Thomas Jefferson University’s Lambert Center for the Study of Medicinal Cannabis and Hemp announced recently that it is co-sponsoring the third annual JAZ Tank Challenge: CannaVATION Edition.
Jefferson Innovation’s 2018 JAZ Tank Challenge: CannaVATION Edition is currently accepting submissions of innovative business models for a chance to compete on October 3, where finalists will each present their business ideas in a 10-minute pitch. Winning submissions could get one free provisional or utility patent application and business and clinical consulting services. The competition will be accepting submissions through August 20, 2018.
Finalists will compete for a $10,000 grand prize, legal support and business consultation services. According to the announcement, in addition to the grand prize winner, up to two other teams could win $5,000 in financial support, one free provisional or utility patent application and consulting services as well.
Zoe McKinley, director of entrepreneurship and social impact initiative at the Lambert Center
According to Zoe McKinley, director of entrepreneurship and social impact initiative at the Lambert Center, the competition is designed to have a national focus, not just on the Pennsylvania cannabis industry. “We are excited to shine a spotlight on Pennsylvania, and Thomas Jefferson University specifically, as a hub for research in medical cannabis, but like the competition, the Lambert Center has a national and even international focus,” says McKinley. She says this is also the first year that the JAZ tank is exclusively focused on cannabis.
Jefferson’s Chief Innovation Officer, Dr. Rose Ritts, notes “the competition is about creating a platform for emerging concepts to get a toe-hold on the path to potential commercialization. Anything that will improve patient access or outcomes …or improve the industrial hemp market in the U.S. is definitely of interest,” says Ritts. “We welcome companies to jump into the Challenge, and we also welcome investors or anyone thinking about getting into this space to be in the audience for our event on October 3.”
Dr. Rose Ritts, Jefferson’s Chief Innovation Officer
The challenge is an annual healthcare startup competition, where new businesses with particularly innovative ideas and technology solutions for the legal cannabis space submit their business models to a panel of judges for review. “This event will bring together the most inventive minds to pitch their solutions to stakeholder problems in the still-emerging medical and medicinal cannabis and industrial hemp industries,” reads the announcement. The Lambert Center is seeking applicants in a wide variety of business areas, including patient access, product design, plant science, information management, horticultural technology, sustainability, transportation, security, workforce training, community outreach, banking and public education.
Lambert Center Director Charles Pollack, MD sees the massive growth potential of the legal cannabis industry. “At our Center we are dedicated to identifying new approaches to developing cannabinoid-based therapies that help patients with various debilitating symptoms and diseases,” says Pollack. “Our JAZ Tank Challenge may identify the next great idea in medicinal cannabis.”
Through the Lambert Center for the Study of Medicinal Cannabis and Hemp, Jefferson is the first major university in the US to provide a comprehensive academic resource for the medicinal, medical and industrial applications and business of cannabis and hemp. The Lambert Center, the first of its kind in academia, provides “expert-developed, unbiased information to clinicians and patients about medical cannabis and cannabinoid-based therapies,” according to their website. They want to “support the development of entrepreneurial and socially responsible business and clinical approaches within the emerging medical cannabis industry and explore and develop new ways to use hemp in medical, industrial, and consumer products,” reads the website.
McKinley mentions they are looking for creative approaches to solving problems in the medical cannabis and industrial hemp industry. “These could be anything from new products or supply chain innovations to patient support tools to energy management systems that lower the environmental impact of grow facilities,” says McKinley. “We are hoping to see companies that have already launched, or are ready to very quickly.” The third annual JAZ Tank Challenge: CannaVATION Edition is accepting submissions through August 20. Click here for more information.
After a year of embarrassing missteps and revelations, along with two well-run advocacy campaigns by the parents of children with drug-resistant epilepsy, the British government is finally throwing in the towel on medical cannabis.
Sadly, politics rather than science has driven the pace of British cannabis legalizationIn the last week of July, a mere two weeks after announcing his review of the issue against mounting domestic pressure and outrage in the media, Sajid Javid, the home secretary, announced that cannabis medications will be rescheduled by the fall, allowing doctors to prescribe them more widely.
“Fall,” it should be noted, is not only when the Canadian government moves ahead with its own fully recreational market, but also when the German bid respondents need to file their paperwork to participate in the country’s first grow bid, Round II.
A Political Embarrassment Beyond Brexit
Sadly, politics rather than science has driven the pace of British cannabis legalization, just like it has in other places. However the UK is one of the best examples of how far medical knowledge has outstripped the pace of political change, and in this case, exposed bare the banal reason.
News broke this summer, as two families mounted a highly successful battle in the public for medical access, that the Prime Minister herself has personally profited from a status quo that is only now slowly going to change.
How and why?
Theresa May, Prime Minister of the UK Image: Annika Haas, Flickr
It was bad enough in May that the publicly anti-pot reformer Victoria Atkins, the cabinet level British drugs minister, was married to the managing director of British Sugar, the company with the exclusive right to grow cannabis in the British Isles. British Sugar is also the sole cultivator for GW Pharmaceuticals, the only company with the license to produce cannabis medications in the UK (and export them globally). In June, however, it emerged that Prime Minister Theresa May’s husband, Phillip May, is employed by Capital Group– an investment firm that is also the largest shareholder in GW Pharma. This is against the backdrop of news that broke earlier this year that GW Pharma had made the UK the single largest exporter of cannabis-based medicine annually. Globally. Even more than all of the Canadian firms combined currently exporting to Europe and beyond. Even as the drug is largely denied to British residents.
You don’t even have to be British to think the entire situation is more than a bit of a sticky wicket.
Vested, If Not Blueblood Interests
This development also came to light right as GW Pharma’s newest focal epilepsy drug faltered to failure in Eastern European trials and as Epidiolex, the company’s drug for certain kinds of childhood epilepsy, was given the green light in the U.S. by the government as the “first” cannabis-based medication to be allowed for sale in America.
No one has yet defined exactly what kind of cannabinoids will be allowed to be prescribed in the UK come fall, but here is the most interesting development of all that still hangs over the British Isles like stale smoke: Will competitors to GW Pharma be allowed to sell their products to medical customers in the UK or will this new opening for patients just create more of a monopolized windfall for one company whose profits, at least, lie in “pharmatizing” the drug rather than creating greater access to the raw plant or its close derivatives? And those profits flow to women (and men) with the greatest political control over the development of the industry in the country.
Is This Really A “Legalization” Victory?
In the short term, no matter how limited, the answer is actually yes. Rescheduling the drug is a step that has not even been taken in the U.S., and will serve, medically, to reset the needle if not the debate about the circumstances under which cannabis should be used for patients.
It will also move the punishment discussion in a way that still has not happened in places like Germany where, technically, the drug has not yet been decriminalized even though doctors are prescribing it and public health insurers cover the costs for increasing numbers of patients. Large numbers of Britons, just like everywhere else, are incarcerated every year or obtain black marks on their records for mere possession that in turn can affect lives.
Finally, it will put recreational reform in the room, even if still knocking at the door. This discussion too has been gaining in popularity over the past year in particular as reform moves elsewhere. Like Germans, like Canadians and like Americans, reform in Colorado and Washington set loose a global revolution, which will clearly not be stopped.
Even if in places like the UK, it is still moving far slower than it should be. For political and business reasons, not driven by science.
CBC, a cannabinoid typically seen in hemp and CBD-rich plants, has been linked to some potentially impactful medical applications, much like the findings regarding the benefits of CBD. The module that tests for it, along with terpenes and degraded THC, can be added to the LightLab without any changes to hardware or sample preparation.
Dylan Wilks, chief technology officer of Orange Photonics
According to Dylan Wilks, chief technology officer of Orange Photonics, this could be a particularly useful tool for distillate producers looking for extra quality controls. Cannabis distillates are some of the most prized cannabis products around, but the heat used to create them can also create undesirable compounds,” says Wilks. “Distillate producers can see potency drop more than 25% if their process isn’t optimized”. With this new Terpenes+ Module, a distillate producer could quantify degraded THC content and get an accurate reading for their QC/QA department.
We spoke with Stephanie McArdle, president of Orange Photonics, to learn more about their instruments designed for quality assurance for growers and extractors alike.
Stephanie McArdle, president of Orange Photonics
According to McArdle, this could help cultivators and processors understand and value their product when terpene-rich products are the end goal. “Rather than try to duplicate the laboratory analysis, which would require expensive equipment and difficult sample preparation, we took a different approach. We report all terpenes as a single total terpene number,” says McArdle. “The analyzer only looks for monoterpenes (some common monoterpenes are myrcene, limonene and alpha-pinene), and not sesquiterpenes (the other major group of cannabis terpenes, such as Beta- Caryophyllene and Humulene) so the analysis is semi-quantitative. What we do is measure the monoterpenes and make an assumption that the sesquiterpenes are similar to an average cannabis plant to calculate a total terpene content.” She says because roughly 80% of terpenes found in cannabis are monoterpenes, this should produce accurate results, though some exotic strains may not result in accurate terpene content using this method.
The LIghtLab analyzer on the workbench
As growers look to make their product unique in a highly competitive market, many are looking at terpenes as a source of differentiation. There are a variety of areas where growers can target higher terpene production, McArdle says. “During production, a grower may want to select plants for growing based on terpene content, or adjust nutrient levels, lighting, etc. to maximize terpenes,” says McArdle. “During the curing process, adjusting the environmental conditions to maximize terpene content is highly desirable.” Terpenes are also beginning to get recognized for their potential medical and therapeutic values as well, notably as an essential piece in the Entourage Effect. “Ultimately, it comes down to economics – terpene rich products have a higher market value,” says McArdle. “If you’re the grower, you want to prove that your product is superior. If you’re the buyer, you want to ensure the product you buy is high quality before processing it into other products. In both cases, knowing the terpene content is critical to ensuring you’re maximizing profits.”
Orange Photonics’ LightLab operates very similarly to instruments you might find in a cannabis laboratory. Many cannabis testing labs use High Performance Liquid Chromatography (HPLC) to analyze hemp or cannabis samples. “The primary difference between LightLab and an HPLC is that we operate at lower pressures and rely on spectroscopy more heavily than a typical HPLC analysis does,” says McArdle. “Like an HPLC, LightLab pushes an extracted cannabis sample through a column. The column separates the cannabinoids in the sample by slowing down cannabinoids by different amounts based on their affinity to the column.” McArdle says this is what allows each cannabinoid to exit the column at a different time. “For example, CBD may exit the column first, then D9THC and so on,” says McArdle. “Once the column separates the cannabinoids, they are quantified using optical spectroscopy- basically we are using light to do the final quantification.”
At the National Cannabis Industry Association’s (NCIA) Cannabis Business Summit and Expo last week there was a presentation titled, “Raising the Standard for Dispensary Education: Building a Better Breed of Budtender.” Speakers included Adam Cole, learning and development specialist at Native Roots Dispensaries and Dr. Aseem Sappal, provost and dean of faculty at Oaksterdam University. Nancy Whiteman, owner of Wana Brands, was the moderator. Let’s look at some of the ways they have standardized their process in cannabis retail education.Health effects achieved in one patient are not always replicated for every patient. This is true of all medicine.
The standard education module at Native Roots (20 retail locations throughout Colorado, and were awarded licenses in Manitoba, Canada) for onboarding a budtender includes laws and compliance, ID checking and sales limits, customer service and physical effects. Oaksterdam University provides cannabis education and focuses on botany, introduction to the endocannabinoid system, bioavailability, CBD, and edibles vs. smoking as a delivery mechanism. In addition to the already mentioned classes, Wana Brands also teaches the concept of sustained release and capsules (due to product specificity). The Native Roots educational program contains continuing education in the history of cannabis, the endocannabinoid system, methods of consumption, phytocannabinoids and terpenes. For those of you in medical professions beginning your cannabis education, these modules provide a great outline to launch your own learning and development program.
How can dispensaries integrate the medical profession at the point of distribution?The presentation highlighted the legal aspects of providing cannabis information and cannabis products. A licensed medical professional oversees all educational content and everything is run through a legal department. It is important that all cannabis providers use language that offers no definitive medical outcomes. Health effects achieved in one patient are not always replicated for every patient. This is true of all medicine. At Native Roots Dispensary, they address symptoms not diseases. They have specific language to avoid giving medical advice. For good reason, there is a state regulatory body called the Marijuana Enforcement Division (MED) that oversees dispensaries and their adherence to the “no medical advice” decree, along with a slew of other regulatory compliance issues.
Dispensaries offer careful symptom-based product recommendations to many types of consumers. How can dispensaries integrate the medical profession at the point of distribution? Native Roots has partnerships with doctors and the Rocky Mountain Cancer Institute. Additionally, the CEO of Wana Brands mentioned the use of medical kiosks in some dispensaries. My question to Adam Cole was, “Would you like to see trained cannabis nurses on staff or on board as a consultant in dispensaries to deal with patients and have the budtenders service the customer?” His answer: “Absolutely.”
Calls for more testing have been a watchword of both cannabis reform advocates and opponents alike for many years.
However, now is a really good time for cannabis companies to consider sponsoring medical trials across Europe for their cannabis products. This is why:
The Current Environment On The Ground
Germany is Europe’s biggest consumer of both prescription medications and medical devices dispensed by prescription. It is, as a result, Europe’s most valuable drug market. And ground zero for every international cannabis company right now as a result.Targeting Germany for your latest pharmaceutical product is difficult no matter who you are.
Here, however, are a few problems that face every pharma manufacturer, far beyond cannabis. Targeting Germany for your latest pharmaceutical product is difficult no matter who you are.
The vast majority by euro spending on all drugs and devices dispensed by prescription must be pre-approved. To add to this problem, before they can be prescribed, new drugs must get on the radar of doctors somehow. To put this in stark relief, the entire prescription drug and medical device annual spend is about 120 billion euros a year in Germany. Only 20 billion euros of that, however, may be obtained relatively easily (without pre-approval from an insurer). Preapproval also only comes when there is trialor other scientific evidence of efficacy.
There are strict rules banning the advertising of prescription drugs to patients and highly limiting this outreach to doctors.
There are strict rules prohibiting the use of the word “cannabis” to promote anything.
There is a strong reliance on what is called “evidence-based medicine.” That means that large numbers of doctors and insurance company approvers need to see hard data that this drug or device actually works better than what is currently on the market.
How then, is a new drug supposed to get on the radar of those who prescribe the drug? Or patients?
If this sounds like an impossible situation to navigate, do not despair. There is a way out.
Largely unknown outside Europe, this agency actually has a hugeinfluence on how drugs are brought into the region. Specifically, this is the EU-wide agency (aka the EMA) that both regulates all drugs within Europe, but has also, since 2016, been making clinical reports submitted by pharmaceutical companies, available to anyone who asks for them. That includes doctors, members of the public and of course, the industry itself.
In the middle of July, the agency also published a report on the success of its now three-year-old program, including the usage of its entry website. Conveniently written in English, it is possible to easily search new trial data, which, also now must be made public.
Medical trial data, in other words, that can be created by sponsored cannabis company backed trials.
It remains the best way to get patients, doctors and insurance companies familiar with new drugs. Or even new uses for old drugs in the case of cannabis.
Will Trials Move Legalization Discussions?
Of all the established cannabis companies now in operations with producton the ground, GW Pharmaceuticals has learned that this strategy can actually cut both ways.
However,there are no other cannabis companies in the position of GW Pharma – namely with a monopoly on a whole country (the UK), where it alone can legally grow cannabis crops and process the same into medication and further for very profitable export. In addition, even more disturbingly, and clearly an era that is coming to an end, the vast majority of British patients have been excluded from access to cannabis except in the case of GW Pharma products.
GW Pharma said their product Epidiolex (for the treatment of childhood epilepsy) is being considered by the European Medicines Agency
However, that is the UK.
Other cannabis companies can take a page out of the company’s handbook. All that is required for faster market entry, is a slightly altered recipe.
By sponsoring cannabis-related trials in each country they want to enter, starting with Germany, cannabis companies can literally put themselves on the medical map.
Why?
Because doctors, patients andother researchers will be easily able to see and access country-specific medical data on each use of cannabis covered by a trial, per EU country. All made possible, of course, by the new open door policy of the EMA.
Growing the Medical Market
While this may sound like an “expensive” proposition, there are really few other alternatives. And with no advertising budget, plus a marketing budget that must include outreach to everyone in the supply chain including doctors, distributors and even pharmacies, the trial approach in the end may be the most efficacious in broadening both the demand and market. Not to mention the cheaper option.
How such a trial strategy might be coordinated at a time when domestic cultivation is still on hold is still a question. However for those companies considering market entry and cultivation bid if not domestic processing strategies for their products is an industry strategy that will pay off in spades.
