Genetics may influence experience with cannabis and CBD. With increased access to legal cannabis and the research community expanding their focus on the medicinal uses of cannabinoids, more and more consumers are seeking cannabis for health and wellness. However, cannabinoids and terpenes are extremely complex and research tells us that users can have vastly different physiological responses to individual strains/chemovars or products. This makes it almost impossible to find a perfectly aligned product through trial and error. The truth is, cannabis is personal, and uncovering true endocompatibility for each individual user can be scientifically validated. Combining genomics with biomarkers and measurable outcomes allows us to develop better predictive inferences.

Learning Objectives:

1. State the case that we are at the intersection where Precision Medicine meets Digital Health

2. Discuss how EndoDNA is using phyto-canabinoids and therapeutics to align with your DNA and Biometrics

3. Discuss the breakthrough scientific approach Endocanna Health has taken to solving for an individualized response to cannabinoids;

4. Define HyperPersonalization and BioCommerce

5. Discuss the latest research and scientific evidence to evaluate and confidently use cannabinoid therapeutics for individually defined optimal outcomes;

6. Explain the scientifically based, genetically focused resource that consistently and reliably matches individuals with the most compatible cannabinoid products;

7. Introduce research Endocanna Health is currently undertaking with industry partners.

While nearly all of the research on phytocannabinoids has focussed on decarboxylation products like THC and CBD, many are surprised to learn that the cannabis plant does not directly produce these compounds. The acidic cannabinoids produced by the plant, such as THCA and CBDA, have previously been considered inactive precursors to their more well-known counterparts, but increasing evidence demonstrates that these compounds have powerful therapeutic potential. In this presentation, Dr. Sulak reviews the preclinical and clinical literature demonstrating potent physiologic effects and high bioavailability of the acidic cannabinoids. He provides practical strategies for clinicians and patients to take advantage of the power of raw cannabis.

Learning Objectives:

1. Summarize the preclinical findings on acidic cannabinoids.

2. Describe the pharmacokinetics of acidic cannabinoids compared to neutral cannabinoids.

3. Describe strategies for the clinical application of acidic cannabinoids.

Radicle Science's ACES (Advancing CBD Education & Science) study was an IRB approved 4 week, 14 arm, open label randomized clinical trial of 13 CBD products plus a waitlist control group, involving nearly 3,000 diverse participants, assessing validated outcome measures of well being, quality of life, pain, sleep, and anxiety, and tracking usage behavior and side effects. 

Learning Objectives:

1. Discuss current knowledge of the therapeutic potential of CBD.

2. Evaluate the current regulatory landscape for CBD in the U.S. and the mislabeling of products.

3. Assess lessons from the ACES study regarding the product attributes most associated with improvements.

As another psychedelic renaissance begins to take flight, it seems that myths and misconceptions rise to meet it. As a molecular pharmacologist studying cannabinoids and psychedelics with training in psilocybin-assisted therapy, I believe it’s vital to dispel these misconceptions. Whether you are a consumer, an investor or simply interested in navigating the chaos that surrounds this burgeoning industry, below are a few mind munchies (aka food for thought) intended to provide some accessible guidance and insight. The topics discussed in this webinar will be regarding the pharmacological history of psychedelics, the varieties of sources of psychedelics, the mechanisms of action of psilocybin and LSD, publicly traded companies in this space, and misconceptions about some of the health outcomes attributed to psychedelics.

Learning Objectives:

1. Summarize the mechanisms of action of psychedelics such as psilocybin and LSD.

2. Discuss the various sources of psychedelics substances, and related environmental issues associated with certain sources.

The agricultural sector has been through significant changes since the 2018 Farm Bill was enacted. Hemp production was legalized at the federal level in the United States. Hemp production and testing are regulated by the United States Department of Agriculture (USDA).

The USDA, in January 2021, published the Final Rule that defines important federal guidelines for hemp testing, effective March 22, 2021. The new federal rules provide guidelines on sampling, test methods, measurement of uncertainty, disposal of hot hemp, and reporting of test results. The total THC threshold was maintained at 0.3% in the USDA's final rule. The “negligent violation” threshold has been increased from 0.5% to 1% THC. This means that hemp that tests above 0.3% THC but below 1% THC is not considered a violation of the law. 

