The industry decamps to San Diego this week for BIO 2026, the mid-year ritual where everyone takes the sector's temperature, runs the partnering circuit, and tries to guess what the regulators are about to do. That last part is harder than usual.
Among the many things competing for attention, two are worth carrying into the week. The first is in the room itself: an industry squinting at a US regulator that has lost its commissioner and much of its senior leadership. The second is an ocean away, where the EU has just handed down the first verdict from a market-access system that will eventually judge every new drug in Europe, and attached a warning to it.
At BIO, AI Takes Center Stage and the FDA Arrives Short-Handed
Every June, the BIO International Convention works like a mid-season check-in, the counterpart to January's J.P. Morgan meeting where the year gets its opening forecast. This year it runs June 22 to 25 in San Diego, and the program tells you what the industry is preoccupied with. Artificial intelligence has nudged cell and gene therapy out of the spotlight as the convention's hot topic. But dealmaking, finance, and the perennial question of what regulators will do next remain the gravitational center of the week.
The dealmaking and finance panels still draw the biggest crowds, running alongside thousands of one-on-one partnering meetings. The AI track is large too, mostly small companies showing off platforms and explaining how they are bolting AI onto drug discovery, trial recruitment, data crunching, and due diligence. Running through nearly everything is the China question: the heavy volume of US and European deals with Chinese firms, and Washington's effort to slow China's biotech rise, including the Pentagon putting WuXi AppTec on a possible path to losing federal contracts, and pending legislation that would route biotech equity investments through Treasury review.
But the subplot worth watching is the FDA. Several senior leaders will be in San Diego to talk priorities, against an awkward backdrop: the agency is missing its commissioner, Martin Makary having departed in May, and the senior ranks that emptied out in the purge that followed. The people now running its two most important review centers are doing so in an acting capacity. On June 23, CDER acting director Michael Davis and CBER acting director Karim Mikhail take part in a town hall, both having stepped up only after that purge. The wider regulatory agenda is dense with the year's live wires: children in clinical trials, real-world data, novel endpoints, PDUFA reauthorization, UK drug regulation, animal testing guidance, and how the Trump administration's One Big Beautiful Act will land on Medicare and Medicaid. On June 24, EMA Executive Director Emer Cooke sits for a fireside chat; she retires by April 30, 2027, with the search for her successor already on.