Vanessa Shaw-Dore is the Director of the China Office in the FDA’s Office of Global Policy and Strategy (OGPS). Ms. Shaw-Dore previously served as Deputy Program Director of the Center for Disease Control’s (CDC’s) Division of Global Health Protection (DGHP) overseeing CDC’s Global Health Security Agenda (GHSA) work in Vietnam. Prior to her time in Vietnam, Ms. Shaw-Dore served in the same office as the Deputy Program Director for CDC’s Democratic Republic of the Congo country office.
Before CDC, Ms. Shaw-Dore served as a Branch Chief in the Health Resources and Services Administration HIV/AIDS Bureau, Division of State HIV/AIDS Programs. In that role, Ms. Shaw-Dore oversaw $490 million in Federal funds in support of Ryan White Part B and AIDS Drug Assistance Program grants for 20 states and U.S. territories, including Washington D.C., Puerto Rico, and the U.S. Virgin Islands. Ms. Shaw-Dore brings 13-plus years of operations and management experience with domestic and international U.S. Government-funded public health programs. She has also led the coordination of high-level interagency programs within global work settings.
Ms. Shaw-Dore holds a Master of Public Health in Community Health Sciences from the University of California at Los Angeles, and a Bachelor of Science in Biology, with a concentration in Molecular Biology from Hampton University in Virginia.
Latasha A. Robinson is the Deputy Director of the China Office in the FDA’s Office of Global Policy and Strategy (OGPS). Prior to moving into her current role, she served as the International Relations Specialist for human food and animal feed in the China Office, where she was responsible for identifying and implementing the strategic objectives to advance FDA’s food safety mission in China, as well as fostering capacity building with relevant stakeholders, including Chinese competent authorities, industry, and academia.
Ms. Robinson’s career includes 10 years of experience in the FDA’s Center for Food Safety & Applied Nutrition (CFSAN), Office of Compliance. Prior to joining the China Office in 2018, she was CFSAN’s Chief of the Dietary Supplement and Labeling Assessment Branch. There she oversaw a staff who were responsible for the implementation of enforcement programs for dietary supplements (Good Manufacturing Practices, New Dietary Ingredients, labeling, product claims, and safety), nutrition labeling, food and color additives, infant formula, medical foods, and cosmetics.
Before coming to the FDA, Ms. Robinson worked as a System Safety Engineer for the U.S. Navy’s Naval Surface Warfare Center in Dahlgren, VA, where she ensured the biological and chemical safety of Navy combat ships.
Ms. Robinson holds a Bachelor of Science in Biology from Howard University in Washington, DC, and a Master of Science in Regulatory Science with a concentration in drugs and biologics from the University of Maryland, School of Pharmacy in Baltimore, Maryland.
Sarah McMullen, Ph.D., is the Director (Acting) of the India Office in the FDA’s Office of Global Policy and Strategy (OGPS). Her professional experience includes analytical method development and testing for multiple FDA-regulated commodities, establishment inspections, import operations and policy, and foreign office service. Dr. McMullen’s FDA career spans over 15 years working as a chemist, tissue residue specialist, consumer safety officer, and manager. The last five years of her experience focused on international arenas, including import operations and foreign office service.
Dr. McMullen has a Doctor of Philosophy in inorganic chemistry from Emory University in Georgia and a Bachelor of Science in chemistry from Emory University in Georgia.
Ritu Nalubola, Ph.D., is the Director of the Europe Office in the FDA’s Office of Global Policy and Strategy. Before assuming this role in July 2018, she served as a Senior Policy Advisor in the FDA’s Office of Policy in the Office of the Commissioner. She advised senior leadership at the FDA, the Department of Health and Human Services, and other U.S. government agencies on complex and cross-cutting policy issues, including those related to biotechnology, nanotechnology, food safety, nutrition, and trade-related matters. Most recently, Dr. Nalubola served as the primary lead for FDA’s efforts, working in conjunction with the broader U.S. government, in modernizing the federal regulatory system for biotechnology products. She has been the agency’s voice on this subject in numerous domestic and international fora. She led and coordinated FDA’s nanotechnology regulatory policy activities and played a leadership role in establishing specific regulations to implement the FDA Food Safety and Modernization Act, representing and leading FDA delegations in multilateral standards-setting and scientific dialogues.
