Gold dimensions of pharmaceutical drug development indicate that it takes on average 11.9 years, with an investment around US$ 0.8 Billion, to launch one product on the market. Furthermore, approximately 22% of the drug candidates successfully complete clinical testing. These universally acknowledged proportions largely originate from one single, much cited publication; Dimasi et al. . However an additional six articles describing new chemical entities (NCE) development were identified, which contain little, if any, information on vaccines. Published cumulative success rates range from 7% to 78% and investments calculations span US$ 0.8 to 1.7 Billion. Obviously this disserves further clarification?
"observed that resources consumed during R&D do not result in the anticipated number of product launches . One aspect of this phenomenon is the success rate: the probability a candidate will successfully transition through the value chain phases . When taking pre-clinical development as a starting point, approximately 6% of the vaccine candidates reach regulatory approval (unpublished work). 2 By comparison, inter-pandemic influenza vaccines are considered lucrative, attaining an estimated 10% success rate (unpublished work). "
[Show abstract][Hide abstract] ABSTRACT: As infectious diseases cause approximately 25% of the annual global mortality, vaccines are found to be a time proven and promising response to infectious disease need. However, like for pharmaceutical small molecules, vaccine development is lengthy, risky and resource demanding. Faced with an attrition rate estimated around 80%, key opinion leaders were interviewed with the question: is there a recipe for success?
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