TransCelerate to Lead AI and Real-World Evidence Charge at PHUSE US Connect 2026

AUSTIN, TX – March 12, 2026 – As the clinical data science community converges on Austin later this month, nonprofit consortium TransCelerate BioPharma is poised to take a leading role, steering critical industry discussions on artificial intelligence, real-world evidence (RWE), and the modernization of clinical trials. The organization's significant presence at PHUSE US Connect 2026, which runs from March 22–26, will feature two high-profile keynotes and participation in several influential panel discussions.

This prominent role at one of the industry's premier data science gatherings signals a concerted push to address the most pressing challenges in drug development. TransCelerate, a collaborative of 18 major biopharmaceutical companies, will leverage the platform to advocate for the practical, patient-centered solutions needed to make clinical research faster, safer, and more efficient. The keynotes will be delivered by two of the organization's leaders: Lilliam Rosario, Ph.D., a Program Director and former FDA official, and Rob DiCicco, Vice President of Portfolio Management.

The New Frontier: AI and Real-World Evidence

The discussions in Austin arrive at a pivotal moment for the pharmaceutical industry. The integration of artificial intelligence and the use of real-world evidence are no longer theoretical concepts but active drivers of transformation. Industry forecasts have highlighted AI's potential to dramatically shorten drug development timelines and reduce costs, while RWE—data derived from electronic health records, patient registries, and wearable devices—is increasingly shifting from a supportive role to a decision-driving one.

PHUSE US Connect, which saw a record-breaking attendance of over 675 professionals at its 2023 event, has become a crucial forum for navigating these complex advancements. TransCelerate’s agenda directly confronts the core issues. The organization has a history of foundational work in this space, having previously completed initiatives focused on establishing frameworks for using Real-World Data (RWD) in regulatory submissions and leveraging rapid data analysis for safety signal assessment. Their presence in Austin represents the next phase of this long-term strategy: driving widespread adoption and solving implementation hurdles through cross-industry collaboration.

Bridging the Implementation Gap in Evidence Generation

A central theme of the conference will be the gap between the promise of technology and its current reality. This issue will be tackled head-on by Rob DiCicco in his keynote, "Modernizing the Clinical Trials Enterprise: Evidence Generation in the Next 10 Years." He is expected to address why the full potential of the 2016 Twenty-First Century Cures Act—specifically its mandate to leverage electronic health data—has yet to be fully realized.

While the legislation was designed to accelerate medical innovation by promoting the use of RWE, progress has been hampered by persistent challenges in data quality, interoperability between systems, and the development of robust analytical methodologies. DiCicco, whose extensive background includes leadership roles at GSK and IBM Watson Health, is uniquely positioned to dissect these issues. His talk will explore how new technologies and collaborative frameworks can finally overcome these barriers to create scalable evidence generation across the entire clinical trial ecosystem.

Furthering this discussion, DiCicco will join a panel on "Transforming Real-World Evidence: Integrating AI, Digital Health and Patient-Centric RWE." He will also participate in a session focused on how standards organizations are working together to break down data silos between research and clinical care, challenging persistent myths about interoperability and showcasing real-world examples of successful alignment.

A Patient-First Approach to Innovation

While technology and data dominate the agenda, TransCelerate is ensuring the ultimate beneficiary—the patient—remains at the forefront. This will be the focus of the keynote by Lilliam Rosario, Ph.D., titled "Patients First: Collaboration and Innovation Shaping the Future of Safe and Effective Medicines." Drawing on her invaluable experience as a former Director within the FDA's Office of Computational Science, Rosario will argue that patient safety is intrinsically linked to the industry's ability to align on data standards and collaborate effectively.

Her presentation will explore how shared standards and structured digital workflows can reduce uncertainty in drug development, strengthen regulatory confidence, and lead to safer, more patient-centric decisions. This perspective is critical as the industry embraces powerful but complex tools like AI, where transparency and trust are paramount.

"Translational safety, in particular, depends on how effectively we align data, standards and collaboration across the industry," said Rosario in a statement leading up to the conference. "PHUSE brings together the leaders shaping clinical data science, making it a timely venue to advance these conversations and support innovation that leads to safer outcomes for patients."

Rosario will also lend her expertise to two key panels. The first, "From Knowledge to Harnessing Insight," will explore how organizations can foster adaptive learning cultures. The second, "Lead the AI Era – Act Now, Transform Pharma," will convene senior leaders to discuss the responsible scaling of AI, balancing rapid innovation with robust governance to build organizational capability and public trust. Her participation underscores the dual need for both technological advancement and the thoughtful, ethical frameworks required to manage it.