Cannabis continues to be legalized state by state in the USA and in countries around the world. Many people are seeking solutions to either their current medication regimen that is not adequately treating their condition or symptoms or trying to get off current prescription medications for a myriad of reasons. This presentation will help the attendees understand how to safely incorporate cannabis into a treatment regimen that may allow them to improve their quality of life, decrease or eliminate other prescription medication and do it safely. We will discuss the importance of the route of administration and product formulations have on treatment outcomes, common adverse events and some treatment protocols and case studies.

Learning Objectives: 

1. List three medical conditions that cannabis has successfully helped or treated.

2. Describe the importance that formulation and route of administration has on the onset and duration of action of cannabis in humans.

3. List three routes of cannabis administration.

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. There are statistics of adverse events with delta9 THC consumption and drug-to-drug interaction resulting in vomiting, abdominal pain and psychotomimetic effects.

Personalized precision therapeutics can be used to support in mitigation of these adverse events by looking at Single Nucleotide Polymorphism (SNPs) along with Pharmacogenomics (PGx) for drug to drug interaction and Pharmacokinetics for dosing based on metabolic function.

Learning Objectives:

1. Discuss how Genetics may influence experience with cannabis and CBD.

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

3. Discuss how a patented technology like EndoDNA uses phyto-canabinoids and therapeutics to align with your DNA and Biometrics for precise dosing and efficacy.

Imagine if your doctor told you, or your mother, or your child, that you have a serious infection.  Imagine that they told you that you needed an antibiotic, but didn’t tell you which one, how much to take, how to use it, or what side effects it might have.  You’d be confused and feel abandoned.  Frankly, that lack of guidance, and informed consent, would be considered malpractice. Our current medical cannabis system does just that:  It tells patients who are sick and vulnerable to "just go figure it out.” Nearly daily patients call me wondering why their medicine doesn’t work, or even worse, why it’s making them feel ill.  Nearly every call reveals that the patients didn’t get the medicine that I had recommended. Not only does this harm patients as they desperately seek the relief they need, but the current system undermines the very trust on which a medical system must be built. Of course, the solution to this problem already exists!  And it’s functioning in nearly every community right now. The pharmacy system was developed to ensure the safety of patients and the reliability of medicines.  Prescriptions ensure that the correct medication at the proper dosage, and with proper information is given to patients.  This, in turn, boosts the credibility of the whole medical industry. Two key ingredients form the backbone of this system: the prescription, and the prohibition of unsubstantiated medical claims. We will discuss lessons both the federal government and our industry can take away from existing systems.  We will also address the lessons learned from the "incubators of the states" and review what a "greatest hits" of the states' programs might look like if implemented as national policy. 

Learning Objectives:

1. Summarize the key differences between patients and recreational users.

2. Discuss the importance of and key elements to a prescription.

3. Describe key elements of federal cannabis reform that are necessary of a functional national medical system.

The objective of this randomized, blinded controlled trial was to evaluate the safety and relative effects of different formulations containing Cannabidiol (CBD) and melatonin, with and without the addition of minor cannabinoids, on sleep. Participants (N=1,793 adults experiencing symptoms of sleep disturbance) were assigned to receive a 4-week supply of 1 of 6 products (all capsules) containing either 15mg CBD or 5mg melatonin, alone or in combination with minor cannabinoids. Sleep disturbance was assessed using Patient-Reported Outcomes Measurement Information System (PROMIS^TM ) Sleep Disturbance SF 8A, administered via weekly online surveys. All formulations exhibited a favorable safety profile (12% of participants reported a side effect and none were severe) and led to significant improvements in sleep disturbance (p<0.001 in within-group comparisons). Most participants (56% to 75%) across all formulations experienced a clinically important improvement in their sleep quality. There were no significant differences in effect, however, between 15mg CBD isolate and formulations containing 15mg CBD and 15mg Cannabinol (CBN), alone or in combination with 5 mg Cannabichromene (CBC). There were also no significant differences in effect between 15mg CBD isolate and formulations containing 5 mg melatonin, alone or in combination with 15mg CBD and 15mg CBN. Our findings suggest that chronic use of a low dose of CBD is safe and could improve sleep quality, though these effects do not exceed that of 5 mg melatonin. Moreover, the addition of low doses of CBN and CBC may not improve the effect of formulations containing CBD or melatonin isolate.

