Funding global health product R&amp;D: the Portfolio-To-Impact Model (P2I), a new tool for modelling the impact of different research portfolios

Terry, Robert F; Yamey, Gavin; Miyazaki-Krause, Ryoko; Gunn, Alexander; Reeder, John C.

doi:10.12688/gatesopenres.12816.1

Cited by 6 publications

(12 citation statements)

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“…First, the P2I v.1 tool that we used and adapted is available online, as are our model assumptions, model inputs and outputs, and detailed information on the portfolio review, which means that readers can replicate, improve on, and further adapt our work 12 . The P2I v.1 tool was designed for flexibility, as shown in the way in which we adapted it, and we encourage others to refine it further.…”

Section: Discussionmentioning

confidence: 99%

“…The P2I v.1 tool is a user-friendly, public Microsoft Excel file (see Supplementary with reference 12) with costing assumptions and formulae built in 12 . The tool was developed by TDR.…”

Section: Methodsmentioning

confidence: 99%

“…Based on the results of this review, we estimated the costs to move these candidates through the pipeline, the likely launches, and the “priority” health technologies that would be “missing” under the status quo. To do this, we used an adaptation of a financial tool—the Portfolio to Impact (P2I) model—developed by TDR, the Special Programme for Research and Training in Tropical Diseases, for the World Health Organization 11 12 . We made the adaptations of the P2I tool ourselves, resulting in P2I version 2 (P2I v.2); adaptations included adding more product types (e.g., vector control products) and modifying some of the tool’s underlying assumptions based on additional data.…”

Section: Introductionmentioning

confidence: 99%

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Developing new health technologies for neglected diseases: a pipeline portfolio review and cost model

et al. 2018

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Background: Funding for product development for neglected diseases fell from 2009-2015, other than a short-term injection of Ebola funding. One impediment to mobilizing resources is a lack of information on product candidates, the estimated costs to move them through the pipeline, and the likelihood of specific launches. This study aimed to help fill these information gaps. Methods: We conducted a pipeline portfolio review to identify current candidates for 35 neglected diseases. Using an adapted version of the Portfolio to Impact (P2I) financial modelling tool, we estimated the costs to move these candidates through the pipeline over the next decade and the likely launches. Since the current pipeline is unlikely to yield several critical products, we estimated the costs to develop a set of priority “missing” products. Results: We found 685 product candidates for neglected diseases as of August 31, 2017; 538 candidates met inclusion criteria for input into the model. It would cost about $16.3 billion (range $13.4-19.8B) to move these candidates through the pipeline, with three-quarters of the costs incurred in the first 5 years, resulting in about 128 (89-160) expected product launches. Based on the current pipeline, there would be very few launches of complex new chemical entities; launches of highly efficacious vaccines for HIV, tuberculosis, or malaria would be unlikely. Estimated additional costs to launch one of each of 18 key missing products range from $13.6B-$21.8B, depending on product complexity. Over the next 5 years, total estimated costs to move current candidates through the pipeline and develop these 18 missing products would be around $4.5-5.8B/year. Conclusions: Since current annual global spending on product development is about $3B, this study suggests the annual funding gap over the next 5 years is at least $1.5-2.8B, which is probably an underestimate. The current portfolio is not balanced across health needs.

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Section: Discussionmentioning

confidence: 99%

“…The P2I v.1 tool is a user-friendly, public Microsoft Excel file (see Supplementary with reference 12) with costing assumptions and formulae built in 12 . The tool was developed by TDR.…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Developing new health technologies for neglected diseases: a pipeline portfolio review and cost model

et al. 2018

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“…The Special Programme for Research and Training in Tropical Diseases (TDR) recently developed a new modelling tool, called Portfolio-to-Impact (P2I), that allows users to model the impact of different research portfolios 1 . The P2I tool can be used to estimate the costs of moving a portfolio of candidate products for poverty-related and neglected diseases (PRNDs) through the pipeline and the likely launches that would result.…”

