Yale University-Mayo Clinic CERSI

Yale University

Guneet Janda

Doctorate of Medicine Candidate, Yale School of Medicine

Project Title: Characterizing the Approvals and Supporting Evidence of Qualified Infectious Disease Products from 2012-2020

Guneet Janda is a medical student at the Yale School of Medicine. His research interests include health policy and clinical trial design. Prior to medical school, he studied biochemistry and then engaged in structural biology research at the National Cancer Institute. He has also worked in the Center for Outcomes Research and Evaluation (CORE) while at Yale. His CERSI scholar project aims to characterize the evidence behind recent antimicrobials in the context of evolving antimicrobial resistance and changes in reimbursement.

• Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics
  

Osman Moneer

Doctorate of Medicine Candidate, Yale School of Medicine

Project Title: Agreement of Treatment Effects from Observational Studies and Clinical Trials Evaluating Therapeutics for COVID-19: A Meta-Epidemiological Study

Osman Moneer is a medical student at Yale School of Medicine interested in health policy for medical technologies. Through the CERSI Scholars program, he is studying the agreement of treatment effects between observational studies and randomized controlled trials for COVID-19 therapeutics. His work seeks to inform future clinical and regulatory decision-making in the context of limited evidence.

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Sara Mullin, PhD, MS

Postdoctoral Fellow, Yale Center for Medical Informatics

Project Title: Identifying Opioid Misuse and Abuse Phenotypes and Subtypes in the Emergency Department

Dr. Mullin's research focuses on modeling information contained in electronic health record and health data repositories. She holds a PhD in Biomedical Informatics and an MS in Statistics. She is primarily interested in using machine and deep learning in conjunction with terminological and ontological information to pursue precision medicine with a focus on substance abuse and mental health outcomes, especially related to the use of opioids. She developed an interest in substance abuse and misuse policy while working as a statistician in a clinical psychology lab and through various drug-drug interaction and substance abuse and misuse prediction projects during her doctoral work.

Reshma Ramachandran, MD, MPP

National Clinician Scholars Program Fellow, Yale School of Medicine

Project Title: Assessment of FDA Approval of Drugs Not Meeting Pivotal Study Primary Endpoints

Reshma Ramachandran, MD, MPP is a health services researcher, family physician, and National Clinician Scholars Program fellow at the Yale School of Medicine. Her research focuses on the realignment of incentives for healthcare stakeholders including pharmaceutical companies, hospitals, and universities towards prioritizing equitable patient access to safe, effective health technologies. Through her CERSI Scholar project, Reshma hopes to determine the frequency of and the rationale for FDA approval of drugs and biologics not meeting pivotal study primary endpoints. Doing so may inform the need for additional confirmatory evidence to help inform decision-making around such therapies for clinicians and patients.

Xiaoting Shi

Doctoral Student, Department of Environmental Health Sciences, Yale School of Public Health

Project Title: Quantitative Bias Analysis Methods for Epidemiological Studies: A Systematic Review

Xiaoting Shi is a current PhD student in the Department of Environmental Health Sciences at Yale School of Public Health. Her research and training focus on synthesizing evidence and conducting meta-research (i.e., research on research) projects. In particular, she is interested in synthesizing and assessing evidence from the literature, evaluating current publication practices, and conducting research on regulatory science. Her current project, which is also an essential component of her doctoral dissertation work, aims to systematically identify, summarize, and compare all the quantitative bias analysis approaches that have been proposed in the existing literature for observational studies. The proposed study has the potential to guide researchers and regulators, who conduct observational studies or make decision on the basis of imperfect data, and therefore, help make optimal use of real-world data.

