Cognitive engineering - The tools, mindset, and strategy for an integrated development standard

In an attempt to address the various challenges of modern drug development, pharmaceutical and biotechnology companies have embraced new technologies and methodologies. But while Internet technology facilitates connectedness it often fails to foster collaboration. And while advanced modeling techniques can provide insight for development discussions, too often, these techniques fail to generate the knowledge required for real-time decision-making. Cognitive engineering fuses human expertise and creativity with technology and provides the strategy for maximizing human, company, and product potential to address these deficiencies. Cognitive engineering is based on a classic model of strategic decision-making - the OODA loop (observe, orient, decide, act). The power of the OODA loop exists in its conversion of information to knowledge, and the communication of that knowledge, in real time, to a global team at key milestones when flexibility still exists to rationally adjust or change course. The successful implementation of cognitive engineering has three critical components: aggressive data management and assembly processes; innovative data analysis, modeling and simulation strategies; and capability to engage globally dispersed teams in the use of knowledge. Cognitive engineering requires individuals to function at a demanding and creative level. However, the use of generated knowledge often challenges pre-conceived notions of the desirable dosing and development strategy and the collective bias that may exist as to whether a target product profile is being met. Failure to generate, critically evaluate, and utilize knowledge at critical milestones can result in lost opportunities.