Its role in the legalization of cannabis as medicine, as well as the speedier introduction of new drugs overall into the European system,cannot be underestimated, even if it is currently underutilized by the cannabis industry specifically now.
Federal trademark registrations are invaluable tools for emerging businesses. They put the world on notice of a company’s name; they can secure nationwide priority over others using similar names; they distinguish a product in the marketplace; they provide crucial advantages in trademark infringement lawsuits; and they are instrumental in building goodwill. But if you sell cannabis, a federal trademark registration will not do any of those things for you … because you can’t get one.
Someday, the USPTO policy may change and there could be a gold rush for federal cannabis trademark registrations.The United States Patent and Trademark Office (USPTO) continues to refuse to register federal trademarks for cannabis businesses, even if the sale of cannabis is legal in the state where the businesses are located. The USPTO’s reasoning goes something like this: federal trademark law allows for the registration of trademarks associated with goods in “lawful” commerce, which means that the goods are not illegal under federal law. Cannabis, and its psychoactive component, THC, remain Schedule I substances under the federal Controlled Substances Act (CSA). Therefore, irrespective of state laws to the contrary, and irrespective of whether the federal law is actually enforced, the manufacture and sale of cannabis is not “lawful” commerce.
This reasoning is of fairly recent vintage. In 2009, by which time about fifteen states had legalized medical cannabis, Attorney General Eric Holder announced that the Drug Enforcement Administration would cease raids on state-sanctioned medical cannabis facilities. The USPTO followed Holder’s lead in 2010 and created a new category of acceptable goods and services for marks related to “medical marijuana.” Within months, however, the USPTO had retreated from this “mistake” and changed its practice manual expressly to preclude such registrations.
David Kluft, partner in the Boston office of Foley Hoag, LLP
Many argue that the USPTO’s position is unjustifiable as a matter of public policy. Making it easier to infringe the trademarks of state-sanctioned businesses does not advance the purposes of the CSA, and it directly undermines a key goal of trademark law, which is to prevent the proliferation of confusingly similar trademarks. But the merits of these arguments have been lost on the USPTO, which continues to refuse to register marks for anything it perceives to be prohibited by the CSA.
So if you own a cannabis business, what can you do to protect your goodwill while the federal government maintains its current policy? Below are some ideas. Admittedly, none of them– individually or collectively – is a substitute for federal registration. But each of them is better than nothing, and all of them may help to establish your ownership and priority when and if the USPTO changes its policy.
State Trademark Registrations. Each state has its own trademark registration system. State registration may offer protection from infringers within the state, or at least within the parts of the state where the registrant operates, and for that reason alone it is probably worth the small cost involved. However, state registration will have little to no efficacy outside the state. You cannot use a State A registration to file a lawsuit in State B, or to stop infringement in State B, or even to prevent conflicting registrations in State B. Additionally, most state trademark registrants, unlike federal registrants, do not benefit from presumptions of validity and ownership in the litigation context.
Related Federal Registrations. Many cannabis businesses also pursue federal registrations for whatever aspects of their business are not prohibited by the CSA. For example, even though the USPTO refused the POWERED BY JUJU mark for cannabis vaporizers (because it was CSA-prohibited “paraphernalia”), it allowed the same company to register the same mark for “vaporizers for smoking purposes not for use with cannabis.” The USPTO has also allowed registrations for cannabis-related business consulting (e.g., CANNACARD; PRAIRIEJUANA); investment analysis (e.g., FORTUNE420); clothing (e.g., CANNABIS COUTURE, THE MARIJUANA COMPANY); and for CBD – as opposed to THC – derivatives (e.g., CBD LIQUID GOLD). Once the USPTO permits federal registrations for cannabis marks and the inevitable disputes over ownership arise, such federal registrations for these related products and services are likely to be highly persuasive evidence in the registrants’ favor. Moreover, even in the current legal climate, federal registrations (especially when cited in a demand letter) are of great practical use in convincing others not to use confusingly similar marks.
Common Law Unfair Competition. Unfair competition is a state common law cause of action that was a precursor to modern trademark law, and it is still available to protect commercial goodwill even in the absence of a state or federal trademark registration. However, unfair competition law has similar territorial restrictions as state registration. In some cases, the protected territory may be even narrower, limited only to the area within which the plaintiff can prove consumer recognition of the mark.
