Investigational Drug Branch (IDB)
The Investigational Drug Branch (IDB) implements and oversees an innovative investigational experimental therapeutics program. IDB:
- Collaborates with academia and industry through an NCI-funded, Phase I and Phase II grant and contracts program to carry out the clinical evaluation of novel anti-cancer agents.
- Develops drug development plans, including Phase I, Phase II and Phase III trials, for anti-cancer agents and coordinates with both intramural and extramural investigators and the pharmaceutical industry in the design and the conduct of these trials.
- Monitors clinical trials of anti-cancer drugs for safety, efficacy, and clinical pharmacology.
- Investigates and prepares reports concerning adverse events (AEs) for all INDs.
- Provides annual reports to FDA on oncologic drugs.
- Works closely with the Investigational Drug Steering Committee and its Task Forces to increase the transparency and openness of the trial design and prioritization process, achieve optimal phase I and phase II trial designs for the most promising agents and, ultimately, increase the predictive value of early phase trials, resulting in the design of more successful phase III trials.
IDB is comprised of the following Sections and agent portfolios:
|Investigational Therapeutics I||Stem cell pathways; cell death; radiation sensitization; DNA-interactive agents; angiogenesis|
|Investigational Therapeutics II||PI3 kinase/AKT/mTOR; protein metabolism; cell cycle; microtubules; DNA repair; c-met|
|Investigational Therapeutics III||Ras/Raf/Mek/Erk; Her-targeted agents; cytokines; oncolytic viruses; epigenetic therapies; imids; cell therapies; monoclonal antibodies; vaccines; nuclear receptors|
For academic investigators with new ideas interested in submitting an unsolicited LOI, please contact the IDB Senior Investigator in charge of the appropriate drug portfolio for further discussions. This step will help to ensure the proposed LOI will not be duplicative and is written in an efficient and effective manner that will increase its likelihood of acceptance and funding by CTEP. The names of the Senior Investigators are written in the Excel spread sheet which can be found under CTEP Agents and Active Agreements.
About the Branch Chief
James Zwiebel received the MD degree from the Mount Sinai School of Medicine, where he also completed his residency training in internal medicine. Following a clinical fellowship in hematology and oncology at the George Washington University Medical Center and research fellowships at both the National Cancer Institute and the National Heart Lung and Blood Institute, he continued his laboratory work on cancer gene therapy as a member of the faculty at Lombardi Cancer Center of the Georgetown University Medical Center, where he also practiced hematology and oncology. More…