Decision Gates

of the product. Drug candidates that represent new targets for therapy while representing a hope for improved efficacy do require more interactions with regulators and investigators, adding to development expense. In addition, because the target is unproven, there is a greater relative risk for therapeutic failure compared to proven pharmacological targets of disease intervention. Therefore, when attempting to express the risks involved in developing a drug, it is important to understand the varying perspectives of each major group of stakeholders.

Before risk assessment can be fully appreciated in the context of decision making in drug development, it must be balanced with the perceived benefits of the product. For example, the patient and physician would tolerate a high level of risk to the patient if the potential benefits offered by a novel therapeutic are for a life-threatening disease for which there is no effective treatment. In a similar way, a high degree of business risk may be tolerated by investors in novel drug candidates if the return on investment, if successful, were very high. Like risk, benefits are also in the eye of the beholder.

Ideally, on many occasions during drug development, each stakeholder is asked to assess his or her view of risk versus benefit based on current data. This assessment will become part of the decision-making process that drives drug development in a logical and, hopefully, collaborative way. Effective decision making requires integrating these varying risk-benefit assessments in a balanced way. The decision gate approach is a useful way to integrate these needs into the drug development process.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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