Gunn Alexander, Bandara Shashika, Yamey Gavin, D Alessio Flavia, Depraetere Hilde, Houard Sophie, Viebig Nicola K, Jungbluth Stefan
Center for Policy Impact in Global Health, Duke Global Health Institute, Duke University, Durham, USA.
European Vaccine Initiative (EVI), Heidelberg, Germany.
F1000Res. 2019 Jul 11;8:1066. doi: 10.12688/f1000research.19810.2. eCollection 2019.
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. 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. 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. 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.
投资组合到影响（P2I）模型是一种最近开发的产品组合工具，它能让用户估算将候选健康产品（如疫苗和药物）组合从临床前后期推进到III期临床试验，以及随着时间推移进行潜在产品上市所需的资金。在本研究中，我们描述了使用该工具分析欧洲疫苗倡议（EVI）的疫苗组合。该组合包括处于不同开发阶段的针对各种贫困相关疾病和新发传染病的候选疫苗。使用P2I工具中整合的现有假设，以及基于EVI自身与疫苗开发相关的内部数据对成本、周期时间和成功概率进行修改后的假设，进行了投资组合分析。根据P2I工具，将EVI投资组合中目前的18种候选产品推进到上市阶段的总估计成本约为4.7亿美元，在2019 - 2031年期间，EVI投资组合中所有六种疾病的预期上市次数为0.69次。使用EVI内部参数运行该模型导致预期产品上市次数显著增加。由于可用数据有限，我们的研究中无法对P2I工具的所有基础假设进行测试。尽管如此，我们预计基于越来越多可用的受控人类感染模型加速疫苗（和药物）的临床试验，以及监管机构例如针对严重病症的加速批准，将加快产品开发并大幅降低成本。讨论了项目结果以及P2I工具未来可能的修改，旨在改进P2I模型的基础方法。
