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Implementation of In Vitro Drug Resistance Assays: Maximizing the Potential for Uncovering Clinically Relevant Resistance Mechanisms
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Enabling technologies driving drug research and development.

Panna Vass1, Dara Sevkan Akdag2, Gabriel Enemark Broholm2

  • 1Regulatory Science and Innovation Task Force, European Medicines Agency, Amsterdam, Netherlands.

Frontiers in Medicine
|March 27, 2023
PubMed
Summary
This summary is machine-generated.

This study analyzed the impact of enabling technologies (ETs) on drug development from 2019-2022. It identified emerging technologies for inclusion and proposed excluding underutilized ones from the European Medicines Agency list.

Keywords:
European Medicines AgencyEuropean Medicines Regulatory NetworkInnovation Task Forceenabling technologiesregulatory science

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Area of Science:

  • Pharmaceutical Sciences
  • Regulatory Science
  • Biotechnology

Background:

  • The European Medicines Agency (EMA) prioritizes innovative methods in medicine development.
  • Enabling Technologies (ETs) are novel, fast-growing technologies impacting drug development.

Purpose of the Study:

  • To analyze the impact of EMA-identified ETs on drug development.
  • To track the "Journey of Innovation" for these technologies from 2019-2022.
  • To review and update the EMA's list of ETs.

Main Methods:

  • Analysis of publications, early regulatory interactions, and clinical trials.
  • Scrutiny of EMA submissions data to identify new innovative technologies.
  • Tracking the presence of ETs across different data sources.

Main Results:

  • Significant variations observed in the appearance of ETs across data sources.
  • Identification of emerging technologies for inclusion in the EMA ET list.
  • Proposal for exclusion of certain ETs due to low regulatory and publication activity.

Conclusions:

  • Continuous monitoring of ETs is crucial for drug development innovation.
  • The study provides insights into the innovation journey of new technologies.
  • Supports Europe's leadership in developing innovative medicines and methodologies.