Drugs

Drug Companies Using AI to Speed Submissions

Drug companies say that while artificial intelligence (AI) still cannot find new molecules that could lead to breakthrough drugs, it is being used to speed up some of the tedious, time-consuming aspects of drug development and application submission. “AI is helping find participants and sites for clinical trials and drafting documents for regulators,” a Reuters report says, “shaving weeks off these labor-intensive processes, seven large drugmakers and six smaller biotech companies said at the recent JP Morgan Healthcare Conference.”

The article says companies have announced deals for tools to unleash the promise of AI, seen as the biggest technological upheaval since the Internet. It says the McKinsey consulting firm predicted last year that agentic AI (AI that is autonomous and requires little human intervention) could increase clinical development productivity by about 35% to 45% over the next five years.

Companies reported using AI to track and maintain the thousands of pages of documents needed for regulatory submissions across multiple geographic areas and using it to help with clinical trial participant outreach, education, screening, and scheduling.

A Novartis representative described how the typical four-to-six-week clinical trial site selection process was cut to a two-hour meeting as AI helped identify higher-performing sites and allowed the company to choose participant enrollment with just 13 patients above its total target, describing AI as “augmenting intelligence.”

Amgen research chief Jay Bradner concluded that AI is delivering on multiple fronts in the drug development and regulatory documents preparation process. “What everybody’s waiting for is the AI drug. When do I get the AI drug?” he said. “I actually think those molecules are in pipelines right now.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome