Tag Archives: thc

June 18, 2018

Designing the Perfect Cannabis Edible in California

By Celia Schebella

Are you a product designer in the edible cannabis market? Well, you live at the intersection of the food and pharmaceutical industries and need to know both worlds, utilizing best-practice product development principles, regardless of which industry you are working in. In the cannabis industry, this means knowing your chemistry principles, food science, food safety, Good Manufacturing Practices (GMPs, applicable to the food industry) along with the more intense records and documentation requirements of the pharmaceutical industry.

California is the most recent state to implement legal recreational cannabis. It is estimated to deliver $7.7B in sales by 2021, including a reduction of medical use cannabis and an uptake of adult recreational use. How often do you live at the inception of such a potentially enormous market? Not often, so product developers, here is an opportunity. However, with that opportunity comes the responsibility. A recent emergency legislation adopted by the California Cannabis Safety Branch states:

Operational Requirements Licensees must have written procedures for inventory control, quality control, transportation, security and cannabis waste disposal. Descriptions of these procedures or Standard Operating Procedures (SOPs) must be submitted with the annual license application. Cannabis waste cannot be sold, must be placed in a secured area and be disposed of according to applicable waste management laws. Good manufacturing practices must be followed to ensure production occurs in a sanitary and hazard-free environment, cannabis products are contaminant free and THC levels are consistent throughout the product and within required limits. Extractions using CO2 or a volatile solvent must be conducted using a closed-loop system, certified by a California-licensed engineer. Volatile, hydrocarbon-based solvents must have at least 99% purity. Finally, volatile solvent, CO2 and ethanol extractions must be certified by the local fire code official.

Part of this emergency legislation for all California cannabis product manufacturers is the newly published GMP requirements, which appear to be a combination of food, supplements and HACCP requirements. Helpful resources to learn more about this new California emergency legislation impacting cannabis product manufacturers can be found at the California Manufactured Cannabis Safety Branch with the details of the emergency cannabis regulations.

Once developers have decided on a product, research and education to develop a good understanding of the regulatory environment is a must. For example, in order to develop compliant cannabis edibles, compliance with state, and in some cases local regulations, for food and cannabis must be met. Proactive compliance is a big part of designing a successful product in the most efficient manner.The attention to detail here will create a safe and satisfying experience for consumers as they receive a consistent product every time.

As a product developer you must first know the incoming cannabis plant characteristics to determine what type of cannabinoids they contain to determine what types you wish to source. This requires a strong and well documented supplier program that can identify reliable suppliers of high purity and consistent cannabis raw materials, the same principles that are typically required of food manufacturers. When looking for examples of credible ingredient supplier programs, looking at those used by the food industry is a good start. Make sure supplier management programs apply to all the raw materials and direct-contact packaging that you plan to use in your new product.

Once reliable sources of raw material have been secured, the next challenge is to conduct periodic tests of cannaboids levels found in your incoming cannabis. With this information, you need to adjust blending amounts to reflect the correct cannaboid dose in the finished ready-to-eat (RTE) product. Like any other medicinal product, the active ingredient dosage will directly impact the effect on the consumer, thus it is important that you, the manufacturer, are completely aware of the exact cannaboid levels in your incoming ingredients, your blending amounts and your final product levels. This will require a robust either in-plant or commercial laboratory testing program. There is a great deal of technology and chemical analyses available to help dose the product accurately. This must also include robust testing and verification steps. If a consumer of your product were to over-consume from “normal” consumption rates of your cannabis-based food product, the liability, both financial, civil, ethical and criminal would fall on your company. The attention to detail here will create a safe and satisfying experience for consumers as they receive a consistent product every time.

design your products with commercial manufacturing viability in mindOnce regulatory responsibilities for manufacturing and marketing a cannabis-based food product have been met, so that you may sell a compliant and consistent product, it is time to add some creative juices and make the product interesting and enjoyable to consumers. With cannabis edibles, for example, explore what sort of food is appealing to consumers. Consider when, where and with whom your potential customers would be eating that food. Evaluate the best packaging design and size to suit the occasion. Ensure the packaging is child resistant yet practical for adult consumers. And above all manufacture a food that is delicious. Curiosity will attract your customers for the first time but quality and consistency will keep them coming back.

Product developers are usually fantastic at developing great lab scale products, but part of a developer’s job is to ensure that the design and manufacturing process is scalable for consistent and compliant commercial manufacturing. So design your products with commercial manufacturing viability in mind. Try to minimize the number of ingredients whilst still making a consumer-desirable product. Finally, rationalize your ingredients across your portfolio to avoid overcrowding the warehouse and risking expired ingredients.

