The Fellowship in Regulatory Science provides scientific training needed to modernize and improve the way medical products are developed, reviewed, and evaluated. Established in 2014, the Georgetown University Fellowship in Regulatory Science provides fellows with one to two years of specialized training with access to expert faculty and scientists from Georgetown University, industry partners, and the U.S. Food and Drug Administration (FDA).
Fellows conduct research, learn, teach, and mentor graduate and undergraduate students. Each fellow is awarded up to two years of salary support and research stipends, beginning with a one-year term, with possibilities for renewal after successful completion of the first year. This postgraduate fellowship will help develop researchers and scholars to reach their fullest potential in advancing innovative research to benefit public health.
Regulatory science is an applied scientific discipline that generates and makes use of evidence-based knowledge to inform decision-making about the safety and benefits of medical products, and comprises an emerging, specialized, and interdisciplinary field of biomedical research and education. Early in its evolution, the field holds great promise for scholarship, innovation, and application to enhance the safety and effectiveness of medical products and improve public health.
Ideal candidates will demonstrate a strong interest in regulatory science through their professional and educational backgrounds. Candidates should be enthusiastic, self-motivated individuals who are able to articulate a strong interest in regulatory science, and have a deep desire to develop their careers at the intersection of academia, industry and government. Specifically, candidates should possess the following qualifications:
- Advanced degree in a related scientific field (e.g., MD, PhD, PharmD, MPH)
- Clinical research experience
- Basic understanding of the design, conduct, and analysis of clinical trials
- Ability to write and communicate clearly and thoughtfully
- Comfort working in an academic research setting
- Demonstrated capacity to work independently and collaboratively
Questions about the fellowship may be directed to firstname.lastname@example.org.
Michael J. Fox Foundation Sponsorship
The Michael J. Fox Foundation (MJFF) announced its support of the Fellowship in Regulatory Science at Georgetown University. This fellowship will provide a postgraduate training opportunity and will advance innovative research benefiting Parkinson’s disease.
- August 1, 2016: Optional Letter of Intent Due
- August 12, 2016: Applications Due
- September 27, 2016: In-Person Candidate Interviews
- January 3, 2017: Fellowship Term Begins
The Pharmaceutical Research and Manufactures of America (PhRMA) provided initial sponsorship for the Fellowship in Regulatory Science. Over time, PhRMA has and continues to support the training of three fellows at Georgetown University. Read more about each of the PhRMA-supported fellows below.
2016 Fellow in Regulatory Science
Daphne Guinn, PhD, is a PRSM-PhRMA fellow in regulatory science. She received her PhD in Biomedical Sciences in May 2016 from The Ohio State University. While at Ohio State, she worked in a translational laboratory developing novel therapeutics for chronic lymphocytic leukemia (CLL). One of her projects was focused on elucidating the microRNA profile associated with ibrutinib therapy in primary patient samples. Ibrutinib is an irreversible inhibitor of Bruton’s tyrosine kinase (BTK), which is an integral kinase in the B cell receptor signaling pathway and is essential to the survival of CLL tumor cells. That work lead to the identification of oncogenic miR-155, which Dr. Guinn and her colleagues found to be associated with poor prognosis markers in CLL and could be down-modulated in patients treated with ibrutinib. This work was published in the journal Leukemia and presented at the 2014 American Society of Hematology meeting. She also worked on another project that focused on studying the impact that acquired ibrutinib resistant mutations have on CLL biology and disease progression. She developed ibrutinib-resistant cell lines as a model to study resistance. This work earned her authorship on two publications in Blood.
During her PhD, Dr. Guinn was exposed to pre-clinical and clinical development of therapeutics. Those experiences led her to pursue a career in regulatory science to further study clinical drug development with a particular interest in adaptive clinical trial designs and modernization of the therapeutic review process.
