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Fig. 4.12. Discovery & Development Decision Points need and high opportunity (medical and financial) markets. The scientific advances in understanding cell growth, both normal and abnormal as in cancer, have been legion over the last 10 plus years, along with the need for less toxic and more effective treatments. Patients living longer (chronic type disease) and the fatal nature of these diseases combine to drive companies to invest in cancer research. Infectious disease area is a constantly changing arena with new product needs, based on continued evolution of resistant organisms.

Given the cost and complexity of drug development, it is essential that processes be in place that allow for ongoing review, discussion, and then decisions (go-no go or more work is needed). An example of a sequential decision matrix is shown in Figure 4.12, where discovery and early development is broken into the essential studies and information needed to move forward. The studies are further divided to address four decision points for progression of the compound, focusing on, first, targets, second, lead candidate, third, animal pharmacology, and fourth, IND enabling, especially toxicology, studies. Thus, if selection fails to identify an appropriate target at stage one, the project may be terminated or alternatives to the existing process must be investigated.

Integral to the success of this process is the establishment of criteria needed to allow a determination of "success" at each step. Thus, it generally is not sufficient to have a lead candidate that simply has activity. Rather, in order to move a lead on to the next phase, its in vitro and in vivo activity must be above a predefined threshold that, with some degree of certainty, has a high probability of being efficacious in humans. As an aid to this process, many organizations create a brief, one-page document (viz., a product profile or specification sheet) that outlines many of the biological, clinical, and practical criteria that are deemed important for product success. As development progresses, the properties of the candidates are then compared to the sheet, which becomes a benchmark that allows researchers and management to gauge progress along the development path. If a compound fails to meet the desired specifications, either new compounds need to be identified or the criteria used to develop the sheet should be reevaluated. The criteria may have set hurdles too high given the science available. Many companies use external expert groups from academia and practice to create such spec sheets, avoiding internal group-think favoring internal compounds and achieving a better profile of acceptable properties and improved care of patients.

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