Other Intellectual Property Protection. Copyright law, unlike federal trademark law, has no “lawful” commerce requirement, and the U.S. Copyright Office regularly issues registrations for cannabis-related copyrights. While copyright will not protect a short phrase such as a business name, it will protect a creative logo design or original packaging, and can be very effective when it comes to getting infringing uses taken down from the internet. Note also that the USPTO does not appear to have the same qualms about legality when it comes to patents, and it often grants patent protection to useful, new and non-obvious inventions related to the cannabis industry.
Save stuff. Finally, if you do nothing else, save stuff. Document that first sale; keep a copy of that first shipping invoice; and save that file containing your original packaging design. Someday, the USPTO policy may change and there could be a gold rush for federal cannabis trademark registrations. Your lawyer is going to ask you for proof of your first uses of the mark, and you don’t want your response to be a glassy stare. So keep your eyes on the eventual prize and stay ready.
Editor’s Note: The views expressed in this article are the author’s opinions based on his experience working in the laboratory industry. This is an opinion piece in a series of articles designed to highlight the potential problems that clients may run into with labs.
In the last two articles, I discussed the laboratory’s first line of defense (e.g. certification or accreditation) paperwork wall used if a grower, processor or dispensary (user/client) questioned a laboratory result and the conflicts of interest that exist in laboratory culture. Now I will discuss the second line of defense that a laboratory will present to the user in the paperwork wall: Quality Control (QC) results.
Do not be discouraged by the analytical jargon of the next few articles. I suggest that you go immediately to the conclusions to get the meat of this article and then read the rest of it to set you on the path to see the forest for the trees.
QC in a laboratory consists of a series of samples run by the laboratory to determine the accuracy and precision of a specific batch of samples. So, to start off, let’s look at the definitions of accuracy and precision.QC Charts can provide a detailed overview of laboratory performance in a well-run laboratory.
Accuracy: estimate of how close a measured value is to the true value; includes expressions for bias and precision.
Precision: a measure of the degree of agreement among replicate analyses of a sample.
A reputable laboratory will measure the Accuracy and Precision of QC samples in a batch of user samples and record these values in both the analytical test report issued to the user and in control charts kept by the laboratory. These control charts can be reviewed by the user if they are requested by the user. These control charts record:
Accuracy (means) chart: The accuracy chart for QC samples (e.g., LRB, CCV, LFBs, LFMs, and surrogates) is constructed from the average and standard deviation of a specified number of measurements of the analyte of interest.
Precision (range) chart: The precision chart also is constructed from the average and standard deviation of a specified number of measurements (e.g., %RSD or RPD) for replicate of duplicate analyses of the analyte of interest.
Now, let’s look at what should be run in a sample batch for cannabis analyses. The typical cannabis sample would have analyses for cannabinoids, terpenes, microbiological, organic compounds, pesticides and heavy metals.
Each compound listed above would require a specific validated analytical method for the type of matrix being analyzed. Examples of specific matrixes are:
Cannabis buds, leaves, oil
Edibles, such as Chocolates, Baked Goods, Gummies, Candies and Lozenges, etc.
Vaping liquids
Tinctures
Topicals, such as lotions, creams, etc.
Running QC analyses does not guarantee that the user’s specific sample in the batch was analyzed correctly.
Also, both ISO 17025-2005 and ISO 17025-2017 require the use of a validated method.
ISO 17025-2005: When it is necessary to use methods not covered by standard methods, these shall be subject to agreement with the customer and shall include a clear specification of the customer’s requirements and the purpose of the test and/or calibration. The method developed shall have been validated appropriately before use.
ISO 17025-2017: The laboratory shall validate non-standard methods, laboratory-developed methods and standard methods used outside their intended scope or otherwise modified. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application.
The laboratory must have on file for user review the following minimum results in an analytical statistical report validating their method:
accuracy,
limit of quantitation,
ruggedness,
precision,The user must look beyond the QC data provided in their analytical report or laboratory control charts.
linearity (or other calibration model),
confirmation of identity
selectivity,
range,
spike recovery.
limit of detection,
measurement uncertainty,
The interpretation of an analytical statistical report will be discussed in detail in the next article. Once the validated method has been selected for the specific matrix, then a sample batch is prepared for analysis.
