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
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:
- 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
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: