Rational Selection

Stage-Gates

Together with experts throughout the world, Aeras has established comprehensive, measurable and globally acceptable criteria for selecting, assessing and advancing the best vaccine candidates in the pipeline. These “stage-gate” criteria at each phase of the R&D lifecycle provide a data-driven framework that maximizes the chances of developing new vaccines to prevent TB. The criteria are based on the novelty of the scientific approach; phase of development; and data showing whether the product is technically feasible, safe and effective against TB.

Target Product Profiles

Aeras and our partners have developed target product profiles (TPPs) for each vaccine candidate in the product pipeline to maximize the public health impact and serve as a guidepost on whether or not to move forward with a candidate. The TPP criteria could include the target population, specific number of doses, a certain percentage of efficacy and a clear safety profile. If the candidate does not meet these criteria - for example, if it is determined to be ineffective in the target population or if it requires more doses than were predetermined in the TPP - then it will not move forward into later stage trials.