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Center of Excellence in Regulatory Science and Innovation

CERSI Scholars

The CERSI Scholars represent individuals with experience at the FDA who are pursuing training in regulatory science at Johns Hopkins. These men and women express a deep commitment to the field and are likely to remain in public service upon completion of their university training. In addition to the distinction of participation in the program, the CERSI provides structured mentoring and privileged access to Agency staff and scientists as well as Johns Hopkins faculty whose work involves regulatory science

Current Scholars


Sheriza Baksh, MPH, PhD

Postdoctoral Fellow, Center for Clinical Trials and Evidence Synthesis
Johns Hopkins Bloomberg School of Public Health
Dissertation: Cardiovascular safety of dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes mellitus

Sheriza Baksh received her PhD in the Department of Epidemiology, concentrating in Clinical Trials and Evidence Synthesis, and is now in a post-doctoral position with the Center for Clinical Trials and Evidence Synthesis' data coordinating center.  While at the School of Public Health, she has previously worked as a research assistant in the data coordinating center for the Center for Clinical Trials and Evidence Synthesis as well as a research assistant for the Risk Sciences and Public Policy Institute.  


Yu Du, MS

Phd Student, department of biostatistics
johns hopkins bloomberg school of public health
dissertation: statistical methods to identify subgroup of patients that benefit from the new treatment in clinical trial

Yu Du is a doctoral student in the Department of Biostatistics at the Johns Hopkins Bloomberg School of Public Health. His research focuses on the development of new, adaptive randomized trial designs to identify patient subgroups that benefit from the new treatment. 


Vy Tran, BS

PhD Student, Department of Environmental Health and Engineering
Johns Hopkins Bloomberg School of Public Health

Vy Tran is a PhD student in the Environmental Health and Engineering Department at the Johns Hopkins Bloomberg School of Public Health. She is currently working at the Center for Alternatives to Animal Testing. Her research focuses on integrating -omics data for system toxicology assessment..


Adarsh Subbaswamy, BS

PHD STUDENT, DEPARTMENT OF COMPUTER SCIENCE
JOHNS HOPKINS WHITING SCHOOL OF ENGINEERING
RESEARCH FOCUS: Improving the reliability of data-driven decision support tools 

Adarsh Subbaswamy is a PhD student in computer science working at the intersection of machine learning and healthcare. In particular, his research focuses on improving the reliability of data-driven decision support tools and reasoning about how to correct biases in observational data.


Bingkai Wang, BS

PHD STUDENT, DEPARTMENT OF BIOSTATISTICS
JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH
DISSERTATION: Clarifying Common Misconceptions about Covariate Adjustment in Randomized Trials

Bingkai Wang is a doctoral student in the Department of Biostatistics at the Johns Hopkins Bloomberg School of Public Health. His research focuses on baseline variable adjustment in randomized clinical trials and development of new estimators of average treatment effect that have high relative efficiency. 


Yuchen Yang, BS

PHD STUDENT, DEPARTMENT OF BIOSTATISTICS
JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH
RESEARCH FOCUS: Survival, longitudinal and multivariate data analysis, clinical trial design and evaluation.

Yuchen Yang is a doctoral student in the Department of Biostatistics and the Johns Hopkins Bloomberg School of Public Health. Yuchen’s research is focused on innovative methods to improve the efficiency and quality of randomized trials. Recently presented research concerns robustness of multiple testing procedures in confirmatory clinical trials that test for treatment effects in multiple populations.


Graduated Scholars


Lauren Brown, PhD, MSPH

PhD, Department of International Health
Johns Hopkins Bloomberg School of Public Health
Dissertation: Stakeholder Preferences and Decision Making in International Health

Lauren Brown is currently an External Evaluator with Catholic Relief Services' SMILE Program. Lauren completed her doctorate in the Department of International Health at the Johns Hopkins Bloomberg School of Public Health. Her research focused on informing decision making through stakeholder engagement and the application of stated-preference methods in international health contexts. Utilizing both qualitative and quantitative methods, her work focused on optimal design and implementation of community-based primary health care programs in Tanzania. She contributed to the CERSI project under the FDA’s Project CURE. This included engaging in the needs assessment and evaluation of a web-based application to be developed by emocha that captured novel uses of existing drugs to treat drug-resistant and neglected tropical diseases in the absence of established safe and effective options.


Lauren (Lee-Lee) Ellis, PhD, MA

PhD, Department of Health Policy and Bioethics
Johns Hopkins Bloomberg School of Public Health
Dissertation: Exploring Patient Engagement in PCORI-funded Health Research

Lauren “Lee-Lee” Ellis is currently a researcher with Mathematica Policy Research. Lee-Lee completed her doctorate in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. Her dissertation focused on the experiences and perceptions of patients and researchers engaged in the generation of scientific knowledge supported by the Patient-Centered Outcomes Research Institute (PCORI).


Kevin Fain, DrPH, JD, MPH

Doctor of Public Health, Department of Epidemiology
Johns Hopkins Bloomberg School of Public Health
Dissertation: Prescription Opioid Use in Elderly Nursing Home Residents

Kevin Fain is currently a Senior Advisor for Policy Research with the National Library of Medicine's ClinicalTrials.gov program. Kevin completed his doctorate in the Department of Epidemiology at the Johns Hopkins Bloomberg School of Public Health. Having worked as an attorney at FDA for 15 years, he has extensive experience in the litigation of cases focused on food and drug safety. His dissertation focused on the utilization, safety and regulation of prescription opioids in nursing homes and other institutional settings.


Emily Huang, PhD

PhD, Department of Biostatistics
Johns Hopkins Bloomberg School of Public Health
Dissertation: Statistical Methods to Determine Proportion who Benefit

Emily Huang is currently a Postdoctoral Fellow in Biostatistics at the Harvard T.H. Chan School of Public Health. Emily completed her doctorate in the Department of Biostatistics at the Johns Hopkins Bloomberg School of Public Health. Her dissertation focused on developing a statistical method that uses randomized trial data to learn about the proportion of patients who would have a better outcome under treatment than under control. 


Ellen Janssen, PhD

PhD, Department of Health Policy and Management
Johns Hopkins Bloomberg School of Public Health
Dissertation: Measuring Treatment Preferences in Patients with Type 2 Diabetes: Using Discrete Choice Methodology

Ellen Janssen is currently a Principal at ICON Plc. Ellen completed her doctorate in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. Her dissertation focused on stated-preferences, using preferences of patients with type 2 diabetes for glucose lowering medications as a case study, and on the role of patient and stakeholder preferences in policy making.


Jimmy Le, MA, ScD

ScD Student, Department of Epidemiology
Johns Hopkins Bloomberg School of Public Health
Dissertation: Exploring a Patient-Centered Framework for Improving Outcome Selection in Clinical Trials

Jimmy Le completed a ScD in the Department of Epidemiology at the Johns Hopkins Bloomberg School of Public Health. His dissertation focused on exploring a patient-centered framework for improving outcome selection in clinical trials. 


Tianchen Qian, PhD

PhD, Department of Biostatistics
Johns Hopkins Bloomberg School of Public Health
Dissertation: Statistical Methods for Improving Efficiency in Adaptive Enrichment Designs and Double Sampling Designs

Tianchen Qian is currently a Postdoctoral Fellow in Statistics at Harvard University. Tianchen completed his doctorate in the Department of Biostatistics at the Johns Hopkins Bloomberg School of Public Health. His research focused on developing a statistical method for improving efficiency in adaptive enrichment designs and double sampling designs.