Mayo Clinic

Jamie Felzer, MD MPH

Clinical Fellow, Pulmonary & Critical Care, Mayo Clinic Rochester

Project Title: Disparities in Vaccine-Preventable Respiratory Illnesses by Race, Socioeconomic Status, and Rurality

Dr. Felzer is a second-year Pulmonary & Critical Care Fellow at Mayo Clinic where she is passionate about researching healthcare disparities and finding actionable ways to reduce these disparities. Her CERSI Scholars research project will evaluate factors of race, socioeconomic status, geographic region and marital status to see if they are associated with respiratory vaccine (COVID-19, influenza, pneumococcus) uptake for adults, including smokers, deemed high-risk for pneumococcal disease in southeastern Minnesota. Longitudinal vaccine data will be compared to COVID vaccination to evaluate if there are factors uniquely impacting COVID immunization. Previously, while obtaining her Master of Public Health at Emory University, Dr. Felzer evaluated disparities in cancer treatment and conducted pneumococcal vaccine research in collaboration with the Centers for Disease Control and Prevention. Dr. Felzer hopes that this research can lead to a successful career combining pulmonary medicine with translational action for reducing disparities in both access to healthcare and related clinical outcomes.

Delaney Liskey, BA

Postdoctoral Student, Regenerative Sciences, Mayo Clinic Graduate School of Biomedical Sciences

Project title: The Utility of OCT Papillary Retinal Nerve Fiber Layer Thickness in Differentiating Recurrent Optic Neuritis

Delaney is a first-year graduate student in the inaugural Regenerative Sciences PhD track, and formerly, a Post-Baccalaureate Research Education Program (PREP) student at the Mayo Clinic. She is interested in promoting regeneration in the central nervous system after degenerative injury, especially for conditions such as multiple sclerosis (MS). Specifically, she is interested in uncovering the cellular mechanisms that underlie vision restoration in this context. Her CERSI Scholars project aims to contribute to clinical trial design by establishing criteria thresholds for retinal swelling and consequent thinning in conditions that cause recurrent optic neuritis.

Vishal Shah, MD

Postdoctoral Fellow, Kern Knowledge Synthesis Center

Project Title: Laboratory Correlates of Infectivity for SARS-CoV-2

Vishal is a research fellow in the Knowledge Synthesis Unit at Mayo Clinic. After completing medical school at St. Louis University, he completed his Internal Medicine training at New York University and his Preventive Medicine fellowship at Mayo Clinic. His research interests include population health, vaccine preventable illness, and the translation from data to guideline development. His primary research currently focuses on improving the understanding and safety of occupationally acquired COVID-19 in the healthcare setting. Additionally, he is working to better understand the burden of chronic hepatitis B in the United States among Immigrants of African descent in the United States.

Andrew Tseng, MD

Cardiovascular Disease Fellow, School of Graduate Medical Education

Project Title: Ambulatory QT Monitoring during Antiarrhythmic Drug Loading Using an Artificial Intelligence-ECG Algorithm on a Mobile ECG Platform

Andrew Tseng is cardiovascular diseases fellow at the Mayo Clinic in Rochester, Minnesota. His research interests include the application of artificial intelligence and mobile device data in clinical cardiovascular care. Specifically, he has been interested in the application of artificial intelligence-enhanced interpretation of electrocardiograms on conditions such as prediction of atrial fibrillation, aortic stenosis, heart failure, etc. His CERSI Scholars project seeks to evaluate the use of artificial intelligence-enhanced interpretation of electrocardiograms obtained from mobile devices for antiarrhythmic drug loading.

Yale University

Victoria Bartlett

Doctorate of Medicine Candidate (2022), Yale School of Medicine
Project Title: Physical Activity, Atrial Fibrillation Episodes, and Patient-reported Symptoms: an analysis of personal digital device data from patients undergoing catheter ablation of atrial fibrillation
(Click here for publication)

Victoria Bartlett is a medical student at the Yale School of Medicine. Her research interests include the use of real world data and health technology to generate medical evidence. Her CERSI Scholars project aims to characterize associations between physical activity and recovery from atrial fibrillation ablation procedures using personal digital device data. Victoria first developed an interest in health technology and innovation while working in management consulting before medical school.

