Role Of Biomarkers In Discovery And Preclinical Development

guidance document [ 3]. Many companies start evolving a TPP even at the earliest go/no go decision gates of drug development. In this way, a common way of thinking is preserved throughout the life of the product. The development program plan is assembled by determining what studies need to be done and their design that would provide information critical to answering the key questions at each go/no go decision gate.

The value of a solid drug development plan based on a decision gate approach can be leveraged only if there is discipline in the decision-making process. What method will be used to make a decision: a majority vote of a committee or a single decider who is advised by others? Each stakeholder needs to understand clearly his or her role in making the decision at each gate. Is he or she a decider, a consultant, or just someone who needs to know what the decision is in order to do the job effectively? Go/no go decisions need to be made when all information required to answer the key questions is available. Go/no go decisions should not be revisited. If this occurs, there is either a lack of decision discipline or key information was missing when the original decision was made, representing a failure in planning.

Some go/no go decision gates require agreement to proceed by different groups of stakeholders. This is particularly true when the question "Is the drug candidate safe to give to humans?" is addressed. The sponsor must decide whether to file an investigational new drug (IND) application based on the data and information collected so far from animal tests and in vitro assays. The same data are also evaluated by the regulators (e.g., the FDA), who must have time (30 days) to object if they feel the safety of the subjects in the first few clinical trials will be compromised unduly. Finally, the data are reviewed again by the IRB, who look specifically at how safety will be evaluated and managed in the clinical trials and who represent the interests of the volunteers. It is as if the gate has three locks, each with a key owned by a separate entity which will decide independently whether they open their lock. One cannot pass through the gate until all three locks are open.

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Project Management Made Easy

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