Abstract
Background: The Portfolio-To-Impact (P2I) P2I model is a recently developed product portfolio tool that enables users to estimate the funding needs to move a portfolio of candidate health products, such as vaccines and drugs, along the product development path from late stage preclinical to phase III clinical trials, as well as potential product launches over time. In this study we describe the use of this tool for analysing the vaccine portfolio of the European Vaccine Initiative (EVI). This portfolio includes vaccine candidates for various diseases of poverty and emerging infectious diseases at different stages of development. Methods: Portfolio analyses were conducted using the existing assumptions integrated in the P2I tool, as well as modified assumptions for costs, cycle times, and probabilities of success based on EVI's own internal data related to vaccine development. Results: According to the P2I tool, the total estimated cost to move the 18 candidates currently in the EVI portfolio along the pipeline to launch would be about US $470 million, and there would be 0.69 expected launches across all six diseases in EVI's portfolio combined during the period 2019-2031. Running of the model using EVI-internal parameters resulted in a significant increase in the expected product launches. Conclusions:Not all the assumptions underlying the P2I tool could be tested in our study due to limited amount of data available. Nevertheless, we expect that the accelerated clinical testing of vaccines (and drugs) based on the use of controlled human infection models that are increasingly available, as well as the accelerated approval by regulatory authorities that exists for example for serious conditions, will speed up product development and result in significant cost reduction. Project findings as well as potential future modifications of the P2I tool are discussed with the aim to improve the underlying methodology of the P2I model.
Highlights
The Portfolio-To-Impact (P2I) P2I model is a recently developed product portfolio tool that enables users to estimate the funding needs to move a portfolio of candidate health products, such as vaccines and drugs, along the product development path from late stage preclinical to phase III clinical trials, as well as potential product launches over time
The mission of European Vaccine Initiative (EVI) is to accelerate the development of vaccines for diseases of poverty and emerging infectious diseases
At EVI, decision regarding which vaccine candidates to include into the organisation’s portfolio, and which ones to move forward, are based on a rigorous selection of candidates made by the EVI Board, based on input from an independent scientific advisory committee
Summary
Any reports and responses or comments on the article can be found at the end of the article. The modelling tool, which is deterministic, uses Excel based software to estimate the “minimum funding needs to accelerate health product development from late stage preclinical study to phase III clinical trials” and to “visualize potential product launches over time1.”. To the best of our knowledge, the first published use of the tool was by Young and colleagues[2] These researchers first conducted a pipeline portfolio review to identify current candidates in the pipeline for 35 PRNDs. These researchers first conducted a pipeline portfolio review to identify current candidates in the pipeline for 35 PRNDs They used the P2I tool to estimate (a) the costs to move these candidates through the pipeline, (b) the likely launches, and (c) the highly needed products that would still be “missing” at the end. The P2I tool is complementary to other available tools that can help guide prioritization in vaccine development, such as the multi-stakeholder Vaccine Innovation Prioritization Strategy[1] and Total Systems Effectiveness Framework[2]
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