Christopher N. Cross, PhD

Postdoctoral Research Fellow, Yale Cancer Biology Training Program, School of Public Health

Project Title: Public Health Implications for African Americans in Real-World Clinical Trials

Dr. Cross is a population geneticist with expertise in policy and non-profit development. During the 113th Congress, he completed a year on Capitol Hill as a Congressional Science Fellow to the U.S. House of Representatives Committee on Science, Space, and Technology. Prior to joining Yale, he completed a PhD-level internship with BioMarin Pharmaceuticals Inc. in U.S. Regulatory Policy and Patient Engagement. His passion lies in using scientific research to understand and address the etiology of population health disparities. Dr. Cross is the Founder and Managing Director of Cross River Strategies.

Meera Dhodapkar

Doctorate of Medicine Candidate (2023), Yale School of Medicine
Project Title: Characterizing the Evidence Supporting Supplementary New Drug Approvals and New Biologics Licensing Applications for New Indications from 2017-2019
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Meera Dhodapkar is a current MD candidate at Yale School of Medicine whose interests lie in health and drug policy research. She developed an interest in drug policy while pursuing her undergraduate degree from the University of Chicago in Public Policy, with a concentration in Health Policy, where she was before coming to Yale. Her previous research experiences range from basic science to health policy and health outcomes research. She hopes to bring her diverse research experience to her current project, which aims to describe the characteristics of pivotal efficacy clinical trials supporting supplemental new drug and biological licenses approvals for new indications.

Tristan Furnary

Master of Public Health Candidate (2021), Yale School of Public Health
Project Title: Exploring the Potential Role of Acetaminophen in the Developmental Origins of Autism Spectrum Disorder via a Stem Cell Model
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Tristan Furnary is a graduate student at the Yale School of Public Health. His research interests center around the role environmental factors play in the developmental origins of disease. In particular, he is interested in the neurological abnormalities associated by prenatal exposure to non-prescription drugs and environmental toxins. His CERSI Scholars project aims to utilize a stem cell model to assess the genomic effects of acetaminophen on early fetal development. Doing so may offer some understanding as to why maternal use of acetaminophen has been epidemiologically associated with increased risk of Autism Spectrum Disorder in offspring. In the future, Tristan hopes to attend medical school before conducting clinical research as a practicing pediatrician.

Aaron Long

Doctorate of Medicine Candidate (2022), Yale School of Medicine
Project Title: Evaluating Clinical Trial Evidence for Single-enantiomer Drugs Based on Existing Racemic Drugs
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Aaron is a medical student at the Yale School of Medicine. He studied biomedical engineering as an undergraduate and became interested in regulatory research in medical school. His research interests include how clinical trial results are presented in biomedical literature and understood by providers and patients. His current project focuses on chiral switching, a practice in which an existing racemic drug (a mixture of two mirror image enantiomers) is introduced as a new single-enantiomer formulation. The goal of the project is to evaluate the scope of clinical trial evidence available on the benefits of these new drug formulations. In the future, Aaron hopes to incorporate similar research into his practice.

Mayo Clinic

Paul Jacobs, BS

Post-Baccalaureate Student, Mayo Clinic
Project Title: Computational Modelling of MRI Heating from Passive Medical Implants at 7T

Paul is currently a student in the Mayo Clinic’s Post-Baccalaureate Research Education Program (PREP). He became interested in working with medical devices at Drexel University while involved in several engineering focused internships. His primary research interests reside in the application of electromagnetics in medicine and studying ways to improve current imaging techniques. His primary research project involves determining if passive medical implants are compatible with new clinical high field strength MRI scanners through the use of computer simulations. Once finished as a PREP student, Paul plans on pursuing his research goals at the graduate level within a biomedical engineering program.

David H. Jiang, BA

Associate Health Services Analyst, Department of Health Services Research
Project Title: Enhancing FDA Regulation of Artificial Intelligence/Machine Learning Devices and Algorithms

David Jiang is an Associate Health Services Analyst in the Department of Health Services Research. His research interests lie at the intersection of health policy, delivery, and law. His current research projects include analyzing the distribution of cost of healthcare utilization in the United States and the adverse patient outcomes of high deductible health plans. His CERSI Scholars project aims to study by what standard the artificial intelligence/machine learning (AI/ML) software as a medical device (SaMD) are evaluated, and what quality matrices of testing, trials, and data are used to justify and approve an AI/ML SaMD.

