CERSI Scholars | Center of Excellence in Regulatory Science and Innovation

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

Alyssa Columbus

PHD STUDENT, DEPARTMENT OF BIOSTATISTICS
JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH

Alyssa Columbus is a Vivien Thomas Scholar and PhD student in the Department of Biostatistics. She has over seven years of statistical industry and research experience, including as a data scientist, information security analyst, and consultant. Her research focuses on biomedical data science and informatics, information security and privacy in public health, and statistics and data science education. She is particularly interested in the impact of information security incidents on patient health outcomes and the regulation of IT applications and data in healthcare. Recently, she has also been involved with the National COVID Cohort Collaborative (N3C) and studied the efficacy and safety of COVID-19 vaccines and treatments in vulnerable populations.

Kiefer Ahn, MS

PHD STUDENT, DEPARTMENT OF HEALTH POLICY AND MANAGEMENT
JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH

Kiefer Ahn is a PhD student in the Department of Health Policy and Management. His research focuses on intellectual property of medical devices and effects of regulatory policies and incentives on innovation.

Jesse Anderson, MPH

DRPH STUDENT, DEPARTMENT OF HEALTH POLICY AND MANAGEMENT
JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH

Jesse Anderson is a doctoral student in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. His research focuses on the evolving field of collecting and representing real-world data to support regulatory decisions.

Negin Atri, MPH

DRPH STUDENT, DEPARTMENT OF HEALTH POLICY AND MANAGEMENT
JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH
DISSERTATION: FDA-REGULATED CLINICAL TRIALS AND OPPORTUNITIES FOR IMPROVED ADHERENCE TO FDA LAWS, REGULATIONS, AND GUIDELINES

Negin Atri is a doctoral student in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. Her research focuses on opportunities for improved adherence to FDA clinical trials regulations including Good Clinical Practice (GCP) based on review of the Form FDA-483 database.

Arnaldo Suba Garcia, PT, DPT, MS

MASTERS STUDENT, DEPARTMENT OF REGULATORY SCIENCE
JOHNS HOPKINS KRIEGER SCHOOL OF ARTS & SCIENCES

Arnaldo Garcia is a masters student in the Department of Regulatory Science at Johns Hopkins Krieger School of Arts and Sciences. His research interests focus on developing assessment tools to improve the safe and effective use of electronic health records and softwares as medical devices through regulatory science methodologies.

Brian Gilbert, Sc.B.

PHD STUDENT, DEPARTMENT OF BIOSTATISTICS
JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH

Brian Gilbert is a doctoral student in the Department of Biostatistics. His research lies at the intersection of spatial statistics and causal inference, in particular the assessment of spatially-varying exposures in the presence of confounding, effect heterogeneity, and other complications. As a Gordis Teaching Fellow, he has delivered an undergraduate course about decision-making in the face of uncertainty and the role of statistics in society.

Pavithra Peranamallur Thirumalai, MS

MASTERS, DEPARTMENT OF REGULATORY SCIENCE
JOHNS HOPKINS KRIEGER SCHOOL OF ARTS & SCIENCES

Pavithra Peranamallur Thirumalai is a masters student in the Department of Regulatory Science at Johns Hopkins Krieger School of Arts & Sciences. While pursuing her degree, she is working as a Data Integrity and Software Validation Manager. Her focus is computer system implementation per 21 CFR Part 11 and enabling paperless offices.

Angela Yu, MS

MASTERS, DEPARTMENT OF REGULATORY SCIENCE
JOHNS HOPKINS KRIEGER SCHOOL OF ARTS & SCIENCES

Angela Yu is completing her masters in the Department of Regulatory Science at Johns Hopkins Krieger School of Arts & Sciences. While pursuing her degree, she is working as a Regulatory Specialist II in the medical device and in vitro diagnostic industry based in San Diego.

Jinqi Zhan, MPH

PHD STUDENT, DEPARTMENT OF EPIDEMIOLOGY
JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH

Jinqi Zhan is a Ph.D. student in the Clinical Trials and Evidence Synthesis Track at the Department of Epidemiology. She completed her MPH (Chronic Disease Epidemiology) at Yale University and worked in a biotech company for several years before starting her doctoral training. She gained experience in clinical trial regulatory submissions, Institutional Review Board applications, data monitoring, and patient recruitment in the US and Asia through executing an international oncology trial. For her future research, she hopes to explore adaptive design clinical trials, precision medicine, and regulatory science in cancer drug development.

Graduated 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 completed her 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.

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 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. She contributed to the CERSI project under the FDA’s Project CURE.

Yu Du, PhD

PHD, 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 completed his doctorate in the Department of Biostatistics at the Johns Hopkins Bloomberg School of Public Health. His research focused on the development of new, adaptive randomized trial designs to identify patient subgroups that benefit from the new treatment.

Ala Elhelali, PhD, MSc

POSTDOCTORAL FELLOW, DEPARTMENT OF PLASTIC AND RECONSTRUCTIVE SURGERY
JOHNS HOPKINS SCHOOL OF MEDICINE

Ala Elhelali, PhD, MSc completed a post-doctoral fellowship in the Department of Plastic and Reconstructive Surgery at the Johns Hopkins School of Medicine, focusing on clinical trials for peripheral nerve regeneration and vascular reconstruction.

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

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 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 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 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, 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 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.

Adarsh Subbaswamy, BS

PHD STUDENT, DEPARTMENT OF COMPUTER SCIENCE
JOHNS HOPKINS WHITING SCHOOL OF ENGINEERING
DISSERTATION: IMPROVING THE RELIABILITY OF DATA-DRIVEN PREDICTIVE MODELS

Adarsh Subbaswamy completed his doctorate in computer science working at the intersection of machine learning and healthcare. He is an Oak Ridge Institute for Science and Education (ORISE) fellow at the FDA and in Fall 2023 will begin his role as Assistant Professor of Computer Science at the University of Illinois, Chicago.

Vy Tran, PhD

PHD, DEPARTMENT OF ENVIRONMENTAL HEALTH AND ENGINEERING
JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH

Vy Tran completed her PhD in the Environmental Health and Engineering Department at the Johns Hopkins Bloomberg School of Public Health. Her research focused on integrating -omics data for system toxicology assessment.

Bingkai Wang, PhD

PHD, DEPARTMENT OF BIOSTATISTICS
JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH

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

Yuchen Yang, PhD

PHD, 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 completed her PhD with the Department of Biostatistics in the Johns Hopkins Bloomberg School of Public Health. Yuchen’s research focused on innovative methods to improve the efficiency and quality of randomized trials.