Bhanu Ramineni, M.S., M.S.
Regulatory Affairs Specialist
Bhanu Ramineni joined the Drug Regulatory Group in the Regulatory Affairs Branch in 2010. She holds two Master’s degrees: one in Environmental Sciences from Nagarjuna University, India and a second one in Biochemistry and Molecular Biology with a specialization in Biotechnology from Georgetown University. She comes with experience in FDA Regulatory Affairs, pre-clinical and clinical development of vaccines with a special focus in immunology. She manages a portfolio of investigational agents, which involves the maintenance of the complete life cycle of Investigational New Drug Applications (IND) and facilitates FDA communications related to that portfolio. Before coming to CTEP, she spent 10 years at the NIAID (Laboratory of Malaria Immunology and Vaccinology), WRAIR (Division of Viral Diseases) and NIEHS (Environmental Autoimmunity Group) providing scientific, regulatory and management support to the development and implementation of vaccine (malaria and dengue) strategies, as well as participating in drafting MTA’s, RFP’s, proposal writing and the ad hoc review of proposals.
About the Branch Chief
Jan Casadei, PhD joined the National Cancer Institute in 1991, where she is now chief of the Regulatory Affairs Branch, CTEP. Her area of expertise covers FDA regulations, policies and guidelines for the conduct of clinical studies with investigational agents. As the chief of the Regulatory Affairs Branch, Dr. Casadei is responsible for facilitating the development of promising investigational anti-cancer agents, by providing regulatory/IND support More…