Learning Objectives:

1. Explain why Sleep is important for health.

2. Discuss why alternatives to melatonin are needed.

3. Extrapolate that cannabinoids have shown to benefit sleep but there are few studies especially on CBN.

4. We show that chronic use of 15 mg of CBD is safe and benefits sleep but not better than 5mg of melatonin.

In this session, attorney Bob Hoban will explore the current legal and regulatory landscape in the United States related to intoxicating hemp cannabinoids. Anyone who is keeping a pulse on the cannabis industry knows of the rise of products containing such cannabinoids, like delta-8 tetrahydrocannabinol, over the last 5 years after the passing of the 2018 Agricultural Improvement Act, or 2018 Farm Bill. Delta-8 - and other variations of intoxicating hemp cannabinoids like THC-O, THC-JD, and Delta-10 – represent a controversial cannabis industry segment that some industry pundits attribute to a “legal loophole” created in the definition of hemp under the 2018 Farm Bill. Regardless of legislative intent behind establishing a formal definition of hemp, the 2018 Farm Bill expressly allows for commercial activities related to products that contain under 0.3% delta-9 tetrahydrocannabinol and that are sourced from lawful hemp, including delta-8, as affirmed by the 9th Circuit of Appeals in their recent decision in AK Futures v. Boyd Street Distro. 

While the federal legality of such products has been confirmed by the federal judiciary, administrative agencies like the FDA and DEA have declined to issue regulations pertaining to those products. States have stepped in and passed varying versions of regulations pertaining to intoxicating hemp products. On one hand, some have approached the regulation of such products similarly as to the ways they regulate cannabis by requiring firms engaged in manufacturing or selling those products to be licensed. On the other hand, some have taken more of a free market approach and allow such products to be introduced into commerce freely, with the condition that they are sourced from lawful hemp. 

Bob will explore the contours of the intoxicating hemp product landscape, including a comparison of different regulatory approaches and the pros and cons of each. Further, Bob will share his personal thoughts on the future of intoxicating hemp product regulations and their role in the emerging cannabis industry. 

Learning Objectives: 

1. Demonstrate an understanding of the federal regulatory scheme pertaining to intoxicating hemp derived products.

2. Be able to differentiate between different state frameworks currently regulating intoxicating hemp derived products. 

3. Visualize the current legal landscape in the United States for intoxicating hemp derived products.

4. Explain the legal and practical differences between intoxicating hemp derived products and intoxicating marijuana derived products. 

The cannabis market has been rapidly growing with the list of identified cannabinoids constantly increasing. Analytical methods for detecting cannabinoids by means of HPLC (High Pressure Liquid Chromatography) analysis have been explored and currently there are methods to separate 21 cannabinoids in a single run. Expanding the list of cannabinoids is possible, however stereoisomers challenge the current methods and, therefore, further method optimization is needed. The process of method development was made easier and faster with the use of an analytical method development software. The software uses “Analytical Quality by Design (AQbD)” concepts to help determine the optimal method for cannabinoid separation. 

Six Daicel chiralpak columns (IA-U, IB-U, IC-U, ID-U, IG-U, IH-U: 3.0mmx100mmx1.6µm) with varying stationary phase chemistries were used with a method scouting system and AQbD software to separate the (6aR,9R)-Δ10-THC, (6aR,9S)-Δ10-THC, 9(R)- Δ6a,10a-THC, and 9(S)- Δ6a,10a-THC stereoisomers along with twenty other cannabinoids. Standards were diluted in methanol to prepare a 25µg/mL mix standard for analysis. The mobile phase was 0.085% phosphoric acid in water and 0.085% phosphoric acid in acetonitrile.

Utilizing the software, the six columns were used to run mobile phase concentrations ranging from 45% to 65% organic to determine the optimal column and mobile phase combination. Of the six columns IA-U (stationary phase: amylose tris(3,5-dimethyl-phenylcarbamate) and IG-U (stationary phase: amylose tris(3-chloro-5-methyl-phenylcarbamate) were the only two columns with separation of all compounds. Using the optimization step, it was determined that the best mobile phase condition was a stepwise gradient using a 60:40 ratio for a hold time of two minutes and then a 50:50 ratio for 13 minutes. The resolution between the 9(R)- Δ6a,10a-THC and 9(S)- Δ6a,10a-THC isomers, which were not separated on the other columns, was 1.285 and 1.298 for the IG-U and IA-U column, respectively. In the robustness stage, the desired flow rate and column oven temperature was determined to be 0.8 mL/min and 35℃. This method can also be applied to more complex cannabinoid mixtures. 

