Probability of Success in Drug Development

Graaf, Piet H. van der

doi:10.1002/cpt.2568

Cited by 8 publications

(5 citation statements)

References 7 publications

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“…Equation 2 conceptually recognizes that the regulation-innovation relationship is relatively weak relative to other factors influencing the medical product development lifecycle, such as risks to technical success [ 16 ], access to financing [ 17 ], and so on.…”

Section: Conceptual Model and Empirical Datamentioning

confidence: 99%

“…The key assumption of this model is that MPI would be proportional to a medical product regulatory (MPR) influence of an unknown degree (α), which would be time dependent as both the regulations and the subsequent interpretation and implementation by the firm would be serially correlated (with some unknown time lag); i.e., Equation 2 conceptually recognizes that the regulationinnovation relationship is relatively weak relative to other factors influencing the medical product development lifecycle, such as risks to technical success [16], access to financing [17], and so on.…”

Section: Conceptual Modelmentioning

confidence: 99%

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The Impact of US Medical Product Regulatory Complexity on Innovation: Preliminary Evidence of Interdependence, Early Acceleration, and Subsequent Inversion

Daizadeh

2023

Pharm Res

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Purpose Is the complexity of medical product (medicines and medical devices) regulation impacting innovation in the US? If so, how? Methods Here, this question is investigated as follows: Various novel proxy metrics of regulation (FDA-issued guidelines) and innovation (corresponding FDA-registrations) from 1976–2020 are used to determine interdependence, a concept relying on strong correlation and reciprocal causality (estimated via variable lag transfer entropy and wavelet coherence). Results Based on the observed interdependence, a mapping of regulation onto innovation is conducted and finds that regulation seems to accelerate then supports innovation until on or around 2015; at which time, an inverted U-curve emerged. Conclusions If empirically evidentiary, an important innovation-regulation nexus in the US has been reached; and, as such, stakeholders should (re)consider the complexity of the regulatory landscape to enhance US medical product innovation. Study limitations, extensions, and further thoughts complete this investigation. Graphical abstract Supplementary Information The online version contains supplementary material available at 10.1007/s11095-023-03512-1.

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Section: Conceptual Model and Empirical Datamentioning

confidence: 99%

Section: Conceptual Modelmentioning

confidence: 99%

The Impact of US Medical Product Regulatory Complexity on Innovation: Preliminary Evidence of Interdependence, Early Acceleration, and Subsequent Inversion

Daizadeh

2023

Pharm Res

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“…In our May editorial, editor‐in‐chief Piet van der Graaf reviewed predicting success in industrial drug development 1 and pointed to Hampson’s 2 and Lalonde’s 3 thoughtful explorations of optimized decision making in this domain. Those involved in generating new therapeutics understand the path involves (i) understanding the pathophysiology and the biology of the system under study, and (ii) then expanding this understanding by modulation of drug targets.…”

Section: Figurementioning

confidence: 99%

Clinical Pharmacology and the Best Use of Public Research Investment

Kraft

2022

Clin Pharma and Therapeutics

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“…The pharmaceutical industry routinely conducts animal studies as an integral component of drug discovery and development, employing them to assess key properties, such as absorption, distribution, metabolism, excretion, and pharmacokinetic profiles, and to perform proof of concept studies. This standard practice often results in the identification of candidate drugs deemed unsuitable, leading to the termination of their progression [ 1 ]. Given the resource-intensive nature of animal studies and the consequential attrition rate [ 2 ], there exists a critical need for innovative approaches that can enhance the efficiency of drug discovery.…”

Section: Introductionmentioning

confidence: 99%

Multimodal Mass Spectrometry Imaging of an Osteosarcoma Multicellular Tumour Spheroid Model to Investigate Drug-Induced Response

Pearce,

Cross,

Smith

et al. 2024

Metabolites

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A multimodal mass spectrometry imaging (MSI) approach was used to investigate the chemotherapy drug-induced response of a Multicellular Tumour Spheroid (MCTS) 3D cell culture model of osteosarcoma (OS). The work addresses the critical demand for enhanced translatable early drug discovery approaches by demonstrating a robust spatially resolved molecular distribution analysis in tumour models following chemotherapeutic intervention. Advanced high-resolution techniques were employed, including desorption electrospray ionisation (DESI) mass spectrometry imaging (MSI), to assess the interplay between metabolic and cellular pathways in response to chemotherapeutic intervention. Endogenous metabolite distributions of the human OS tumour models were complemented with subcellularly resolved protein localisation by the detection of metal-tagged antibodies using Imaging Mass Cytometry (IMC). The first application of matrix-assisted laser desorption ionization–immunohistochemistry (MALDI-IHC) of 3D cell culture models is reported here. Protein localisation and expression following an acute dosage of the chemotherapy drug doxorubicin demonstrated novel indications for mechanisms of region-specific tumour survival and cell-cycle-specific drug-induced responses. Previously unknown doxorubicin-induced metabolite upregulation was revealed by DESI-MSI of MCTSs, which may be used to inform mechanisms of chemotherapeutic resistance. The demonstration of specific tumour survival mechanisms that are characteristic of those reported for in vivo tumours has underscored the increasing value of this approach as a tool to investigate drug resistance.

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Probability of Success in Drug Development

Cited by 8 publications

References 7 publications

The Impact of US Medical Product Regulatory Complexity on Innovation: Preliminary Evidence of Interdependence, Early Acceleration, and Subsequent Inversion

The Impact of US Medical Product Regulatory Complexity on Innovation: Preliminary Evidence of Interdependence, Early Acceleration, and Subsequent Inversion

Clinical Pharmacology and the Best Use of Public Research Investment

Multimodal Mass Spectrometry Imaging of an Osteosarcoma Multicellular Tumour Spheroid Model to Investigate Drug-Induced Response

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