Hemp testing laboratories need to register with the Drug Enforcement Administration (DEA) by December 31st, 2022, to avoid regulatory penalties. The Farm Bill dictates that the total THC must be tested and reported on a dry weight basis. Hemp testing laboratories must include a measurement of uncertainty (MU) when reporting THC test results. 

Hemp testing laboratories need to comply with the Final Rule to avoid regulatory penalties. Laboratories need to maintain quality assurance to generate valid and reliable test results and document internal SOPs for testing and retesting hemp. Laboratories should include a disposal procedure for hot hemp. Hot hemp is the hemp that tests more than 0.3% THC on a dry weight basis. Laboratories should ensure representative sampling and homogenize samples before testing. They need to determine total THC using post-decarboxylation or similar reliable methods. Hemp testing laboratories need to report test results to the USDA, licensed producer, and the appropriate state department of agriculture or tribe.

A LIMS can streamline QA/QC processes, automate hemp testing and reporting, and help laboratories easily adapt to these changes.

Learning Objectives:

1. Break down an overview of the USDA’s new rules for hemp testing laboratories.

2. Distinguish how hemp testing laboratories can comply with the USDA’s new hemp testing rules with ease.

3. Explain how a LIMS helps hemp testing laboratories comply with the new rules and stay ahead of the regulatory curve.

There is much discussion by cannabis growers about the prevention of plant diseases, oftentimes circling back to the idea of curating a sterile cultivation system. However, keeping microbial populations in balance between beneficials and pathogens is just as effective in preserving plant health. Sterile production systems are extremely hard to procure and maintain, and most often can only be administered in clinical laboratories. Current research in plant-microbiome interactions has revealed several beneficial, if not essential, symbiotic relationships between plant hosts and their microbial communities. Also, heavy sterilization of systems can cause damage to these plant-microbe relationships. In this presentation, Mr. DiLegge will provide an overview of sterile systems, low and high microbe-biomass cultivation systems, as well as highlight some important roles a plant’s microbiome can play in benefiting the growth and development of their hosts.

Learning Objectives:

1. Explain that “sterile” doesn’t always mean “good” for plant growth and development.

2. Discuss the importance of plant-microbe interactions.

3. Support for growers to be conscious of their plants microbiome(s) in practice.

Cannabis falls into a number of categories such as medicine, recreational drug, food source, and fiber, but it is first and foremost an agricultural crop. As such, Cannabis is subject to treatment with pesticides to improve quality and yield, and may also be unintentionally contaminated with pesticides. Regulatory agencies in various US states have enacted rules about pesticide use on Cannabis. These are typically found in states that have legalized high THC Cannabis for medicinal and recreational use, but pesticide regulations have recently been adopted by state hemp regulatory agencies such as the New York Cannabinoid Hemp Program. Other standards organizations have proposed testing limits and requirements for pesticides in Cannabis, such as the AOAC Standard Method Performance Requirements for Identification and Quantitation of Selected Pesticide Residues in Dried Cannabis Materials (AOAC SMPR 2018.011). In this presentation, the validation of an LC-MS/MS and GC-MS/MS method using a single extraction step for quantitation of 104 pesticides in Cannabis in accordance with AOAC SMPR 2018.011 will be discussed. The method has been developed for high throughput with minimal cleanup steps. Method performance such as recovery, RSD, and LOQ will be discussed, as well as the extraction efficiency of various solvents tested during the method development.

Learning Objectives:

1. Explain the purpose of AOAC SMPR 2018.011.

2. Describe how pesticides are regulated in cannabis in the United States.

In-house testing is not required federally; however, states differ in their requirements. Cannabis extraction laboratories need to test extracts for pesticides, heavy metals, residual solvents, cannabinoid content, depending on the state regulations to ensure product purity and consumer safety. Many extraction laboratories have started establishing in-house testing facilities to maintain quality standards, save re-extraction costs, and reduce compliance testing failures. 