Before joining the Office of Policy, Dr. Nalubola spent eight years at the FDA’s Center for Food Safety and Applied Nutrition on a range of nutrition and food safety policy matters. Her post-doctoral work with the Johns Hopkins University and later the U.S. Agency for International Development involved setting up international public health programs.
Sandra L. Kweder, M.D., is Deputy Director of the Europe Office in FDA’s Office of Global Policy and Strategy (OGPS). Before joining OGPS, Dr. Kweder was Deputy Director, Office of New Drugs in FDA’s Center for Drug Evaluation & Research (CDER). In CDER, she actively led several initiatives including improvements in the drug review process, modernizing nonprescription drug review, building a systematic drug shortage prevention and management program, patient-focused drug development and clinical outcomes assessment, and the growth and development of pediatrics and maternal health as standard aspects of drug development.
Dr. Kweder was commissioned in the U.S. Public Health Service upon entering the Uniformed Services University of Health Sciences (USUHS) (retiring in 2013 at the rank of Rear Admiral). Following internal medicine training at Walter Reed Army Medical Center, she joined the FDA in the Division of Antiviral Drugs to address the growing field of HIV drug development. She has since held many positions with the FDA in premarket and postmarket regulation. Dr. Kweder was active in medical education as an adjunct faculty member of USUHS, training residents and medical students in Internal Medicine and utilizing her fellowship training from Brown University in Obstetric and Consultative Medicine.
Latin America Office
Katherine (Katie) Serrano is the Director of the Latin America Office in FDA’s Office of Global Policy and Strategy (OGPS). Ms. Serrano has over 15 years of experience in the medical device field, with nine years spent in the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health’s Office of In Vitro Diagnostics and Radiological Health. She began her FDA career as part of the 2008 inaugural class of FDA fellows and has worked as a scientific reviewer and served as the Diabetes Diagnostic Devices Branch Chief and the Deputy Director of FDA’s Division of Chemistry and Toxicology Devices. While at CDRH, she served as the technical and policy lead for the Agency’s efforts related to Laboratory Developed Tests. Before working at the FDA, Ms. Serrano held positions as a regulatory affairs professional for Boston Scientific Corporation and as a Biomedical Engineer at the United States National Institutes of Health, supporting new programs focused on cutting edge technologies in the field of bioengineering.
Ms. Serrano received a Bachelor of Science degree in Biomedical Engineering and a Bachelor of Arts degree in Spanish from the University of Minnesota.
CDR Michelle Rodriguez serves as the Deputy Director for the Latin America Office in FDA’s Office of Global Policy and Strategy (OGPS). Prior to joining OGPS, she held various leadership and supervisory roles in the areas of regulatory compliance, import and export operations, and emergency response activities as Branch Chief within the FDA Center for Tobacco Product’s Office of Compliance and Enforcement. CDR Rodriguez was also a compliance reviewer and later post-market team leader in the Center for Devices and Radiological Health’s Office of In Vitro Diagnostics and Radiological Health. Before FDA, CDR Rodriguez served in the Center for Disease Control’s (CDC’s) National Center for Emerging and Zoonotic Infectious Diseases, managing regulatory applications required for stockpiling in the U.S. Strategic National Stockpile, and the national and international deployment and use of medical countermeasures housed there. She also supported CDC’s emergency preparedness, response and outbreak activities in Latin America. Since her commissioning in the U.S. Public Health Service in 2011, she has deployed and collaborated with various government agencies in support of public health responses impacting the Latin American community.
CDR Rodriguez holds a microbiology degree from the University of Puerto Rico. She completed her doctoral studies in immunology at the University of Florida and later completed a postdoctoral ORISE fellowship at the CDC.