Learning Objectives:

1. Observe the difference in cannabinoid separation between chiral and reverse phase stationary phases.

2. Discuss the benefits of using AQbD principles for method development.

3. Discuss software techniques to separate overlapping peaks.

Cannabis laboratory employee turnover is common, extraordinarily expensive, time consuming, and risks harming internal culture.  Surprisingly, most cannabis laboratories are unaware of an extensive body of science describing best processes in talent acquisition.  As a result, most laboratories use employee selection methods (ESMs) that have very low predictive scores for job success (~30%) which directly contribute to comparatively high employee turnover rates.  By incorporating modern and validated ESMs, predictive job success scores can increase to >90%.

Learning Objectives:

1. Compare and contrast various ESMs.

2. Discuss their relative predictive value for hiring highly productive and engaged employees.

3. Provide an example of an accessible and fiscally responsible pre-hire ESM to increase both new hire job success and retention.

This webinar provides an interdisciplinary look at the global changes observed in the laws, standards and politics around the cannabis plant and its products. An overview will be provided on the history of medical and adult use cannabis laws, federal cannabis laws, and the conflict between state and federal laws. Participants will learn about the public health effects of cannabis laws, incorporating aspects of how cannabis research is conducted under current federal regulations. The webinar is designed to give individuals a foundation of key laws, standards and other issues pertaining to cannabis and hemp businesses, as well as the regulations that govern day to day operations and oversight. Webinar attendees will learn how cannabis laws were created, where standards for products come from, and the science that informs policy decisions, technology, and medical utility. Students will develop an understanding of the public health consequences of unregulated cannabis products.  Attendees will also understand the difference between legal and illegal cannabis products and the impact on abuse potential.

Learning Objectives:

1. Summarize how cannabis laws, regulations, and/or standards have changed over the last few decades.

2. Discuss standards for cannabis operations and the products they produce.

3. Describe the major differences between cannabis, hemp, and illicit marijuana products

I will discuss and present data and viewpoints so discuss the current situation with THC Lab shopping, it’s impact on the industry from growers through labs to end-users, how we got here in 2023 and potential options and paths forward to remediate this situation for the benefits of all parties.  I’ll start by discussing my qualifications and scientific expertise to speak about this issue, including my scientific career, Ph. D. in molecular biology, along with direct experience as cannabis analytical Lab Director in four different testing labs in three states (CA, OR & NM) so far. 

I’ll next go into a dive into how we got here as a legal cannabis consumption industry in many US states both medicinally and recreationally.  The hunt for highest THC from consumer demand through producers and extractors of flower, concentrates, edibles, oils and other products has been a long and slippery one.  Now science is beginning to take a foothold and end users and industry insiders, through learning and education, are learning that other compounds in these cannabis spectrum of chemistry beyond THC contribute immensely to the consumers experience, such as terpenes, flavinoids, other cannabinoids etc. to the overall experience whether for relief of a medical condition or otherwise. I’ll discuss where the cannabis field is currently on this issue from my professional Lab Director experience and a lot of what I’ve read on other forums i.e., Linked In expressing their views and potential solutions.  I’ll describe areas in the process from bud to end-user where inflated cannabinoid THC, CBD or other compounds can occur both biologically, in sample selection and collection, via laboratory SOPs, instrument and data handling practices, scope and impact of state regulations, vendor and customer desire and potential deceitful practices among other factors in the legal vs black market for cannabis products. These factors and reasons behind each will be discussed during this presentation..

Finally I’ll conclude with some suggestions and views for courses of action and the likelihood of those coming into play to help remedy and correct the accuracy and comparability/fairness of current practices.  How can things be changed, approximately when and how long might these changes take along with their potential impact and where I forsee we’ll eventually get on this topic. An important goal for me is to give everyone listening a deeper and more informed view of the current situation with THC lab shopping and it’s impact on cannabis consumers by offering a better scientific understanding of the variables that go into sampling, testing and dosing of all commercially available cannabis products.

Learning Objectives:

1. Identify from the presentation how the practice of laboratory shopping for highest THC level and issues of value inflation started and where the situation is currently in early 2023.
 
2. Discuss what are the possible areas where inflated cannabinoid THC and CBD can occur both biologically, in sample collection, laboratory SOPs, data handling practices, State regulations, customer desire and vendor deceit or others,  and the factors and reasons behind each.
 
3. Describe in detail several ways forward to help rectify and eventually eliminate the issue of THC lab shopping and your rationale for these options and relative potential impact they would have.

Pre-clinical research on cannabis use for arthritis has established clear mechanisms of action, but a few potential problems. While clinical studies are sparse, several surveys of cannabis patients generally and arthritis patients specifically differentiate therapeutic users from nonusers and characterize how therapeutic users have changed over time.

