In the May edition, this column discussed the importance of and the steps involved in the “ideation” process and its role in “New Product Development” (NPD). Once a concept or idea has been formed and an opportunity has been identified, the next steps in NPD involve finding the product(s) and ensuring the source of their supply. In the natural products world, this can be extraordinarily complex work, the importance of which cannot be underestimated.
Finding the Goods: The Discovery Process
Developing products is challenging, and making the transition from concept to the creation of the actual product is especially difficult. Often times the concept begins with a therapeutic indication or a geographical location in which one wants to develop a product. Discovering and locating these ingredients or products involves several elements that are suited to people who have training in these fields. In the natural products world this means “hunting” for ingredients or formulas, often times in remote locations.
Similarly, developing supply chains for these products, once developed, can be equally as challenging. Despite these complexities, many companies today still rely solely on ingredient distributors and brokers to locate and source important ingredients. Regardless of who ends up supplying the product, it is wise to understand the dynamics first.
According to Kerry Hughes, executive director, EthnoPharm, a natural products consultancy firm, the process for discovering products in the natural world is different than in the pharmaceutical world, where plants (or chemical compounds found in plants) are screened in a variety of pharmaceutical models without much consideration for the traditions, knowledge, people or environment. In the case of natural and wellness products developed for these purposes, the screening process must involve all of these criteria. This is where ethnobotany comes in.
Understanding Traditional Knowledge Systems
Simply put, ethnobotany is the study of the relationship between people and plants. Greg Pennyroyal, president of Natural Product Innovations, which assists people and companies with sourcing as well as developing appropriate technologies, reminds us that 100 years ago, when much of the modern pharmacopoeia and formulary was being established in the U.S., the traditional knowledge route to product development was everything. Even today, many pharmaceutical drugs and many successful natural products have come from understanding the intricacies of traditional knowledge systems.
Josef Brinckmann, vice president, Research & Development at Traditional Medicinals Inc., explains that there are two primary approaches to developing natural products: Traditional Knowledge and Codified (Scholarly) Systems. In Traditional Knowledge systems, the knowledge is generally passed on from generation to generation through oral traditions. Therefore, maintaining these systems are very important. The role of the ethnobotanist is to help bridge the gap in communications and ensure benefit sharing as well as informed consent.
Codified Systems are the documented bodies of work, such as pharmacopoeias and formularies, which exist in Asia, Europe and even the Americas, and establish the safety and efficacy of products and formulas. According to Mr. Brinckmann, the genesis of some Central European formulas, for example, can be traced back to ancient Rome, Greece and Egypt. These formularies are the accumulated (traditional) knowledge evidence of many generations.
A Recipe for NPD Success
Trish Flaster, executive director at Botanical Liaisons, a renowned ethnobotanist, educator and supplier of botanical references, outlines some of the important steps to successfully developing products using Traditional Knowledge systems:
1. Develop a trusting relationship with a group of people and establish open lines of communication. Try to develop an appreciation for the traditions, culture, language, environment and hierarchy within each cultural group. Ethnobotany has a great deal to do with developing this sense of appreciation.
2. Do some homework and narrow the focus of your search. Have specific targets in mind.
3. Ensure the communication is clear. Detail as much as possible about the discovery using universal languages.
4. Continue to use the principals of Ethnobotany (Traditional Knowledge) in the lab. Understanding the clues provided by the communities can greatly reduce the time and investment into characterizing a product chemically.
5. Use the same principals of Ethnobotany in measuring the safety and efficacy of the product. Try to demonstrate and understand why the “traditional recipe” works.
6. Developing the supply chain also requires the same sensibility. Employ Traditional Ecological Knowledge (TEK)—what, how, when and where to harvest.
a. Will the product be cultivated or wild harvested?
b. Gain permission!
c. Understand the balance of power in the communities.
7. Conduct a feasibility study.
a. How much can be harvested/cultivated?
b. Who should gain the benefits, including benefits from potential intellectual property?
8. Factor in local, state, federal and tribal regulations/rules.
9. Consider establishing multiple supply chains—conduct risk/benefit analysis.
Supply Chain Management: Quality and Sustainability
Traditional Medicinal’s Mr. Brinckmann explains that his company does not develop products based on market trends. This is primarily because it makes long-term commitments to products and their respective supply chains. Traditional Medicinals has a strategic supply chain group, with people from several departments, including herbalists, who prioritize the most important species. About 20 of the 100 botanicals it works with are prioritized for additional investment. The group focuses on a variety of factors when looking at the supply chain and considers above all the viability, quality and ethical standards of the plants.
According to Mr. Pennyroyal of Natural Product Innovations, one of the major challenges with supply chain programs is that the marketplace does not have the tools to recognize high quality products. Consequently, most of the products based on traditional knowledge fall under the public domain where there is very little IP protection, or exclusivity.
Given these challenges, how does one gain a market advantage and establish IP? Mr. Pennyroyal, who worked with Dr. Albert Leung of Phyto-Technologies on an NIH SBIR (Small Business for Innovation and Research) grant several years ago, investigated the use of modern scientific techniques to capture traditional medicinal wisdom. What they came up with were methods to identify good quality products from bad products, and even adulterated products, using commonly available analytical techniques and a bio-assay called Gene Microarray Assay to screen the products. They found a very strong correlation between what traditional people considered to be the “good” products and their chemical as well as biological screenings.
The Upside to Investment?
The product developer might be wondering why they should go through these processes when many of the steps outlined in this article may require a significant investment of money and time. In anticipation of this, the question was posed to the experts and the consensus response came down to five answers:
1. There is no assurance of quality control, safety, traceability, identification and supply chain sustainability unless you implement at least some of these steps.
2. It is difficult to honestly claim benefits in marketing a plant for which the relationship to the plant is so distant.
3. In essence, ignoring all these steps and claiming the knowledge and understanding from them can be an indication of “bio-piracy.”
4. Marketing is all about story—by truly understanding the plant and its traditional knowledge, there is a great chance you will get the story right.
5. The natural products industry was founded by people motivated by a sense of “equitable exchange.” This includes appreciation for the traditions, knowledge, values and property of the people involved.