Yale University-Mayo Clinic CERSI

Project Title: Brand Name Extensions Among OTC Drugs

Kanhai is a first-year medical student at Yale School of Medicine. He graduated from Yale College in 2024 with a double major in Economics and Molecular, Cellular, and Developmental Biology. Between college and medical school, he worked in the Office of the CEO at Aledade, where he helped build AI technologies to improve patient care and care coordination. Kanhai is passionate about ensuring healthcare policy and regulation—and the market incentives they shape—are aligned with patient wellbeing and outcomes.

Project Title: Systematic Evaluation of Clinical Validity of Digital Endpoints used in Clinical Trials

Rohini Ghosh, MD, MPH is a Post-Doctoral Associate at Yale CRRIT, Yale School of Medicine and received her MPH in Biostatistics from the Yale School of Public Health. Her research focuses on evaluating the evidentiary basis of clinical decision-making, including the clinical validity of digital endpoints, the evidence behind GLP-1 microdosing practices, and the use of advanced statistical methods to study health system policies such as the impact of the Affordable Care Act on 340B Federally Qualified Health Centers. She aims to advance regulatory-relevant research that strengthens the rigor underlying decisions about the efficacy and safety of drugs, medical devices, and care delivery systems.

Project Title: Toward a New Generation of Causal Hazard Ratio: A Bayesian Machine Learning Approach for Survival Analysis

Ruyi Liu is a third-year Ph.D. student in the Department of Biostatistics at the Yale School of Public Health. Her research leverages advanced Bayesian tools, including Bayesian nonparametric methods, to address complex methodological challenges in causal inference, with a focus on applications in cluster-randomized trials and observational studies. As a CERSI Scholar, her project focuses on developing a novel Bayesian nonparametric framework for identifying and estimating causally interpretable hazard ratio estimands with coherent propagation of uncertainty for applications in survival analysis.

Project Title: Developing Novel Bayesian Semiparametric Change-Plane Regression for Subgroup Identification in Regulatory Science

Dr. Ohnishi is a postdoctoral associate in the Department of Biostatistics at the Yale School of Public Health, within the Center for Methods in Implementation and Prevention Science. His research interests include the development of Bayesian causal inference methods in clinical trials. His CERSI Scholars project develops a new Bayesian change-plane model that enables simultaneous subgroup identification and treatment effect estimation for the identified subgroup.

Project Title: Use of Sentinel ARIA System in Addressing Safety Concerns Identified During Premarket Review of New Drugs and Biologics, 2016-2025

Erfan Taherifard is a Postdoctoral Associate at Yale School of Medicine and a member of the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT). He received his Medical Doctorate and Master of Public Health degrees from Shiraz University of Medical Sciences. Dr. Taherifard’s research examines how medical products are evaluated, regulated, and covered, with the goal of advancing policies that improve patient safety and healthcare quality. His work focuses on assessment of the U.S. Food and Drug Administration’s regulatory framework, with particular emphasis on the safety of medical products across their lifecycle. He also serves on the leadership team of the Yale Open Data Access (YODA) Project, where his work supports clinical trial data sharing and transparency.

Project Title: Assessment of The Prescription Drug User Fee Act Commitment Letters

Therese Ziaks is a Postgraduate Associate at the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT). Her research focuses on prescription drug user fees at the FDA. Her CERSI Scholars project characterizes the performance goals and commitments expected of the FDA for the fifth, sixth, and seventh Prescription Drug User Fee Act cycles.

Project Title: Evaluating User Experience to Advance Implementation and Regulation of AI Voice Technologies in Clinical Practice

Dr. Taylor B. Harrison is a postdoctoral fellow mentored by Dr. Barbara A. Barry and Dr. Michelle L. McGowan at Mayo Clinic in Rochester, MN. Dr. Harrison is trained in biomedical informatics, and her research focuses on justice-informed artificial intelligence (AI), with emphasis on user experience and regulatory science. The aim of her CERSI Scholar project is to develop and validate a modular, workflow-integrated system for assessing clinician and patient experience with AI voice technologies. This work will establish the foundation for a scalable, validated repository of instruments that can be applied to current and future AI technologies, enabling comparison across products and alignment with FDA post-market evaluation frameworks.

Project Title: Cross-Sectional Technical Audit of Data Streams in mHealth Applications Recommended by ORCHA and Available in France and the United States

Victor Montori is a health services analyst in the Knowledge and Evaluation Research (KER) Unit at Mayo Clinic in Rochester, MN. His research has focused on designing, implementing, and assessing the effect of interventions to aid shared decision making. His CERSI scholar project seeks to characterize privacy risks in how mobile health apps handle user data to better support evidence-based policies in digital health technologies.