Opening a debate on open‐source modeling tools: Pouring fuel on fire versus extinguishing the flare of a healthy debate

As model‐informed drug development becomes an integral part of modern approaches to the discovery of new therapeutic entities and showing their safety and effectiveness, modalities of incorporating the paradigm into widespread practice require a revisit. Traditionally, modeling and simulation (M&S) have been performed by specialized teams who (…)

BPS Article: Model‐Informed Drug Repurposing: a Pharmacometric Approach to Novel Pathogen Preparedness, Response and Retrospection

Abstract During a pandemic caused by a novel pathogen (NP), drug repurposing offers the potential of a rapid treatment response via a repurposed drug (RD) while more targeted treatments are developed. Five steps of model‐informed drug repurposing (MIDR) are discussed: i) utilize RD product label and in vitro NP data to determine initial proof of potential, ii) … Continued

Model-Informed Precision Dosing: Background, Requirements, Validation, Implementation, and Forward Trajectory of Individualizing Drug Therapy

Model-informed precision dosing (MIPD) has become synonymous with modern approaches for individualizing drug therapy, in which the characteristics of each patient are considered as opposed to applying a one-size-fits-all alternative. This review provides a brief account of the current knowledge, practices, and opinions on MIPD while defining an achievable vision for MIPD in clinical care … Continued

Enabling Warp Speed Using the Hypervelocity Innovation Model: A Blue Print for Drug Development in Pandemics

Pharmaceutical R&D is organized around prioritized investments, delivering on assets with the greatest return of investments. Linear sequencing of trials and financial risks are determinants of speed in an enterprise. There is less flexibility in leveraging expertise around priorities that are thrust on the system by external forces. This commentary provides an insight into enabling … Continued

Clinical trials of disease stages in COVID 19: complicated and often misinterpreted

As of July 28, 2020, 1840 clinical trials were registered globally, with 1001 clinical trials recruiting patients for COVID-19 management.1 Despite this large number, only 30 trials have been published as peer-reviewed or preprint publications.2 Media reports and prepublications on medRxiv and bioRxiv represent the most frequent mechanism for data sharing, with wide public reach and usually with little detail. However, … Continued

Accelerating Clinical Evaluation of Repurposed Combination Therapies for COVID-19

As the global COVID-19 pandemic continues, unabated and clinical trials demonstrate limited effective pharmaceutical interventions, there is a pressing need to accelerate treatment evaluations. Among options for accelerated development is the evaluation of drug combinations in the absence of prior monotherapy data. This approach is appealing for a number of reasons. First, combining two or … Continued

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