CERSI Scholars - Advancing Science to Improve Public Health
Are you an affiliate of Georgetown University or MedStar Health who is committed to improving public health or medical product development through research and education?
About CERSI Scholars
CERSI Scholars is a collaborative effort between the Georgetown CERSI, Georgetown University Medical Center (GUMC), and MedStar Health Research Institute (MHRI). The program engages individuals who are deeply committed to public health and actively pursuing research, education, or training in regulatory science.
CERSI Scholars will raise awareness among their peers and throughout their careers about regulatory science and how its application can improve innovation in medical product development. This program will elevate training and mentorship opportunities for rising leaders in regulatory science.
Submit the following materials, in the order listed, as a single PDF:
- Cover Letter (no more than 500 words) describing professional background, interest in regulatory science, and how participation in the program will contribute to your career goals.
- Curriculum vitae or Resume
- Regulatory Science Research Proposal (1-2 pages including references): The proposal should discuss the project that the research stipend will support. The proposal may describe a novel project or on-going research that is relevant to regulatory science. If you have questions about how your current research projects (or interests) are regulatory science relevant, please contact us for a consultation.
- One professional letter of reference from Georgetown or MedStar faculty or staff; letters should be addressed to Daphne Guinn, PhD, Fellow in Regulatory Science, Program for Regulatory Science & Medicine, Georgetown University Medical Center (GUMC).
- PDF filename should follow this format: Applicant Last Name. GU CERSI Scholars Application.pdf.
Submit applications to Daphne Guinn via email (firstname.lastname@example.org).
Application deadline is June 15, 2017
For more information, please review the complete Request for Applications (RFA).
- CERSI Scholars are provided with research stipends of up to $5,000 to be applied toward related activities, such as support ongoing research, fees associated with peer-review publication, or travel costs to conferences.
- CERSI Scholars will have access to structured mentoring from Georgetown and MedStar faculty whose work involves regulatory science as well as FDA staff and scientists.
Duration and Program Activities
- This is a one-year program, which will allow Scholars to engage with their peers and thought leaders from industry, academia and the FDA to discuss important topics in regulatory science.
- Scholars will be required to attend all seminars and will be expected to give a presentation on their work.
- For an overview of the program in its inaugural year, review the Progress Report.
2016-2017 CERSI SCHOLARS
G. Elliott Cook, MS Graduate, Regulatory Science Progream, GUMC / Chief Pharmacist, Provider Resources, Inc.
Dr. Cook is the Chief Pharmacist for Provider Resources, Inc. (PRI), a consulting firm based in Erie, PA. In this role, he provides drug information support, clinical expertise, policy guidance and oversight to two of PRI’s national contracts within the Centers for Medicare and Medicaid Services (CMS). Dr. Cook received a Doctor of Pharmacy Degree (PharmD) from Lake Erie College of Osteopathic Medicine (LECOM) School of Pharmacy, completed an American Society of Health-System Pharmacists accredited Post-Graduate Year One (PGY1) Pharmacy Residency at Hillcrest Hospital – A Cleveland Clinic Hospital, and completed his MS in Clinical and Translational Research, Regulatory Science concentration, from Georgetown University in 2016. Dr. Cook has a demonstrated yet nascent interest in regulatory science. His research interests include using real-world data to inform the FDA about the effectiveness of public-facing communications, including drug labels, medication guides, and drug safety alerts to prescribers; he has presented related research at the FDA and at national conferences.
Sarra Djemil, PhD Candidate, Department of Pharmacology and Physiology, GUMC
Ms. Djemil’s thesis research focuses on the role of nicotinic cholinergic receptors in modulating neural network dynamics and how nicotine, a widely used addictive drug, shifts the default state of the network. Although nicotine has been implicated in promoting cancer, many studies have shown that nicotine is also a neuroprotective cognitive enhancer. This dual effect of risk and benefit is not unique to nicotine, and is one of the main reasons that regulatory science is an essential discipline within the biomedical field. Ms. Djemil believes that there is an inherent ethical obligation on every participant in the drug discovery process, whether at the basic or translational level, to ensure that these risks and benefits are clearly communicated. As a pharmacologist, Ms. Djemil’s goal is to advance innovation in drug discovery and medical products. The CERSI Scholar program will facilitate her arrival at this goal as she gains access to the necessary training and mentorship by leaders in regulatory science.