Montserrat Lara-Velazquez, MD, PhD

Postdoctoral Research Fellow, Department of Neurosurgery, Mayo Clinic Florida
Project Title: Study of SERPINA3 as a Cerebrospinal Fluid Biomarker for Prognosis and Treatment Response in Patients with Glioblastoma
(Click here for publication)

Dr. Lara-Velazquez is finishing the doctoral portion of the MD-PhD track from the PECEM program from the National Autonomous University of Mexico (UNAM). She is being trained by Dr. Hugo Guerrero-Cazares and Dr. Alfredo Quinones-Hinojosa in the Neurogenesis and Brain Tumors Laboratory at Mayo Clinic Florida. Her research is focused in the effects of cerebrospinal fluid (CSF) on the malignancy of glioblastoma (GBM) cells. More specifically, she investigates the role that molecules in the CSF can have in the regulation of GBM-cells dispersal, and the molecular pathways by which cancer cells can respond to boost cell migration. Her CERSI Scholars project will study the CSF responsive factor-SERPINA3 and its potential role as therapeutic target and biomarker for GBM. Dr. Lara-Velazquez wants to pursue a clinical residency in neurosurgery. In the future, she plans to stablish her own laboratory in neuro-oncology to educate the future generations of neurosurgeon-scientists.

Stephanie Zawada

Predoctoral Student, Mayo Clinic Graduate School of Biomedical Sciences
Project Title: Blockchain Application Feasibility in Telehealth for DSCSA Compliance
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Stephanie Zawada is a predoctoral student and dean's fellow at the Mayo Clinic Graduate School of Biomedical Sciences. Her research focuses on the development and translation of predictive artificial intelligence applications, shuttling secure and interoperable SaMD (Software as a Medical Device) technologies from the modeling phase through clinical validation and into the marketplace. Before Mayo Clinic, she was a consultant for one of Forbes' Most Promising AI Companies (AI 50) and a health policy fellow at a top D.C. think tank, where her recommendations informed the development of telemedicine provisions in the first COVID-19 relief bill.

Yale University

James Johnston

Doctorate of Medicine Candidate (2022), Yale School of Medicine
Project Title: How Health Canada and the FDA Regulate Moderate to High Risk Medical Devices: A Comparative Study
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James Johnston is a medical student at Yale School of Medicine. His research interests include health policy and how it relates to patient outcomes. Currently, he is focusing on projects regarding the regulation of medical devices. His CERSI Scholars project is a comparison between the Canadian and American regulatory systems for medical devices. He first became interested in medical device regulation after doing statistical and coding work for a device start up during his gap year and hopes to incorporate regulatory science research into his future practice.

Jeremy Puthumana

Doctorate of Medicine Candidate (2020), Yale School of Medicine
Project Title: Comparison of Expedited Development Programs Across Four Regulatory Agencies

Jeremy is a medical student at the Yale School of Medicine. He is interested in the impact of the US Food and Drug Administration and its policies on clinical care. In particular, he is interested in special regulatory pathways to expedite the development and approval of promising new therapies. He has previously conducted studies evaluating the FDA's compassionate use program as well as the Breakthrough Therapy Designation.

Mayo Clinic

Tyler Benning

Doctorate of Medicine Candidate (2022), Mayo Clinic Alix School of Medicine
Project Title: Effects of Pediatric Pharmaceutical Legislation on Drug Prescribing Patterns
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Tyler Benning is a medical student at the Mayo Clinic Alix School of Medicine, and he is pursuing a joint degree in the Science of Health Care Delivery. He is interested in the intersections among law, medicine, and politics, as well as in the ways that academic research affects health policy. Tyler is currently studying federal legislation which encourages greater enrollment of children in clinical trials. His project seeks to describe the effects of this legislation on pediatric pharmaceutical prescribing patterns and to assess whether federal policies have been effective in promoting evidence-based prescribing in pediatrics. In the future, Tyler hopes to practice in pediatrics and to study the specific challenges of pediatric health care delivery.

