Message from the DCTD Director

Message from the DCTD Director 

The Division of Cancer Treatment and Diagnosis (DCTD) focuses its activities on developing novel diagnostics and therapeutics for cancer. DCTD staff members, along with colleagues throughout the National Cancer Institute (NCI), academia, and industry, are working to generate a seamless pipeline of biomarkers and therapeutics that runs the gamut from initial efforts in drug discovery through late-stage clinical trials. New cancer imaging techniques play a critical role in support of this pipeline as advances in image-guided diagnosis and image-guided therapies continue to emerge.

A primary goal of DCTD is to decrease the time necessary to bring anticancer drugs and biomarkers to the clinic while enhancing our ability to predict which treatments will be most useful for each patient (Modernizing Clinical Trials). At the core of this objective is the implementation of the recommendations of the Strategic Plan developed by NCI’s Clinical Trials and Translational Research Advisory Committee. The Strategic Plan focuses on facilitating the delivery of patient-centric clinical trials while alleviating many of the burdens that currently affect patients and clinical trial sites participating in NCI-supported investigational studies. Implementation of efforts to enhance NCI’s clinical trial system that were stimulated by the COVID-19 pandemic include: 

• Shipping oral anticancer agents to research sites for local distribution
• Enhanced use of local laboratories and imaging facilities to reduce the need for travel to distant academic centers to obtain routine components of research protocols
• Increased use of telemedicine visits
• A major effort to decrease collection of superfluous data elements in all trials in an effort to diminish the workload of both local trials sites and central biostatistical operations. This has been possible, in part, because of the development of a common data management system for all trials, and a comprehensive, centralized patient registration and regulatory support from NCI’s Cancer Trials Support Unit.

To take advantage of the rapid expansion of our knowledge of the genomic basis for many cancers and the relationship of specific genetic characteristics in tumors to therapeutic efficacy, DCTD has organized a network of molecular characterization laboratories to assist in the development and use of investigational, study-specific biomarkers to improve potential outcomes for patients entered on NCI-supported studies that are carried out across a broad range of diseases. These activities range from proof-of-mechanism pharmacodynamic investigations to the evaluation of predictive molecular genetic markers in prospective, randomized trials. NCI will play an important role in developing analytical standards for the critical assays needed in the development of modern therapeutic molecules, will perform investigational assays, and will provide training in the conduct of critical correlative studies so that they can be performed at the highest level in academic institutions conducting NCI-supported clinical trials. The goal is to develop more trials that attempt to define distinct patient populations within each type of tumor, thereby enhancing the potential for target-based, therapeutic success.

DCTD also supports a major effort to coordinate and enhance NCI’s drug discovery program. To bridge the gap between academic drug discovery and the development of anticancer agents in the clinic, NCI has reinvigorated the process by which academics, the private sector, and the government can work together to move novel compounds along the entire path from molecule synthesis to target validation, pharmacologic investigation, toxicologic study, formulation, and the conduct of first-in-human trials. The pipeline for this effort is called the NCI Experimental Therapeutics (NExT) Program; it has consolidated all new drug discovery and development efforts within the Division, and provides direct access for extramural scientists to the full range of NCI-supported resources needed to bring new molecules to patients.  

Furthermore, the NExT Program encompasses immunotherapeutic, as well as small molecule, approaches to cancer treatment. DCTD is engaged in producing a range of both cellular- and antibody- based therapeutic reagents that have been deployed in national clinical trials. To carry out the effective evaluation of these and other molecules, DCTD expanded its cellular therapy production facilities at the Frederick National Laboratory for Cancer Research; these production resources are being used to produce CAR-T and other cell therapy products that are under study in several multisite clinical trials.

Finally, in the rapidly changing world of cancer therapy and diagnosis, DCTD continues to evaluate unmet needs and understudied areas of cancer therapeutics and diagnostics. The DCTD Research Interests section accompanying this message provides a summary of areas that we believe will require additional attention and investigative interest by the academic community in the coming years. We are focusing on areas that require enhanced attention to improve the pace of progress.

DCTD Research Interests

Areas of research interest that are under-investigated or that require expanded emphasis in the DCTD portfolio include:

• Enhancing Tumor Response to Therapy
  • Target-based drug development for rare cancers
  • Development of combination therapies in novel, clinically relevant models
  • Targeting molecular signaling pathways to enhance understanding of cellular immunotherapy
  • Reducing toxicity using image-guided interventions to target drug delivery and activation
  • Studies on the beneficial or harmful effects of anticancer agents on unintended targets
  • Development of approaches, including complementary medicine approaches, to improve the therapeutic index of standard and investigational anticancer therapies
     
• Investigations of the Tumor Microenvironment
  • Design and testing of agents that target the tumor microenvironment using clinically relevant models
  • Exploiting the tumor microenvironment’s role in therapy
  • Understanding the dynamic relationship between tumors and cells in the microenvironment
  • Understanding the role of the microbiome on therapeutic efficacy and resistance to both small molecules and immunotherapy
  • Measuring and evaluating the role of the tumor microenvironment in tumor transformations through imaging and other noninvasive methods
     
• Development of New Methods and Technologies
  • Development of new imaging technologies, including novel hardware, new research interfaces, refinement of image processing, and further development of virtual imaging
  • Validation of imaging as a biomarker, including development of methods to better determine a response to therapy
  • Development of new imaging agents
  • Development and application of diagnostic devices and technologies that support multi-analyte molecular assays
  • Development of integrated lab-on-a-chip diagnostic devices for real-time analysis of biospecimens
  • Methods, mechanisms, and technologies to ensure the availability of clinical specimens for translational research
     
• Clinical Studies
  • Translational and clinical studies in the following under-investigated diseases: pancreatic cancer, squamous cell carcinoma of the head and neck, bladder cancer, sarcoma, and pediatric solid tumors
  • Validation of the clinical utility of molecular profiles
  • Clinical studies using imaging approaches to characterize disease anatomy, physiology, and molecular biology
  • Validation of the clinical utility of novel, innovative clinical diagnostic devices
  • Development of personalized medicine approaches including the discovery, development, and qualification of biomarkers to define efficacy, toxicity, dosing, and schedule of therapy