Some of the biggest names in biotech, pharma, venture capital, and artificial intelligence converged on the San Diego Convention Center this week for BIO International, the world’s largest gathering of the biotechnology and life sciences industry. But the most consequential conversations happened behind closed doors at the nearby Marriott Marquis, where 88 CEOs and senior executives spent hours grappling with a pressing question: What does AI mean for the future of global health care?
“It’s not going to just take one person, one group, or one entity. It has to be all of us moving together,” said Capt. Dianne Paraoan, acting director of the Office of Medical Policy at the Food and Drug Administration, who flew in from Washington to attend the conference. The San Diego Union-Tribune reported that Paraoan participated in discussions about how the FDA should approach AI tools that are increasingly being used in drug discovery and development. The conference drew participants from around the world to San Diego’s waterfront.
The tech industry did not wait for regulatory answers before deploying AI in the lab. During Nvidia’s private panel, executives listed dozens of companies that have deployed AI agents already testing molecules and running experiments, with some outperforming human scientists. Nvidia’s agentic model can create new molecules, predict whether a drug will do well in clinical trials, and run simulated experiments in a fraction of the time of traditional methods.
San Francisco-based Chai Discovery has inked over $1 billion in big pharma deals this year alone. The company built a model that can design molecules and antibodies for drug discovery. CEO Josh Meier said that a year ago, finding a viable antibody meant screening a thousand molecules to get one that worked. “Today that success rate has jumped to 10% to 15%, two orders of magnitude in 12 months,” he said.
On Monday, the Department of Health and Human Services and the FDA announced “Operation Trailblazer,” a broader program designed to speed up drug development from the early investigational stage through late-stage clinical trials. The FDA has been loosening guidelines while creating new AI frameworks. Earlier this year, the agency decided that recommendation-based AI tools did not require premarket review when used with clinician oversight.
However, much of the oversight is done by the companies themselves. “FDA isn’t going to regulate what we haven’t regulated,” Paraoan said, noting that AI lab work does not directly impact patients and therefore falls outside the agency’s jurisdiction. Yet as these models increasingly enter clinical trials, the FDA is under pressure to create more concrete guidelines.
After the conference, some attendees questioned whether self-given safety benchmarks were legitimate. “It’s easy to pass a test that you write,” one attendee said. The debate, held in San Diego, a city that has positioned itself as a global hub for biotech and life sciences, highlights the tension between rapid innovation and regulatory oversight in an industry where the stakes are measured in human lives.