Thulasee (Tulsi) Jose, MD

Post-Doctoral Research Fellow, Department of Anesthesiology and Preoperative Medicine, Mayo Clinic
Project Title: Assessment of Electronic Nicotine Delivery Device Use in Electronic Medical Records
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Dr. Jose is a Postdoctoral Research Fellow training with Dr. David O. Warner at Mayo Clinic and investigating tobacco use interventions during the perioperative period. Dr. Jose is also training to be a physician builder on EHR-Epic and collaborates with the Mayo Clinic Nicotine Dependence Center on the NCI Moonshot Initiative Grant to implement comprehensive tobacco control among oncology patients at the Mayo Clinic Cancer Center. Her current research is focused on developing patient registries within EHR-Epic and optimizing patient-generated EHR data to improve tobacco use (including electronic nicotine delivery devices) assessments in EHR. After her fellowship, Dr. Jose plans to pursue a clinical residency training in Anesthesiology and become a clinician scientist, working on clinical and translational science research to enhance tobacco cessation treatment reach and effectiveness among clinical cohorts.

Cambray Smith, BS

Post-Baccalaureate Research Assistant, Biomedical Ethics Research Program, Mayo Clinic
Project Title: Exploring Oncologists’ Knowledge and Attitudes Regarding FDA’s Expanded Access Program and Right to Try
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Cambray Smith has worked as a research assistant in biomedical ethics since graduating from NC State University in 2018. Her primary projects surround the ethics of regenerative medicine, specifically focusing on the unproven stem cell therapy marketplace and appropriate translation of biomedical advances. Previously, she has worked on studies in anthropology, epidemiology, nutrition, and immunology, covering a wide variety of topics including religion and health beliefs, HPV vaccination, and maternal and infant nutrition. She is pursuing a career in academic medicine, with plans to focus her research on ethical, policy, and regulatory concerns that impact public health.

Kirk D. Wyatt, MD>

Clinical Fellow, Pediatric Hematology/Oncology, Mayo Clinic
Master of Advanced Study Candidate (2020), Health Informatics, Arizona State University
Project Title: Clinical Evaluation of Apple Watch Abnormal Heart Rate and Rhythm Alerts
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Dr. Wyatt is a third-year clinical fellow in Pediatric Hematology/Oncology at Mayo Clinic. He is also completing a Master’s degree in Health Informatics at Arizona State University. His primary research interest is clinical informatics, including patient- and provider-facing health information technology. Research aims include studying the safety and effectiveness of end-user health information technology applications. His CERSI Scholars project aims to study the costs associated with false-positive abnormal pulse alerts from a smartwatch.

Yale University

Greg Rhee, PhD, MSW

NIA Postdoctoral Fellow, Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine
Project Title: Association of Industry Payments to Physicians’ Prescribing Patterns: A Case Study of Recently FDA-approved Prescription Drugs
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Dr. Rhee is a geriatric pharmaco-epidemiologist and health services researcher. He is also a social worker by clinical training. One of his research interests is post-market surveillance of prescription drugs and its association with quality of care and patient outcomes. Through this research project, he is interested in guiding both clinical and public health interventions to improve clinical practice and patient care.

Michael Solotke

Doctorate of Medicine Candidate (2020), Yale School of Medicine
Project Title: Medicare Formulary Coverage After FDA Black Box Warnings
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Michael Solotke is a medical student at Yale School of Medicine. His research interests include policy-relevant issues such as drug safety and insurer formulary coverage. Michael's recent research has focused on characterizing Food & Drug Administration (FDA) black box warnings, and his CERSI Scholars project will examine the impact of black box warnings on Medicare formulary coverage. He developed an interest in health policy while working as a consultant at IMS Consulting Group (now known as IQVIA), where he worked for several years on pharmaceutical and biotechnology projects related to drug pricing, payer issues, research and development, and international health policy.