If successful, your consumers will desire your product, your compliance team will be satisfied, your manufacturing partners will be thankful, the State of California will determine that you are fully compliant and your sales team’s job will have great business and professional success. In the end, you will have developed and launched a successful legacy product!

June 11, 2018

The Four Pillars of Cannabis Processing

By Christian Sweeney

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Cannabis extraction has been used as a broad term for what can best be described as cannabis processing. A well-thought-out cannabis process goes far beyond just extraction, largely overlapping with cultivation on the front-end and product development on the back-end¹. With this in mind, four pillars emerge as crucial capabilities for developing a cannabis process: Cultivation, Extraction, Analytics and Biochemistry.

The purpose and value of each pillar on their own is clear, but it is only when combined that each pillar can be optimized to provide their full capacities in a well-designed process. As such, it is best to define the goals of each pillar alone, and then explain how they synergize with each other.

At the intersection of each pillar, specific technology platforms exist that can effectively drive an innovation and discovery cycle towards the development of ideal products.Cultivation is the foundation of any horticultural process, including cannabis production. Whether the goal be to convert pigments, flavors or bioactive compounds into a usable form, a natural process should only utilize what is provided by the raw material, in this case cannabis flower. That means cultivation offers a molecular feedstock for our process, and depending on our end goals there are many requirements we may consider. These requirements start as simply as mass yield. Various metrics that can be used here include mass yield per square foot or per light. Taken further, this yield may be expressed based not only on mass, but the cannabinoid content of the plants grown. This could give rise to a metric like CBD or THC yield per square foot and may be more representative of a successful grow. Furthermore, as scientists work to learn more about how individual cannabinoids and their combinations interact with the human body, cultivators will prioritize identifying cultivars that provide unique ratios of cannabinoids and other bioactive compounds consistently. Research into the synergistic effect of terpenes with cannabinoids suggests that terpene content should be another goal of cultivation². Finally, and most importantly, it is crucial that cultivation provide clean and safe materials downstream. This means cannabis flower free of pesticides, microbial growth, heavy metals and other contaminants.

Extraction is best described as the conversion of target molecules in cannabis raw material to a usable form. Which molecules those are depends on the goals of your product. This ranges from an extract containing only a pure, isolated cannabinoid like CBD, to an extract containing more than 100 cannabinoids and terpenes in a predictable ratio. There are countless approaches to take in terms of equipment and process optimization in this space so it is paramount to identify which is the best fit for the end-product¹. While each extraction process has unique pros and cons, the tunability of supercritical carbon dioxide provides a flexibility in extraction capabilities unlike any other method. This allows the operator to use a single extractor to create extracts that meet the needs of various product applications.

Analytics provide a feedback loop at every stage of cannabis production. Analytics may include gas chromatography methods for terpene content³ or liquid chromatography methods for cannabinoids^{3, 4, 5}. Analytical methods should be specific, precise and accurate. In an ideal world, they can identify the compounds and their concentrations in a cannabis product. Analytics are a pillar of their own due simply to the efforts required to ensure the quality and reliability of results provided as well as ongoing optimization of methods to provide more sensitive and useful results. That said, analytics are only truly harnessed when paired with the other three pillars.

Biochemistry can be split into two primary focuses. Plant biochemistry focuses back towards cultivation and enables a cannabis scientist to understand the complicated pathways that give rise to unique ratios of bioactive molecules in the plant. Human biochemistry centers on how those bioactive molecules interact with the human endocannabinoid system, as well as how different routes of administration may affect the pharmacokinetic delivery of those active molecules.

Each of the pillars require technical expertise and resources to build, but once established they can be a source of constant innovation. Fig. 1 above shows how each of these pillars are connected. At the intersection of each pillar, specific technology platforms exist that can effectively drive an innovation and discovery cycle towards the development of ideal products.

For example, at the intersection of analytics and cultivation I can develop raw material specifications. This sorely needed quality measure could ensure consistencies in things like cannabinoid content and terpene profiles, more critically they can ensure that the raw material to be processed is free of contamination. Additionally, analytics can provide feedback as I adjust variables in my extraction process resulting in optimized methods. Without analytics I am forced to use very rudimentary methods, such as mass yield, to monitor my process. Mass alone tells me how much crude oil is extracted, but says nothing about the purity or efficiency of my extraction process. By applying plant biochemistry to my cultivation through the use of analytics I could start hunting for specific phenotypes within cultivars that provide elevated levels of specific cannabinoids like CBC or THCV. Taken further, technologies like tissue culturing could rapidly iterate this hunting process⁶. Certainly, one of the most compelling aspects of cannabinoid therapeutics is the ability to harness the unique polypharmacology of various cannabis cultivars where multiple bioactive compounds are acting on multiple targets⁷. To eschew the more traditional “silver bullet” pharmaceutical approach a firm understanding of both human and plant biochemistry tied directly to well characterized and consistently processed extracts is required. When all of these pillars are joined effectively we can fully characterize our unique cannabis raw material with targeted cannabinoid and terpene ratios, optimize an extraction process to ensure no loss of desirable bioactive compounds, compare our extracted product back to its source and ensure we are delivering a safe, consistent, “nature identical” extract to use in products with predictable efficacies.

