Current Status and Future Directions: The Application of Artificial Intelligence/Machine Learning for Precision Medicine.

Journal: Clinical pharmacology and therapeutics
Published Date: Jan 3, 2024

Abstract

Technological innovations, such as artificial intelligence (AI) and machine learning (ML), have the potential to expedite the goal of precision medicine, especially when combined with increased capacity for voluminous data from multiple sources and expanded therapeutic modalities; however, they also present several challenges. In this communication, we first discuss the goals of precision medicine, and contextualize the use of AI in precision medicine by showcasing innovative applications (e.g., prediction of tumor growth and overall survival, biomarker identification using biomedical images, and identification of patient population for clinical practice) which were presented during the February 2023 virtual public workshop entitled "Application of Artificial Intelligence and Machine Learning for Precision Medicine," hosted by the US Food and Drug Administration (FDA) and University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI). Next, we put forward challenges brought about by the multidisciplinary nature of AI, particularly highlighting the need for AI to be trustworthy. To address such challenges, we subsequently note practical approaches, viz., differential privacy, synthetic data generation, and federated learning. The proposed strategies - some of which are highlighted presentations from the workshop - are for the protection of personal information and intellectual property. In addition, methods such as the risk-based management approach and the need for an agile regulatory ecosystem are discussed. Finally, we lay out a call for action that includes sharing of data and algorithms, development of regulatory guidance documents, and pooling of expertise from a broad-spectrum of stakeholders to enhance the application of AI in precision medicine.

Authors

  • Kunal Naik
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Rahul K Goyal
    Center for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, Maryland, USA.
  • Luca Foschini
    Evidation Health, Inc., San Mateo, CA, USA.
  • Choi Wai Chak
    Business Strategy, Owkin, Paris, France.
  • Christian Thielscher
    Competence Center for Medical Economics, FOM University, Essen, Germany.
  • Hao Zhu
    State Key Laboratory of Advanced Technology for Materials Synthesis and Processing, Wuhan University of Technology Wuhan 430070 PR China chang@whut.edu.cn suntl@whut.edu.cn.
  • James Lu
    Modeling and Simulation/Clinical Pharmacology, Genentech, South San Francisco, CA.
  • Joseph Lehar
    From the Departments of Radiology (J.Z., J.T., J.S., A.S.) and Neurosurgery (M.P., M.B., A.C., J.B., E.K.O.), Icahn School of Medicine, 1 Gustave Levy Pl, New York, NY 10029; and Department of Bioengineering and Bioinformatics, Boston University, Boston, Mass (J.L.).
  • Michael A Pacanoswki
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Nadia Terranova
    Merck Institute for Pharmacometrics, Merck Serono S.A., Switzerland, a Subsidiary of Merck KGaA, Darmstadt, Germany. nadia.terranova@merckgroup.com.
  • Neha Mehta
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Niklas Korsbo
    Pumas AI, Annapolis, Maryland, USA.
  • Tala Fakhouri
    Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Qi Liu
    National Institute of Traditional Chinese Medicine Constitution and Preventive Medicine, Beijing University of Chinese Medicine, Beijing, China.
  • Jogarao Gobburu
    Center for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, Maryland, USA.

Keywords

External Resources

Popular Topics
Recent Journals