FDA News: Issue 1-2 January 2023

Author: [AUTHOR] Published on 1/27/2023 5:00:00 AM

FDA and M-CERSI Announce a Virtual Public Workshop on the Application of Artificial Intelligence and Machine Learning for Precision Medicine

On February 17, 2023, the US Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will hold a virtual public workshop entitled "Application of Artificial Intelligence and Machine Learning for Precision Medicine." The purpose of this workshop is to review current methodologies, opportunities, challenges, and best practices to address the rapidly changing landscape of artificial intelligence (AI) and machine learning (ML) in the setting of drug development and precision medicine.

As compared to traditional statistical or pharmacometrics modeling, AI/ML excels at handling high dimensional data and often has superior predictive capability, making it a powerful tool for prediction of clinical outcome, including disease prognosis and/or treatment response (for both efficacy and safety) based on patient characteristics and treatment information. AI/ML has potential to improve the efficiency of drug development and advance precision medicine, but also presents challenges such as bias, issues with generalizability, opacity, disparity, fairness, and trustworthiness.

Workshop Objectives:
  1. Review progress made from implementing artificial intelligence and machine learning in drug development and precision medicine.
  2. Discuss methodologies and best practices used today in this field.
  3. Discuss technical challenges such as bias, generalizability, and opacity and how they can lead to issues of data disparity, fairness, and trustworthiness. How to address these challenges will also be discussed.
Date/Time of the Workshop: 
Date: February 17, 2023
Time: 10:00 a.m. – 4:15 p.m. ET

This virtual workshop is open to the public; however, registration is required at the M-CERSI registration website. More information about this event can be found at the Application of Artificial Intelligence and Machine Learning for Precision Medicine workshop webpage.

The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at https://public.govdelivery.com/accounts/USFDA/subscriber/topics and select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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