Learning Objectives:

1. Discuss cannabis mechanisms of action for treating arthritis.

2. Discuss potential problems with using cannabis for arthritis.

3. Characterize arthritis patients who use cannabis therapeutically.

Laboratory shopping is a concerning practice in the legal cannabis industry that can compromise public health and safety, create an uneven playing field for businesses, and most importantly undermine consumer trust. This presentation provides an overview of laboratory shopping, including how it works and its negative impact on the cannabis industry. We will discuss regulatory efforts to address laboratory shopping – including the implementation of standardized methods and regulatory harmonization. The presentation also includes a look forward to what the future may hold for the cannabis industry in light of these delegitimizing challenges.

Learning Objectives:

1. Explain the practice of laboratory shopping in the legal cannabis industry, including how it works and its potential impact on public health and safety.

2. Identify the regulatory challenges associated with laboratory shopping and explore potential solutions to mitigate the risks associated with this practice.

3. Discuss the importance of testing in the cannabis industry and how laboratory shopping can compromise the integrity of this process.

The most common complaint cannabis producers have about their testing labs is that the turnaround time is too long. Without test results, they cannot package, label, or sell their product, which affects small businesses the most. Low throughput labs are averaging 3-4 days to return results and high throughput labs take 5-7 days or longer. This talk will reveal how labs can maintain turnaround times under 2 days without cutting corners or sacrificing accuracy.

Learning Objectives: 

1. Explain why turnaround time matters in cannabis testing and what pitfalls to avoid in the pursuit of speed.

2. Identify the key bottlenecks in cannabis testing and how to overcome them.

3. Create a list of equipment and expenses to research when starting a testing lab or increasing the capacity of an existing lab.

In today’s modern Cannabis laboratory, automation is critical for business success and sustainably. A LIMS (Laboratory Information Management System) is essential, enabling laboratories to provide reliable data, meet regulatory compliance goals (ISO 17025), and remain competitive/profitable.  In addition to the LIMS software, many integrated features facilitate high throughput for sample analysis. These include positive ID, (1D barcoding, 2D barcoding, and RFID), and integration with instrumentation, (such as HPLCs for potency testing, ICP-MS for heavy metals, LC-MS-MS for pesticides).. In addition to instrument integration LIMS offers integration with enterprise systems, seed to sale, METRC, financial packages, ERP systems, client portals, ELNs, and more.  it is important that the solution has the ability to seamlessly integrate and share information to promote accelerated communication. Data consumers, whether internal or external, expect results quickly, accurately, and affordably. They often require 24/7 access, and look for simple, easy to understand final analysis reports, automatically delivered to them or accessible through a portal. Laboratories that can deliver automation will be in a leadership role. Sensors that track laboratory conditions (temperature, light, humidity) will also play a key role in the future of automation; these can all be integrated with the LIMS for a total automation solution. With increased labor costs, unreliable supply chains, and inflation, automation is playing an increasingly important role in business success.

Learning Objectives:

1. Discuss the effects of using a relational database to securely manage, store, and analyze data, versus relying on Excel or partial solutions that often have a larger financial burden.

2. Explain the role that LIMS play in the Cannabis laboratory, together with the integration of other systems.

3. Discuss the role of data security and integrity in ensuring regulatory compliance.

Controlled Environment Agriculture (CEA) is predicted to reduce environmental impacts and build resilient, local agricultural systems. In addition to high-value food crops, CEA is used to cultivate therapeutic natural products, such as cannabis. Cannabis is increasingly recognized for its medicinal and recreational value, however, unlike many other medicines and consumed goods, quality and product safety standards have not been established in the United States. 
 
As the cannabis industry continues to evolve, one of the largest hurdles for cannabis manufacturers is the rigorous compliance testing of cannabis products. Microbial contamination is the leading cause of compliance failures for cannabis flower products, which often fail microbial tests due to heavy bioburdens of indicator microorganisms and/or detection of human pathogens. Although microorganisms are a risk to cannabis manufacturers on several levels, little is understood about their role across the cultivation and post-harvest processes and how they may positively or negatively influence plant, worker, and consumer health. Therefore, practical guidelines on how to identify and manage microbial populations in these indoor cultivation environments must be established.
 
This presentation will explore the factors that allow various microorganisms to survive and thrive in the indoor environment and provide practical guidelines and tools for cultivators, scientists, and quality professionals to understand and combat microbial threats to plants, humans, and product quality. 

Learning Objectives:

1. Describe the broad groups of microorganisms tested for in cannabis compliance.

2. Explain how indoor agricultural environments, combined with the inputs of raw materials, building materials, plants, air, water, and humans, all contribute to the microbial populations that survive and thrive in these CEA environments.

