Full Service CRO or Use Multiple Niche CROs?

Peter Clompen

As Global Clinical Outsourcing Manager at Actelion Pharmaceuticals, based in Basel Switzerland, Peter is part of a small team that is responsible for strategic and tactical support of outsourced services for all phase II and III studies across the...

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