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Research and development of therapeutic mAbs: An analysis based on pipeline projects.

ABSTRACT: As the subject of active research and development (R&D) in recent decades, monoclonal antibodies have emerged among the major classes of therapeutic agents for treatment of many human diseases, especially cancers, infections, and immunological disorders. This article surveys the landscape of R&D projects of therapeutic monoclonal antibodies (mAbs), which are mostly used for disease immunotherapy, from a number of perspectives, including therapeutic indications, development phases, participants, and citation of related patents. The results of this research can be used as a reference resource for pharmaceutical researchers, investors, and policymakers in the field of therapeutic mAbs.

SUBMITTER: Geng X

PROVIDER: S-EPMC4916486 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Research and development of therapeutic mAbs: An analysis based on pipeline projects.

Geng Xiaomei X Kong Xiangjun X Hu Hao H Chen Jiayu J Yang Fengqing F Liang Hongyu H Chen Xin X Hu Yuanjia Y

Human vaccines & immunotherapeutics 20150101 12

As the subject of active research and development (R&D) in recent decades, monoclonal antibodies have emerged among the major classes of therapeutic agents for treatment of many human diseases, especially cancers, infections, and immunological disorders. This article surveys the landscape of R&D projects of therapeutic monoclonal antibodies (mAbs), which are mostly used for disease immunotherapy, from a number of perspectives, including therapeutic indications, development phases, participants, ...[more]

PMID: 26211701

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Project description:ObjectivesHealthcare budgets are limited, and therefore, research funds should be wisely allocated to ensure high-quality, useful and cost-effective research. We aimed to critically review the criteria considered by major Australian organisations in prioritising and selecting health research projects for funding.MethodsWe reviewed all grant schemes listed on the Australian Competitive Grants Register that were health-related, active in 2017 and with publicly available selection criteria on the funders' websites. Data extracted included scheme name, funding organisation, selection criteria and the relative weight assigned to each criterion. Selection criteria were grouped into five representative domains: relevance, appropriateness, significance, feasibility (including team quality) and cost-effectiveness (ie, value for money).ResultsThirty-six schemes were included from 158 identified. One-half of the schemes were under the National Health and Medical Research Council. The most commonly used criteria were research team quality and capability (94%), research plan clarity (94%), scientific quality (92%) and research impact (92%). Criteria considered less commonly were existing knowledge (22%), fostering collaboration (22%), research environment (19%), value for money (14%), disease burden (8%) and ethical/moral considerations (3%). In terms of representative domains, relevance was considered in 72% of the schemes, appropriateness in 92%, significance in 94%, feasibility in 100% and cost-effectiveness in 17%. The relative weights for the selection criteria varied across schemes with 5%-30% for relevance, 20%-60% for each appropriateness and significance, 20%-75% for feasibility and 15%-33% for cost-effectiveness.ConclusionsIn selecting research projects for funding, Australian research organisations focus largely on research appropriateness, significance and feasibility; however, value for money is most often overlooked. Research funding decisions should include an assessment of value for money in order to maximise return on research investment.

Project description:Background and aimsInvolving research users in collaborative research approaches may increase the relevance and utility of research findings. Our primary objectives were to (i) identify and describe characteristics of Canadian federally and provincially funded health research projects that included research users and were funded between 2011 and 2019; (ii) explore changes over time; and (iii) compare characteristics between funder required and optional partnerships.MethodsRetrospective analysis. Inclusion criteria were projects that included research users. We analyzed publicly available project variables, and coded field and type of research using established classification systems. We summarized data with descriptive statistics and compared variables across three funding year blocks and partnership requirement status.ResultsWe identified 1153 partnered health research projects, representing 137 fields of research and 37 types of research categories. Most projects included a required partnership (80%) and fell into health and social care services research (66%). Project length and funding amount increased from average of 24.8 months and $266 248 CAD in 2011-2013 to 31.6 months and $438 766 CAD in 2017-2019. There were significantly fewer required partnerships in 2017-2019.ConclusionsBetween 2011 and 2019 Canadian federally and provincially funded partnered health research reflected primarily care services research across many fields. The observed breadth suggests that partnered health research approaches are applicable in many fields of research. Additional work to support partnered research across all types of health research (especially biomedical research) is warranted. The administration of larger grants that are funded for longer time periods may address previously identified concerns among research teams engaging in partnered research but may mean that fewer teams receive funding and risk delaying responding to time-sensitive data needs for users. Our process and findings can be used as a starting point for international comparison.

Dataset Information

Research and development of therapeutic mAbs: An analysis based on pipeline projects.

Publications

Research and development of therapeutic mAbs: An analysis based on pipeline projects.

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