Tasmeen Shiny Weerakoon, MS

MPH Health Care Management Candidate (2019), Yale School of Public Health in conjunction with Yale School of Management
Project Title: Improving Clinical Trial Diversity via Novel Partnerships between Industry Sponsors, Community Partners, and CTSA Sites

Shiny is a recent graduate of the MS program in Cell, Molecular and Structural Biology at Miami University. Currently, she is an MPH Health Care Management candidate who is committed to a career that applies management tools to advance scientific discovery and patient outcomes. Shiny looks forward to building upon her diverse backgrounds in science research and healthcare management consulting to increase patient diversity in clinical trials. Her research aims to develop a framework for creating novel and strategic partnerships between major partners in clinical trials, such as industry sponsors or Big Pharma, community partners, and CTSA sites. As an emerging healthcare consultant, Shiny has a vested interest in improving patient well-being by aligning incentives of multiple stakeholders in the multifaceted and interconnected healthcare industry.

Audrey Zhang, AB

Postgraduate Associate, Yale School of Medicine
Doctorate of Medicine Candidate (2020), NYU School of Medicine
Project Title: Characteristics of Pivotal Trials Supporting Supplemental Indications for FDA-Approved Novel Therapeutics
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Audrey is a current MD candidate at the NYU School of Medicine with an interest in evidence-based translation of research into policy and practice, including the evaluation of new therapeutics and incorporation into the standard of care. She has previously worked with Connecticut and Massachusetts state agencies on initiatives regarding the appropriate use of medication and pharmaceutical cost containment, respectively. Her recent research has focused on factors influencing FDA decision-making on novel therapeutics, including different forms of evidentiary support.

Audrey was the recipient of the 2019 Society of General Internal Medicine Lipkin award.

Mayo Clinic

Luz Milbeth Cumba Garcia, MS

Predoctoral Student, Mayo Clinic Graduate School of Biomedical Sciences, Department of Immunology
Project Title: Characterization of Plasma-derived Exosomes in Patients with Glioblastoma for Potential Use as Liquid Biopsies
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Luz Milbeth Cumba Garcia is a second-year Immunology PhD student at Mayo Clinic Graduate School of Biomedical Sciences. She taught basic science skills to college science students in China before being recruited to Mayo Clinic’s Post baccalaureate Research Education Program (PREP/PostBac) in 2014. While at Mayo, Luz has worked on the structure of amyloid proteins from amyloidosis patient samples and the pathologic contribution of T cells during acute neuroinflammation, which resulted in two publications. She is currently working with Dr. Ian Parney, analyzing the molecular signature of plasma extracellular vesicles shed from glioblastoma tumors and exploring the potential of these particles as liquid biopsies.

Shaheen Kurani, ScM

Predoctoral Student, Mayo Clinic Graduate School of Biomedical Sciences
Project Title: Area Deprivation Index as a Predictor of Opioid Overdose
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Shaheen is a current predoctoral student at the Mayo Clinic Graduate School of Biomedical Sciences. Her area of focus is mixed methods research and interests include big data and marginalized populations. Shaheen’s current research aim is to understand area deprivation as it relates to opioid overdose mortality in an effort to inform policy surrounding opioid prescriptions. Upon graduating, Shaheen plans to work as a health services researcher improving access and quality of care for populations in need.

Srishti Saha, MBBS, MD

Postdoctoral Research Trainee, Mayo Clinic Division of Gastroenterology and Hepatology
Project Title: Durability and Safety of Fecal Microbiota Transplantation in Clostridium Difficile Infection: A Long Term Follow Up Study

Click the following links for publications:
Gastroenterology, 2019. Long-term safety of fecal microbiota transplantation in the treatment of recurrent Clostridioides difficile infection.
Clinical Infectious Diseases, 2020. Long-term safety of fecal microbiota transplantation for recurrent Clostridioides difficile infection.
Gastroenterology, 2021. Durability of response to fecal microbiota transplantation after exposure to risk factors for recurrence in patients with Clostridioides difficile infection.

Dr. Saha recently completed her Internal Medicine Residency from All India Institute of Medical Sciences (AIIMS), New Delhi, India. She is interested in the human gut microbiome and fecal microbiota transplantation (FMT); specifically, FMT for Clostridium difficile and other infections. FMT is a highly efficacious new therapy which holds immense potential in treating several diseases. As its therapeutic net widens, it will be vital to have robust safety data. In her current project, she plans to study the durability, safety, and tolerability of FMT and provide long-term follow up data. Her future plan is to establish herself as a clinician-investigator and, through similar research, generate high-quality evidence that helps both physicians and patients make well-informed treatment decisions.

