Exploratory Product Development Brief (EPDB) for Drug substance and Drug product

Exploratory Product Development Brief (EPDB) for Drug substance and Drug product

1. Exploratory Product Development Brief (EPDB) for Drug substance and Drug product

2. EPDB • Many companies are finding themselves in an environment that is uncertain, fast-changing and increasingly complex.  • In this kind of environment, where much is unknown and evolving, the traditional product development approach cannot reliably identify new kinds of risk . • It is not possible to completely define a product before starting development .  • When companies try to maintain a traditional phased- and-gated process in a changing environment, the product development team is unable to manage to the scope, timeline and budget approved at the outset.

3. EPDB • The result usually includes changing product requirements, unexpected problems, rework, schedule delays, breaking the budget and commercial failure. • The product development team needs an approach that allows them to adapt to change in customer needs, markets, competition, technology and more .

4. EPDB EPDB proposes a new approach to developing products, using a two-pronged solution : 1.treating product development from a comprehensive systems perspective, and 2. fundamentally redesigning the development process based on reducing project uncertainties and risk.

5. EPDB EPDB differs from the traditional phased and gated process in its fundamental redesign of the development process to reduce uncertainties and risks.   It is an adaptive approach that responds quickly to changes in internal and external factors . This process helps project teams identify, evaluate, and prioritize uncertainties and risks throughout a project .  It then helps the team determine how and when to resolve the uncertainty or when it is appropriate to kill a project.