BIO 2026: Crowley On Competing With China And Modernizing The FDA

John Crowley, president and CEO of the Biotechnology Innovation Organization (BIO), held an exclusive press conference at this year’s BIO International Convention in San Diego where he reflected on the industry’s 50-year history and offered an optimistic look at the years ahead. He fielded audience questions and provided updates on BIO initiatives around increasing clinical trials, strengthening U.S. biotech’s leadership relative to China, and the industry’s use of artificial intelligence.

Cutting The U.S. Ecosystem’s Reliance On China

“Biotechnology is a national security imperative,” Crowley stressed in his response to a question about the Biosecure Act and competition with China.

“We believe that the world is a better, safer, healthier, and more prosperous place when the U.S., together with their allies, continue to lead in biotechnology, and we need to be very clear-eyed about the challenges and the threats,” Crowley told the audience.

Of course, China’s intention to take this lead is no secret. They’ve laid out their plan and have executed it well, admitted Crowley, providing great science and great services in the process. The U.S. needs to avoid the dependency “trap” China is trying to create, Crowley says, and reduce its reliance on Chinese products and services.

According to Crowley, there’s tremendous bipartisan support across the U.S. to maintain our lead and independence in biotech. He says BIO is working closely with Congress to devise appropriate strategies and policies to that effect, while also acknowledging that blanket bans on Chinese products and services are not practical.

“I do worry about the unintended consequences and effectiveness of trying to put bans in place,” said Crowley. He believes they can be disruptive and potentially distract from the real work of fostering innovation, and they may also risk restricting U.S. access to life-saving technologies.

To truly advance its lead in the industry and out-compete China, the U.S. needs to focus on reforming its systems to enable innovative breakthroughs and increase speed to market, which BIO and this administration are “perfectly aligned” on, said Crowley.

Embracing AI Is A Key BIO Initiative

Next to the U.S.’ competition with China, Crowley named AI as the second key initiative BIO is focusing on. He expressed optimism in its ability to transform the industry, from accelerating discovery to improving clinical trials, patient selection, data interpretation, regulatory reviews, and patient access. This optimism was tempered by acknowledging the disruptive nature of the technology, especially for biotech, where long development timelines and regulatory red-tape conflicts with Silicone Valley’s motto of “Move fast and break things.”

One particular challenge Crowley noted was the major disparity between small and large biotech companies.

“Our biggest companies have the resources and the focus to think about AI,” he said, resources that smaller companies simply don’t have.

While it seems like BIO recognizes this disparity and its implications, Crowley didn’t offer specifics on how exactly the organization plans to bridge this gap.

He did, however, note that the organization is working to bring on experts to inform the conversation, highlighting the recruitment of people like Joe Franklin, Ph.D., BIO’s chief legal and policy officer, whose background at both Google and the FDA offers the kind of regulatory and digital expertise needed to navigate these early stages.

Expanding Clinical Trials

During the media Q&A, Crowley highlighted the U.S. Department of Health and Human Services’ (HHS) cross-agency Operation TrialBlazer initiative, a roadmap of strategic reforms to modernize and accelerate medical product development in the U.S. According to Crowley, this program was informed by a white paper BIO provided to former FDA commissioner Marty Makary last fall, as well as a subsequent working session with the Reagan-Udall Foundation and top leadership from the FDA’s drug and biologics divisions.

“The fact is, drug development has just gotten too costly, too burdensome, and it takes too much time,” Crowley said. “And in this world, in a bioeconomy where we need to compete and out-compete countries like China, these are the reforms that are needed.”

The ultimate goal is to “open the top of the funnel,” Crowley said, to get more programs quickly and efficiently into clinical trials, an approach he compared to Australia’s regulatory system: “Mindful and making sure to protect patient health, but also realizing that the FDA needs to be a beacon of innovation.”