chapter  13
10 Pages

Clinical Operations: Business Principles for Biomarker Applications

Providing effective operational support for the application of established and

novel biomarkers across all phases of drug development and commercialization

is resource intensive, logistically and technically daunting, and, increasingly, a

critical success factor for timely regulatory approval and speed to market.

Understanding the business principles that underpin successful clinical

operations units allows pharmaceutical sponsors to address these challenges

and build a competitive advantage. They include standards or attributes of an

ideal biomarker database that are required to support claims of efficacy and safety

and facilitate successful commercialization. Additional principles include

effective sourcing strategies for determining the testing mode (central vs.

local), selecting competent service providers, and developing business partner-

ships that are tailored to the needs of a sponsor’s organization and portfolio.

Finally, as with all areas of pharmaceutical research and development (R&D),

organizational effectiveness is critical to the successful execution of biomarker