Small Business Innovation Research Awards

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Small Business Innovation Research Awards

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Small Business Innovation Research Awards

Randy Beavers Principal Investigator on All Projects

Project Title, Agency/Program/Award Number (Date)

Outcome

Establishing a Viable Organic Goldenseal Production System for Small Family Farms Phase I, SBIR, USDA # 2001-33610-10417(05/2001-12/2002)

Domestication of Hydrastis from the wild, Demonstrated feasibility of USDA NOP compliant Hydrastis plantation establishment, Enhancement of seed germination protocols

Goldenseal, Processing and Value-Added Product Development  Phase I, SBIR, USDA # 2003-33610-13119 (05/2003-12/2003)

Established basic extraction method, Development of HPLC method for QC/QA, Demonstrated feasibility of a grower owned processing facility

Establishing a Viable Organic Goldenseal Production System for Small Family Farms  Phase II, SBIR, USDA # 2003-33610-13898 (09/2003-12/2006)

Optimized and established raw material production and post-harvest handling controls. Taught system to 23 other growers

Goldenseal, Processing and Value-Added Product Development  Phase II, SBIR, USDA # 2004-33610-14721  (09/2004-12/2007)

Optimization of extraction process, Development of NOP compliant SOP for Hydrastis, Observation of synergy between berberine and Hydrastis leaf extract against oral pathogens, Activity against biofilm formation

USDA Phase I SBIR Goldenseal, Germplasm Improvement Through Micropropagation  Phase I, SBIR, USDA # 2006-33610-16845 (05/2006-12/2007)

Identification and selection of high alkaloid yielding germplasm Identification of genetic markers correlated with alkaloid content,

Development of Research Grade Goldenseal
SBIR, NIH/NCCAM # R41-AT00365-01A2
(10/2007- 9/2008)

Demonstrated feasibility of standardizing Hydrastis products to specified levels of bioactivity, Development of Activi-Tox profiling technology and FDA cGMP compliant SOP, Observed synergy between Hydrastis extracts and ciprofloxacin against Multi Drug Resistant Staph. aureus

Development of Research Grade Goldenseal Phase II
SBIR, NIH/NCCAM # 2R44-AT003365-02
(9/2011- 8/2013)

Validation of standardization process.  Production of highly characterized goldenseal products for use in NIH funded human studies.  Initiation of human pharmacokinetic studies.  Establishment of Drug Master File with FDA as support for an Investigational New Drug Application

Marketing a New Paradigm in Goldenseal Product Standardization Phase I  USDA SBIR # 2011-33610-30438
(6/2011-12/2013

Marketing plan for a radically new method of standardizing goldenseal to specific levels of bioactivity rather than just chemical markers.

 

*These statements have not been evaluated by the Food and Drug Administration.  These products are not intended diagnose, treat, cure, mitigate, or prevent any disease.  This statement is required by the Food, Drug, and Cosmetic Act.

Support for this work is gratefully acknowledged from a series of Small Business Innovation Research Awards from the United States Department of Agriculture/National Institute for Food and Agriculture (USDA/NIFA) and the National Institutes of Health/National Center for Complementary and Alternative Medicine(NIH/NCCAM). The opinions expressed are those of the Author and do not necessarily represent those of USDA/NIFA and/or NIH/NCCAM.

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