DTP Organizational Structure

DTP Branches And Staff

Office of the Associate Director (OAD)
Jerry M. Collins, Ph.D., Associate Director, EPN Room 8018
James A. Crowell, Ph.D., Deputy Associate Director

OAD provides planning, implementation, and oversight for all DTP activities, including participation in the NCI Experimental Therapeutics (NExT) initiative and the NCI-60 cell line testing program.

NCI-60 Cell Line Screening

Grants and Contracts Operations Branch (GCOB)
Chief - Dr. Mary K. Wolpert, EPN Room 8150

GCOB resides in a unique situation in relation to the extramural grant community and DTP's drug discovery and development activities. Through management of a large grant and cooperative agreement portfolio, GCOB staff maintains extensive interactions with the external research community and can provide advice to foster DTP's drug discovery mandate. Such activities include assisting grantees to access the NCI drug and Natural Product repositories, inviting scientists to participate in a DTP seminar series, and arranging for characterization of molecular targets in the 60-cell line screen. Staff can advise grantees regarding availability of NCI resources for development of their agents to clinical trial.

Drug Synthesis and Chemistry Branch (DSCB)
Chief - Dr. Joel Morris, EPN Room 8028

DS&CB is responsible for the following activities in support of the discovery and development of novel anti-cancer agents: worldwide scientific liaison activities with universities and industries to stimulate the input of a wide variety of synthetic compounds, natural products, and combinatorial libraries for in vitro cancer screening; management of the storage, inventory, documentation, and distribution of samples for research purposes; and synthesis of cold and radiolabelled compounds for in vivo studies and anti-angiogenesis standards.

Natural Products Branch (NPB)
Chief - Dr. David J. Newman, FNLCR, Riverside B

The primary responsibility of NPB is the acquisition of crude natural product materials from terrestrial and marine environments, usually via competitive contracts worldwide, for extraction and screening of extracts in the NCI cancer cell line screen. Extracts are distributed to qualified organizations worldwide for testing against any human disease, subject to the signing of a Material Transfer Agreement recognizing the rights of the source countries. NPB is also establishing collaborative programs through the signing of a Memorandum of Understanding with qualified research organizations in source countries for the screening of natural product extracts for anti-tumor activity, and for the preclinical and clinical development of active agents meeting NCI selection criteria. Other responsibilities are the oversight of operations of the Natural Products Repository and the Natural Products Extraction Laboratory.

Pharmaceutical Resources Branch (PRB)
Chief - Dr. B. Rao Vishnuvajjala, EPN Room 8052

PRB's goal is to provide DTP and the clinical research community with high-quality and well-characterized chemical substances and drug products. Whenever possible, USP/NF grade excipients with a proven track record for consistency and safety are used. The clinical supplies PRB provides are guaranteed to meet or exceed FDA accepted potency and purity requirements while in use. The end use stability studies are designed to provide maximum comfort to the patients and convenience for the health care professionals. PRB contract resources generally are used for drug candidates selected for clinical development. PRB becomes involved when drug candidates are approved by either the Drug Development Group.

Biological Testing Branch (BTB)
Chief - Melinda G. Hollingshead, D.V.M., Ph.D., FNLCR Bldg 1043/11

BTB operates out of the National Cancer Institute at Frederick (NCI-Frederick), providing budgetary oversight and technical direction for an extensive contractual effort designed to discover chemotherapeutic agents for cancer and AIDS. Specifically, BTB's mission is five-fold: 1) to plan, direct, and implement a contract-supported program to screen compounds for indication of clinical efficacy in vivo; 2) to develop new screening models; 3) to produce, provide quality control for, and distribute to NCI, NIH, and the grantee community genetically and biologically defined rodents; 4) to maintain a repository of experimental animal and human tumor cell lines for use in research performed by the program and other qualified investigators; and 5) to define and publish biological testing screening protocols.

Toxicology and Pharmacology Branch (T&PB)
Chief - Myrtle Davis, D. V. M., Ph.D, EPN Room 8034

The primary responsibility of T&PB is to obtain the toxicology and pharmacology data necessary for NCI to file an Investigational New Drug (IND) application with the FDA in order to conduct Phase I clinical trials of new oncolytic agents in humans. To accomplish this goal, T&PB, through its network of contractors, determines or develops analytical methods for quantifying drug levels in biological fluids and tissues, plasma drug distribution and elimination kinetics in animal models, plasma protein binding and stability, metabolic potential, and maximum tolerated doses (MTD) and dose-limiting toxicities (DLT) in preliminary range-finding and IND-directed toxicology studies.

Information Technology Branch (ITB)
Chief - Dr. Dan Zaharevitz, EPN Room 8010

ITB is the primary automated resource of information and data within DTP. ITB manages chemical and biological databases to support DTP's ongoing research efforts. ITB employs state-of-art software and hardware facilities to provide support for DTP and engages in collaborative research to promote further implementation of information technology within the branch.

Biological Resources Branch (BRB)
Chief - Dr. Stephen P. Creekmore, FNLCR, ATRF

The BRB supports preclinical and early (e.g., Phase I) clinical studies of biological response modifiers (BRMs) research in the biomedical community through a program of grants and contracts. These studies assess the effects of novel biological agents and explore relationships of biological responses with anti-tumor activity. An NCI Preclinical Repository distributes selected agents for peer-reviewed preclinical studies performed by both extramural and intramural investigators. Other contracts support the production and in vivo evaluation of monoclonal antibodies, immunoconjugates, and other biologicals.

BRB program staff oversee the Biopharmaceutical Development Program (BDP) at the Frederick Cancer Research and Development Center (FCRDC). BDP produces a variety of biopharmaceuticals under current Good Manufacturing Practices (cGMP) for Phase I/II human clinical trials or advanced preclinical animal testing. BDP is operated under contract by Science Applications International Corporation (SAIC) Frederick, which provides operations and technical support to FCRDC.

Screening Technologies Branch (STB)
Chief - Dr. Robert H. Shoemaker, FNLCR

STB is the organizational component of DTP responsible for the development and operation of in vitro drug screening tools and detailed development and investigation of novel therapeutic agents for the treatment of cancer, AIDS opportunistic infections, and AIDS-related malignancies. This is accomplished through research contracts, projects conducted by the operations and technical support contractor--SAIC--at NCI-Frederick and efforts of staff scientists.