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Reportlinker Adds Biomarker SOPs: Getting Optimum Value from Your Biomarker Programs

Tuesday, October 27, 2009 General News J E 4
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NEW YORK, Oct. 26 Reportlinker.com announces that a new market research report is available in its catalogue.

Reportlinker Adds Biomarker SOPs: Getting Optimum Value from Your Biomarker Programs

http://www.reportlinker.com/p0156600/Reportlinker-Adds-Biomarker-SOPs-Getting-Optimum-Value-from-Your-Biomarker-Programs.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=prnewswire

As biomarkers have grown in importance throughout the pharma R&D cycle, managers have moved from informal, intuitive ways of dealing with biomarker discovery and implementation to more formal procedures. In all pharmaceutical companies, standard operating procedures (SOPs) for planning, implementing, and employing biomarkers remain a work in progress, continually evolving as still-scarce outcomes data from biomarker-driven programs becomes available.

Based on extensive interviews with senior managers and thought leaders, Biomarker SOPs: Getting Optimum Value from Your Biomarker Programs addresses four primary elements in planning and deploying biomarkers:

For instance, strategic planning for biomarkers attempts to address issues such as whether a clinical measurement will suffice, whether an existing validated biomarker can do the job, or whether a biomarker must be discovered and a method for its measurement must be developed and validated. Although big pharma companies differ in the methods and timing for biomarker strategic planning, they generally start planning very early in the discovery process. In some cases, planning and implementation for efficacy-related biomarkers begin before a final disease target has been determined. Since getting a new biomarker on-line can take a year or more, planning for biomarkers to be used in early development needs to begin as soon as strategic issues can be clarified.

Biomarker SOPs: Getting Optimum Value from Your Biomarker Programs delivers the following value-added insight and analysis into biomarker planning:

When biomarker timelines and costs start to mount, some level of business analysis can be beneficial. This can take the form of ROI analysis, cost/risk-vs-benefit analysis, or both. Pfizer is one of the few pharma companies to provide its project teams with a formal software tool for ROI analysis and to encourage its use. This and other biomarker-related efforts under way at Pfizer are presented in a compelling case study of how one big pharma entity is attempting to implement biomarker SOPs.

Biomarkers have moved beyond being used merely to assuage scientific curiosity. They are increasingly being used to answer specific questions that provide critical decision-support data as a compound moves down the pipeline and soaks up more and more R&D dollars. Thus, biomarkers are being used to measure clinical response to a drug, to quantify drug-target interactions, to demonstrate the relevance of a molecule to the pathophysiology of a particular disease, and as safety indicators that can identify subjects who might react adversely to a drug. The rising importance of biomarkers underscores the need for ways to rationally plan for their use. Biomarker SOPs: Getting Optimum Value from Your Biomarker Programs is a must-read for managers charged with making biomarkers pay off for their company.

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

To order this report:

Reportlinker Adds Biomarker SOPs: Getting Optimum Value from Your Biomarker Programs

http://www.reportlinker.com/p0156600/Reportlinker-Adds-Biomarker-SOPs-Getting-Optimum-Value-from-Your-Biomarker-Programs.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=prnewswire

More market research reports here!

-- Strategic planning for biomarkers in discovery and development -- Tactical planning for the implementation of biomarkers in R&D programs -- Organizational structures for biomarker implementation -- Approaches to risk/cost-benefit analysis of biomarker programs

SOURCE Reportlinker
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