Larisa Rudenko, PhD DABT
Larisa Rudenko is a Visiting Scholar in the Program on Emerging Technology at MIT where she is studying forms of governance for emerging biotechnologies.
She has been the Senior Advisor for Biotechnology at FDA (CVM) for 15 years, where she led the agency initiative to develop novel risk-based approach for the regulation of genetically engineered (GE) animals, including building a new administrative unit for the implementation of that program. She has worked in different US and international venues to develop risk/safety paradigms for genetic alterations in systems from microorganisms to plants and animals (including humans). Her “firsts” include developing a regulatory strategy for the first food from a GE plant; the first comprehensive assessment of the safety/risk of animal health and foods from animal clones; overseeing the first guidance for the regulation of GE animals, and implementing that guidance by overseeing several approvals for GE animals for different uses. Dr. Rudenko internationally recognized for successful leadership and collegial collaboration in developing coordinated strategies and harmonized consensus documents. She has served as a safety advisor to the iGEM competitions, peer-reviewer on public and private sector grant review sections and peer-reviewed journals. Prior to her tenure at FDA, Dr. Rudenko worked in the consultancy and venture capital fields, with emphasis on the development of novel biopharmaceuticals. She received her PhD in Cellular and Molecular Biology from Stony Brook University after completing her doctoral work in DNA damage and repair at the Brookhaven National Laboratory; she is a Diplomate of the American Board of Toxicology.