Maryam Zolnoori, PhD, MS

Postdoctoral Research Fellow, Mayo Clinic Department of Health Sciences Research
Project Title: Utilizing Patient-Generated Data to Identify Significant Factors Associated with Non-adherence to Antidepressants: A Text Mining Approach
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Dr. Zolnoori is a Postdoctoral Research Fellow in the field of text mining and machine learning at Mayo Clinic. Her long-term research goal focuses on integrating data sources from electronic health records, patient-generated data, and biomedical literature to improve medication non-adherence, pharmacovigilance, and mental healthcare. She is also interested in developing interventions to support and promote patient engagement and patient-centered care. Her diverse educational and research background in health and information science has prepared her with a unique skill-set, such as terminology, statistical analysis, text mining, and knowledge management for tackling complex problems in biomedical informatics research and providing innovative solutions for current healthcare problems.

Yale University

Sanket S. Dhruva, MD

Postdoctoral Fellow, Robert Wood Johnson Foundation Clinical Scholars Program, Department of Internal Medicine, Yale School of Medicine
Project Title: Post-Market Surveillance with a Novel mHealth Platform
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Dr. Dhruva is a board-certified general cardiologist and Robert Wood Johnson Foundation Clinical Scholar at Yale University School of Medicine. His research interests focus on technology assessment, particularly ensuring that therapies employed in clinical practice are targeted to patients who may benefit. He has studied Food & Drug Administration (FDA) approval decisions for high-risk medical devices, Centers for Medicare & Medicaid Services (CMS) national coverage determinations, and Medicare Part D formulary coverage decisions. Dr. Dhruva has a track record of generating research findings that inform evidence development for high-value care and translating them into meaningful, policy-relevant contributions that also make a mark in the scientific literature.

Ravi Gupta, MD

Doctorate of Medicine Graduate 2017, Yale School of Medicine
Project Title: Generic Drug Competition in the US: Role of Drug Acquisitions and Potential of Importation
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Dr. Gupta is a recent graduate of the Yale School of Medicine with an interest in FDA regulation and pharmaceutical policy. His most recent research experience has focused on uncovering barriers in access to medications for patients, including generic availability and drug pricing. He has worked as a Research Assistant for the MIT Jameel Poverty Action Lab in India on rigorous evaluations of health and education development programs. He has also worked with the Centers for Medicare and Medicaid Innovation on designing and implementing state delivery and payment models. Dr. Gupta has gained strong domestic and international research experience from his work in India, Switzerland, Bhutan, and the United States.

Jeremy O’Connor, MD

Postdoctoral Fellow, National Clinician Scholars Program, Yale University School of Medicine
Project Title: Adoption of Immunotherapy Following FDA Approvals: Insights from the Use of Checkpoint Inhibitors
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Dr. O’Connor is a general internist who is committed to a career that advances health equity for patients with cancer. He became interested in health equity during residency, and is pursuing postgraduate training in health services research. His previous work has focused on financial toxicity in cancer treatment, as well as the relation between social isolation and cost-coping strategies among patients with cancer. Because health policy has an important role in rising costs of care, as well as in the equity of care that is delivered to patients, he became interested in work that focuses on the intersection of health policy, access to care, and socioeconomic disparities in cancer outcomes. In addition, he became interested in the role of structural and regulatory processes in the perpetuation of racial disparities in cancer treatment. After fellowship, Dr. O’Connor hopes to work as a clinician-investigator who generates policy-relevant research that informs efforts to reduce barriers to care among vulnerable populations.

Anand D. Gopal, BA, BS

Doctorate of Medicine Candidate (2018), Yale School of Medicine
Project Title: Characteristics of Clinical Studies of Off-Label Indications for Novel FDA-Approved Therapeutics in Ophthalmology
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Anand is a current MD candidate at the Yale School of Medicine and an aspiring ophthalmologist whose academic interests rest at the intersection of meta-research and policy. He hopes to shed light on avenues through which research and regulation may better align to serve clinical decision-making and patient care. He is specifically interested in issues pertaining to integrity and transparency in clinical research and the implications that these issues have on evidence quality. As a rising clinician, Anand has a vested interested in ensuring that clinical practice is driven by the highest standards of unbiased evidence.