Sample Batch: A sample batch is defined as a minimum of one (1) to a maximum of twenty (20) analytical samples run during a normal analyst’s daily shift. A LRB, LFB, LFM, LFMD, and CCV will be run with each sample batch. Failure of any QC sample in sample batch will require a corrective action and may require the sample batch to be reanalyzed. The definitions of the specific QC samples are described later.
The typical sample batch would be set as:
Instrument Start Up
Calibration zero
Calibration Standards, Quadratic
LRB
LFB
Sample used for LFM/LFMD
LFM
LFMD
Samples (First half of batch)
CCV
Samples (Second half of batch)
CCV
The QC samples are defined as:
Calibration Blank: A volume of reagent water acidified with the same acid matrix as in the calibration standards. The calibration blank is a zero standard and is used to calibrate the ammonia analyzer
Continuing Calibration Verification (CCV): A calibration standard, which is analyzed periodically to verify the accuracy of the existing calibration for those analytes.
Calibration Standard: A solution prepared from the dilution of stock standard solutions. These solutions are used to calibrate the instrument response with respect to analyte concentration
Laboratory Fortified Blank (LFB): An aliquot of reagent water or other blank matrix to which known quantities of the method analytes and all the preservation compounds are added. The LFB is processed and analyzed exactly like a sample, and its purpose is to determine whether the methodology is in control, and whether the laboratory is capable of making accurate and precise measurements.
Laboratory Fortified Sample Matrix/Duplicate (LFM/LFMD) also called Matrix Spike/Matrix Spike Duplicate (MS/MSD): An aliquot of an environmental sample to which known quantities of ammonia is added in the laboratory. The LFM is analyzed exactly like a sample, and its purpose is to determine whether the sample matrix contributes bias to the analytical results. The background concentrations of the analytes in the sample matrix must be determined in a separate aliquot and the measured values in the LFM corrected for background concentrations (Section 9.1.3).Laboratories must validate their methods.
Laboratory Reagent Blank (LRB): A volume of reagent water or other blank matrix that is processed exactly as a sample including exposure to all glassware, equipment, solvents and reagents, sample preservatives, surrogates and internal standards that are used in the extraction and analysis batches. The LRB is used to determine if the method analytes or other interferences are present in the laboratory environment, the reagents, or the apparatus.
Once a sample batch is completed, then some of the QC results are provided in the user’s analytical report and all of the QC results should be recorded in the control charts identified in the accuracy and precision section above.
But having created a batch and performing QC sample analyses, the validity of the user’s analytical results is still not guaranteed. Key conclusion points to consider are:
Laboratories must validate their methods.
Running QC analyses does not guarantee that the user’s specific sample in the batch was analyzed correctly.
QC Charts can provide a detailed overview of laboratory performance in a well-run laboratory.
The user must look beyond the QC data provided in their analytical report or laboratory control charts. Areas to look at will be covered in the next few articles in this series.
The Canadian cannabis community has just gotten a new member. Tree of Knowledge, Inc. just became Canada’s newest public cannabis company. The company is also planning on raising $10 million in private placement capital. According to the company’s most current pitch deck, the planned use of proceeds includes $6.5 million for new capex expenditures in Canada and Macedonia plus new product development. The rest is slated for patient and doctor outreach including via social media, new hires and working capital.
Who Is Tree of Knowledge Inc.?
Founded originally in Washington State in 2015, today TOK has a global market presence with CBD products on three continents and is already positioning itself to run with the big boys on the international scene, just on its CBD footprint. In the online marketplace, they are doing business as EVR CBD. That includes state markets in the United States, Europe, South America, Australia and China.
The company also has a distinguished board that includes doctors to former professional sports stars. As of April, the company engaged in a reverse merger with Courtland Capital, a Nevada subsidiary company.
And as of July 2018, the company purchased 5% of NYSK Holdings – a rapidly establishing Macedonian start-up with an eye to the European market – starting with Germany.
Who Is NYSK Holdings?
NYSK Holdings is absolutely on an upward trajectory. The company, founded by Americans with strong ties to the home country along with local partners, broke ground in Skopje, Macedonia last year.