With in-house testing, extractors can test their products at different stages of the extraction process to ensure full compliance with state and local regulations. Cannabis extraction laboratories need to manage samples, tests, and test results, streamline QA/QC processes and generate custom Certificates of Analysis (CoAs). They also need to integrate analytical instruments with a Laboratory Information Management System (LIMS) for data interoperability. Furthermore, they need to optimize in-house testing workflows to improve extraction efficiency. 

An ERP collects, stores, manages critical business metrics and supports business operations of extraction laboratories. An ERP also helps address traceability and compliance issues faced by extraction laboratories.  

A LIMS helps optimize in-house testing workflows and supports complete process automation by integrating with analytical instruments and an ERP. A LIMS compares the test results of QC samples with the test samples and flags out-of-specification results to prevent errors. It helps schedule the calibration and maintenance of analytical instruments, digitally stores documents such as SOPs, and generates custom CoAs. A LIMS is an important tool to boost operational efficiency and meet the evolving needs of cannabis extraction laboratories.  

Learning Objectives:

1. Explain the importance of in-house testing for cannabis extractors.

2. Describe how digitization enables cannabis extraction laboratories to overcome operational challenges and boost efficiency. 

3. Discuss the role of a LIMS in automating in-house testing workflows and meeting the evolving needs of extraction laboratories with ease.

Recent reports on the consumption of delta-8 Tetrahydrocannabinol (THC) have led to a qualmish riddle. Delta-8 THC is an isomer of delta-9 THC, that some believe is legal to synthesize under the 2018 Hemp Farm bill. The U.S. Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) websites list delta-8 THC as schedule 1 drug.  Despite this conundrum and a lack of safety data, delta-8 THC products have exploded into the market. 

We explored the only known national adverse event reporting system: FDA Adverse Event Reporting System (FAERS), a US database originally designed to support the FDA's post marketing safety surveillance program for approved drugs and biologics. 

Repeated FAERS queries have been performed.  Product names (aka search terms): delta-8 THC; delta- 9 THC, cannabis sativa (CS), and cannabidiol (CBD) were searched.  

FAERS Data as of March 31, 2021, showed a total of 160 cases reporting delta-8 THC, 56 delta-9 THC cases, 591 CS and 7274 CBD reported as “suspect product active ingredient” 

Respiratory events were most common in the Delta-8 suspect cases compared to cannabidiol and cannabis sativa. Most cases occurred in 18 to 64 year-old males. 

Our results suggest a potentially different safety profile for delta-8 THC containing products. It is unclear if delta-8 THC or another factor, such as an adulterant or contaminant, is the cause of these events. Understanding the limitations of FAERs and our experience analyzing the AE data, we have designed a data collection tool for collecting more granular information on cannabis-derived products www.budsinfo.com.

Learning objectives:

1. Define the lack of and importance of collecting adverse events on cannabis-derived products.

2. Discuss cannabis-derived products that are available outside of the medical /regulated cannabis market that may not be that safe.
 

Most people are familiar with the main bioactive metabolites in Cannabis – cannabinoids and terpenes.  The profile of each can be quite complex both in terms of numbers of different species, but also their abundance.  In a similar fashion, varying types and abundances of flavonoid compounds also contribute to the complex chemotype of a Cannabis flower.  Flavonoids are polyphenolic compounds that confer antioxidant capacity.  Anthocyanins are a type of flavonoid that also confer colors, such as red, yellow, blue, and purple to a plant.  To date, these have not been comprehensively profiled in Cannabis, despite clearly wide variations in plant colorations.  In this work, we developed a liquid chromatography – triple quadrupole – mass spectrometry (LC-MS) method to target and identify anthocyanins in a series of low-THC Cannabis samples, or hemp.  Anthocyanins can yield rich chemical fragmentation patterns in a mass spectrometer that can be used for identification of species.  Initially, we started with a precursor ion scan approach to identifying anthocyanins.  Identified species were ultimately targeted using highly sensitive and specific multiple reaction mode transitions.  The differences among anthocyanin profiles from different plant genetics is remarkable.  Each plant appears to have its own unique fingerprint of 5 – 10 major anthocyanins.  Further, these anthocyanin profiles can be modulated based on lighting conditions during cannabis growth.  The controlled deliverance of distinct photoperiods using white in combinations with additional red LED lighting created marked changes in anthocyanin profiles, as well as terpene and cannabinoid profiles.  The hemp color palate is indeed rich, and like other bioactive metabolites, can be altered through judicious choice of growth conditions.

