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This invitation-only event for senior pharmaceutical delegates will offer a facilitated boardroom-style discussion to brainstorm key issues in biomarker validation and implementation, with special emphasis on strategies to secure maximum returns from the investment in biomarker development.
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* Participation limited to senior managers at big pharmaceutical companies. There is no additional fee for participation in the Executive ThinkTank, but you must be a registered attendee for Protein Biomarkers 2004. All participants are subject to approval by conference organizers.
9:00-9:30 Executive ThinkTank Registration and Coffee
9:30-10:00 Biomarker Implementation in Drug Development
Discussion Facilitator: Dr. Scott D. Patterson, Director, Medical Sciences, Amgen Inc.
Discussion Questions Include:
• Discovery of new candidate biomarkers vs. validation of existing candidate biomarkers?
• Which assay platforms are ready for GLP/GLP-like analyses?
• Can the challenges of GLP/GLP-like be met for all assay formats?
• What synergies can be gained from transcript, protein and metabolite analyses?
• Pharmacodynamic biomarkers as opposed to diagnostics, how often will they overlap?
• Biomarkers as surrogate endpoints: how long does it take and who should do it?
• What is the shortest path to biomarker development, how late can one begin the process?
10:00-10:30 ROI on Biomarker Development
Discussion Facilitator: Dr. Stephen Williams, Executive Director and Worldwide
Head of Clinical Technology, Pfizer Global Research and Development
Discussion Questions Include:
• How can ROI be estimated and measured for biomarker R&D?
• When is it economic to develop biomarkers?
• What are acceptable tradeoffs against cost?
• When can/should costs and risks be shared with others?
• How should risk be managed in biomarker development?
• What issues can prevent full financial benefit of biomarkers from being realized?
10:30-11:00 Pharma/Biotech Alliances: Outsource vs. In-house
Discussion Facilitator: Dr. Mohan Bangalore, Manager, Biomarker Outsourcing,
Human Biomarker Center, GlaxoSmithKline
Discussion Questions Include:
• How to outsource strategically maintaining control and creativity?
• What to outsource and what to keep in-house?
• How to define and build strong outsourcing relationships with vendors?
• How to manage time and resources effectively in outsourcing?
• What are some early warning signals of trouble and how to troubleshoot?
• What is the role of sample/study logistics in outsourcing?
11:00-11:30 Open
Brainstorming
11:30-1:00 Networking Luncheon for ThinkTank Participants