Section: Introductionmentioning

confidence: 99%

“…It can also help to identify potential funding bottlenecks and operational challenges. 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 time 1…”

Section: Introductionmentioning

confidence: 99%

Pipeline analysis of a vaccine candidate portfolio for diseases of poverty using the Portfolio-To-Impact modelling tool

et al. 2020

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The Portfolio-To-Impact (P2I) P2I model is a recently Background: 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 Methods: 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 Results: 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 Conclusions: 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. PubMed Abstract | Publisher Full Text | Free Full Text 2. Young R, Bekele T, Gunn A, et al.: Developing new health technologies for neglected diseases: a pipeline portfolio review and cost model [version 1; peer review: 1 approved, 2 approved with reservations]. Gates Open Res. 2018; 2: 23. PubMed Abstract | Publisher Full Text | Free Full Text 3. Mestre-Ferrandiz J, Sussex J, Towse A: The R&D Cost of a New Medicine. UK Office of Health Economics. 2012. Reference Source 4.

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Building a tuberculosis-free world: The Lancet Commission on tuberculosis

et al. 2019

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growing political momentum to definitively address tuberculosis, could all make ending the pandemic within a generation more feasible than ever before. Moving forward with bold, comprehensive strategies Globally, the priority must be to deliver person-centred and family-centred services to all individuals with tuberculosis who present to care. This approach means ensuring that high-quality diagnostics, treatment, and prevention modalities are available to all, wherever they seek care. Improving quality of tuberculosis care in the private sector is crucial to end tuberculosis in high incidence countries such as India, the country with the highest tuberculosis burden. Modelling shows that optimising private sector engagement in India could avert 8 million deaths from tuberculosis between 2019 and 2045 (appendix p 3). In high drug-resistant tuberculosis burden countries, access to rapid drug susceptibility testing (DST) and second-line drugs is essential to success. In Moldova, where more than 25% of all tuberculosis cases are drug-resistant, improving access to DST and second-line drugs would reduce mortality from drug-resistant tuberculosis by 44% in the coming generation (appendix p 3). Secondly, tuberculosis programme budgets must increase to enable reaching these people and populations at high risk of tuberculosis. In Kenya, for example, where the proportions of HIV and tuberculosis coinfection are high, scaling up access to both antiretroviral therapy and tuberculosis preventive therapy can help save an additional 3 million lives over the next generation (appendix p 3). However, ultimately, the fight against tuberculosis will not be won unless countries also ensure that everyone, not just high-risk groups, can access essential health Key messages The Commission recommends five priority investments to achieve a tuberculosis-free world within a generation. These investments are designed to fulfil the mandate of the UN High Level Meeting on tuberculosis. In addition, they answer the question of how countries with high-burden tuberculosis and their development partners should target their future investments to ensure that ending tuberculosis is achievable. Invest first to ensure that high quality rapid diagnostics and treatment are provided to all individuals receiving care for tuberculosis, wherever they seek care This priority includes rapid drug susceptibility testing and second-line treatment for resistant forms of tuberculosis. Achieving universal, high-quality person-centred and family-centred care-including sustained improvement in the performance of private sector providers-usually should be the top policy and budget priority. Reach people and populations at high risk for tuberculosis (such as household and other close contacts of people with tuberculosis, and people with HIV) and bring them into care Active case-finding and treatment in high-risk populations demands adequate resources to reach and care for these populations. At the same time, reaching certain high-risk populations, such as people co-infec...

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Funding global health product R&D: the Portfolio-To-Impact Model (P2I), a new tool for modelling the impact of different research portfolios

Cited by 6 publications

References 6 publications

Developing new health technologies for neglected diseases: a pipeline portfolio review and cost model

Developing new health technologies for neglected diseases: a pipeline portfolio review and cost model

Pipeline analysis of a vaccine candidate portfolio for diseases of poverty using the Portfolio-To-Impact modelling tool

Building a tuberculosis-free world: The Lancet Commission on tuberculosis

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