The Emerald Conference is embracing Evolution in the Cannabis Industry by adopting a slightly different organizing approach for the 2020 Emerald Conference. We are targeting presentations to broadly defined key Cannabis Industry Segments that reflect products aimed at “Medicinal” as well as “Lifestyle” usage. We intend to cover aspects of product routes of administration (inhaled, ingested, and applied) as well as products utilizing either Hemp (THC < 0.3 %), or Cannabis (THC > 0.3 %) as starting materials.
We are featuring similar Interest Areas as in previous years. These include a focus on Regulatory & Compliance, as well as a focus on Preclinical and Clinical (Translational) Research. Furthermore, we include presentations related to the Development of Cannabis (Bulk) Substances which include the Upstream Topic Areas of Cultivation and Alternative Strategies for generating starting materials, and the Downstream Topic Areas of Extraction and Separation. Cannabis Product Development which includes Formulation and Fill/Finish (stability studies and packaging and labeling) will be included. We will, of course, include our cornerstone Interest Area of Analytical Testing, with an expanded breadth relevant to 3rd party testing as well as In-House analyses. We are also incorporating Genomics (PhytoGenetics, Microbial Genetics, and Human Genetic Screening) within the Interest Area of Analytical Testing.
Overall, we see this approach as reflecting the development paradigms embraced by industries such as Biotechnology. The classification of presentations by Industry Segment as well as by Interest Areas aids us to assemble an overall matrix of presentations that bringsyou broad coverage in the area of cutting edge Cannabis Science and breakthrough Product Development approaches in our rapidly evolving Industry.
– JS Abrams, Ph.D., Scientific Director of the 6th Annual Emerald Conference
Regulatory & Compliance:
Cannabis Substance and Product Terminology in relation to the USP and ICH Guidelines in support of International Trade
- International quality agreements for distributing cannabis require scientific justification of measurable critical quality attributes that can be tested, and the appropriate descriptive language to describe what is being traded.
- Regulators have relied on testing for public assurance that products are safe to consume. Conversely, manufacturers receive little guidance from regulators on how to safely manufacture products of various routes of administration via the application of Good Manufacturing Practices. Cannabis testing laboratories have identified root causes for product non-conformance to jurisdictional specifications, but the manufacturers have insufficient language and tools to manage meeting batch release criteria and requirements.
- Terminology related to manufacturing pharmaceutical drug substances and drug products has been characterized within GMP harmonization efforts. The leader of these efforts has traditionally been the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use. Multiple National Competent Authorities have adopted ICH guidelines as the basis for regulating their pharmaceutical supply chain regulations and the quality of the drugs within it.
- In addition to ICH, the United States Pharmacopoeia (USP) has provided significant insights on herbal dietary supplements and herbal drug substances with a focus on quality specifications and the appropriate terminology for naming such products in monographs.
- This session aims to explore the harmonization of terminology required for quality agreements in international trade of cannabis substance and cannabis products intended for pharmaceutical and dietary supplement supply chains by reference of both the USP and ICH guidelines, with special focus on primary use cases.
Translational Approaches to Cannabis Research
Cannabis prohibition has slowed the evolution of Cannabis product development. Social misunderstanding has retarded the investigation of Cannabis in human clinical trials. Currently, there is no accepted or validated measure of human endocannabinoid tone or study to correlate clinical significance. Cannabis products are produced without potency standards or recommended dosage. In order to evolve toward medical claims, research must lay the groundwork for comparison. Translational science emphasizes interdisciplinary research in order to improve diagnosis and prevention and hasten treatment. Translational approaches to Cannabis research include traditional preclinical and clinical studies, which may incorporate newer technical and crowd-sourcing techniques. In December 2011, The National Center for Advancing Translational Science (NCATS) was established within the NIH to “transform the translational science process so that new treatments and cures for disease can be delivered to patients faster.
Examples of Cannabis research topics include:
- In vitro and animal models involving cannabinoids and other relevant phytochemicals
- Advances in establishing reputable Chemical Manufacturing and Control (CMC) dossiers for Cannabis-related products
- The Pharmacology & Recepterology of the EndoCannabinoid System (ECS)
- ECS Diagnostics development
- ECS and its interaction with other systems (e.g., Immune, Cardiovascular, & Reproductive /Endocrine)
- Pharmacokinetic properties of Cannabis active ingredients
- Drug interaction and adverse effects of Cannabis active ingredients
We see the translational emphasis in Cannabis research as fundamental to advancing and expediting the process of evidence-based label claims for Cannabis products.
Cultivation and Alternative Strategies:
Ensuring Upstream Success
Cultivation is the foundation of the Cannabis industry; however, because of widespread prohibition Cannabis cultivation has, until recently, been a largely clandestine enterprise, unable to benefit from rigorous scientific study. With the loosening of laws in many jurisdictions, Cannabis cultivation can now be researched with the appropriate rigor and traditional methods can be reconciled with horticultural science to establish best practices. This topic area aims to highlight the best agricultural technologies and practices that produce highly marketable crops that perform with optimum vigor, expressing identical phenotypes, consistent potency and are free from pests and disease. Other topics will include how to use lab data in conjunction with plant phenotypic data to determine the best lighting, pruning and defoliation techniques, proper irrigation and nutrient management for diverse cultivars.
