The biggest obstacle to accelerating new drugs is not AI, but regulatory fragmentation between countries.

The pharmaceutical industry is at a crossroads where technological innovation is moving at one speed, and regulation at a very different one . To analyze this landscape, representatives from Veeva Systems—Anthony Corso, Vice President of Public Policy; Crystal Allard, Regulatory Strategist and former FDA official; and Werner Engelbrecht, Director of Clinical Strategy—met in a roundtable discussion at the Veeva Summit 2026 , which explored the challenges of a world seeking to eliminate paper in clinical development management but fearing artificial intelligence (AI).

The conversation began with refreshing candor from Crystal Allard. After 15 years at the FDA, Allard knows the regulator's inner workings well. "Veeva used to be a passive recipient of information, but today we decided to be proactive," she stated. Her criticism was directed at a technical complexity that sometimes borders on the absurd: "There are countries that still require page numbering to go down instead of up. The patient doesn't care about the number format; they care about access to medicine. We are fighting against requirements that slow down processes without adding any real value ."

The clash of two worlds: USA vs. Europe

The debate intensified when comparing the two sides of the Atlantic. According to experts, while the European Union's AI Act seeks to "put up guardrails" before the car even starts moving, the United States has opted for a "Pandora's Box" approach: seeing what happens and adjusting as it goes . Werner Engelbrecht, with his experience at the Austrian Agency for Medicines and Health Products (EMA network), offered a balanced perspective: "AI in Europe feels over-regulated, but we must sell it as a safety net. If patients feel protected by the law, they will participate more in clinical trials."

For his part, Anthony Corso offered a perspective from the research field. For him, the biggest enemy is fragmentation. " There's nothing standardized from country to country, or from market to market. Everything is fragmented ," he lamented. Corso, who describes his role as an advocate for legislation that incentivizes technology, emphasized that public policy must cease being a barrier and begin to be the driving force that simplifies the lives of research centers and, consequently, patients.

The human side of the digital transition

In a more intimate interview with Gaceta de Salud, Anthony Corso moved away from technical jargon to show the more human side of this digital transition. When asked if technology will end up excluding the most vulnerable, Corso sighed empathetically: "Look, we mustn't let perfection be the enemy of what is 'good enough.' If we can get 80% of consent done digitally, we will have gained precious time ."

Corso recalled, laughing, that he himself bought his house using DocuSign, but that in clinical trials we're still stuck in a mountain of paperwork. "It's crazy. 67% of consent forms are still on paper . If someone in a rural area has to travel three hours to sign a form or get their blood pressure checked, we're failing them. With a wearable device and a video call, we give them back their lives. It will never be 100% digital—I still go to the doctor and they give me a printed form—but we're fighting to make that the exception, not the rule."

AI as the invisible "reviewer"

The roundtable also addressed the growing trend of both sponsors and regulators (FDA and EMA) using AI to evaluate applications. "There's increasingly more AI on the sponsor side and more AI on the regulator side evaluating each other's output," Allard explained. This raises a liability dilemma: if the algorithm fails, who is responsible? The experts' answer was unanimous: ultimate responsibility remains with the human and the sponsor, who must ensure accurate and verifiable data .

However, transparency remains a challenge. While the FDA has been more open about how it is prototyping AI tools to expedite reviews, the EMA maintains a more reserved profile . "We know they're using it, but they're not telling us how," Corso noted. This lack of communication creates unnecessary friction in an industry that needs clarity to invest in new data-sharing platforms.

The future is built with standards that speak the same language

The closing session focused on the need for a digital "Esperanto" for healthcare. Crystal Allard appealed to standards organizations like HL7: " You've created duplicate standards for the FDA and the EMA. Please stop doing that . That complexity makes it harder to build technology that's fun to use." The goal, according to the speakers, is a future where data exchange is natively digital, eliminating the absurd process of manually printing, scanning, and validating.

Ultimately, the message from the Veeva Summit 2026 was clear: the technology is ready, the industry has the will, but regulation must evolve from censoring formats to facilitating innovation . As Corso aptly summarized before closing the session: "At the end of the day, what we need is for the wheels to turn smoothly so that medicines reach those who need them sooner."