SBIR-STTR Award

The use of dietary supplements has become increasingly popular in the US, and these supplements are not subject to stringent pre-marketing testing or post-marketing surveillance. More than a third of American adults report using some form of CAM, with total visits to CAM providers each year now exceeding those to primary-care physicians. An estimated 15 million adults take herbal remedies or high-dose vitamins along with prescription drugs. NCCAM studies are designed in scientifically rigorous manners and patients are monitored for product usage. However, measuring biological markers and metabolites would greatly benefit the accuracy and reliability of data. NCCAM has requested the development of "common methods, measures, and standards for the generation and interpretation of evidence necessary for making decisions about the use of CAM and conventional therapies." Caldera Pharmaceuticals will develop a new technology to objectively assess patient adherence to the use of complementary and alternative medicines (CAMs). Caldera proposes to develop and optimize technology that will capture, in minimally invasive and objective ways, adherence to certain CAMs in ambulatory and clinical settings, and from a range of patient groups engaging in intervention strategies. Caldera anticipates that this tools will be particularly relevant to commonly used mineral supplements (such as chromium picolinate, magnesium sulfate, and organic and inorganic selenium), but will eventually address adherence to other CAMs. This project will use Reagentless Pharmacoproteomic Measurement (RPM), a technique that uses X-ray fluorescence to quantify the binding of metals to proteins. RPM can be used to identify and quantify biologically active CAM agents and their metabolites in body fluids. Caldera will tailor and optimize its unique RPM technology to specifically measure patient adherence in CAM studies. Phase I consists of using RPM to measure metal content of proteins in a yeast model. Phase II consists of using RPM to measure CAM adherence using biological specimens from existing CAM clinical trials to benchmark this technique. More than a third of American adults report using some form of complementary and alternative medicines (CAM), with total visits to CAM providers each year now exceeding those to primary- care physicians. NCCAM has requested the development of common methods for the generation and interpretation of evidence necessary for making decisions about the use of CAM and conventional therapies. Caldera Pharmaceutical will develop technology to objectively assess patient adherence to the use of CAM.

Thesaurus Terms:
There Are No Thesaurus Terms On File For This Project.

Caldera Pharmaceuticals uses protein fractionation techniques and XRpro technology to determine protein CAM/metabolite binding as a means to determine adherence to CAM regimens in NCCAM clinical trials. Caldera will use their high-throughput proteomics technology to identify CAM Adherence Biomarkers (CABs) using our unique, national award winning XRpro technology. Caldera, in collaboration with Los Alamos National Laboratory, developed XRpro. This technology allows the identification and measurement of CAM adherence by measuring CABs consisting of protein-ligand adducts and protein-metal metabolites with no a priori knowledge of which proteins are involved. Therefore, antibodies to specific proteins or specific protein assays are not required. Caldera Pharmaceuticals has 2000 square feet of lab space and 1800 square feet of office space. This area is well equipped for chemical and biological R&D. Equipment available for this work includes: fume hoods, sterilization ovens, reaction glassware, rotary evaporator, vacuum lines for reactions and distillations, atmosphere controlled glove boxes, heating/stirring mantles, spectrometers (UV-VIS-NIR), NMR, crystallography, fluorimeters, FTIR, TGA and DSC, microscopes, a customized EDAX Eagle III MXRF spectrometer and a customized EDAX Eagle II MXRF spectrometer and Horiba XGT 5000 XRF microscope, and a custom-built confocal XRF microscope, FPLC, and an Applied Biosystems Voyager-DE STR MALDI-TOF and QSTAR XL MS/MS mass spectrometer. Caldera has access to machine and electronics shops. Caldera facilities meet environmental laws and regulations of federal, state, and local governments relating to: airborne emissions, waterborne effluents, external radiation levels, outdoor noise, solid and bulk waste disposal practices, and handling and storage of toxic and hazardous materials