Table of Contents
Chapter 1. Introduction
- 1.1. Historical Perspective on Biomarkers in Pharma
- Terminology Recently Evolved
- A Shift in Emphasis
- 1.2. Current Status of Biomarkers in Pharma
- 1.3. Planning and Implementation Issues
- Strategic Planning Issues
- Tactical Planning Issues
- Organizational Considerations
- Business Considerations
- 1.4. Precommercial, Collaborative Biomarker Work
- The Biomarkers Consortium
- Consortium Projects
- European Union Consortium
- 1.5. Exploratory Investigational New Drug Applications and the Pipeline
Paradigm
Chapter 2 BIOMARKER STRATEGIC PLANNING
Biomarkers Can Serve Multiple Purposes
- 2.1. Planning for Biomarkers
- Variations among Therapeutic Areas
- 2.2. Biomarkers for Stages along the Pipeline
- Prediscovery
- Discovery
- Early Clinical Development
- Late-Stage Clinical Development
- Efficacy Biomarkers
- 2.3. Postmarketing
- 2.4. The Biomarker Strategic Plan
Chapter 3. BIOMARKER IMPLEMENTATION PLANNING
- 3.1. Biomarker Validation
- Pre-analytical Considerations
- Method Development
- Exploratory Method Validation
- Advanced Method Validation
- In-Study Validation
- 3.2. Industry Experts' Comments on Biomarker Guidelines, Standard
Operating Procedures, and Validation
- 3.3. In-House versus Outsourced Biomarker Identification and Method
Development
- The Biomarkers Consortium
- Example of Biomarker Implementation
Chapter 4. ORGANIZATIONAL ISSUES
- Translational Medicine
- Centralization vs. Decentralization
- 4.1. Explicit Model
- 4.2. Implicit Model
- 4.3. Hybrid Model
Chapter 5. THE BIOMARKER BUSINESS CASE
- 5.1. Comments on Business Analysis from Industry Experts
- Cost for One, Benefit for Another
Chapter 6. CASE STUDY IN BIOMARKER PLANNING AND IMPLEMENTATION
- 6.1. Biomarker Typology and Linkage to Outcome: Target, Mechanism, and
Outcome Biomarkers
- 6.2. Validation Typology
- 6.3. Stages in the Biomarker Life Cycle: Pathfinding, Research, and
Development
- 6.4. Business Considerations: Expense of Development vs. Cost of Wrong
Decision
- 6.5. Biomarker Best Practices: Optimize, Maximize, and Balance
- 6.6. Biomarker Validation
- 6.7. Minimally Acceptable Criteria
Chapter 7. RESULTS OF BIOMARKERS SURVEY
- Results and analysis of a Web survey conducted in October 2006
Chapter 8. OBSERVATIONS AND CONCLUSIONS
APPENDIX
- Interviews with Industry Experts
- Ernie Bush, PhD, Director New Initiatives, Cambridge Healthtech Associates
- Claudio Carini, MD, PhD, Vice President, Translational Medicine,
Development & Regulatory Services, MDS Pharma Services
- Cynthia Cheesman, Assistant Vice President, Preclinical Project
Management, Wyeth
- Nicholas Dracopoli, PhD, Vice President, Clinical Discovery Technologies,
Bristol-Myers Squibb
- Darrick Fu, MBA, Associate Vice President for Science and Regulatory
Affairs, PhRMA
- Orest Hurko, MD, Assistant Vice President, Translational Research, Wyeth
- David S. Lester, PhD, New York Site Head, Pfizer Human Health
Technologies, Global Clinical Technology-Pfizer Global Research and Development
- Terry Lindstrom, PhD, Distinguished Research Fellow; Drug Disposition,
Global Pharmacokinetics, and Toxicology, Eli Lilly & Co.
- Bruce H. Littman, MD, Global Head of Translational Medicine, Pfizer
- Michael Stocum, MS, Managing Director, Personalized Medicine Partners
- Stephen A. Williams, MD, PhD, Vice President and Worldwide Head of
Clinical Technology, Pfizer
References
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