Early-phase organizations typically start their clinical programs with a strong fundamental understanding of their technology, but frequently underestimate the duration and costs of clinical studies; the typical regulatory hurdles and review times associated with products in a given class; and the magnitude of the task of developing and implementing a manufacturing process for a commercial product. This is exacerbated by the FDA's propensity to change the rules in midstream.

A case in point is the recent FDA/CDER/Oncology Division change in requirements for Accelerated New Drug approvals. It may not be possible to anticipate all of these problems, but through experience and continual interaction with the relevant regulators, it is possible to identify the risks associated with a development strategy and to develop hedging options.

Another pivotal issue facing the management team is determining what activities to perform in-house versus what should be outsourced. As senior executives experienced in all phases of product development, Sierra MRC can contribute to and provide valuable independent assessment of business plans and organizational capabilities that can identify opportunities for efficiencies and significantly reduce unexpected delays in meeting critical milestones.