Learning Objectives:

1.    Explain the role and use of liquid chromatography – tandem mass spectrometry for cannabis analysis.

2.    Describe anthocyanin flavonoid compounds and their role in providing color to cannabis plants.

The analysis of Cannabis is important for the Health and Safety of a wide swath of the population.  The use of appropriate analytical tools to measure potency and other key metrics is becoming increasingly important.

We are seeing increased awareness of the need to be more environmentally sound in our practices by minimizing the dangerous solvents and high-energy-usage instruments.  The use of First Principles in Chromatography can lead to:
•    1000X savings in HPLC solvents
•    100X savings in Electric Usage
•    Higher degrees of employee safety by reducing exposure to carcinogens
•    Higher Profits for Cannalytical Labs 
•    Faster turn-around times for customers and immediate answers for grow-house making in situ decisions

Learning Objectives:

1. Create a safer laboratory environment for your employees.

2. Make your lab more efficient and less wasteful implementing capillary chromatography methods.

3. Use “First Principles” of chromatography to enhance your LOD’s, throughput, and profitability.

Like any other agricultural crop, pesticides are applied to hemp plants to protect it from pests and improve growth yield. Chronic exposure to pesticides can lead to serious health risks and therefore pesticide analysis in hemp products is important for consumer safety and quality control. Different states in USA and Canada regulate different number of pesticides with different action limits in hemp.  Among different states in USA, Colorado has issued most stringent regulatory limits for 102  pesticides residues in hemp products. In addition to pesticide residues, Canada, Colorado and other USA states also require hemp and cannabis products to be tested for 5 mycotoxins (4 aflatoxins and ochratoxin A). Normally pesticide analysis in hemp and other food matrices is done by both GC/MS/MS and LC/MS/MS since some nonpolar and chlorinated pesticides such as pentachloronitrobenzene, etridiazole, fenvalerate, iprodione, chlorfenapyr and others are difficult to ionize with electrospray source used in LC/MS/MS systems.   We would demonstrate how we measured these compounds at low levels using LC/MS/MS with APCI source to meet action limits for 102 pesticides regulated by Colorado state in hemp. The ionization mechanism of chlorinated pesticides such as pentachloronitrobenzene and others using LCMSMS system with APCI source would be presented. Hemp matrix is challenging and therefore it causes ion suppression and matrix inference for response of some of pesticides. We would demonstrate approaches to mitigate these ion suppression and matrix effects from hemp matrix to achieve lower detection limits to meet Colorado state action limits for 102 pesticides and 5 mycotoxins in hemp matrix. Sample preparation is the main bottleneck for achieving the high throughput analysis of pesticides in cannabis and hemp testing labs. For sample preparation, we used automated solvent extraction since it is quicker, simpler, cheaper, greener and easier way to achieve high extraction efficiency for pesticides in comparison to other time-consuming, difficult and expensive sample preparation techniques like solid phase extraction (SPE) and QuEChERS with dSPE( dispersive solid phase extraction) which show poor extraction efficiency. We added a number of internal standards to compensate for matrix effects in order to achieve method accuracy in range of 70-120 %. 

Learning Objectives:

1. List of Pesticides and their different action limits in different USA states and Canada for hemp/cannabis.

2. Analyze non-polar pesticides using novel LC/MS/MS method with dual ESI and APCI source.

3. Discuss ionization mechanism of non-polar pesticides with APCI source in negative ion mode.

4. Discuss mitigation of hemp matrix effects with LC and MS method optimization to improve method sensitivity to meet Colorado state action limits for 102 pesticides and 5 mycotoxins in hemp matrix.

5. Explain the rationale for selecting sample preparation method as automated solvent extraction with good extraction efficiency, less cost and higher throughput. 

