Ayman Chit1, Jayson Parker2, Scott A Halperin3, Manny Papadimitropoulos4, Murray Krahn2, Paul Grootendorst2. 1. University of Toronto, Toronto, Ontario, Canada. Electronic address: Ayman.Chit@utoronto.ca. 2. University of Toronto, Toronto, Ontario, Canada. 3. Canadian Center for Vaccinology, Dalhousie University, Halifax, Nova Scotia, Canada. 4. University of Toronto, Toronto, Ontario, Canada; Eli Lilly Canada Inc., Scarborough, Ontario, Canada.
Abstract
BACKGROUND: The ability to calculate the development costs for specific medicines and vaccines is important to inform investments in innovation. Unfortunately, the literature is predominated by non-reproducible studies only measuring aggregate level drug research and development (R&D) costs. We describe methodology that improves the transparency and reproducibility of primary indication expected R&D expenditures. METHODS: We used publically accessible clinical trial data to investigate the fate of all seasonal influenza vaccine candidates that entered clinical development post year 2000. We calculated development times and probabilities of success for these candidates through the various phases of clinical development. Clinical trial cost data obtained from university based clinical researchers were used to estimate the costs of each phase of development. The cost of preclinical development was estimated using published literature. RESULTS: A vaccine candidate entering pre-clinical development in 2011 would be expected to achieve licensure in 2022; all costs are reported in 2022 Canadian dollars (CAD). After applying a 9% cost of capital, the capitalized total R&D expenditure amounts to $474.88 million CAD. CONCLUSION: Clinical development costs for vaccines and drugs can be estimated with increased specificity and transparency using public sources of data. The robustness of these estimates will only increase over time due to public disclosure incentives first introduced in the late 1990s. However, preclinical development costs remain difficult to estimate from public data. Crown
BACKGROUND: The ability to calculate the development costs for specific medicines and vaccines is important to inform investments in innovation. Unfortunately, the literature is predominated by non-reproducible studies only measuring aggregate level drug research and development (R&D) costs. We describe methodology that improves the transparency and reproducibility of primary indication expected R&D expenditures. METHODS: We used publically accessible clinical trial data to investigate the fate of all seasonal influenza vaccine candidates that entered clinical development post year 2000. We calculated development times and probabilities of success for these candidates through the various phases of clinical development. Clinical trial cost data obtained from university based clinical researchers were used to estimate the costs of each phase of development. The cost of preclinical development was estimated using published literature. RESULTS: A vaccine candidate entering pre-clinical development in 2011 would be expected to achieve licensure in 2022; all costs are reported in 2022 Canadian dollars (CAD). After applying a 9% cost of capital, the capitalized total R&D expenditure amounts to $474.88 million CAD. CONCLUSION: Clinical development costs for vaccines and drugs can be estimated with increased specificity and transparency using public sources of data. The robustness of these estimates will only increase over time due to public disclosure incentives first introduced in the late 1990s. However, preclinical development costs remain difficult to estimate from public data. Crown
Authors: Nancy J Cox; Julian Hickling; Rebecca Jones; Guus F Rimmelzwaan; Linda C Lambert; John Boslego; Larisa Rudenko; Leena Yeolekar; James S Robertson; Joachim Hombach; Justin R Ortiz Journal: Vaccine Date: 2015-10-23 Impact factor: 3.641
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