Mayo Clinic

Ali Duarte-Garcia, MD

Rheumatology Fellow, Mayo Clinic
Project Title: Clinical Uptake, Utilization Patterns and Safety of Belimumab and Rituximab in Systemic Lupus Erythematosus

Dr. Duarte-Garcia is a Rheumatology Fellow at the Mayo Clinic focusing on comparative effectiveness of biologic medications in multiple inflammatory arthritides. Dr. Duarte-Garcia plans to identify the best practices to deliver rheumatologic care that are efficient, safe, and cost effective.

Joseph A. Gottwald, PharmD

Doctorate of Medicine Candidate (2020), Mayo Clinic School of Medicine
Project Title: Effect of Sodium Channel Blocking Antiepileptic Drugs on Electrocardiogram Markers of Sudden Cardiac Death in Epilepsy
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Dr. Gottwald is a graduate of the Doctor of Pharmacy program at Albany College of Pharmacy and Health Sciences. As an MD Candidate at Mayo Clinic School of Medicine, he hopes to integrate a focus on pharmacotherapy into his future practice. His current research aims to develop improved predictive models and preventative strategies for patients at high risk of cardiac arrhythmias and sudden death, with a particular focus on patients with epilepsy.

Yanina Natanzon, PhD, MS

Postdoctoral Research Fellow, Mayo Clinic
Project Title: Germline Genetic Variation Effect on Second-Line Drug Efficacy in Epithelial Ovarian Cancer
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Dr. Natanzon is a Postdoctoral Research Fellow in the field of Cancer Genetic Epidemiology. During her undergraduate training, she collected and evaluated prospective epidemiological data for a CDC-funded project as part of the San Francisco Department of Public Health Tuberculosis Control Division. She has further built upon this knowledge during her doctoral work in genetic epidemiology, during which time she collaborated with a large multi-ethnic women’s cohort study and designed a project utilizing repeated measures modeling to evaluate how genetic variation affects complex traits over time. She has also tackled methodological difficulties by applying multivariate analysis and data reduction techniques to real-world multi-omic datasets, and computational approaches to solve these problems. Dr. Natanzon has been immersed in learning all aspects of ovarian cancer etiology and treatment in her postdoctoral training at Mayo. Prior to her doctoral program, she completed a Master’s degree in applied anatomy which included in-depth study of the four anatomical sciences. Her long-term research interests lie in how the utilization of pharmacogenomics data, incorporated into the FDA regulatory guidelines, can aid optimization and repurposing of currently available drugs to improve survival in rare and recalcitrant cancers.

Liwei Wang, MD, PhD

Research Fellow of Medical Informatics, Mayo Clinic
Project Title: Combining Electronic Medical Records with Spontaneous Reports in Discovering Adverse Drug Events: A Case Study of Conventional DMARDs for Rheumatoid Arthritis
(Click here for publication)

Dr. Wang’s current work is centered on drug knowledge discovery, based on various data sources such as Electronic Medical Records (EMRs), drug package inserts, and the FDA Adverse Event Reporting System (FAERS). She has medical informatics training and research experience in ontology and Natural Language Processing (NLP) as well as medical sciences. Previously Dr. Wang has leveraged NLP methods to normalize FAERS and produced a freely accessible knowledge-enhanced data mining set, i.e., AERS-DM. After joining the Mayo Clinic, she worked on a U24 project and compared three information sources for smoking information, including narrative text of clinical notes, patient-provided information, and diagnosis codes in EMRs. In terms of academic service, she has helped organize AMIA iHealth 2016 Pre-Conference Workshops, Innovative Informatics and Analytics in Medicine, and the 2014 Workshop on Translational Biomedical and Clinical Informatics in conjunction with the 8th International Conference on Systems Biology and the 4th Translational Bioinformatics Conference (ISB/TBC 2014).