Biomarker SOPs: Getting Optimum Value from Your Biomarker Programs
Ken Rubenstein, PhD
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
Company Index with Web Sites