Using these tools, we can confidently set about the task of processing safe, reliable and well characterized cannabis extracts for the development of world class products.

[1] Sweeney, C. “Goal-Oriented Extraction Processes.” Cannabis Science and Technology, vol 1, 2018, pp 54-57.

[2] Russo, E. B. “Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects.” British Journal of Pharmacology, vol. 163, no. 7, 2011, pp. 1344–1364.

[3] Giese, Matthew W., et al. “Method for the Analysis of Cannabinoids and Terpenes in Cannabis.” Journal of AOAC International, vol. 98, no. 6, 2015, pp. 1503–1522.

[4] Gul W., et al. “Determination of 11 Cannabinoids in Biomass and Extracts of Different Varieties of Cannabis Using high-Performance Liquid Chromatography.” Journal of AOAC International, vol. 98, 2015, pp. 1523-1528.

[5] Mudge, E. M., et al. “Leaner and Greener Analysis of Cannabinoids.” Analytical and Bioanalytical Chemistry, vol. 409, 2017, pp. 3153-3163.

[6] Biros, A. G., Jones, H. “Applications for Tissue Culture in Cannabis Growing: Part 1.” Cannabis Industry Journal, 13 Apr. 2017, www.cannabisindustryjournal.com/feature_article/applications-for-tissue-culture-in-cannabis-growing-part-1/.

[7] Brodie, James S., et al. “Polypharmacology Shakes Hands with Complex Aetiopathology.” Trends in Pharmacological Sciences, vol. 36, no. 12, 2015, pp. 802–821.

May 30, 2018

German Health Insurer Issues First Look at Impact of Medical Cannabis

By Marguerite Arnold

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If anyone (read Auslanders) had any illusions that the German take on medical cannabis was going to be casual or unscientific if not painstakingly documented, think again.

Techniker Krankenkasse (or TK as it is referred to by the locals) is one of Germany’s largest public health insurance companies. In other words, it is a private company that is required to provide so called “statutory” health insurance which covers 90% of Germans.

As such, they are also on the front lines now of the medical cannabis debate. Approximately one year after the new law requiring public health insurance companies like TK to reimburse cannabis claims went into effect, the company has just issued what would surely be a best-seller if it were being sold.All of the medical cannabis now being prescribed and reimbursed is coming from abroad.

The Cannabis Report, as it is titled, produced with the help of professors at the University of Bremen, is also the first of its kind. In its pages, along with the corporate summary produced for the recent press conference in Berlin, are several fascinating snapshots of what is going on.

By the numbers.

The Cannabis Report

For those who cannot understand German, this summary by Business Insider is quite educational. Here are the major takeaways: There are now almost 16,000 German patients who are receiving some kind of medical cannabis by prescription. From a doctor. These patients are also paying about $12 for their monthly supplies – even if they have to wait for reimbursement. This is in contrast to the 1,100 patients who managed to obtain cannabis by prescription and pay for it themselves before the law changed last spring.

Do the math and that is a 1,450% uptick. Add in the additional 15,000 left out of this report who are getting cannabis prescribed but their claims turned down, and that is an even more amazing story.

Here is the next obvious fact: All of the medical cannabis now being prescribed and reimbursed is coming from abroad. A significant amount is still coming from Holland. The rest? Canada.

For that reason, the cost of medical cannabis is a major concern, along with the medical efficacy of cannabis and the authors’ frustrations about dosing.

The most interesting takeaway? Chronic pain and spasticity arehigh on the list of prescriptions (MS is currently the only condition which is “on label” for cannabis). So is Epilepsy and AIDS. Most interestingly are the high numbers for ADD. This is also highly significant in a country where amphetamine prescriptions for the same are almost unheard of.

TK, like the other health insurers who have started to provide numbers, also approved approximately two thirds of the requests they received. And it has cost them $2.7 million. That bill will begin to reduce as Germany cultivates medical cannabis domestically. However, the tender bid, which now apparently includes 11 contenders, is still undecided, with growing apparently pushed off now until (at the earliest) sometime next summer.

