Research - Natural Products

http://www.olemiss.edu/depts/ncnpr/researchNCNPR.html

Natural Product Discovery and Development Program Medicinal Plant Research Development of Products and Technologies Commercialization of Natural Product Discovery and Development Program

The Natural Product Discovery and Development Program is divided into two major areas of research: the Drug Discovery and Development Program and the Agrochemical Discovery and Development Program. Drug Discovery and Development Program Agrochemical Discovery and Development Program

Drug Discovery and Development Program

The goal of the Drug Discovery and Development Program is to discover single entity and multicomponent bioactive natural products that may serve as leads for the development of new pharmaceuticals that address unmet therapeutic needs. Emphasis is on agents that control certain infectious diseases, cancer and immune disorders. Chemical constituents responsible for biological effects are identified and then either isolated and purified in the search for new single entity pharmaceutical ingredients or characterized and standardized in the search for new multicomponent botanical products. The Center builds on a strong foundation and history of excellence in natural products research at The University of Mississippi. Particularly noteworthy strengths of this program are in the areas of: Sourcing, acquisition and sample preparation Biological evaluation in contemporary and relevant targets Isolation and structure elucidation

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The discovery program starts with the collection of natural products from worldwide sources. Sources of natural products include plants, marine organisms and microorganisms. The sourcing, acquisition, and sample preparation efforts of the Center are built upon a well-documented track record of unique strengths, including: experience in collecting and processing higher plants, marine organisms and microbes for biological evaluation expertise to develop novel and unique sourcing strategies maintenance of a unique, biodiverse extract and compound library expertise in microbial and semi-synthetic transformations capability to follow-up on active leads The biological evaluation conducted in the Center is aimed at supporting the discovery of promising lead compounds by using a combination of mechanism-blind and mechanismspecific biological assays to detect agents that show novel activity against selected infectious diseases, cancer, and immunological targets. The Center also collaborates with many academic, government and private sector laboratories that run complimentary biological assays in support of the discovery program. With a strong critical mass of expertise the Center is particularly well suited to undertake the bioassay-directed fractionation of plant, marine, and microbial extracts that exhibit promising biological activities. Promising leads are then developed either as single chemical entities or as multicomponent botanical ingredients. In the case of single chemical entities, analogs are synthesized using computer-aided design, and structure activity relationship (SAR) studies and molecular modeling are used to optimize the desired pharmacological properties. Selected lead compounds are then progressed into an early development program where preclinical, chemical development, analytical, preformulation, formulation and stability studies necessary for the successful filing of an Investigational New Drug Application (IND) are completed. These activities are done in collaboration with academic or private sector laboratories. In cases where a natural product sample contains several components that may act through different mechanisms of action within the body, and therefore act additively or synergistically to exert a therapeutic effect, early development work is based on standardization of the multicomponent mixture rather than isolation of individual constituents. Current projects include the discovery and development of antifungal agents for life-threatening infections, anticancer agents that target specific critical processes in the cancer cell, antibiotics effective against bacteria that are resistant to many current antibiotics, new drugs for tuberculosis, malaria and other tropical parasitic diseases, antioxidants for cancer prevention, immunostimulatory botanicals, anti-inflammatory botanicals, immunomodulatory natural products, and the development of Dronabinol Hemisuccinate (THC) suppositories to control nausea due to chemotherapy and for pain management. Research is also conducted on the optimization of yields of desirable bioactive constituents in plants.

Agrochemical Discovery and Development Program

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http://www.olemiss.edu/depts/ncnpr/researchNCNPR.html

The goal of the Agrochemical Discovery and Development Program is to identify lead compounds for the development of environmentally benign and toxicologically safe pest management agents. This program is done in collaboration with scientists in the Natural Products Utilization Research Unit of the USDA Agricultural Research Service. Emphasis is on the discovery and development of agents that are useful in the control of pests affecting small niche crops. Information about the Natural Products Utilization Research Unit of the USDA can be found on their Home Page at http://olemiss.edu/depts/ncnpr/usda.