Zach Hettinger, MD, MS, National Center for Human Factors in Healthcare, MedStar Health
Dr. Hettinger is an Assistant Professor of Emergency Medicine at Georgetown University of School of Medicine and the Medical Director of the National Center for Human Factors in Healthcare. He is board certified in Emergency Medicine and Clinical Informatics and has a Master of Science in Clinical Investigation. In these roles, Dr. Hettinger has the opportunity to translate the languages of medicine, informatics, and human factors with the goal of improving patient safety and healthcare processes. His primary interests include health information technology, adverse event analysis, and data visualization as they pertain to reducing hazards in the healthcare environment. He has received funding from the NIH, ONC, AHRQ, VA, and several foundations to pursue these avenues of applied research while practicing clinically at MedStar Union Memorial Hospital. As a CERSI Scholar, he is particularly interested in how regulatory science can be used to study the role of health IT systems in the safe use of medications, specifically preventing Look-Alike/Sound-Alike medication errors.
Megan Huizenga, PhD Candidate, Department of Pharmacology & Physiology, GUMC
Ms. Huizenga’s thesis research, under the direction of Dr. Patrick Forcelli, focuses on elucidating specific molecular targets that contribute to the development and persistence of epilepsy despite anti-epileptic drug (AED) treatments. The current first and second line drug treatments for epilepsy are wrought with both adverse developmental and cognitive consequences. Despite the emergence of newer AEDs, some of these adverse effects still persist. To address this treatment gap, Megan is evaluating the therapeutic potential of novel receptor targets in a neonate animal model of epilepsy in addition to using a zebrafish model for high throughput screening of the effect of numerous AEDs on neuronal apoptosis. Additionally, in an adult animal model of epilepsy, Ms. Huizenga is determining the role of the upregulation of localized brain-derived neurotrophic factor in neuronal dendrites as a mechanistic contributor to seizure development. This work will elucidate a potential drug target that will aim to prevent the progression of seizure activity into epilepsy. Using this two-pronged approach, she will determine novel therapeutic targets that minimize adverse effects, for the treatment of epilepsy. In these drug discovery efforts, Ms. Huizenga is looking at both the effect of current AED treatments in neonatal development and identifying molecular drivers of seizure development in adult animal models.
Monica Javidnia, PhD Candidate, Department of Pharmacology & Physiology, GUMC
Ms. Javidnia is working toward her PhD in pharmacology, under the mentorship of Dr. Charbel Moussa, who has successfully taken the FDA-approved cancer drug nilotinib from cells to animal models to his upcoming Phase II clinical trial in Parkinson's disease. In addition to working with Dr. Moussa, Ms. Javidnia will be working on preclinical research on a new compound to see if it will also be a potential therapeutic for neurodegenerative diseases, a unique research opportunity. Ms. Javidnia works closely with Dr. Moussa to learn about the vast amounts of regulatory requirements associated with taking a drug from the bench to the bedside. She is very passionate about this translational work and wishes to continue in the field after graduation.
Roxanne Jensen, PhD, Assistant Professor, Department of Oncology, GUMC
Dr. Jensen is an Assistant Professor at Georgetown University in the Department of Oncology and a member of the Cancer Prevention and Control Program at the Lombardi Comprehensive Cancer Center. Dr. Jensen is an expert in the development and validation of patient-reported outcomes (PROs) measures in oncology, with a focus on new NIH-sponsored measurement systems (PROMIS and PRO-CTCAE). Her research interests include: measuring cancer treatment-related symptoms, function, and quality of life and integrating routine electronic symptom screening in clinical care settings. She is interested in collaborating with regulatory scientists to better understand how PROs are evaluated and certified as clinical outcome assessments.
