Medidata Attends Reagan-Udall Foundation for FDA Gala to Receive Prestigious 2022 Innovation in Regulatory Science Award

Medidata Link, the world’s first comprehensive data-linkage solution, has been awarded the prestigious 2022 Innovations in Regulatory Science Award from the Reagan-Udall Foundation for the FDA—also known as the FDA Foundation. The Innovation Award recognizes individuals or organizations that have made particularly groundbreaking contributions to regulatory science or policy to improve public health.

The FDA Foundation embodies the FDA’s vision of collaborative innovation to address regulatory science challenges of the 21st century. They help create new, applied scientific knowledge, tools, standards, and approaches the FDA needs to evaluate products more effectively, predictably, and efficiently—thereby enhancing the FDA’s ability to protect and promote the health of the American public. 

“Medidata Link’s ability to facilitate data linkage at scale represents a new frontier in clinical development and regulatory science, and we are proud to honor Medidata with our Innovation Award,” said Susan C. Winckler, RPh, Esq., CEO of the Reagan-Udall Foundation.

Medidata Link’s potential was especially apparent during the COVID-19 pandemic, when the technology was used to monitor the long-term safety of a top pharmaceutical company’s breakthrough investigational therapy. The solution was recognized as a powerful tool that generates the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. It allows sponsors and regulators to connect and analyze once-disparate data sources to bridge the gap between the clinical trial and real world.

Medidata Link collects and stores personally identifiable information (PII)—after patients consent—in a secure and fully certified environment that seamlessly integrates into existing clinical trial workflows. The PII is then de-identified through a process called “tokenization.” This “token” enables linkage to a broad, scalable, and centralized RWD ecosystem through Medidata’s technology partnerships. Those partnerships represent real-world data ecosystems which cover 85% of the US patient population.

This year’s gala reception was held at the Mayflower Hotel in Washington D.C., with an address by Robert M. Califf, M.D., Commissioner FDA and acceptance remarks by Medidata co-CEO Sastry Chilukuri. Alongside Medidata Link, the 2022 honorees include:

• Leadership Award: Robert Temple, MD, Senior Advisor for Clinical Science Center for Drug Evaluation and Research, for his lifetime commitment to the FDA’s public health mission
• Advocacy/Policy Award: George Vradenburg, UsAgainstAlzheimer’s, for his tireless advocacy for raising awareness and increasing engagement for Alzheimer’s and dementia