Registration phase, preclinical development

The Integrated Preclinical Development Plans The total time, materials and costs associated with preclinical support for phase 1 through registration are summarized in Table 7.7 and the integrated preclinical support to clinical development is illustrated in Figure 7.5. 

The most risk-filled phase of preclinical development, especially for a biologic, is that associated with the support to phase 3, which should be completed prior to the end of phase 2. Support to phase 3 is the most critical portion of preclinical development, as these are the pivotal studies that, with the carcinogenicity studies run concurrently with phase 3, will support registration. It is therefore essential that the material used to support phase 3 is representative of final product intended for use in humans. 

The success of a project during and for the entire development process can be estimated by the numbers of projects that make it until the next development phase and finally end up as a commercial product. On the basis of data for products developed during the preceding decades until 1994, one must assume that only 50% of the preclinical vaccine development projects enter the clinical phase and another 50% is abandoned during the clinical trials. Having passed all preceding hurdles, product registration seemed to be uncritical, as only a loss of one out of 100 vaccine projects was noted. 

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