Length 
166 pages 

Date published 
January 2007 

Additional info 
Single-site, country, and global licenses are multi-user, searchable, and cut-and-paste ready PDFs delivered by e-mail.

For Corporate Subscriptions, Multi-Reports Orders, Discounts or Order Questions.  

Contact:
Kerri Kelley
Customer Service
781-972-1347 



Biomarker SOPs Table of Contents

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