The Medicinal Plant Research Program has two major areas of research: Botanicals and Human Health and Medicinal Plants as Alternative Crops. Botanicals and Human Health Program Medicinal Plants as Alternative Crops Program

Botanicals and Human Health Program

The goal of the Botanicals and Human Health Program is to identify botanical products with the potential to improve human health and to enable the safe, effective and proper use of high quality botanical products by informed professionals and consumers. Consumer health products based directly on plant and minimally-processed plant products, known as herbal products, botanicals, dietary supplements, phytomedicines, or nutraceuticals have recently shown a rapid sales growth in the U.S. Unfortunately, the quality of the products that are on the marketplace is highly variable and neither the consumer nor the healthcare professional is able to distinguish between high and low quality products. The Center's scientists believe that good science is needed to provide information needed by the public to make good decisions concerning the proper use of these products. The Botanicals and Human Health Program includes both research and educational activities. Research projects focus on enhancing product quality and safety through botanical, pharmacological, chemical and agronomic characterization of botanical products, and the discovery of new botanical products. Current projects that focus on enhancing product quality and safety include working with the Food and Drug Administration to develop a model for the development of botanicals as drug products, developing analytical methods for bioactive constituents, degradation products, and contaminants; and working with USDA on the use of genetic profiling to certify authenticity of seeds and plant specimens. The Center's comprehensive approach for the development of new botanical products relies on traditional use/ethnobotanical information to identify leads, a battery of biological assays (cellular, biochemical and molecular) to detect biological activity and chemical standardization technologies. The Center's botanical research program starts with gathering, assessing, and cataloging literature regarding traditional uses of botanicals throughout the world. This information is reviewed to identify lead candidates for new product research.

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Much of the controversy surrounding existing literature on botanicals results from inadequate research aimed at ensuring quality plant material that has been authenticated botanically and characterized chemically and pharmacologically. The Center's research program includes sample authentication, analytical and biological characterization, and standardization activities. Research is also conducted on the optimization of yields of desirable bioactive constituents in plants. Current projects include identification and development of botanicals with antioxidant, immunostimulatory and anti-inflammatory activities. Educational activities include providing practical information on botanical products to healthcare professionals, government officials and consumers, and conducting market research studies to understand what healthcare professionals and consumers know and don't know about botanical products, how healthcare professionals and consumers use botanical products, and to identify supply chain issues that are unique to manufacturing and distributing botanical products. Scientists in the Center and the academic departments of the School of Pharmacy are involved in continuing education programs for pharmacists, physicians and other healthcare professionals, and serve on advisory committees to the FDA, the National Institutes of Health (NIH), the United States Pharmacopoeia (USP) and industry trade associations.

Medicinal Plants as Alternative Crops Program

The goal of the Medicinal Plants as Alternative Crops Program is to conduct research that can be used to develop medicinal plants as high value alternative crops for U.S. farmers. Research focuses on identifying medicinal plants that are viable economic opportunities for farmers and on correlating cultivation, harvesting and agronomic conditions to the plant's ability to produce the desired chemical and pharmacological profile. Environmental chambers are used to simulate different growing conditions and experimental plots are grown at the Center's Medicinal Plant Garden. Other research activities include determining the optimal post-harvest processes to maximize desirable properties, genetic engineering, crop improvement studies, and translational research and marketing research. Current projects include economical production of podophyllotoxin, an important intermediate in the synthesis of anticancer agents, agronomic potential of medicinal plants in Mississippi, value-added development of botanicals through harvest, post-harvest and storage practices, and market research to quantify commercial potential.

The Center, in partnership with the departments of Medicinal Chemistry, Pharmacology, Pharmacognosy, and Pharmaceutics in the School of Pharmacy; and with external collaborators, has the expertise to complete the studies required to file an Investigational New Drug (IND) application for a new pharmaceutical product, and to complete the early development activities for a new agrochemical product or a botanical dietary supplement. The development capabilities of the Center include: Medicinal Chemistry, Structure-Activity Relationship Studies, Computer-Aided

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Drug Design, and Molecular Modeling Analytical Methods Development, Preformulation and Formulation Development Biochemical Studies and Mechanism of Action Determination In vivo Efficacy and Safety Assessments Greenhouse Studies Optimization of Extraction Processes Funding for development activities is provided by externally-funded grants and contracts. The Center actively seeks collaborations with specific academic and industrial partners to accelerate the development programs.

The primary responsibility of the School of Pharmacy's Office of Technology Commercialization and Business Development is to facilitate the commercialization of the products, technologies, and information discovered and developed by the Center. The Center is committed to the aggressive commercialization of its discoveries so that such discoveries can positively impact society. By meeting its objectives of providing focused leadership in natural products research, culminating in the discovery, development and commercialization of new pharmaceuticals and agrochemicals, the Center will meet its mission of improving human health and agricultural productivity. As a result, the U.S. will enjoy improved competitiveness in the global pharmaceutical and agrochemical market. An additional benefit will be the identification of potential alternative cash crops for U.S. farmers, and the demonstration of the benefits of global biodiversity conservation.

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