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The founders and Premier Experts of NDA Partners have formulated a set of five general principles that provide guidance in the construction of a Product Development Plan and the subsequent updates required to keep the plan current as learning occurs. Our Principles of Optimal Product Development form the basis for defining a decision-based operational model, identifying and quantifying the critical information required at each major decision point, projecting the probabilities of various outcomes, and informing key stakeholders (management, board and investors) with clear and concise status information needed for effective oversight.
The Principles are applicable to all medicinal product development programs regardless of technology, therapeutic area or indication and can be applied to the development of devices and diagnostics as well. However, not all Principles are fully applicable to all product development programs, nor are they applied in precisely the same manner and to the same extent from program to program. Consequently, their use must be guided by individuals with adequate experience and judgment to adapt these principles to the specific needs of each program and who understand how to interpret study results and make mid-course corrections based upon accumulating data.
The Principles are the foundation of NDA Partners' System
for Optimal Product Development. Each Principle has corollaries that provide
more specific guidance and help keep the product development effort focused on
the critical success factors and key data needed to support major decisions. In
addition to the Principles, the System is composed of guidelines and tools that
help development organizations establish world-class standards and procedures.
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