Artificial Intelligence and the Future of the Drug Safety Professional

Danysz, Karolina; Cicirello, Salvatore; Mingle, Edward; Assuncao, Bruno; Tetarenko, Niki; Mockute, Ruta; Abatemarco, Danielle; Widdowson, Mark; Desai, Sameen

doi:10.1007/s40264-018-0746-z

Cited by 40 publications

(24 citation statements)

References 1 publication

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“…Pharmacovigilance professionals must learn new skills and acquire technical knowledge relating to system implementation and CSV to remain successful in this rapidly advancing sector [ 18 ]. A once-siloed working paradigm is shifting, requiring pharmacovigilance professionals to understand business and technical requirements, to select representative data to adequately train and approve AI models, and to understand how, when, and why to retrain their models over time.…”

Section: Discussionmentioning

confidence: 99%

Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices

Huysentruyt¹,

Kjoersvik²,

Dobracki

et al. 2021

Drug Saf

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Pharmacovigilance is the science of monitoring the effects of medicinal products to identify and evaluate potential adverse reactions and provide necessary and timely risk mitigation measures. Intelligent automation technologies have a strong potential to automate routine work and to balance resource use across safety risk management and other pharmacovigilance activities. While emerging technologies such as artificial intelligence (AI) show great promise for improving pharmacovigilance with their capability to learn based on data inputs, existing validation guidelines should be augmented to verify intelligent automation systems. While the underlying validation requirements largely remain the same, additional activities tailored to intelligent automation are needed to document evidence that the system is fit for purpose. We propose three categories of intelligent automation systems, ranging from rule-based systems to dynamic AI-based systems, and each category needs a unique validation approach. We expand on the existing good automated manufacturing practices, which outline a risk-based approach to artificially intelligent static systems. Our framework provides pharmacovigilance professionals with the knowledge to lead technology implementations within their organizations with considerations given to the building, implementation, validation, and maintenance of assistive technology systems. Successful pharmacovigilance professionals will play an increasingly active role in bridging the gap between business operations and technical advancements to ensure inspection readiness and compliance with global regulatory authorities.

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Section: Discussionmentioning

confidence: 99%

Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices

Huysentruyt¹,

Kjoersvik²,

Dobracki

et al. 2021

Drug Saf

Self Cite

View full text Add to dashboard Cite

show abstract

“…Already, there is evidence that AI can equal or exceed human performance in various areas of medical science [47][48][49][50][51]. • Change management with impacted functions and individuals [52]. The PV system spans many areas beyond the safety department of the MAH, and the use of new IT will cause impact to many upstream and downstream stakeholders.…”

Section: Ethical and Policy Implications Of Automation Within Pv Systemsmentioning

confidence: 99%

“…Change management with impacted functions and individuals [ 52 ]. The PV system spans many areas beyond the safety department of the MAH, and the use of new IT will cause impact to many upstream and downstream stakeholders.…”

Section: Ethical and Policy Implications Of Automation Within Pv Systmentioning

confidence: 99%

Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities

Lewis

McCallum

2019

Ther Innov Regul Sci

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There are significant challenges and opportunities in deploying and utilizing advanced information technology (IT) within pharmacovigilance (PV) systems and across the pharmaceutical industry. Various aspects of PV will benefit from automation (e.g., by improving standardization or increasing data quality). Several themes are developed, highlighting the challenges faced, exploring solutions, and assessing the potential for further research. Automation of the workflow for processing of individual case safety reports (ICSRs) is adopted as a use case. This involves a logical progression through a series of steps that when linked together comprise the complete work process required for the effective management of ICSRs. We recognize that the rapid development of new technologies will invariably outpace the regulations applicable to PV systems. Nevertheless, we believe that such systems may be improved by intelligent automation. It is incumbent on the owners of these systems to explore opportunities presented by new technologies with regulators in order to evaluate the applicability, design, deployment, performance, validation and maintenance of advanced technologies to ensure that the PV system continues to be fit for purpose. Proposed approaches to the validation of automated PV systems are presented. A series of definitions and a critical appraisal of important considerations are provided in the form of use cases. We summarize progress made and opportunities for the development of automation of future systems. The overall goal of automation is to provide high quality safety data in the correct format, in context, more quickly, and with less manual effort. This will improve the evidence available for scientific assessment and helps to inform and expedite decisions about the minimization of risks associated with medicines.

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“…Emerging research has indicated familial migraine contains a higher pathologic gene load associated with migraine than sporadic cases [32], while another study has begun to map possible loci containing genes involved in migraine pathology, specifically locating 38 new loci [15]. In addition to physiologic aspects, applications of high end computing are being utilized to analyze high volumes of drug safety data [33]. This approach utilizing personalized medicine has already been put into translational studies for cardiovascular anti-coagulant drugs, such as warfarin, which has highly variable therapeutic windows depending on the DNA variants encoding enzymes in its metabolic pathway.…”

Section: Future Direction Of Field and Precision Medicinementioning

confidence: 99%

https://researchopenworld.com/migraine-a-review-of-basic-clinical-and-translational-approaches-to-new-treatment/#

2019

ARCH Women Health Care

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Migraine is a debilitating neurological primary headache disorder characterized by recurring unipolar headaches lasting 4-72 hours with accompaniment of nausea and sensory sensitivities. Migraine is the most common headache disorder resulting in seeking of medical care [1, 2], in addition to being one of the most debilitating chronic disease conditions in terms of both morbidity and lost economic productivity. Migraine incidence has been observed since ancient times to disproportionately affect women, and most current epidemiological assessments put current incidence estimates at 12% overall for US populations, with an incidence of 18% in women and 6% in men when stratified by sex. This dimorphism of incidence is crucial when assessing overall health of a community, specifically when concerning women's health and therefore must be taken into consideration when developing both clinical and basic models of migraine to enact the best possible outcomes of combined translational research efforts. While major recent advances have been made in the field of pharmacologic intervention for migraine with the recent approval of the anti CGRP and anti CGRP receptor antibody medications, prohibitive cost and limited access have made older treatments, such as the triptans and NSAIDs, still the most commonly utilized medications to combat migraine attacks. Current preclinical research models are heavily interested in modulation of the neuropeptide CGRP, and the phenomenon of cortical spreading depression (CSD), believed to be the underlying trigger of migraine with aura, via pharmacological intervention. Modulations of these phenomena has found to be correlated with menstrual events in women, tying back to the overarching theme of higher morbidity in women. With the advent of pharmacogenomics and personalized medicine, a new epoch of potential customizable treatments looms on the horizon, endearing those afflicted with this severely debilitating condition a new glimmer of hope as research progresses into its next phase.

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Artificial Intelligence and the Future of the Drug Safety Professional

Cited by 40 publications

References 1 publication

Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices

Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices

Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities

https://researchopenworld.com/migraine-a-review-of-basic-clinical-and-translational-approaches-to-new-treatment/#

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