Because of their often complex and variable nature, control of starting materials, drying and curing are of significant importance in the manufacture of medicinal and lifestyle products. The selection of strains, cultivation methods, and harvesting conditions & procedures represent important aspects of the quality and consistency of all final products. Alongside establishing best practices for conventional cannabis cultivation, new and alternative technologies and practices such as automation, aeroponics, biostimulants, microbial symbionts, and organic production must be explored to keep cannabis cultivation at the forefront of agricultural sciences.
Extraction and Separation:
Applying Current Chemical Manufacturing Guidelines to the Cannabis Concentrate Sector
With cannabis laws in place in over 65% of the country, the cultural stigma surrounding; cannabis consumption, means of consumption, and the reasons for consumption are evolving. As the industry evolves so too do the methods for manufacturing cannabis consumer products. In traditional chemical manufacturing, the reason for consuming a product dictates the environment, methods, and quality in which the manufacturing process is executed. Products that are manufactured for lifestyle consumption follow a completely different set of guidelines then products manufactured to treat diseases and medical conditions. Concentrates are among the most sought-after forms of cannabis because they are used to manufacture products such as vape pens, edibles, tinctures, capsules, patches, and topicals. Concentrates are manufactured using solvents such as ethanol, hydrocarbon, and carbon dioxide to selectively target and extract the active chemicals from the plant. The end result of the extraction process is crude oil, which can then be subject to further refinement and formulation. Cannabis-derived phytochemicals are consumed for many purposes, including lifestyle use and medical treatments. This interest area’s intention is to focus on the different requirements for manufacturing chemical concentrates that are consumed for either lifestyle, dietary, or medical purposes.
Formulation and Fill/Finish
Putting Together Ingredients, Manufacturing, & Drug Delivery
This Interest area will offer insights for the success of recreational, dietary or medical type product, for ingredients, methods of manufacture and delivery mechanisms. As the cannabis industry has matured, the finished products have as well. Better dose control, decreased variability, and increased patient acceptance and compliance should be expected. There is a myriad of options from traditional products, like edibles and tinctures, to pharmaceutical type products like metered-dose inhalers and self-emulsifying tablets or capsules. However, many people will attest, combustible flower works the best for treatment of a variety of indications. Can the current state of extraction and formulation deliver the synergistic effect like inhalation of flower? Is the entourage effect real? Can we mimic or improve on mother nature’s design? This Interest area will offer insight from industry leaders to the state-of-the-art artistic products for lifestyle and recreational enjoyment, as well as the state-of-the-art scientific products for the medical market. While these areas may differ in ingredients and methods, good formulation and fil/finish are key to any finished product success. Good formulation and product presentation start with sound science like that denoted by the principles of Quality by Design (QBD). Thoroughly understanding a product through good design of experiments for the formulation as well as the delivery mechanism and stability in packaging is a must in today’s competitive market and is the foundation for successful clinical studies. New areas of focus for formulation include; safe additives/ingredients/flavors for inhalation, enhanced bioavailability, full-spectrum formulations vs. high purity cannabinoids.
Evolving Innovative Technologies That Integrate Across All Industry Sectors
The move towards regulated cannabis markets drives specific testing requirements for compliance. Furthermore, all segments of the Cannabis Industry are impacted by the state of its analytical technologies. Starting with Regulatory Compliance where developing standard methodologies in cannabis testing is crucial. As is Reference Standard development, and Proficiency Testing advances. Analytical solutions relevant to Preclinical and Clinical efforts include Immunoassays for toxins produced by pathogens and food allergens, as well as cell-based bioassays for API potency determination and assignment of International Units. Additionally, relevant Genomics solutions include human genetic screening correlated with EndoCannabinoid System responses. Analytic solutions relevant to Cultivation include Cannabis Pant Genetics and also Microbiome screening for symbiont organisms used for optimized yields. Chemotyping advances with terpenoids and flavonoids are also generally relevant here and in further downstream areas. Analytical solutions that apply here certainly include: investigating matrix effects and the impact of various clean-up strategies with a focus on extraction techniques used to purify samples to remove analytical interferences. In the Formulation arena, we see developments in Stability Study methodologies as key as well as a thorough analysis of Vaping Oil components.given the current health risks associated with this Mode of Administration. We welcome presentations that address new instrumentation and technologies that provide better resolution, such as qPCR that adds specificity to target organisms. Additionally, we encourage submissions about technologies supporting In-House as compared to 3rd Party Testing Our overall goal for the Analytical Solutions Interest area is to explore solutions that truly innovate and integrate across our evolving Cannabis Industry.