Research - Natural Products

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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 thatcontrol 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

earch - Natural Products http://www.olemiss.edu/depts/ncnpr/researchNCNPR.html

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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 mechanism-specific 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) studiesand 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 individualconstituents.

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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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 recentlyshown 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 thediscovery 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 industrytrade 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. Thedevelopment 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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