Regulatory dossiers contain Quality, Non-clinical and Clinical data and information, along with Regional administrative information, as illustrated in Figure 1.  Platform technologies, by definition, are reproducible from one product to the next and the potential for re-use of data and information, or prior knowledge, to support those technologies is significant. 

Figure 1:  ICH Common Technical Document Triangle 

 A cross-functional review of the information typically contained in the dossier, as recommended by ICH M4, was completed within CEPI to identify prior knowledge that could be leveraged and it is summarized Table 1.  The degree to which the prior knowledge could be leveraged would depend on the degree of similarity between the processes, specifications, equipment and Quality Management Systems used in manufacture.  The more similar they are, the more could be leveraged.  Use of this prior knowledge could shave months to years from a product development timeline, as many lengthy equipment or assay qualification and validation activities may be considered complete or mostly complete, with only confirmation testing needed in support of the dossier Quality section.   

Similarly, prior knowledge about pharmacology and toxicology could drastically reduce or eliminate the need for additional data when a single platform is used and only minor changes are made.  Likewise, Clinical Pharmacology, Safety and Efficacy data from one product manufactured using a platform may increase confidence in other products manufactured using that platform. 

This is not to say that additional Quality, Non-clinical and Clinical testing will not be needed, it is more to advocate for use of the prior knowledge to support new products on a platform and the idea that the more data and information that exist that show consistency in a platform, the lower the risk of development. 

 Table 1:  Examples of Prior Knowledge that May be Leveraged to Support Use of Platforms