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Expertise is available for conducting preclinical efficacy and biomarker studies in various carcinogen-induced and genetically engineered animal models of cancer. These studies include but not limited to in vitro and in vivo testing of preventive agents; pharmacokinetic (PK) and PK/PD modeling to evaluate efficacy; optimizing dosing regimen; characterization of immune responses to vaccines and immunomodulatory agents; identification and evaluation of intermediate biomarkers (Supported Projects).
Toxicology support is available for IND-supporting evaluations for agents in the advanced stage of agent development. In use are the standard models for in vivo assessments as well as an array of in vitro assays. The standard animal models that have been used in PREVENT toxicology assessments are beagle dog, guinea pig, Göttingen minipig, C57BL/6 mouse, New Zealand white rabbit, and rats (CD and Sprague Dawley). Many contracts have supported toxicology evaluations of cancer prevention agents delivered through different routes (oral/systemic, dermal, inhalation, intravaginal, intramuscular) (Supported Projects).
Investigational New Drug (IND) application and regulatory support is available to all PREVENT applicants. The program offers regulatory support through all stages of agent development. Early agent development support is offered through consultation on available regulatory pathways, preclinical packages and pre-IND meeting requests. For agents in late-stage development, resources include preparation of chemistry, manufacturing and control (CMC), toxicology, pharmacology and clinical data for IND submission. Support for clinical trials is also available for domestic and international studies. Through the Cancer Prevention Clinical Trials Network, the program Sponsors IND submissions and maintains all applicable regulatory requirements such as exemption requests, adverse event reporting, annual reporting, and protocol submissions. In addition, the program is able to facilitate collaboration with industry partners by establishing the appropriate documentation including Cooperative Research and Development Agreements (CRADAs), Clinical Trial Agreements (CTAs), Material Transfer Agreements (MTAs) and Confidential Disclosure Agreements (CDAs).
Current Good Manufacturing Practice (CGMP)
Current Good Manufacturing Practice (CGMP) production component was added to the program in 2017. This resource is instrumental in production of vaccines and biologicals and expertise is available for formulation optimization for enhanced bioavailability and clinical usefulness; analytical method development for investigational agents in bulk form and in biological fluids and tissues; stability testing of bulk and formulated material; scaleup cGMP and non-cGMP production of investigational agents.
The DCP Repository provides drug development services and logistic organization for the procurement, manufacturing, formulation, tracking, packaging, labeling, storage, shipping, inventory maintenance, agent testing, quality control, distribution and disposal of research and investigational agents. It serves as the centralized source of research and development services necessary to encourage and promote early and late phase chemoprevention, immunoprevention, and cancer-interception studies.
The Repository is well-equipped to connect an investigational agent with an investigator or trial subject in a safe, legal, and timely manner. It maintains a robust procurement and inventory management system that ensures adequate agent levels at both the Repository and at the research or clinical site. They have proper packaging supplies and shipping services to reach sites both domestic and abroad. The main headquarters is in Kansas City, Missouri and it has a full array of analytical testing, animal testing, drug synthesis, and formulation services available. The warehouse is nearby with 10,000 square feet of storage that provides receiving, quarantine, and shipping areas combined with many different environmentally controlled agent storage areas. Overall, the Repository has the resources to supply, support and facilitate collaborations with DCP investigators.