FDA Releases A Discussion Paper on Artificial Intelligence and Machine Learning in Drug Development

FDA Releases A Discussion Paper on Artificial Intelligence and Machine Learning in Drug Development

Rohit Mahajan

The U.S. Food and Drug Administration has published and released a comprehensive "paper for discussion" designed to spur the conversation about artificial intelligence and machine learning in drug development and manufacturing.

The discussion paper is a collaboration among the FDA’s Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health, including its Digital Health Center of Excellence. The paper aims to spur a discussion with interested parties in the medical products development community, such as pharmaceutical companies, ethicists, academia, patients and patient groups, and global counterpart regulatory and other authorities, on using AI/ML in drug and biologic development, and the development of medical devices to use with these treatments.?

According to an FDA press release regarding the discussion paper, "The paper includes an overview of the current and potential future uses for AI/ML in therapeutic development. It also discusses the possible concerns and risks associated with these innovations and ways to address them.”

For example, the paper describes the importance of having human involvement, which will vary depending on how the technologies will be used. The paper also emphasizes adopting a risk-based approach to evaluate and manage AI/ML in facilitating innovations and protecting public health.?

The paper characterizes certain risks, such as biases in data used to train ML algorithms or inaccuracies and completeness of these data. In addition, the paper outlines the role of monitoring the performance of models to ensure they are reliable, relevant, and consistent over time.

The agency says that releasing the paper represents the FDA's commitment “to ensuring that drugs are safe and effective while facilitating innovations in their development.”

In a statement about the purpose of the paper, the FDA said, “As with any innovation, AI/ML creates opportunities and new and unique challenges. To meet these challenges, FDA has accelerated its efforts to create an agile regulatory ecosystem that can facilitate innovation while safeguarding public health.”

Adding, “As part of this effort, [FDA and its collaboration partners] issued an initial discussion paper to communicate with a range of stakeholders and to explore relevant considerations for the use of AI/ML in the development of drugs and biological products. The agency will continue to solicit feedback as it advances regulatory science in this area.”

Citadel and AI for Drug Discovery

Citadel Discovery ( https://www.citadeldiscovery.io/) was launched in 2021 and has since taken a leading role in promoting AI and ML for drug discovery and research. We hope that we can contribute to the FDA's call for discussion on this very crucial topic.

Citadel brings much real-world experience to this discussion. We created a kind of “open access” to the data and technology that will drive the future of pharma research with the ultimate goal of streamlining and lowering the costs of drug discovery and biological research.

The costs of drug discovery continue to rise, with current estimates exceeding $2 Billion. Not to mention that bringing a drug successfully through all clinical trial phases takes, on average, 10-12 years in research and development. Artificial intelligence and machine learning in drug discovery hold the key to reducing these costs and timelines.

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You can read much more about how AI is redefining drug discovery in my new book Quantum Care: A Deep Dive into AI for Health Delivery and Research . It’s a comprehensive look at how AI and machine learning are being used to improve healthcare delivery at every touchpoint, with a particular emphasis on drug discovery and Pharma research.

Rohit Mahajan is the President and Co-Founder of Citadel Discovery. He has particular expertise in the development and design of innovative solutions for clients in Healthcare, Financial Services, Retail, Automotive, Manufacturing, and other industry segments.

Citadel Discovery is dedicated to leveraging AI and MI for the purpose of democratizing access to the data and technology that will drive the future of biological exploration, drug discovery, and health technologies.?If you would like to benefit from our expertise in these areas or if you have further questions on the content of this article, please do not hesitate to?contact us .

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