Epidemiology & Public Health
Medical Director, Pharmacovigilance Global Safety Lead Takeda Pharmaceutical Company
Howard Hall 142G
Education and Training
- 1983-89: Faculty of Medicine, M.B., B.Ch., Alexandria University, Alexandria, Egypt
- 1994: Faculty of Medicine, Master of Science in Surgery (M.S.), Alexandria University, Alexandria, Egypt
- 2001: Johns Hopkins University School of Public Health, Master of Public Health (M.P.H.), Baltimore, Maryland
Post Graduate Education and Clinical Training
- 1990-91: Alexandria University Hospitals, Internship, Alexandria University, Alexandria, Egypt
- 1991-94: Dept. of General Surgery, Residency/General & Pediatric Surgery, Division of Pediatric Surgery, Alexandria University, Alexandria, Egypt
- 1995-98: Department of Pediatrics, Residency/Pediatrics, Maimonides Medical Center, Brooklyn, New York
- 1998-99: Department of Pediatrics, Chief Resident/Pediatrics, Maimonides Medical Center, Brooklyn, New York
- 1999-2003: Department of Pediatrics, Post-Doctoral Fellow, Division of General Pediatrics & Adolescent Medicine, General Academic Pediatrics Fellowship Program, Johns Hopkins University
Dr. El-Kamary is a pediatrician and infectious disease epidemiologist. He joined the University of Maryland School of Medicine, Department of Epidemiology and Public Health (D.E.P.H.) and the Department of Pediatrics as an Assistant Professor and was subsequently promoted to a tenured Associate Professor. During his tenure, he conducted research on the epidemiology of hepatitis infections, particularly hepatitis C virus (HCV) infections in Egypt. He studied the incidence, prevalence, and risk factors of HCV in pregnant women and their children, and the immune responses that affect vertical transmission and persistence of infection; and worked with the Center for Vaccine Development to conduct vaccine and therapeutic clinical trials in the US and Egypt. He also attended a weekly pediatric clinic and served as Course Director of an Infectious disease epidemiology course, and as the Director of the M.P.H. Global Health Concentration, and the track leader for the Ph.D. Epidemiology track.
In 2017, he joined the Food and Drug Administration (F.D.A.) as a Medical Officer and Clinical Reviewer at the Division of Antivirals, Office of Infectious Diseases, Center for Drug Evaluation and Research (C.D.E.R.); and continued to teach and attend the pediatric clinic at the University of Maryland as an Adjunct Associate Professor, then as an Adjunct Professor. At the FDA he resumed his work on viral infections by conducting clinical and regulatory reviews of new drug applications and served on several FDA guidance working groups. To date, he was responsible for the approval of several drugs including a drug for the treatment of hepatitis B virus infection, and another one for HIV treatment, in children 2 years and older; the first three drugs for the treatment of HCV infection in children 3 years and older; and recently one of only two available treatments for Ebolavirus infection.
In 2022, he joined Takeda Pharmaceutical Company as a Medical Director in Pharmacovigilance, Marketed Products, Global Medical Safety. In this role, he will apply his significant drug safety experience and his array of expertise in the fields of clinical research, pediatrics, regulatory work, global health, and epidemiology, to review marketed drugs in order to identify safety signals early and avoid potential adverse events in patients.
Dr. El-Kamary received his medical degree and M.S., from the University of Alexandria, Egypt, and his post-doctoral fellowship training from the Johns Hopkins University School of Medicine, and his M.P.H. from the Johns Hopkins Bloomberg School of Public Health.
General Pediatrics, Drug Safety, Global Health, Epidemiology, Bioethics, Vaccinology
Dr. El-Kamary has published over 75 peer reviewed journal articles and six book chapters.
Dr. El-Kamary’s research interests are focused on studying the epidemiology and immunology of viral hepatitis infections, particularly in pregnant women and their children. After the introduction of universal hepatitis B vaccination in Egypt, Dr. El-Kamary demosntrated that hepatitis C viral infections (HCV) became the predominant blood borne virus; and that dental care in children was a major risk factor for continued HCV transmission. He also studied the morbidity of acute and chronic hepatitis and conducted clinical trials in Egypt to test allopathic and alternative therapies to alleviate symptoms and treat acute hepatitis infections. In addition to his work on HCV in Egypt, his global health work includes collaborations with several investigators on campus in studies of HIV, poliomyelitis and tuberculosis (TB) in Nigeria.
As a clinician and vaccinologist, he worked with colleagues at the Center for Vaccine Development on several vaccine trials including a safer small pox vaccine, a norovirus vaccine, and an oral anti-diarrheal vaccine derived from enterotoxigenic Escherichia coli.
Dr. El-Kamary's research activities focus on identifying safety signals in drugs, and the use of artificial intelligence and machine learning in the review of adverse reactions to drugs. At the FDA, he explored the association between treatment of HCV infection using directly acting antiviral (DAA) drugs and the concurrent occurrence of herpes zoster infection, which has been a concern in the medical community after the increased use of DAAs in the treatment of HCV infection. After reviewing data at the FDA from 37 clinical trials it was definitively demonstrated that there was no association between the use of DAAs and herpes zoster infection. He also served as the FDA lead investigator on a collaborartive project with UCSF to utilize Machine Learning and Artificial Intelligence to identify safety signals from real world data in physician's clinical notes.
Dr. El-Kamary is a general pediatrician who sees patients once every two weeks.
- 2012 Recipient: Faculty Mentor Award, Epidemiology and Human Genetics Program, University of Maryland School of Medicine, Baltimore, Maryland
- 2014 Recipient, Faculty Teacher of the Year Award, Department of Epidemiology and Public Health Graduate Program, University of Maryland School of Medicine, Baltimore, Maryland
- 2014 Recipient, Medical Student Teacher of the Year Award, Department of Epidemiology and Public Health Graduate Program, University of Maryland School of Medicine, Baltimore, Maryland
- 2014 Inductee, Delta Omega Honorary Society for Public Health
- 2018 Certificate of Appreciation: In recognition of valuable contributions to The Office of New Drugs Learning and Career Development Team, CDER, FDA.
- 2021 Center Director’s Special Citation: Awarded by the Director of the Center for Drug Evaluation and Research (CDER), FDA to the COVID-19 Response Activities Group, in recognition for protecting public health through multidisciplinary expert teams that collaboratively addressed prioritizing response activities.
- 2021 Center Director’s Special Citation: Awarded by the Director of the Center for Drug Evaluation and Research (CDER), FDA. For collaboration and interdisciplinary teamwork to support approvals for the treatment of infection caused by Ebolavirus.
- 2021 Group Recognition Award: Awarded by the Director of the Center for Drug Evaluation and Research (CDER), FDA. For rapidly developing and issuing two guidances to support the efficient development of drugs and biologics to address COVID-19.
- 2022 FDA Commissioner's Special Citation as part of the EBANGA Review Team, for exceptional teamwork and management in the review of EBANGA (ansuvimabzykl) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients.