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02406 DETERMINING THE COST: GETTING TO PROOF OF CONCEPT Lamphear, Trisha The objectives of this research are to: (1) Ascertain the costs for taking a single microbicide candidate to proof of concept; (2) Determine the costs of advancing all microbicide candidates in the pipeline to proof of concept. Methods: The number of microbicides in the current pipeline was taken from the Microbicide Research and Development Database (MRDD). Developers with candidate microbicides were contacted to collect data on their calculations of the costs of imminent, planned, and projected clinical trials. We then obtained illustrative numbers for the minimal pre-clinical requirements for IND submission, which were then used to construct two profiles. The first profile is an estimate based on the average costs for pre-clinical and clinical phases to ascertain the cost of taking a single microbicide to proof of concept. The second profile is an estimate for moving all microbicide candidates in the pipeline to proof of concept. As there is no adequate basis for determining fallout, all candidates were assumed to advance and it was also assumed that each candidate would fulfil minimal pre-clinical and early clinical requirements and one trial in each of phases 2 and 3. Results: Results of these analyses are being cleaned and will be provided as the conclusions of this abstract. Implications: A major challenge for microbicide research and development is identifying and securing sufficient funding commitments. For present and prospective funders, having a clear picture of what is needed will be essential to wise judgments about forthcoming allocations and, possibly, collaborative decision-making. Research Associate, Trisha Lamphear |
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