Mindi Messmer, MS Student, Regulatory Science Program, GUMC
Ms. Messmer is interested in the areas of neurological disorders and developing better ways of incorporating drug development tools. For example, interests include developing objective ways to incorporate the voice of the patient in assessing drug efficacy. Her interests also include regulatory innovation for developing clinical trials. She began her studies in the MS in Clinical and Translational Science program, regulatory science concentration, in 2014 as a part-time student. Ms. Messmer has worked for more than 25 years as an environmental analyst and consultant, and developed an interest in regulatory science as an encore career. The concepts and analytic approaches that she has relied upon in her environmental work are closely related to the approaches needed for drug development – to balance risk and benefit favorably, to ensure people are protected from harm as much as possible. The CERSI Scholars program will provide Ms. Messmer with the opportunity to further engage with the GU CERSI and regulatory scientists from all of its key stakeholders, including FDA.
Jennifer Purks, Clinical Trials Manager, MedStar Georgetown University Hospital / Huntington Disease Care, Education, and Research Center, GUMC
Ms. Purks is the Program Manager of Clinical Trials at the Huntington Disease Care, Education, and Research Center (HDCERC). At the center, Ms. Purks manages and conducts two HD clinical trials (SIGNAL-HD and PRIDE-HD), one observational HD trial (ENROLL-HD), and two Tardive Dyskinesia (TD) Clinical Trials (AIM-TD and RIM-TD). Her primary research interest is in Patient Reported Outcomes and the challenge of effectively capturing and analyzing patient reported cognitive symptoms in a neurodegenerative disease population. Working in Clinical Trials and Patient Reported Outcomes research in Huntington Disease for over two years, Ms. Purks has been inspired by what regulatory science has to offer all stakeholders in the research community and impressed with how much current investigation and present research gaps fall under regulatory science. As a junior investigator, Ms. Purks will utilize the CERSI Scholar award to present current research at national and international society meetings, benefit from rich dialogue with expert colleagues in the field, publish results, and continue to foster growth and exploration of regulatory science research. Ms. Purks is currently applying to medical school to matriculate in August 2017.
Erica Savage, Project Manager, National Center for Human Factors in Healthcare, MedStar Health
Ms. Savage focuses on health IT policy and is currently working on a project with Dr. Raj Ratwani and Dr. Terry Fairbanks comparing the regulatory and enforcement mechanisms used by federal agencies, Federal Aviation Administration, Food and Drug Administration and Office of the National Coordinator for Health Information Technology (ONC), to identify regulatory mechanisms used in other industries that could be leveraged to optimize the usability of electronic health records. She is also working on an ONC contract that aims to identify gaps and steps forward that federal agencies and the larger community can take to optimize EHR implementation and use. Ms. Savage is currently working toward her Master of Healthcare Administration at the University of North Carolina (as a distance learner). Her studies and current projects have piqued her interest in how regulatory science can drive improvements in patient and provider safety and public health.
Rebecca Torguson, Director, MedStar Cardiovascular Research Network, MedStar Health
Ms. Torguson has worked in a research capacity with MedStar Health for almost 15 years, assisting with and conducting clinical research and associated activities. At MedStar she has developed an academic clinical research organization that facilitates the investigator-sponsored research both as a single center (MWHC) and multicenter clinical trials. These trials include phase 3b IND, IDE and observational studies. She obtained her MPH in Biostatistics from Columbia University in 2007 and returned to MedStar. She has co-authored over 250 peer-reviewed manuscripts, with several focusing specifically on regulatory sciences. Currently she supervises a team of project leads who manage MedStar Cardiovascular Research Network’s clinical trials; these works include protocol design, protocol writing, FDA submission (when necessary), regulatory oversight, site oversight, data management, statistical analysis and final manuscript/ report generation. Additionally, she manages the internal epidemiological research being conducted for cardiology within MedStar Heart and Vascular Institute (MHVI). Rebecca applies regulatory practices in her daily activity, and she is interested in the scientific approaches and tools that underpin these regulations and guidances. Being appointed as a CERSI Scholar will provide Ms. Torguson with opportunities to expand her horizons in this regard.
FOR MORE INFORMATION
If you have questions about the CERSI Scholars program, contact Erin Wilhelm, MPH, Executive Director, Program for Regulatory Science & Medicine, Georgetown University (email@example.com).