She began her fellowship in August 2016 and will use this training opportunity to pursue her interest in adaptive clinical trial designs by working with academic, industry, and FDA mentors to design and simulate a late-phase basket trial informed by real-world data. This type of novel clinical trial design would serve to improve the development process for niche or orphan indications. She will also assist in building the CERSI Scholars program and advocate for the importance of regulatory science through education and research.
2015 Fellow in Pediatric Regulatory Science
Evgenia (Jenny) Gourgari, MD, is an Assistant Professor of Pediatric Endocrinology at MedStar Georgetown University Hospital and a PRSM-PhRMA fellow in pediatric regulatory science. She received her Medical Degree from Aristotle University (Greece) and became Board Certified in Pediatrics in 2010 after completing her residency at Miami Children’s Hospital. She completed her Pediatric Endocrine Fellowship at NIH where she was not only trained to manage common endocrine conditions in children, such as diabetes, short stature, puberty disorders and PCOS, but also she was exposed to the rigors of scientific research. During her fellowship Dr. Gourgari was the lead investigator and responsible for all aspects of conduct of the clinical protocol “Adrenal hyperplasia among young women with Polycystic Ovary Syndrome (PCOS)”. She received three awards from the Endocrine Society for her work and has published several original research manuscripts.
Dr. Gourgari was fascinated by the presence of multiple lipoprotein abnormalities in this young group of PCOS patients and that sparked her interest in the role of lipoproteins in stratifying the cardiovascular risk in children with other risk factors for cardiovascular disease such as diabetes. She joined Georgetown University as a new faculty member in 2013, where she encountered new challenges in clinical management as nearly a third of her patients have type 1 diabetes and are therefore at increased risk for Cardiovascular Disease (CVD). Dr. Gourgari was successful in receiving two pilot awards in 2014 to further investigate the lipoprotein abnormalities in children with diabetes and she is now the Principal Investigator of the study, ”Identifying children with diabetes at high risk for cardiovascular disease.”
In June 2015, she accepted the regulatory science fellowship. This training opportunity will give Dr. Gourgari the tools to navigate further into the pathophysiology of lipoprotein anomalies using a bio-informatics approach. Furthermore, Dr. Gourgari will be trained on the regulatory aspects of conducting a clinical trial in pediatric populations using experimental drugs.
2014 Fellow in Regulatory Science
Shahla Riazi, MD, Ph.D., was the inagural PRSM-PhRMA Fellow in Regulatory Science at Georgetown University. Her appointment was through the Georgetown University Program for Regulatory Science & Medicine (PRSM) and the Pharmaceutical Research and Manufacturers of America (PhRMA) Fellowship in Regulatory Science. Dr. Riazi engaged with Georgetown's Innovation Center for Biomedical Informatics on regulatory science research. She completed her Master of Science in Clinical and Translational Research at Georgetown University at the same time. In addition to regular meetings with her mentors from Georgetown and industry partner Biogen, Dr. Riazi had the opportunity to engage with FDA, present her work at several conferences, and spend time at Biogen’s headquarters, experiencing the inner workings of a biopharmaceutical company.
Since completing her fellowship in 2015, Dr. Riazi accepted an ORISE Fellowship at the U.S. Food and Drug Administration.
About PRSM and Partners
PRSM seeks to advance regulatory science and medicine through research and education, drawing on the expertise of a diverse group of scholars and knowledgeable faculty. PRSM includes an array of innovative research and education opportunities, engaging faculty, students, and researchers at the university in the rapidly developing field of regulatory science. With proximity to regulators and scientists in government, academia, and industry, Georgetown University offers a unique milieu for regulatory science training and research.
PhRMA represents the country’s leading innovative biopharmaceutical research companies that are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested more than $550 billion in the search for new treatments and cures, including an estimated $51.1 billion in 2013 alone.
The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. As the world’s largest nonprofit funder of Parkinson’s research, The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers.
PRSM and its partners value the human, educational, and research resources that encompass evidence-based regulatory science and are committed to supporting and sustaining education, training, mentoring, and scholarship in regulatory science.