Sandy spent over 15 years inside and outside FDA-regulated companies including Abeona Therapeutics, Corcept Therapeutics, and Atara Biotherapeutics. CIPP/US certified privacy professional. Two provisional patent applications filed February 2026, with Sandy as sole inventor. Stanford Law AI Strategy certificate (in progress), with deep working familiarity with FDA submission requirements and the regulatory frameworks NexusRWE is built around.
NexusRWE holds a growing patent portfolio covering the core query and aggregation architecture, with Sandy Estremera-Zink, JD as sole inventor. The architecture is designed from the ground up for regulatory-grade submissions.
NexusRWE has engaged directly with FDA staff focused on real-world evidence, rare diseases, and AI/ML. That engagement shapes how we think about submission architecture, audit trails, and compliance requirements.
The December 2025 FDA guidance created a new category of privacy-preserving evidence infrastructure. NexusRWE is among the first platforms designed specifically for this regulatory moment, not retrofitted to fit it.
The federated query model powering NexusRWE has been validated in production across major academic medical centers and clinical trial networks. This is not a concept. It has been deployed at scale.
Whether you are evaluating evidence generation, exploring network participation, or considering an investment, we would like to hear from you.