The bottom line, however, in the report from Socium, a university-based think tank that focuses on social inequality, is that cannabis is a drug that should also be treated like any other medication. Even though study authors conclude that so far, they do not find cannabis to be as “effective” as other drugs, they clearly state that the drug does help patients.

An Equally Interesting Industry Snapshot

Flip to page 20, however, and the authors also confirm something else. The top companies providing medical cannabis to German publicly insured patients who are getting reimbursed are Bedrocan, Aurora andCanopy. Aurora’s brands clock in at the highest percentage of THC, although their German importer Pedianos, clearly offers a range of products that start at less than 1% and increase to 22%. MedCann GmbH (renamed Spektrum last year) is essentially providing the rest, and ranges of THC at least, that go from 5.4%-16.5%. They also provide the products with the highest percentages of CBD.

Page 20 of the Cannabis Report produced by TK

Unlike the other companies, Canopy’s “brands” are also showing up in ostensibly both medical and government reports (Houndstooth, Penelope, Princeton and Argyle). This is interesting primarily because the German government (and regulatory requirements) tends to genericize medications as much as possible.

Dosing, Impact, Results

The next page of the report is also fascinating. Namely a snapshot of what kind of cannabis is being prescribed and at what doses. Patients who are obtaining cannabis flower are getting up to 3 grams a day. Dronabinol, in stark contrast (which is still the only form of the drug many German patients are able to get), is listed at 30mg.

Unlike any corporate report so far, the study also discusses consumption methods (including, charmingly, tea). It is impossible to forget, reading this, how German and structured this data collection has clearly been. There are several fairly stern referrals to the fact that cannabis should not just be prescribed for “vague” (read psychological) conditions but rather aspecific symptomology (muscle spasms and severe pain).

There is also great interest in how flower differs from pills. And how long the effects last (according to the authors, effects kick in about 2-15 minutes after dosing and last for 4 hours). This is, of course, an accurate picture of what happens to just about every patient, in every country. What is striking, particularly to anyone with an American perspective, is how (refreshingly) clinical much of this basic data collection and discussion is.

And no matter how much the authors call for more research, they clearly have observed that cannabis can have positive, and in many cases, dramatic impacts on patients. According to the handy graphs which are understandable to English speakers, study authors find significant evidence that the drug significantly helps patients with severe pain and or muscle spasms – see MS and Epilepsy, AIDS patients with wasting syndrome and paraplegics (wheelchair bound individuals). Authors list the “strong possibility” that the drug can help with Tourette’s and ADHD. Fascinatingly, however, so far, German researchers are not impressed with the efficacy of the drug for Glaucoma. “Psychological” and psychiatric conditions are also low on the list.

Regardless, this is an important line in the sand. As is the clear evidence that cannabis has efficacy as medication.

The great German cannabis science experiment, in other words, is well underway. And further, already starting to confirm that while many questions remain, and more research is required, this is a drug that is not only here to stay, but now within reach of the vast majority of the population.

May 23, 2018

Breeding Cannabis For Unique Therapeutic Benefits

By Cannabis Industry Journal Staff

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Cannabis Cultivation Virtual Conference: Part 1

Breeding Cannabis For Unique Therapeutic Benefits

By Adam Jacques, Co-Founder of Grower’s Guild Gardens, Sproutly

This presentation covers topics related to proper breeding procedures, “hunting” particular phenotypes and developing specific cannabinoids and terpenes.
Adam highlights some of the major advancements in breeding and how to use available resources to develop a successful breeding program.

May 22, 2018

Soapbox

Why Traceability Is Crucial for the Cannabis Industry

By Steven Burton

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The stage is set: cannabis legalization is rolling out around the world. With legalization comes regulations and smart companies will adapt to make new requirements work for them. In the end, our shared goal (as industry, consumers and government) is the same: provide safe, high-quality, reliable products. This is where traceability comes in.

If a cannabis product isn’t safe (cannabis is vulnerable to the same kinds of hazards as most food products), the reputation of the entire industry suffers. Earning public trust is the first step toward favorable government regulations. With upcoming decisions that will decide taxation and distribution, it’s more important than ever that cannabis producers can react quickly if recalls should occur – and that means taking traceability seriously.

Comprehensive Traceability for Cannabis Means More Than Legality

A crucial key to producing safe and high-quality cannabis products is detailed traceability. Many states require cannabis businesses to use systems like Metrc, a technology that uses RFID tags to track cannabis from seed to sale to ensure nothing is diverted to the black market. However, Metrc focuses only on the chain of custody, not on the safety or quality of the product.

