Enrico Polastro, Arthur D. Little01.22.14
The pharmaceutical product creation process — defined as covering the discovery up to the commercial scale supply of a NTE (New Therapeutic Entity) — is one of the most complex endeavors undertaken by man. It involves the daunting task of effectively conducting — either in parallel or sequentially — and combining in a seamless way a large number of modules requiring a diverse set of activities and steps.
A major complicating factor and challenge is represented by the extremely diverse array of skills and bodies of competences required to perform these tasks — some at the leading edge of science while others are fairly routine. The execution of these various tasks is handled by different people, most often organized in distinct departments. This multiplies the number of interfaces and hand-over steps, bringing a corollary risk of delays and recycling.
Additional issues are associated with the long timelines for development, spanning several years, and the massive resources (be they financial or in human talent), regulatory and ethical requirements intrinsic to the pharma industry that contribute extra layers of complexity
A major complicating factor and challenge is represented by the extremely diverse array of skills and bodies of competences required to perform these tasks — some at the leading edge of science while others are fairly routine. The execution of these various tasks is handled by different people, most often organized in distinct departments. This multiplies the number of interfaces and hand-over steps, bringing a corollary risk of delays and recycling.
Additional issues are associated with the long timelines for development, spanning several years, and the massive resources (be they financial or in human talent), regulatory and ethical requirements intrinsic to the pharma industry that contribute extra layers of complexity
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