Bhanumati Ramineni, M.S., M.S.

Bhanumati Ramineni heads CTEP’s Regulatory Affairs Branch, which is responsible for:  

• Negotiating and executing agreements with pharmaceutical companies for the co-development and clinical trials of investigational anticancer agents 
• Preparing and submitting Investigational New Drug Applications (INDs) and Investigational Device Exemptions (IDEs) to the Food and Drug Administration (FDA)
• Meeting all FDA regulatory requirements pertaining to CTEP IND agents. 

As branch chief, she manages and provides guidance on all agreement-related matters pertaining to CTEP, and on the strategy and execution of all regulatory submissions involving CTEP agents through all phases of development. She serves as CTEP’s primary liaison to Regulatory Health Authorities, including US FDA, HC, EMA, and PMDA. 

Before CTEP, Ms. Ramineni spent 10 years at the NIAID (Laboratory of Malaria Immunology and Vaccinology), WRAIR (Division of Viral Diseases) and NIEHS (Environmental Autoimmunity Group) providing scientific, FDA regulatory and management support to the development and implementation of malaria and dengue vaccine strategies