[DT Roster]

The Developmental Therapeutics [DT] Study Section reviews applications addressing the experimental therapy of neoplastic diseases in in vitro systems and in vivo model systems, including some early-stage, pilot clinical trials. The major emphasis of this study section is on the rational development of novel therapeutic strategies that have a significant potential for early translation to the clinic.

Specific areas covered by DT include:

• Evaluation of drug-delivery strategies for cancer treatment (including nanoparticles, liposomes and other delivery vehicles).
  
  
• Translational studies of novel antineoplastic agents.
  
  
• Development of anti-angiogenic therapeutic strategies.
  
  
• Development and application of mathematical and computational methods for the investigation of combination chemotherapy using small molecules and other modalities.
  
  
• Rational combination of cytotoxic drugs with novel agents including those targeting: growth factors, signaling, cell cycle regulation, angiogenic, and differentiation pathways
  
  
• Pre-clinical drug toxicity and pharmacokinetic/pharmacodynamic studies of anticancer agents.
  
  
• Gene therapy involving non-immunologic targets for treatment of cancer.
  
  
• Therapeutic approaches involving biologic response modifiers, (including cytokines, and hormonal agents) either alone or in combination with novel or conventional drugs for cancer treatment.
  
  
• Early-stage, pilot clinical trials of novel anticancer therapeutic and drug-delivery strategies involving pharmacokinetic, pharmacodynamic, toxicologic, or pharmacogenomic endpoints.
  
  
• Study of biomarkers in response to anti-neoplastic drug action in preclinical systems

DT has the following shared interests within the ONC IRG:

• With Cancer Biomarkers [CBSS] in validating molecular markers of tumor response. When the focus is on prediction of the patient's response to therapy, the study could be assigned to CBSS. Studies focusing on the assessment of new drug activity could be assigned to DT.
  
  
• With Radiation Therapeutics and Biology [RTB] in studies involving combinations of ionizing or electromagnetic radiation with conventional or novel cytotoxic drugs. If the emphasis is on radiation, the study could be assigned to RTB; if the emphasis is on the cytotoxic drug it could be assigned to DT.
  
  
• With Cancer Immunopathology and Immunotherapy [CII] in studies of combinations of biologic response modifiers with cytotoxic drugs or gene therapy. Gene therapy studies involving immunologic targets could be assigned to CII.
  
  
• With Drug Discovery and Molecular Pharmacology [DMP]: Synthesis of new anti-angiogenic agents could be assigned to DMP. Studies that emphasize early stage development of drugs (e.g., identification, modification, and synthesis, SAR) could be assigned to DMP while translational studies in animals and patients could be assigned to DT. 
  
  
• With Basic Mechanisms of Cancer Therapeutics [BMCT]: Studies involving mechanism of action or molecular effects of anti-neoplastic or anti-angiogenic agents could in general be assigned to BMCT. However, advanced animal experiments and studies containing a strong translational component could be assigned to DT. 

DT has the following shared interests outside the ONC IRG:

• With the Bioengineering Sciences and Technologies [BST] IRG: When the major goal is the development of general gene therapy approaches, the application could be assigned to BST. If the proposed gene therapy approach is being applied to improve cancer therapy, the application could be assigned to DT. Applications involving formulation-type studies of drug-delivery strategies for cancer treatment could be assigned to BST. Once a lead particle, liposome or other vehicle has been developed, the application could be assigned to DT.

• With the Infectious Diseases and Microbiology [IDM] IRG: Studies that focus on viral replication and virology could be assigned to IDM, while studies involving viral vectors for cancer treatment could be assigned to DT.
  
  
• With the Hematology [HEME] IRG:  In general, studies focused on the diagnosis and treatment of lymphomas and leukemias could be assigned to DT.
  
  
• With the Hematology [HEME] and Cardiovascular Sciences [CVS] IRGs: In general, studies of the treatment of angiogenesis that are focused on developmentally related processes or reactivation of embryonic processes could be assigned to HEME or CVS; studies of treatments focused on tumor-related angiogenesis could be assigned to DT.
  
  
• With the Endocrinology Metabolism, Nutrition and Reproductive Sciences [EMNR] IRG: When the primary focus of basic or clinical studies is on the hormone or endocrine organ, assignment may be made to EMNR while studies that focus on translational research for cancer treatment, where hormones receive a secondary consideration, could be assigned to DT.
  
  
• With the Digestive Sciences [DIG] IRG: Studies of the treatment of Barrett's Esophagus and GI polyps could be assigned to DIG, while all other translational cancer treatment studies involving GI cancers could be assigned to DT.
  
  
• With the Brain Disorders and Clinical Neuroscience [BDCN] IRG: In general, chemo-therapy and gene therapy studies that focus on outcome variables associated with CNS functions could be assigned to BDCN; while all other translational therapeutic brain tumor studies could be assigned to DT.