Regulatory Affairs Branch (RAB)
About RAB
Bhanumati Ramineni is CTEP's Regulatory Affairs Branch Chief.
The Regulatory Affairs Branch provides regulatory support to CTEP-supported network trials. There are two groups in RAB: the Agreements Coordination Group (ACG), and the Drug Regulatory Group (DRG).
- The Agreements Coordination Group develops necessary agreements to support collaborative clinical and nonclinical studies, including Cooperative Research & Development Agreements (CRADAs), Clinical Trial Agreements (CTAs), Data Use Agreements (DUAs), and Material Transfer Agreements (MTAs). ACG coordinates work with industry collaborators.
- The Drug Regulatory Group provides support for all phases of Investigational New Drug (IND) applications for which CTEP is the IND sponsor. DRG prepares initial IND submissions, maintains active INDs, ensures clinical studies are carried out according to FDA regulations and guidelines, and acts as a liaison with FDA staff.
For information on cooperative drug development and industry collaborations, including model CRADAs and other model documents, please see the CTEP-IND Agents and Collaborative Agreements page.
CTEP RAB Staff Directory
| Name | Role | Email Address |
|---|---|---|
| Bhanumati Ramineni, M.S. | Branch Chief | raminenib@mail.nih.gov |
| Jason Denner, B.S. | Regulatory Program Specialist, R&D Agreements | dennerj@mail.nih.gov |
| Lynne Huang, Ph.D., J.D. | Senior Intellectual Property Adviser | yingling.huang@nih.gov |
| Maria Gema Martin Manso, Ph.D. | Regulatory Affairs Manager | maria.martinmanso@nih.gov |
| Ellen Mintz, Ph.D., M.S. | Regulatory Affairs Specialist | ellen.mintz@nih.gov |
| Nicole Monteiro | Program Specialist | nicole.monteiro@nih.gov |
| Modupeh Palmer-Ochieng, Ph.D. | Senior Regulatory Affairs Manager | dupeh.palmer-ochieng@nih.gov |
| Julie Rhie, Ph.D., RPh | Pharmacologist, Senior Regulatory Affairs Scientist | rhiej@ctep.nci.nih.gov |
| Karen Said, B.A. | Executive Assistant | karen.said@nih.gov |
| Jyotsna R. Sandil, M.D. | Regulatory Affairs Specialist | Jyotsna.sandil@nih.gov |
| Berna Uygur, Ph.D. | Technology Transfer Specialist | berna.uygur@nih.gov |
| Jeffrey Walenta | Technology Transfer and Patent Specialist | Jeffrey.walenta@nih.gov |
| Jianqiao Zhang, Ph.D. | Associate Chief, Agreement Coordination Group | zhangjia@mail.nih.gov |