Ensuring a secure supply chain is only one piece of the cannabis puzzle. Public health hazards like toxic chemical contamination, mold growth and pathogenic contamination introduced by pests or improper employee handling need to be controlled in order to earn public trust and comply with regulations. State-mandated traceability systems don’t address these imperatives, so an effective safety technology that includes traceability, in addition to mandated systems like Metrc, is absolutely necessary to complete the cannabis picture.

Automation Technology Supports Cannabis Companies’ Growth and Helps With Audits

Cannabis professionals are aware of the regulatory scrutiny the industry is under and many have turned to automation technology to help stand up to this scrutiny, as well as collect and manage all the data necessary for compliance. Automating data collection pays off in several ways. For one, interconnected, real-time IoT technologies that are accessible to the entire facility 24/7 are giving cannabis businesses the tools they need to create the best possible products now, as well as providing them with the data they need to make their products even better. Since frequent audits are a part of the legalization transition, automation also makes preparing for audits and inspections a matter of minutes instead of days.

Ron Sigman, chief executive officer of marijuana compliance consulting firm Adherence Corp. and former investigator for the Marijuana Enforcement Division (MED) in Colorado, lists the most common violations for cannabis businesses that he found during more than 200 audits in an interview for Marijuana Business Daily. These violations include:

Metrc issues, especially accounting not matching inventory (too many plants or ounces of marijuana on the premises);
Security issues like lack of sufficient camera coverage;
Failure to upgrade licenses;
Improper or incomplete training of new employees.

Adopting safety and traceability concepts that the food industry developed over many decades can yield huge benefits for cannabis businessesA proper cannabis traceability technology mitigates these problems by providing notifications of inventory inconsistencies, certification expirations and more. Traceability for cannabis must be able to handle the complexities of procedures like terpene extraction and injection. With the rapid growth of the industry, it must be able to set targets and track actuals. It should track, not just cannabis plants and related derivatives, but also every other ingredient, material and packaging material used during production. There must be monitoring at each stage of production and a system in place to ensure all employee training is up to date. Preventative maintenance must be scheduled and tracked and hazards must be identified and controlled. In the event of an audit or recall, precise mass-balance calculations must be available to account for every gram of product, including non-cannabis ingredients like coconut oil and packaging materials like pouches and labels.

Detailed traceability can make the difference between a cannabis business keeping their license or being shut down. “You have to make a diligent effort to stay compliant 365 days out of the year, because you never know when a regulatory agency is going to come knocking on your door,” says Sigman. Knowing exactly what went wrong when and where allows a company to make changes so failures don’t happen again.

Higher Standards Will Be Demanded

The standard sought by most in the cannabis industry is only GMP (Good Manufacturing Practice) certification, which is actually the lowest level of certification possible in food production. With the public demand for edibles and concentrates on the rise and major retailers scrambling for seats at the table, the demand for transparency from growers and manufacturers will increase. Cannabis companies will soon find that GMP compliance simply won’t be enough to earn trust and expand their market share, especially when it comes to edibles and concentrates.

“Every day, patients express interest and assurance of wanting to know that the foods and medicines they consume are safe and of the best quality available,” says Lindsay Jones, president of Curaleaf Florida, the first medical cannabis company in Florida to achieve SQF Certification. Safe Quality Food (SQF) certification ensures a company meets the highest levels of safety and quality on a reliable basis. Curaleaf has set a new bar in the industry that others will be compelled to follow and they should be congratulated for their proactive vision.

Adopting safety and traceability concepts that the food industry developed over many decades can yield huge benefits for cannabis businesses, but it will be interesting to watch the technology evolve to accommodate the specific needs of retailers and consumers. Imagine a traceability system that ensures safety and quality while also tracking consistency and potency.

The Future of Cannabis Is Bright

The emerging cannabis industry is facing challenging hurdles on its path to widespread legalization and acceptance but the forecast is sunny – for companies who are prepared.

New Frontier Data CEO Giadha Aguirre De Carcer, explains that California’s “legal (cannabis) industry is forecast to grow from $2.8 billion in 2017 to $5.6 billion in 2020. That spending will be increasingly directed at products and retailers who understand and serve the market’s evolving tastes and preferences.” That includes implementing comprehensive traceability systems to deliver safe, quality product.

May 16, 2018

Epidiolex Gives GW Pharmaceuticals Boost In Global Markets

By Marguerite Arnold

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GW Pharmaceuticals scored a significant victory in the United States with its cannabis-based epilepsy drug Epidiolex in mid-April. The company received approval from a U.S. Food and Drug Administration (FDA) panel for its use in treating two forms of drug-resistant epilepsy.

