Abstract
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:
- A survey of 33 senior managers involved in biomarker discovery,
development, and application at pharmaceutical and biotech companies. The
survey reveals in easy-to-scan charts their practices, plans and views about
various aspects of biomarker planning and implementation.
- An analysis of 3 basic organizational models for pursuing biomarkers: The
Explicit Model, the Implicit Model, and the Hybrid Model. The report
illustrates each model with detailed examples from industry.
- The decision process for developing biomarkers in-house or through
outsourcing, with examples and case studies from industry.
- A full examination of each element in a tactical biomarker plan,
including: the means for biomarker acquisition (if possible), biomarker
discovery (if necessary), method development, and biomarker validation. In
particular, the report describes the "fit-for-purpose" concept of biomarker
validation.
- 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.
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