To improve cancer therapy, scientific discoveries from cancer research must be translated into practical applications such as new drug development. New drugs need to be produced in specialized facilities, with qualified equipment and trained personnel, for compliance with FDA regulations. Due to the special requirements, new drug production is the most expensive milestone to be achieved. The main goal of the Investigational New Drug Production Core Facility is to provide investigators with new drugs for testing in cancer patients. We have identified five investigators in Texas who have discovered promising biologic drug candidates for the treatment of prostate, breast, colorectal, esophagea...

Read More

To improve cancer therapy, scientific discoveries from cancer research must be translated into practical applications such as new drug development. New drugs need to be produced in specialized facilities, with qualified equipment and trained personnel, for compliance with FDA regulations. Due to the special requirements, new drug production is the most expensive milestone to be achieved. The main goal of the Investigational New Drug Production Core Facility is to provide investigators with new drugs for testing in cancer patients. We have identified five investigators in Texas who have discovered promising biologic drug candidates for the treatment of prostate, breast, colorectal, esophageal, lung, and bladder cancers. These new drugs showed efficacy in cell based assays and/or in cancer model animals, and must be produced in mammalian cells. The Scott & White Cancer Research Institute has two existing special suites for manufacturing new drugs in microorganisms such as yeast and E. coli, but lacks the capability of producing drugs in mammalian cells. This capability can be achieved without construction of a new multimillion dollar manufacturing suite because most equipment can be easily moved into storage space when not in use to allow for different equipment and capabilities depending on the particular production’s needs and demands. We are submitting this proposal to seek equipment necessary for large scale cultivation of mammalian cells and subsequent drug purification, salary support for core staffs, and some material supply support for subsidizing costs for production of promising drug candidates and improving production processes. With the support of CPRIT, the production costs can be significantly reduced. As a result, many Texas-based investigators at various career-stages can utilize the Core Facility for making their drugs. Testing more new drugs in humans will strengthen cancer research in Texas and may provide better therapies to cancer patients.

Read Less