The drug was granted “orphan drug” status in the EU a year ago.Will this be enough to move the conversation forward about cannabis as medicine in the United States?

So what does the future hold for this drug and a company, which has visited this space before? Remember Sativex?. The Company now faces real competition from a raft of companies moving into this space from just about everywhere – both from Canada and of course Europe itself.

The FDA Might be on the Verge of Approving its First Cannabis-Based Drug

It is not like this is either the FDA’s or GW Pharma’s first discussion about the medical efficacy of cannabinoids. Sativex, a mouth spray containing THC, was never granted approval in the United States for the treatment of MS – although it received such approvals in Europe.

If the FDA approves Epidiolex (made from CBD), it will be the first cannabinoid-based drug approved in the United States by the federal agency.

Will this be enough to move the conversation forward about cannabis as medicine in the United States? What will happen in the EU?

A Divergent and Highly Different Drug Market

Will the FDA finally approve at least one form of a CBD-based drug? The chances are that Epidiolex might finally move the agency to approve. However,this is not, despite the hype that the company has made in the press about this, the first cannabinoid-based drug to be approved in the United States. It might be, however, the first drug based on actual natural cannabinoids rather than synthetic ones that it approves for some purpose. Both Cesamet and Dronabinol (or Marinol) are synthetic cannabinoid drugs approved for several conditions from chronic pain caused by chemo to Parkinson’s.

But those who are hoping that this drug approval might open the floodgates at the FDA for startersshould take a pew. While Sativex was not approved in the United States, it was made available after 2011 for MS patients, particularly in Germany, which has the highest rate of MS of any European country. The problem? It was just too expensive for most people to afford – since their insurance would not cover it. And doctors were even more resistant to prescribing than they are now. So even getting a prescription was almost impossible.

That conversation was different in Europe post-2013, and there were people who managed to get a doctor to write a prescription not to mention afford the eye-watering prices sans insurance coverage.

That said, given the choice between whole plant meds, most people still prefer bud cannabis to the spray variety. And in Europe right now, that is what is on the table.

What Will This Mean in the US vs Europe?

In the US, the first thing that FDA approval will mean is drug sales for only one branded drug. That is the cynicism at play here. Furthermore, it also neatly dodges the THC issue.

In Europe? Particularly Germany? This development is not likely to make much of a dent. GW is competing with every single Canadian producer with flower-based oil – and on both the medical and non-medical CBD front. That also now includes local producers. Further, this is a market which prizes genericized drugs over name brands. In France, the distribution of Sativex was held up, primarily because of the row over cost. And who would pay.

It is also unlikely that the FDA approval in the United States will change the discussion either in the US on a federal level – or in Europe.

The most important place this news already made a dent? GW Pharma’s stock price – at least temporarily. It is also a spot of good news the company really needs. In February, the company’s GWP42006 drug designed for focal seizures (drug resistant epilepsy) failed to outperform placebo results and wiped 5% off the company’s stock.

May 16, 2018

Green Relief Enters European Market Via Switzerland

By Marguerite Arnold

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It is old news that Canadian companies are entering the European market. And it is also no stop-the-presses flash that Germany is a big prize in all of this. But there are other Euro markets to watch right now. Switzerland is one of them.

Look for the Canadian influx here too.

One of the more interesting entrants this month? Green Relief – a Canadian LP with a really unique twist. They are the only company in the world to produce cannabis oil from flower grown with aquaponics. This unique method creates unbelievably “clean” cannabis with no pesticides – and no residue of them.

It also sets the company up for a really unique market opportunity on the ground outside Canada. Especially as they have now just announced a partnership with two Swiss companies– Ai Fame GmbH and Ai Lab Swiss AG. Both companies have been leading European pharmaceutical companies since the turn of the century. The idea is to leverage all three company’s intellectual capital with Green Relief’s additional and first international investment with an eye to the entire European cannabis market. Ai Fame specializes in cultivation, manufacturing, sales and distribution to both the food and medical sectors. Ai Lab Swiss AG operates as a laboratory and testing facility.Less than three weeks before Green Relief publicized their European announcement, there were also strategic developments afoot at home.

From this unique perch in the Swiss canton of St Gallen, the three companies are setting up to conquer Europe.

Why Is Switzerland So Strategic?

Switzerland has been on the legalization track since 2011. As of this date, the Swiss government began allowing adults to buy and use CBD-only cannabis. Shops were allowed to obtain licenses. A trickle of sales began. However, rather suddenly, as reform hit Europe, the craze took off. Last year, for the first time, the industry generated a significant amount of revenue (close to $100 million). That is $25 million for the government via taxes- just on CBD sales. Even more intriguing for those looking for market opportunity across borders? Less than a week ago, the German-based budget discount store Lidl just announced they were carrying smokeable CBD – in Swiss grocery stores. The leap across the border is imminent.

