SAN FRANCISCO, California: While artificial intelligence has yet to crack the most complex problem in drug development, discovering breakthrough medicines, pharmaceutical companies say it is already transforming the time-consuming administrative work that surrounds clinical trials and regulatory approvals.

Executives from seven large drugmakers and six smaller biotech companies told Reuters at the JP Morgan Healthcare Conference that AI is helping identify clinical trial sites and participants and draft regulatory documents, cutting weeks from processes that traditionally require extensive manual effort.

Bringing a new drug to market can take a decade and cost about US$2 billion, pharmaceutical companies say. Many firms, including Eli Lilly, which has partnered with chipmaker Nvidia, are betting that AI can also improve the odds of success for experimental medicines.

Drugmakers have announced a wave of deals to adopt AI tools, which executives describe as the most significant technological shift since the internet, mirroring trends across other industries.

So-called agentic AI — systems that operate autonomously with limited human input — could lift clinical development productivity by 35 percent to 45 percent over the next five years, consultancy McKinsey predicted last year.

Israel-based Teva Pharmaceutical Industries said it is applying AI across multiple parts of its business to focus resources on successfully delivering new drugs.

"Everything else that's around that needs to be as efficient and as small as possible," Teva CEO Richard Francis said. "This is where I think AI digitization, modernization, process improvement, all the unsexy stuff that we get actually quite excited about, makes a difference."

Thousands of Documents

Executives from major drugmakers AstraZeneca, Roche, and Pfizer, along with smaller biotechs such as Spyre and Nuvalent, described the challenge of managing thousands of pages of clinical, safety, and manufacturing records required by regulators.

Those documents must be compiled, checked for consistency, and adapted across geographies, often requiring expensive outside contractors, AstraZeneca Chief Financial Officer Aradhana Sarin said.

This eczema patient is testing out a new skin sensor that uses technology from children's toys.

Jorge Conde, a general partner at venture capital firm Andreessen Horowitz, said he is investing in tools to fix what he calls drug development's "messy middle," including a $4.3 million investment in startup Alleviate Health.

Conde described trial enrollment as a "leaky funnel," in which participants drop out at different stages, and said AI could help improve patient outreach, education, screening, and scheduling.

TD Cowen analyst Brendan Smith said the use of AI, including large language models such as Microsoft Copilot, for administrative tasks has become relatively common across the pharmaceutical industry.

Still, Smith said it may take one to three years before investors can clearly measure how much AI is accelerating drug development, noting that cost savings vary depending on how and where the tools are used.

Novartis Uses AI for Heart Drug

Swiss drugmaker Novartis turned to AI in 2023 as it launched a 14,000-patient, late-stage cardiovascular outcomes trial for its cholesterol drug Leqvio, Chief Medical Officer Shreeram Aradhye said.

AI compressed a typical four- to six-week site-selection process into a two-hour meeting, helping Novartis identify higher-performing trial locations and close enrollment with just 13 patients above its target.

"AI becomes augmenting intelligence, not artificial intelligence," Aradhye said.

A Novartis spokesperson said the cumulative time savings from AI can add up to months across a drug development program.

GSK, Genmab, ITM Plan for Savings

British drugmaker GSK said it is combining digital and AI tools to reduce manual data handling and speed trial enrollment, aiming to shorten clinical trials by 15 percent.

That approach helped save about £8 million ($10.87 million) last year in late-stage studies of asthma drug Exdensur, which received U.S. approval last month, a GSK spokesperson said.

Danish antibody developer Genmab said it plans to deploy agentic AI powered by Anthropic's Claude chatbot to support clinical development.

Genmab's head of AI, Hisham Hamadeh, said the company aims to automate post-trial work, including data analysis and the creation of graphs, tables, and clinical study reports.

German radiopharmaceuticals firm ITM said it has developed AI tools to convert lengthy trial reports into U.S. FDA-ready templates, potentially saving weeks of staff time. However, it has not yet rolled them out.

Amgen research chief Jay Bradner said AI is already delivering results across drug development and regulatory preparation.

"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."