6. Discuss addition of Internal standards to improve method method accuracy.

To date, the therapeutic use of cannabinoids in chronic pain management remains controversial owing to the limited clinical evidence found in randomized clinical trials (RCTs), the heterogeneous nature of the clinical indication, and the broad range of cannabis-based medicinal products (CBMPs) used in both experimental and observational clinical studies. Here we evaluate patient-reported clinical outcomes (PROMS) in a cohort of adult patients, diagnosed with chronic pain of diverse etiology, who received adjuvant treatment with oral, cannabis-based, magistral formulations between May and September 2021 at the Latin American Institute of Neurology and Nervous System (ILANS-Zerenia) in Bogotá, Colombia. During this period, 2112 patients completed a PROMS questionnaire aimed at capturing the degree of clinical improvement of their primary symptom and any potential side effects. Most participants were female (76.1%) with an average age of 58.7 years old, and 92.5% (1955 patients) reported some improvement in their chronic pain (p<0.001). Two monovarietal, full-spectrum, cannabis formulations containing either cannabidiol (CBD 30 mg/mL; THC < 2 mg/mL) or a balanced composition (THC 12 mg/mL; CBD 14 mg/mL) accounted for more than 99% of all prescriptions (59.5% and 39.8%, respectively). The degree of improvement was similar between both formulations, although males reported less effectiveness in the first four weeks of treatment. Sex-specific differences were also found in prescription patterns, with male patients increasing the intake of the balanced chemotype overtime. For many patients (71.7%) there were no adverse side effects associated to the treatment and those most reported were mild, such as somnolence (13.0%), dizziness (8.1%) and dry mouth (4.2%), which also appeared to fade overtime. Our results constitute the first real-world evidence on the clinical use of medicinal cannabis in Colombia and suggest that cannabis-based oral magistral formulations represent a safe and efficacious adjuvant therapeutic option in the management of chronic pain.

Learning Objectives:

1. Learn from the first clinical investigation of medicinal cannabis usage in Colombia medical data from over two-thousand patients.

2. Review efficacy and safety associated with the two most-widely prescribed cannabis-based medications in Colombia.

3. Examine the influence of patient sex, age, chemotype selection and duration of treatment on medical outcomes and side effects.

Often overlooked but critical to most cannabis laboratory operations is sample workflow and sample preparation, having these areas figured out early in the start-up process is essential – particularly in the prevention of sample cross-contamination.

The primary focus of this presentation is to discuss sample workflow with an overview of sample intake and processing. Once the sample is accepted at the laboratory – how does it move from one test (or station) to another and what considerations are there to prevent cross-contamination of the sample?  Are there any special storage requirements, retain procedures, and overall best sample-handling practices?

Considerations will be made regarding sampling and sample size(s) which based on the regulatory jurisdiction are typically different, as well as the sample test portion size.
Problem areas for contamination and how to prevent further contamination-possible test fails will also be briefly discussed. 

Learning Objectives:

1. Discuss sample Workflow and Sample Intake/Processing best practices.

2. Discuss sample contamination prevention.

Cannabis science is rapidly evolving and cannabis microbiology is often misinterpreted or even forgotten.  In and industry without standardization there’s a lack of consistency, and at times, questionable consumer safety.  With the patchwork regulations and localized standards among each US state regulating cannabis it’s complex to confirm compliance, protect consumers, and protect your brand now while planning for the future.  Let’s simplify the situation.

Cannabis microbiology does not need to be difficult.  In fact it can be rather simple. 

This talk will focus on the why we test cannabis for microbiology and the impact cannabis microbiology has to your brand, profitability, planning for the future, compliance, and consumer safety.  We will look at the trends amongst the patchwork regulations.  The talk expands into the value of understanding the risks throughout your operations and opportunities to consider to mitigate risk or even predict microbiological challenge protects your business.  This leads us to the core elements to consider in selecting a cannabis microbiology testing method for your in-house lab or your compliance testing lab tying into simple and reliable science.

