Maria Gema Martin Manso, Ph.D.

Dr. Maria Gema Martin Manso manages a large portfolio of investigational new drug applications (IND) throughout their life cycle and ensures that submission documents (i.e., new protocols, protocol amendments, annual reports, adverse events reports, CMC reports, responses to FDA information requests and meeting packages) are sent to the FDA in a timely manner and in compliance with the FDA requirements.

Dr. Martin Manso joined the Drug Regulatory Section of the Regulatory Affairs Branch (RAB) at CTEP in October of 2021. She came from the FDA where she served as a Pharmaceutical Quality Assessor since 2016 in the Division of Biotechnology Manufacturing and in the Division of Microbiology Assessment, Office of Pharmaceutical Quality within the Center for Drug Evaluation and Research (CDER). Prior to joining the FDA, she spent two years as a Staff Scientist in the Program for Cell Enhancement and Technologies for Immunotherapy at Children’s National Research Institute (Washington, DC) where she was responsible for the CGMP-compliant expansion of cytotoxic T lymphocytes for immunotherapies. In addition, she spent nine years as a Research Fellow in the NCI Laboratory of Pathology, Center for Cancer Research where she conducted research in the field of Molecular and Cell Biology of cancer and the tumor microenvironment with a focus on tumor immunology and immunotherapy. Dr. Martin Manso received her Ph.D. and M.S. in Biochemistry and Molecular Biology and her B.S. in Neurobiology from the Complutense University of Madrid, Spain.