FOUNDATION DOCUMENT

National Strategy and Action Plan for Biological Diversity, Vol. 1: National Strategy for Conservation Regarding Biological Diversity and the Sustainable Use of these Resources.

A study commissioned by the Republic of Guinea, Ministry of Mines, Geology, and the Environment in April 2001, supported by PNUD/FEM.

PUBLISHED PAPER

"Linking Medicinal/Nutraceutical Products Research with Commercialization."

S.I. Cameron, R.F. Smith, and K.E. Keirstead, Pharmaceutical Biology, 2005, Vol. 43, No. 5, pp. 425-433.

Abstract

Thousands of bioactive phytochemicals have potential or established pharmaceutical, medicinal, or nutraceutical applications. Developing crops for bioactive compound extraction presents both research and development challenges and market-driven considerations. Demonstrating that cultivation is economically viable is not sufficient. Using examples from both medicinals and our experience with Taxus canadensis Marsh., we discuss two types of market factors that must be considered before commercialization can proceed. Bioproduct market factors include availability of a cheaper product elsewhere from the same species; other species with the same bioactive compound; existence of a synthetic alternative to the naturally sourced phytochemical; the patent suite covering bioproduct extraction and use; commodification; and government bioresource regulation. The role and suitability of an industrial collaborator proposing to fund R&D activities must also be gauged by the R&D partner. The assessment should include the company's knowledge of the marketplace; its capacity to sustain the R&D funding; whether the intent is to market raw biomass or a value-added product; and how it is proposed to handle exclusivity and proprietary information. The economics of cultivating elite Taxus canadensis cultivars are also briefly summarized. It is concluded that consideration of bioproduct marketing realities can help to focus R&D goals and timelines based on both biomass cost reduction (or improvement in quality) and meeting the collaborator's specific needs.

Keywords: Bioproduct marketing, commercialization, medicinal crop, paclitaxel, pharmaceutical crop.

COMMISSIONED STUDY BY THE LYCEUM GROUP

"Assessment of a Pre-Qaulified List of Perennial Non-Timber Forest Species to Ascertain their Commercial Potential as Sources of Sought-For Bioactive Compounds"

Canadian Forest Service, 2005

EXECUTIVE SUMMARY

In 1948 the United States Pharmacopoeia (the compendium used by physicians as a reference to treat diseases in humans) consisted of mostly natural products derived from plant material that occured in "wildcraft" form. Classic pharmaceuticals that have survived from this era are penicillin and digitalis (from foxglove), to name two well-known examples. Many other Over-The-Counter (OTC) medications such as bilberry, psyllum and echinacea are still widely used.

Notwithstanding the intervening decades of pharmaceutical research into effective therapies using synthetic molecules, the pharmaceutical industry, and available products on the market in developed countries, still depend on naturally derived starting material. Surveys of prescription drugs, OTCs, and cosmetic products now available in Canadian pharmacies reveals that over 50% contain starter material or active ingredients derived from natural sources. In fact, most multinational pharmaceutical/natural health product companies have robust discovery programs that focus on plant-derived chemicals and agents.

Natural bioactive compounds are found in:

• Patented drugs and pharmaceutical agents
• Generic drugs and pharmaceutical agents
• Blended drugs and OTC products
• Non-branded drugs and OTC products
• Vitamins and supplements
• Herbal remedies and nutraceuticals
• Cosmetics and essential oil products
• Functional foods

In addition to newly bioprospected compounds, there are thousands of natural products available to scientists and researchers whose safety and efficacy are well established through centuries of traditional use. For example, Crataegus species (hawthorn) products are widely used to control hypertension, and are used in Germany as the first-line treatment for early cardiac pathological symptoms. As associated parallel use for natural products is a growing market to meet the needs of non-drug items such as essential oils, emollients, fillers, flavors, aromatherapies, etc.

In 2004 the Canadian Forest Service in Fredericton - through Dr. Stewart Cameron and Dr. Ron Smith - articulated the need and opportunity to build on experimentation with Taxus canadensis (ground hemlock) and determine whether or not similar opportunities existed in other perennial non-timber forest species, native, or adapted to the Atlantic Provinces in Eastern Canada. A "domain" of 45 plant species was identified as candidates for a marketability study with reviews to be conducted on available research data (chemotaxonomic materials), and emphasis to be placed on known commercial interest.

The goal of the study was to ascertain the potential "interest" by existing commercial entities, and determine the probable positioning of output "products" where these were known. The objectives of this research were to identify the leading six (or more) candidates and produce "dossiers" that would: discuss their potential for propagating and cropping; further elaborate their phytochemistry, biological parameters, possible "niches", regulatory opinion (where available), etc; and importantly define the size and value of their market, including competition from early entrants.

• Enhancement and Elicitation of Biomass by Biotic and Abiotic Mechanisms of Action.
• From Biomass to Bioactive: A Third-World Case Study of Aframomum stipulatum.

CURRENT RESEARCH PROJECTS

• The Development of a Paralytic Peptide for Pain Management - Corporate Development (Ken Keirstead).
• Pilot Study for Production of Antioxidant-Rich Concentrated Extracts from Vaccinium species (Jim McClare).
• Process Engineering Study and Flowsheet Development for the Refining of Jojoba oil and the Manufacture of Esters for the Cosmetic Industry (Jim McClare).
• Improved Design and Validation of a Vertical Counter-Current Extraction System (Jim McClare).