Learning Objectives:

1. Review cannabis microbiology.

2. Discuss the impact of microbiology testing.

3. List the safety and risks of microbiology.

4. Analyze simple reliable science: method selection and AOAC.

The cannabis/hemp market continues to grow each year with more states legalizing recreational marijuana, as well as the 2018 Farm Bill removing hemp from the controlled substance list. This bill defines that any cannabis sativa L. strain with a total tetrahydrocannabinol (THC) concentration of 0.3% or less can be considered hemp and not cannabis. Due to this definition, there is an even higher demand to differentiate hemp from cannabis by determining the correct concentration of THC. More recently, there are more instances of adulterated hemp samples with THC variants and a need to fully identify and quantify each of these variants. Currently most laboratories are only monitoring and reporting delta-8 and delta-9 THC. This study develops an LCMS method that separates, identifies, and quantitates delta-8 and delta-9, as well as, delta-10 and delta-6a/10a THC. A Shimadzu LCMS mass spectrometer coupled with a modular Nexera 40 series UHPLC system and a PDA detector was employed for simultaneous analysis of analyte absorbance and compound ionization. Separation of delta-6a/10a THC, delta-8 THC, delta-9 THC, and delta-10 THC was achieved in a single chromatographic run on both a LCMS-2020 single quadrupole mass spectrometer and a LCMS-8045 triple quadrupole mass spectrometer. The LCMS-2020 utilized SIM events to monitor chromatographic separation as well as a scan event to monitor in-source fragmentation for additional analyte confirmation. The LCMS-8045 was used for a more comprehensive cannabinoid analysis allowing for detection of all 4 THC isomers plus 17 other cannabinoids. Both detection methods demonstrated the capability to simultaneously detect, confirm, and quantitate the four different ΔTHC isomers. 

Learning Objectives:

1. Identify the benefit to separating out the different ΔTHC isomers currently being detected in hemp and cannabis samples. 

2. List alternate detection methods for cannabinoids other than UV/Vis and GC-FID. 

3. Discuss method development and results when using LCMS to chromatographically separate and detect ΔTHC isomers. 

Historically the analysis and study of cannabis and cannabis-related molecules has been challenging because of their collective legal status. With the passage of the 2018 Farm Bill, at least some of those restrictions were eased, and a resulting boom in CBD production and CBD-containing products followed. The analyses of these products were limited to the easiest adaptable technology at the time, which was achiral reversed phase chromatography. For a time, this was sufficient, as the focus of the analyses were achiral in nature. However, more and more cannabinoids being identified or used to challenge the legal status of Δ9 THC are chiral in nature, and these achiral methods are not capable of performing the now necessary chiral separations. Polysaccharide-based chiral stationary phases have been widely used in the pharmaceutical industry for this purpose for many decades now, and are well suited to handle these similar analyses now for the cannabis industry. This presentation will cover the early and current efforts for the separation method development of achiral and chiral mixtures of cannabinoids on polysaccharide-based chiral stationary phases, or both analytical and preparative applications.

Learning Objectives:

1. Discuss the history and application of chiral chromatography.

2. Explain the application of mixed chiral and achiral separations for cannabinoids.

We were interested in determining the effect if any on growing conditions on clones of the same cannabis plant. In particular we were interested in the difference between plants grown outdoors in a highly dynamic environment and those grown indoors in a tightly controlled environment. We took 4 strains of cannabis and split clones between indoor and outdoor growing conditions. The dried cured flowers were analyzed by LCUV, GCFID, and ICPMS to measure specific terpene, cannabinoid, and heavy metals content. These flower samples were also analyzed using a TOF. The TOF data was processed using principal component analysis software which was able to identify component trends distinguishing between indoor and outdoor grows as well as strain specific component trends. Outdoor grows showed a bias towards producing more complicated secondary metabolites while indoor showed a bias towards simpler species. In all cases terpene potencies were elevated in outdoor grown plants while THCa potencies were elevated in most outdoor grown plants. The only plants with measurable heavy metal content were the indoor grown plants. These results could have implications for cultivating cannabis for novel therapeutic components as well as the relative safety and quality of cannabis cultivation approach.

Learning Objectives:

1. Explain how the choice of cultivation impacts secondary metabolites.

2. Describe how combining targeted approaches with untargeted approaches provides a bigger picture on the impact of growing environments.