Cited by 20Pharmaceutical studies and practicesPharmaceutical Economics and PolicyStatistical Methods in Clinical Trials

Facilitating the use of the target product profile in academic research: a systematic review

Open access
Ibnidris, Aliaa, Liaskos, Nektarios, Eldem, Ece, Gunn, Angus, Streffer, Johannes, Gold, Michael, Rea, Mike, Teipel, Stefan +2 more·2024·Journal of Translational Medicine

Abstract

BACKGROUND: The Target Product Profile (TPP) is a tool used in industry to guide development strategies by addressing user needs and fostering effective communication among stakeholders. However, they are not frequently used in academic research, where they may be equally useful. This systematic review aims to extract the features of accessible TPPs, to identify commonalities and facilitate their integration in academic research methodology. METHODS: We searched peer-reviewed papers published in English developing TPPs for different products and health conditions in four biomedical databases. Interrater agreement, computed on random abstract and paper sets (Cohen's Kappa; percentage agreement with zero tolerance) was > 0.91. We interviewed experts from industry contexts to gain insight on the process of TPP development, and extracted general and specific features on TPP use and structure. RESULTS: 138 papers were eligible for data extraction. Of them, 92% (n = 128) developed a new TPP, with 41.3% (n = 57) focusing on therapeutics. The addressed disease categories were diverse; the largest (47.1%, n = 65) was infectious diseases. Only one TPP was identified for several fields, including global priorities like dementia. Our analyses found that 56.5% of papers (n = 78) was authored by academics, and 57.8% of TPPs (n = 80) featured one threshold level of product performance. The number of TPP features varied widely across and within product types (n = 3-44). Common features included purpose/context of use, shelf life for drug stability and validation aspects. Most papers did not describe the methods used to develop the TPP. We identified aspects to be taken into account to build and report TPPs, as a starting point for more focused initiatives guiding use by academics. DISCUSSION: TPPs are used in academic research mostly for infectious diseases and have heterogeneous features. Our extraction of key features and common structures helps to understand the tool and widen its use in academia. This is of particular relevance for areas of notable unmet needs, like dementia. Collaboration between stakeholders is key for innovation. Tools to streamline communication such as TPPs would support the development of products and services in academia as well as industry.

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  • Borrowing from industry, target product profiles may also guide AI-CAC development toward clinically useful, guideline-aligned and financially viable implementations.

    “Borrowing from industry, target product profiles may also guide AI-CAC development toward clinically useful, guideline-aligned and financially viable implementations.67”

    From Prognostication and clinical opportunities with AI for coronary artery calcium: a scoping review (2026) · cites this paper as [67]

    The Introduction describes TPPs as an industry planning tool that guides product development, and the Discussion links them to clinical utility, regulatory considerations, marketability and reimbursement. The paper does not specifically address AI-CAC or alignment with clinical guidelines, so applying those points to AI-CAC is an extrapolation. (LLM, conf=0.82)

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Research works printed but not linked: 2

  1. [1]FDA. Guidance for Industry and Review Staff Target Product Profile — A Strategic Development Process Tool. 2007.
  2. [154]guideline IQRPd-S. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. PMC1364893 8054244

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Authors
Ibnidris, A., Liaskos, N., Eldem, E., Gunn, A., Streffer, J., Gold, M., Rea, M., Teipel, S., Gardiol, A., & Boccardi, M.
Affiliations
  • University of Cape Town (ZA)
  • German Center for Neurodegenerative Diseases (DE)
  • University of Antwerp (BE)
  • Queen Mary University of London (GB)
Corresponding author
Boccardi, Marina
Venue
Journal of Translational Medicine
Published
2024-07-29
Volume
22
Issue
1
Pages
693-693
ISSN
1479-5876 (ISSN-L)
OpenAlex
W4401158091
Cited by
20
References
153
Citations by year
2026: 12 · 2025: 7 · 2024: 1
FWCI
2.37
Type
journal article
Language
en
Open access
Locations
  • Journal of Translational Medicine (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (acceptedVersion)
  • Informationszentrum Lebenswissenschaften (ZB MED) (submittedVersion, cc-by)
Funders
Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE) in der Helmholtz-Gemeinschaft
Topics
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
target product profile, academic research, infectious diseases, therapeutics, dementia, unmet medical needs, stakeholder collaboration, drug development, drug stability
MeSH terms
Academia, Humans, Biomedical Research

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