The Fellowship in Quality of Medical Products, sponsored by the USP Quality Institute, partners with Georgetown University Medical Center, Boston University and University College London. Through the fellowship program, the Quality Institute will develop and disseminate research addressing evidence gaps around quality medicines, ultimately strengthening awareness and understanding of the value of quality.
Fellows
Carly Ching, Ph.D.
Research project: Investigating the role of substandard fluoroquinolone antibiotics on antimicrobial resistance in E. coli as a model for Tuberculosis
Dr. Ching’s doctoral research focused on stress responses in the opportunistic bacterial pathogen Acinetobacter baumannii, a leading cause of multi-drug resistant hospital-acquired infections. Her doctoral work elucidated mechanisms of how A. baumannii responds to DNA damage and how this contributes to mutagenesis and antibiotic resistance acquisition. Dr. Ching has a Ph.D. in biology from Northeastern University.
Matthew Hassett, Ph.D.
Research project: Investigating the link between SF artemisinin and the acceleration of resistance in P. falciparum
Dr. Hassett’s doctoral research focused on mechanisms by which the malarial parasite develops resistance to therapies. His thesis work was highly interdisciplinary, and aided the understanding of drug resistance and identified novel potential drug targets for the next generation of antimalarial medicines. It was through this research that his interest in substandard and falsified antimalarial medicines and their impact on the spread of antimalarial drug resistance developed. Dr. Hassett has a Ph.D. in Chemistry from Georgetown University.
Marissa Malchione, M.S.
Research project: Surveying the prevalence of poor-quality antibiotics in a specific region with high rates of antibiotic resistance (to be determined)
Ms. Malchione most recently was a research specialist at the Georgetown University Center on Medical Product Access, Safety and Stewardship (COMPASS) studying the prevalence and distribution of a drug-resistant strain of E. coli in Asia. Ms. Malchione will enhance the knowledge and awareness of the epidemiology and impacts of substandard and falsified antimicrobials in high-risk areas. She has a Master of Science in Public Health Microbiology and Emerging Infectious Diseases from The George Washington University.
Quality Institute Fellowship Mentors
Fouad Atouf, Ph.D.
Vice President, Science—Global Biologics, USP
Fouad Atouf is Vice President, Science—Global Biologics, for USP. He leads all scientific activities related to the development and maintenance of documentary and reference standards for biologics and antibiotics, and oversees the biologics laboratories in USP–U.S. and USP–India. Dr. Atouf has been at USP for over 10 years and served in a variety of scientific leadership roles including being the regional champion for the Middle East and North Africa Region, where he helped facilitate programs designed to enhance the understanding of the role of regulations and standards in the registration of medicinal products.
Kevin Carrick, Ph.D.
Director, Science & Standards – Global Biologics, USP
Kevin Carrick is a Director of Science & Standards in Global Biologics, USP. He leads a team that to develops Documentary Standards (general chapters and monographs) and Reference Standards that support biopharmaceutical quality assessment. Dr. Carrick and his team work with the five USP biologics Expert Committees, multiple Expert Panels, and internal and external laboratories on development of standards for diverse biopharmaceutical products from proteins to cell therapies.
Jesse Goodman, M.D., M.P.H.
Director, Georgetown University COMPASS
Quality Institute GUMC Fellowship Mentor
Jesse Goodman, M.D., M.P.H., is Professor of Medicine at Georgetown University and Director of Georgetown’s Center on Medical Product Access, Safety and Stewardship (COMPASS), which focuses on informing science based policy to address public health needs in product development and access, the supply chain, and antimicrobial resistance. He is also an Attending Physician in Infectious Diseases at the Georgetown University, Washington DC Veteran’s Administration and Walter Reed National Military Medical Centers.
Dr. Goodman previously served as the Chief Scientist and Deputy Commissioner of the U.S. Food and Drug Administration (FDA), where he worked with industry, academia, government and global public health partners to prepare for and respond to major public health threats, emerging infectious diseases and terrorism. Prior to his role as Chief Scientist, he founded and co-chaired the first U.S. Task Force to Combat Antimicrobial Resistance, and directed the Center for Biologics Evaluation and Research. Before working in government, he was Professor and Chief of Infectious Diseases at the University of Minnesota. He has served on the Decade of Vaccines Research and Development Group and on numerous CDC, NIH, DOD and WHO Advisory Committees and is currently on the Scientific Advisory Board of the Coalition on Epidemic Preparedness Innovation (CEPI). He has been elected to the National Academy of Medicine of the National Academy of Sciences.
