Testing a New Oncology Drug Development Paradigm — Section 2

The following improvements in the use of DCTD resources have been made to accelerate drug development:

• DCTD and the NCI Center for Cancer Research (CCR) have established a formal partnership to enhance pre-clinical and clinical drug testing. The new collaborative effort between the DTP drug developers in DCTD and the programs and clinicians at CCR, called the NCI Experimental Therapeutics (NExT) program, uses PK/PD principles to streamline the development of novel cancer therapeutics. This initiative builds on CCR’s strengths in integrated research and its clinical program, as well as DCTD’s expertise in drug development and its relationships with pharmaceutical companies. The goal is to shorten the drug development timeline for new molecular entities and cytotoxic agents by rapidly screening new drugs in humans before making a commitment in time and resources to a full therapeutic development plan.
• A joint pipeline of new agents is now being actively managed by DCTD and CCR. Decisions about what agents to develop are being made by a newly established joint development committee.
• Molecules entering the pipeline will be managed by teams with members from both DCTD and CCR. Joint drug development teams are being guided by a new DCTD Developmental Therapeutics Project Management Office, bringing a business-focused approach to tracking the progress of agents from discovery through early-phase clinical trial.
• The DCTD Developmental Therapeutics Project Management Office will also lend project management assistance to advance the evaluation of targeted therapies being studied jointly by the DCTD Developmental Therapeutics and Cancer Therapy Evaluation Programs.
• DCTD has initiated a new molecular toxicology laboratory that will develop novel approaches to toxicologic prediction using normal human tissues. This is concurrent with the new commitment by DCTD and CCR to combine resources to focus on developing predictive, preclinical molecular pharmacodynamic assays. These assays will support the clinical development of agents for which NCI holds the IND.
• The division has also expanded its capabilities to develop and standardize diagnostic imaging biomarkers in addition to pharmacodynamic assays. These processes will be aided by the development of new imaging tools and agents that can track molecular events in tumors and normal tissues. Once completed, the portfolio of biomarkers and assays will be made available to all interested cancer researchers. DCTD has identified several resources to help achieve this goal. Chief among them is the establishment by DCTD and CCR of a new National Clinical Target Validation Laboratory (NCTVL). This laboratory will develop and authenticate pharmacodynamic assays well in advance of human studies, so that they can be used in early phase trials to provide information about the safety and efficacy of the entities being tested.