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