Janet Ransom

President and Co-founder of Fast-Track Drugs and Biologics, Dr. Ransom has over 25 years experience in biomedical research including product inception, research, development, clinical trials, and product licensure. She has managed diverse projects including the development of therapeutic cancer vaccines, therapeutic biological products and drugs to treat carcinomas, genetically engineered T cells for the treatment of AIDS/HIV, antitoxins for the treatment of neurotoxins, biological defense vaccines, pipeline for the treatment of substance abuse, and cardiovascular disease in vitro diagnostic tests. Depending upon the development phase of these projects, she was involved with the regulatory development strategy, clinical trial design, pre-clinical development plans, and data analysis and reporting to support product licensure. Dr. Ransom has designed and written Phase 1, 2, 3, and 4 clinical protocols to assess the safety and therapeutic effect of numerous biological and chemical agents for the treatment of malignancies. Furthermore, she has analyzed data from multi-institutional clinical trials and written the Clinical Summary Reports of numerous phase 2 and 3 studies according to the ICH Guidelines for inclusion in Biologics License Applications and New Drug Applications.