Paul Roepe, Ph.D, M.A.
Professor, Georgetown University
Quality Institute GUMC Fellowship Mentor
Paul Roepe, Ph.D., M.A., is a Professor in the Department of Chemistry and the Department of Biochemistry and Cellular & Molecular Biology at Georgetown University. He is also a co-director of the Georgetown Center for Infectious Disease. The primary interest of his research group is the molecular basis of drug resistance phenomena, particularly in malarial parasites.
Prior to moving his laboratory to Georgetown University in 1997, Dr. Roepe served joint appointments at Memorial Sloan-Kettering Cancer Center and the Department of Pharmacology at Cornell University Medical College, where he studied pharmacology and worked on several problems related to tumor drug resistance and the transport of chemotherapeutic drugs across tumor cell membranes.
Veronika J. Wirtz, M.Sc., Ph.D.
Associate Professor, Boston University School of Public Health
Quality Institute Boston University Fellowship Mentor
Veronika J. Wirtz, M.Sc., Ph.D., is an Associate Professor in the Department of Global Health at the Boston University School of Public Health, where she is also Director of the World Health Organization Collaborating Center in Pharmaceutical Policy.
Her research focuses on health system strengthening and program evaluations of medicines access and utilization. Her interest and expertise includes the role of the private sector in promoting equitable access and efficient use of medicines in low and middle income countries, medicines price analysis, generic medicines policies and access to medicines for non-communicable diseases. Between 2014 and 2016 she was the Co-Chair of The Lancet Commission on Essential Medicine Policies which published its report Essential Medicines for Universal Health Coverage in Fall 2016.
She has worked as a technical advisor for various international organizations, among them the World Health Organization, the Pan American Health Organization, the World Bank, the Global Fund to fight AIDS, Tuberculosis and Malaria, the Bill and Melinda Gates Foundation and Alliance for Health Systems and Policy Research.
She is a Visiting Professor of the National Institute of Public Health (INSP), Mexico where she was a faculty member between 2005 and 2012. She received her training as a pharmacist from Albert-Ludwigs-University in Freiburg, Germany and her Master in Clinical Pharmacy and PhD from the University of London, UK.
Muhammad Hamid Zaman, Ph.D.
Professor, Biomedical Engineering
Quality Institute Boston University Fellowship Mentor
Muhammad Hamid Zaman, Ph.D., is the Howard Hughes Medical Institute Professor of Biomedical Engineering and International Health at Boston University. Dr. Zaman’s current research is focused on developing robust technologies, and systems-level solutions, to improve the quality of medicines, particularly as they are related to mortality and morbidity issues associated with antimicrobial resistance. Technologies developed by Dr. Zaman and his lab are in various stages of implementation in a number of developing countries. Scientific American has named technologies from the Zaman lab among the top 10 technologies that will change the world. Dr. Zaman is also part of the advisory committee to implement the United Nations Sustainable Development Goals (SDG) in his native Pakistan where he is working with both public and the private sector. Dr. Zaman holds a PhD in Chemistry from the University of Chicago.
Dr. Zaman currently works on projects in multiple countries including Pakistan, Ghana, Tanzania, Zambia, Indonesia, Lebanon and Brazil. Dr. Zaman also works with frontline public health and refugee relief organizations in Syria and Lebanon, developing engineering solutions to address medical needs in a sustainable manner. His latest book, Bitter Pills (Oxford University Press, 2018), looks at the global challenge of substandard and falsified drugs and the need for integrated solutions, ranging from innovation and technology to public health and regulation, to address the global crisis in the prevalence of substandard drugs and how they relate to global antimicrobial resistance challenges.
The USP Quality Institute supports only direct costs for projects funded through its Fellowship in Quality of Medical Products. Read the Indirect Cost Policy