Landscape of Innovation for Cardiovascular Pharmaceuticals: From Basic Science to New Molecular Entities
Abstract
Purpose This study examines the complete timelines of translational science for new cardiovascular therapeutics from the initiation of basic research leading to identification of new drug targets through clinical development and US Food and Drug Administration (FDA) approval of new molecular entities (NMEs) based on this research.Methods This work extends previous studies by examining the association between the growth of research on drug targets and approval of NMEs associated with these targets. Drawing on research on innovation in other technology sectors, where technological maturity is an important determinant in the success or failure of new product development, an analytical model was used to characterize the growth of research related to the known targets for all 168 approved cardiovascular therapeutics.Findings Categorizing and mapping the technological maturity of cardiovascular therapeutics reveal that (1) there has been a distinct transition from phenotypic to targeted methods for drug discovery, (2) the durations of clinical and regulatory processes were significantly influenced by changes in FDA practice, and (3) the longest phase of the translational process was the time required for technology to advance from initiation of research to a statistically defined established point of technology maturation (mean, 30.8 years).Implications This work reveals a normative association between metrics of research maturation and approval of new cardiovascular therapeutics and suggests strategies for advancing translational science by accelerating basic and applied research and improving the synchrony between the maturation of this research and drug development initiatives.
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Therapies targeting risk factors that are not causal represent a major roadblock to innovation.
“with therapies targeting risk factors that are not causal representing a major roadblock to innovation 3 .”
From Integrating genomics with biomarkers and therapeutic targets to invigorate cardiovascular drug development (2021) · cites this paper as [3]
Drug development in cardiovascular disease is stagnating.
“A notable trend observed over recent decades is that the number of drugs being developed for cardiovascular disease has stagnated. 3”
From Integrating genomics with biomarkers and therapeutic targets to invigorate cardiovascular drug development (2021) · cites this paper as [3]
Lack of validated targets is a major roadblock to innovation in cardiovascular drug development.
“with therapies targeting risk factors that are not causal representing a major roadblock to innovation 3”
From Integrating genomics with biomarkers and therapeutic targets to invigorate cardiovascular drug development (2021) · cites this paper as [3]
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- Authors
- Beierlein, J. M., McNamee, L. M., Walsh, M. J., Kaitin, K. I., DiMasi, J. A., & Ledley, F. D.
- Affiliations
- Bentley University (US)
- Tufts University (US)
- Corresponding author
- Ledley, Fred D.
- Venue
- Clinical Therapeutics
- Publisher
- Elsevier BV
- Published
- 2017-07
- Volume
- 39
- Issue
- 7
- Pages
- 1409-1425.e20
- ISSN
- 0149-2918 (ISSN-L)
- OpenAlex
- W2686044652
- Cited by
- 24
- References
- 87
- Citations by year
- 2024: 1 · 2023: 4 · 2022: 1 · 2021: 3 · 2020: 5 · 2019: 6 · 2018: 3 · 2017: 1
- FWCI
- 7.38
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Research Foundation
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health and Medical Research Impacts
- Health Sciences › Medicine › Reproductive Medicine › Science, Research, and Medicine
- Keywords
- cardiovascular therapeutics, new chemical entities, drug target identification, translational research, technology maturity, drug development timelines, FDA drug approval, phenotypic drug discovery, targeted drug discovery, regulatory process
- MeSH terms
- Cardiovascular Agents, Humans, United States, United States Food and Drug Administration, Drug Approval, Drug Discovery, Translational Research, Biomedical
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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