3. Discuss the benefits and risks of microorganisms to plants, humans, and product quality.

4. Recognize best practices and scientific tools that can be utilized to monitor and manage microbial risks.

In this talk, we will review using LC MS for Quantitative analysis of Pet Hemp product specifically CBD oils. Seven samples of commercial CBD oil marketed for pets were analyzed. LoD and LoQ were obtained. Matrix matched calibratrs were used for quantitative analysis.   The same samples were analyzed qualitatively for spectral compound verification. In addition, comparisons will be made between UV and MSD analysis for Hemp.

Learning Objectives:

1. Discuss the difference between UV and LC MS in regards to potency testing.

2. Explain how using LC MS in potency testing adds more certitude to Hemp analysis especially for confirmation of lower than 0.3% delta 9 THC by weight calculations.

3. Discuss peak purity and  spectral identification relative to potency analysis.

Moving the needle on legalization, the cannabis industry has seen significant growth in the past year. However, this growth has had its dampeners, such as THC potency inflation and rampant lab shopping. The misconception among consumers that higher THC alone is responsible for stronger effects results in high-THC products commanding a premium. This encourages corrupt labs to inflate THC numbers. Unethical producers flock to such labs, while the labs that report actual results lose out on business. The practice is undermining consumer confidence and the industry's integrity. A loophole that corrupt labs exploit is the absence of an industry standard for testing. Labs use different processes and equipment, delivering different results. Dishonest labs take advantage of this and report inflated THC numbers. Furthermore, the scope for manual intervention allows corrupt labs to falsify results and hoodwink regulators. These gaps must be closed to arrest THC potency inflation. Firstly, the industry needs a universal standard for testing. Additionally, the same samples should be tested in different labs, and outliers identified. States should then take swift action against labs that publish inflated numbers. Secondly, there’s a need for dispelling the misplaced notion that higher THC alone is a true indicator of potency. Thirdly, labs must get accredited to ISO/IEC 17025 to demonstrate their competency to produce reliable results and adopt a LIMS to automate their processes by integration with analytical instruments, eliminating manual manipulation of results. By using a LIMS, customers can also be empowered to match the composition reported on the product label with the original CoA, helping boost consumer confidence.

Learning Objectives:

1. Discuss what THC inflation and lab shopping are.

2. Explain how THC inflation harm labs, consumers, patients, and the industry.

3. Discuss how THC inflation and lab shopping can be prevented, and how a LIMS help in doing so.

We are currently facing an Opioid epidemic and a mental health crisis with increased disconnection and addiction and beginning a psychedelic renaissance.   Nociplastic pain is a newer phenomenon. Over time the neural circuitry around the physical and emotional perception of a chronic pain experience strengthens including peripheral and central sensitization (CS). By Using a Biopsychosocial Model of Pain, we can decrease pain and chronic stress changing the sensory processing function of the nervous system getting to the root cause. Ketamine is a dissociative anesthetic that can be personalized based on route of administration, dose, and setting.  Ketamine may play a role in reducing CS or the increased responsiveness of nociceptive neurons to normal stimuli. Psychedelics quiet the Default Mode Network (DMN) and activate the 5HT2A allowing for a Catalyst for change in perception and perspective to Overcome rigid defense mechanisms, depattern, unlearn behavior, increase Neuroplasticity and decrease neuroinflammation.  The integration of enduring memories of the particular states of consciousness that were experienced during the period of drug action is equally important. 

Learning Objectives:

1. Review the history of ketamine’s medical indications.

2. Explain the biological and psychological mechanism of ketamine.

3. Review set, setting, dose, route of administration and importance of integration.

4. Discuss legal challenges and future of psychedelics in medicine.

The use of Δ8-THC in consumer products has caused safety concerns in the US. Though Δ9-THC is the main intoxicating component in the cannabis plant, its isomer, Δ8-THC, naturally occurs in the cannabis plant at low levels. The Δ8-THC used in consumer products is typically produced from hemp-derived CBD which many consider legal under the 2018 US Farm Bill. Regulations governing the use of synthetic components derived from hemp are not clearly addressed which has created a growing market for Δ8-THC production and use. The conversion of CBD to Δ8-THC requires harsh conditions leading to multiple reaction byproducts which need to be characterized to enhance understanding of the chemical components produced. Considering that much is unknown about product composition, how can industry stakeholders determine quality? What role does analytical chemistry play? This presentation will describe how questions regarding cannabis quality and safety can be explored using various chromatography, mass spectrometry, and ion mobility technologies.

Learning Objectives:

1. Explain how the definition of quality varies throughout the cannabis supply chain.

2. Discuss how different types of analytical tools can aid in cannabis characterization.

3. List resources and stakeholder groups that facilitate cannabis science advancement.