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Industry Perspective on Artificial Intelligence/Machine Learning in Pharmacovigilance.

Raymond Kassekert1, Neal Grabowski2, Denny Lorenz3

  • 1GlaxoSmithKline, Global Safety, Upper Providence, PA, USA.

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Summary
This summary is machine-generated.

Pharmaceutical companies are increasingly using intelligent automation for safety report processing. Adoption of rule-based automation grew, with interest in AI and machine learning for advanced data interpretation.

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Area of Science:

  • Pharmacovigilance and Drug Safety
  • Intelligent Automation in Healthcare

Background:

  • TransCelerate conducted surveys in 2019, 2020, and 2021 to assess intelligent automation adoption.
  • Member companies (MCs) are key participants in evaluating automation in pharmacovigilance.

Purpose of the Study:

  • To report on the evolving use of intelligent automation in pharmacovigilance processes.
  • To identify trends in the implementation of automation technologies by pharmaceutical companies.

Main Methods:

  • Analysis of data from three annual TransCelerate member company surveys (2019-2021).
  • Focus on the implementation status and types of intelligent automation solutions used in Individual Case Safety Report (ICSR) processing.

Main Results:

  • Significant increase in the implementation of intelligent automation solutions for ICSR processing from 2019 to 2021.
  • Growth observed in rule-based automations like robotic process automation, lookups, and workflows.
  • Sustained high interest in machine learning (ML) and artificial intelligence (AI) for advanced data interpretation and decision-making.
  • Prevalence of using multiple intelligent automation technologies concurrently for ICSR steps.

Conclusions:

  • Intelligent automation adoption in pharmacovigilance is progressing, particularly rule-based solutions.
  • Future advancements are anticipated with ML and AI, though challenges in data and regulatory harmonization persist.