That has opened up other conversations, including the “legalize everything” push that makes an awful lot of sense to the ever tax-aware Swiss. This is a push afoot just about everywhere across the continent, including, of course, just across the border in Germany.

The cities of Zurich and the cantons of both Winterthur and St Gallen (home of the Swiss companies behind the new venture with Green Relief) have already indicated that they will not pursue possession fines for those busted with 10 grams or less– no matter what kind and even of the THC variety.

Read between the lines, and it is clear that the cannabinoid conversation locally has begun to attract the Canadians. And not just because of the many opportunities of the Swiss CBD market – but the huge medical and THC German and European opportunities now opening beyond that.

No matter which way Green Relief and their new partners slice it, they are now in the game – and across Europe – with a unique new play and product, and further one set to enter both the medical THC and “consumer,” albeit still CBD, market now burgeoning.

A Cross Market Play

Here is the truly interesting part about this new announcement. Less than three weeks before Green Relief publicized their European announcement, there were also strategic developments afoot at home. Cannabis Growth Opportunity Corporation also just announced an investment in Green Relief. The share purchase agreement netted Green Relief $750,000 in both cash and common shares.

With this, Green Relief seems to have set sail on its European expansion. Look for more interesting turns to this developing saga soon!

May 9, 2018

Refining Techniques for Growing Cannabis

By Cannabis Industry Journal Staff

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As the cannabis industry in the United States and throughout the world develops, the market is getting more competitive. Markets in a number of states are experiencing disruptions that will have lasting effects for cultivators, including oversupply and supply chain bottlenecks. Now more than ever, growers need to look for ways to differentiate their product or gain a bigger market share. Looking at yield efficiency, quality improvements and analyzing the cost of inputs versus value of the crop can help growers make the right choices in technology for lighting, irrigation and pest control among other technologies.

adamplants — Adam Jacques, co-founder of Growers’ Guild Gardens and Sproutly

A series of free webinars in two weeks can help growers learn about some of the more advanced techniques in improving yield and quality. The Cannabis Cultivation Virtual Conference on May 23^rdwill explore a variety of tips and tricks for taking their cultivation operation to the next level. This event is free to attendees, made possible by sponsors VividGro and CannaGrow Expo.

Attendees will hear from experts in cannabis cultivation on a range of topics, including breeding, drying, curing, environmental monitoring and micropropagation. Adam Jacques, co-founder of Growers’ Guild Gardens and Sproutly, will discuss some of his experience with breeding high-CBD strains in Oregon. His talk will delve into some of the proper breeding procedures, along with how to hunt for particular phenotypes and developing specific cannabinoids and terpenes.

Dr. Allison Justice, vice president of cultivation at Outco, is going to present some of her findings in drying and curing at the company. She plans on sharing her research on how the post-harvest stages can affect and control the chemical makeup of flower. She’ll also discuss some new protocols to monitor the dry and cure of cannabis flowers so we are able to modulate the terpene and cannabinoid profiles.

More information on the other speakers at this event and how to register for free can be found here.

May 1, 2018

Soapbox

Replacing Opiates with Cannabis is Finally Becoming a Reality: Where do we go from Here?

By Dr. Richard Kaufman

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Opiate abuse is a far-reaching international public health issue, impacting tens of thousands of people every year in the United States alone. As the epidemic continues to spread, the medical community is faced with the immense task of researching and developing safer, non-addictive treatment alternatives for patients of chronic pain and other ailments. The controversial and oft-debated notion of cannabis as an opiate alternative has become increasingly well-researched and gained considerable credibility in recent years. The new challenge lies in advancing the cannabis industry to the point of being a legitimate medicine that can be prescribed and administered by doctors.

Opioids are among the most commonly prescribed medical treatments for severe chronic pain, yet prescription opioid overdoses killed more than 165,000 Americans between 1999 and 2014 according to the Department of Health and Human Services. In fact, the health and social costs of opioids are estimated to be as much as $55 billion a year. As such, it has become more imperative than ever that mainstream medical practitioners take notice of the cannabis plant’s powerful healing properties and shift away from potentially harmful pharmaceutical medications.

