CTEP Branches and Offices
Regulatory Affairs Branch (RAB)
The Regulatory Affairs Branch (RAB) is comprised of two groups, the Drug Regulatory Group and the Agreement Coordination Group. Responsibilities of each group include the following:
Drug Regulatory Group
- Ensure that clinical studies are carried out according to FDA regulations and guidelines
- Provide IND support for agents being developed by CTEP/DCTD, including preparation of initial IND submission followed by maintenance of active IND
- Act as liaison between the FDA and NCI staff/NCI investigators/pharmaceutical collaborators, to facilitate investigational agent development
- Provide regulatory advice to NCI intramural and extramural staff
Agreement Coordination Group
- Foster pharmaceutical collaboration in evaluating promising investigational agents
- Develop necessary agreements to support collaborative nonclinical and clinical studies; including CRADAs, CTAs, CSAs, and MTAs
- Coordinate pharmaceutical collaborator interactions with NCI staff and investigators
About the Branch Chief
Bhanu Ramineni, M.S., M.S., became the Chief of the Regulatory Affairs Branch in October 2019. She joined the Drug Regulatory Group in the 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. Ms. Ramineni comes with significant experience in FDA Regulatory Affairs, as well as preclinical and clinical development of vaccines with a special focus in immunology.
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