TPB Organization

The TPB is a branch within DTP that is functionally organized along two lines, pharmacokinetic/ADME and toxicology. Each of the seven members of the branch serves several functions that fall into one of three categories:

• Pharmacologist and/or Toxicologist
• Contracting Officer’s Technical Representative
• Toxicology PK/ADME Team Expert

As a Pharmacologist and/or Toxicologist, the individual reviews the available data on the agent in question (biological, biochemical, efficacy, mechanism of action, pharmacology, toxicology) to ascertain if additional information is needed to adequately design preclinical pharmacology and toxicology studies and clinical trials or that is necessary to file an IND with the FDA. The scientific significance of the results from ongoing studies is continuously assessed and study protocols are modified accordingly. The data that are generated from the various studies conducted are integrated with information from other sources and the literature in order to make data evaluation as complete as possible.

As a member of a Drug Development team, the individual serves as a primary resource for pharmacology and toxicity information by providing preclinical pharmacology and toxicology data to other NCI staff investigators and managers as well as to toxicologists, pharmacologists, clinicians and other investigators from drug companies, Cancer Centers, universities, etc.

As a Contracting Officer’s Technical Representative (COTR) for one or more of the branch contracts, the staff member provides technical guidance in planning, coordinating and evaluating projects that are performed by the Contractor and collaborates with project leaders on day-to-day technical aspects of the studies. Prior to study initiation, the COTR designs and plans preclinical toxicology and pharmacology protocols; and as studies are in progress, the COTR modifies those studies as necessary in order to capture as much relevant data as possible. From a contract administration point of view, the COTR performs all duties related to contract initiation, negotiation and administration and is knowledgeable of pertinent NCI contract policies, procedures and practices.