The evidence of cannabis’ safety and efficacy is well established. For instance, in a literature review of 38 studies evaluating medical cannabis’ efficacy for treating pain, 71 percent concluded that cannabinoids had empirically demonstrable and statistically significant pain-relieving effects. In addition, a 2015 meta-analysis of 79 studies found a 30 percent or greater reduction of pain with the use of cannabinoids compared to placebos. Further, an analysis of a decade of randomized, double-blind placebo-controlled clinical trials on cannabis for treating pain concluded that cannabis should be a first line treatment for patients with painful neuropathy and other serious and debilitating symptoms, who often do not respond to other available medications.

Not only is cannabis demonstrably safe and effective, but numerous studies also present compelling evidence that the prescription of opiates has dropped sharply in U.S. states and countries that have legalized medical cannabis. For example, a study in the Clinical Journal of Pain followed 176 chronic pain patients in Israel over seven months. Researchers found that 44 percent of participants stopped taking prescription opioids within seven months after starting medical cannabis. Patients cited the following reasons for using cannabis instead of pharmaceutical drugs: 65 percent reported less adverse side effects, 57 percent cited better symptom management and 34 percent found that cannabis had less withdrawal potential than their other medications.The evidence of cannabis’ safety and efficacy is well established.

The tide is quickly turning as many respected doctors are beginning to advocate for the tremendous medical potential of cannabis as a replacement for prescription pills. That said, if the cannabis industry is to help solve the crisis inflicted by modern pharmaceutical painkillers, we must develop next-generation scientifically formulated products and advocate to improve their accessibility.

Inhalation and oral methods of cannabis consumption have no reliable dosage as medicine, rendering them unfit for administration by health professionals. These mainstream consumption methods also have extremely low bioavailability and bioactivity. Bioavailability for ingested cannabis products is only 6 percent and for inhalation methods can be as low as 2 percent. Oral absorption of THC is slow and unpredictable, with peak blood concentration occurring 1–5 hours post dose. Similarly, inhalation methods can take up to two hours to have any effect. The next phase of the medical cannabis industry must focus on fixing problems that prevent cannabis from being a universally recognized health tool. Fortunately, scientists are making major advancements in cannabis delivery technologies, offering novel and innovative administration methods that have proven both effective and reliable.

With products like Evolve’s NanoSerum™ representing a promising solution to help reduce the morbidity and mortality associated with prescription opioid use and abuse, meaningful progress is already underway. It’s been a long and challenging road to arrive at this point, but our efforts are only just beginning. Achieving long-term change on a national and international scale will require professionals from all levels of the cannabis, science and medical communities to push for advanced product offerings that provide consistent, standardized dosing in healthier, smokeless modes of delivery.

April 25, 2018

GW Pharma’s Epidiolex Gets Encouraging FDA Assessment

By Aaron G. Biros

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According to a press release, last week GW Pharmaceuticals’ drug Epidiolex received a positive FDA panel review, which is an encouraging and important step towards getting the drug approved by the U.S. Food and Drug Administration and on the market in the United States. Epidiolex is an anti-epilepsy drug, taken in a syrup form, with the main active ingredient being cannabidiol (CBD), and less than 0.1 % THC.

The drug is targeted to treat Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) a rare early-onset type of epilepsy found in children, according to Reuters. FDA staff said the drug “reduces seizure frequency in patients with drug-resistant LGS or DS while maintaining a predictable and manageable safety profile.”

GW Pharmaceuticals, founded in 1998 and based in London, is a biopharmaceutical company that has made headlines previously for developing cannabis-derived drugs. Sativex, one of the first drugs they developed, is derived from cannabis, but was not approved by the FDA. It is however available in other parts of the world, such as the EU, Israel and Canada.

If Epidiolex actually gets approval by the FDA, it will be the first-ever cannabis-derived drug available via prescription in all of the United States. According to Justin Gover, chief executive officer of GW Pharmaceuticals, this is a momentous breakthrough for the company. “We are pleased by the Advisory Committee’s unanimous recommendation to approve Epidiolex, which would provide an important treatment option for patients with LGS and Dravet syndrome, two of the most severe and treatment-resistant forms of epilepsy,” says Gover “This favorable outcome marks an important milestone in our company’s unwavering commitment to address the significant unmet need for patients with LGS and Dravet syndrome and our resolve to study Epidiolex under the highest research and manufacturing standards. We look forward to our ongoing discussions with the FDA as it continues to review the Epidiolex NDA.”

According to the GW press release, the Peripheral and Central Nervous System Drugs Advisory Committee of the FDA unanimously recommended supporting the approval of the New Drug Application (NDA) for the drug. That advisory committee is sort of like an independent panel; their unanimous vote doesn’t necessarily mean the drug will get approved, but the FDA takes their decision into consideration when approving new drugs. So this panel recommendation is certainly a good sign and shows this drug could potentially be on the path to FDA approval.