Successful clinical development of new therapeutic interventions is notoriously difficult, especially in neurodegenerative diseases, where predictive biomarkers are scarce and functional improvement is often based on patient’s perception, captured by structured interviews. As a consequence, mechanistic modeling of the processes relevant to therapeutic interventions in CNS disorders has been lagging behind other disease indications, probably … Continued
Typical Quantitative Systems Pharmacology (QSP) workflows involve discussion of biology, supported by graphical diagrams, followed by construction of large Ordinary Differential Equation models. QSP Designer facilitates this process by providing enhanced graphical notation, which enables hierarchical presentation with modules and handling of combinatorial complexity with diagram node arrays. Whereas the software includes a simulation engine, … Continued
An novel single dose regimen of tremelimumab combined with durvalumab could be a way to treat unresectable hepatocellular carcinoma. In this recently published Clinical Cancer Research study, co-authored by Certara’s Rajesh Krishna, the findings reveal that overall survival was longer for patients given this drug regimen.
Drug repurposing is promoted as a cost- and time-effective mechanism for providing new medicines. Often, however, there is insufficient consideration by academic researchers of the processes required to ensure that a repurposed drug can be used for a new indication. This may explain the inability of drug repurposing to fulfill its promise.ll
Optimal use and distribution of Covid-19 vaccines involves adjustments of dosing. Due to the rapidly evolving pandemic, such adjustments often need to be introduced before full efficacy data are available. As demonstrated in other areas of drug development, quantitative systems pharmacology (QSP) is well placed (…)
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 (…)
Perhaps the most important lesson learned from the COVID‐19 pandemic is that of preparedness. Enhanced surveillance systems for early threat detection will be crucial to maximizing response time for implementation of public health measures (…)
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