Company principals have been exploring entry into the European market ever since (Macedonia may be in the Balkans, but it is technically not part of the EU). Significantly, this also means that producers there are used to meeting European specs for import purposes, if not hopeful EU inclusion.
Like other EU partners in the west however, (notably Spain and Portugal) labour rates are also much lower than in Germany. This creates a new avenue into the EU and the German market, which is now going to be an import-dominant one until 2020.
What is even more interesting about NYSK? They produce GMP-certified product – both THC and CBD. They have been looking for partners for most of this year. They also had a booth at the ICBC in Berlin, an experience that they found highly satisfactory.
Their strategic importance to TOK is also large. NYSK brings, for the first time, THC products and high-tech processing capacity adjacent to the European Union to a firm with a global footprint.
They might, in other words, have been Europe’s most under-priced production facility. Don’t expect that to last long.
What Is Interesting About The Move
One glance at TOK’s founders, board, andadvisors is enough to establish that this is a company of mostly older Gen X and younger Boomer heavy hitters from other industries who are pooling resources and knowledge to step into a global medical cannabis space. Smartly.
For example, the focus on dosing control, trials and an operational, GMP-certified production facility in Macedonia, plus their Canadian footprint, makes TOK and their partners well suited for “European invasion.” So does their first product – a CBD-based sleep aid.
The cultivation of cannabis at the NYSK facility in Macedonia
This creates, in other words, a company with Canadian and Macedonian production, American entry and global reach, including into countries other cannabis companies have so far not breached (see China), with an interesting, low-cost, lower risk entry profile. Their expanded market entry is also occurring right at a time when Europe, including the about to be Brexited UK, is now moving forward on medical reform sans very much local production.
Perhaps this comes from the experience of the principals. TOK Cofounder Michael Caridi started his involvement in the cannabis industry in Washington State in 2014 after a successful real estate and promotions career on the East Coast (New York) and experience in ex-im. However, Caridi rapidly grew disillusioned with the state’s focus if not an obsessionon a more recreational space than medical users. He and Brian Main, now president of US operations, founded TOK a year later. Current CEO, John-Paul Gaillard, has a history that includes the creator of the Marlboro Classics brand and a stint as the CEO of Nestle Nespresso who put the idea on the map if not kitchen counters globally.
No newbies here when it comes to global market strategies, penetration and experience.
Imagine this: you are taking medication for cancer pain. One day, it works perfectly. The next, you feel no relief. On some days, you need to take three doses just to get the same effect as one. Your doctor can’t be completely positive how much active ingredient each dose contains, so you decide for yourself how much medication to take.
Doesn’t seem safe, right? It is crucial that doctors know exactly what they are prescribing to their patients. They must know that their patients are receiving the exact same dose of medication in their prescription each time they take it, and that their medication contains only the intended ingredients.
consistency is key to creating products that are safe for consumers.In the cannabis industry, lack of certainty on these important factors is a major problem for drug manufacturers as they attempt to incorporate cannabidiol (CBD), a compound found in cannabis that has no psychoactive effects but many medical benefits, into pharmaceutical drugs.
When using these compounds as medications, purity is essential. Cannabis contains a wide variety of compounds. Delta-9 tetrahydrocannabinol (THC) is the most well-known compound and its main psychoactive one1. Safety regulations dictate that consumers know exactly what they are getting when they take a medication. For example, their CBD-based medications should not contain traces of THC.
The cannabis industry greatly needs a tool to ensure the consistent extraction and isolation of compounds. In 2017, the cannabis industry was worth nearly $10 billion, and it is expected to grow $57 billion more in the next decade2. As legalization of medical cannabis expands, interest in CBD pharmaceuticals is likely to grow.
If compounds such as CBD are going to be used in pharmaceutical drugs, consistency is key to creating products that are safe for consumers.
CBD’s Potential
CBD is a non-psychoactive compound that makes up 40 percent of cannabis extracts1. It is great for medical applications because it does not interfere with motor or psychological function. Researchers have found it particularly effective for managing cancer pain, spasticity in multiple sclerosis, and specific forms of epilepsy3.
Figure 1: The chemical structure of cannabidiol.
Other compounds derived from cannabis, such as cannabichromene (CBC) and cannabigerol (CBG), may also be beneficial compounds with medical applications. CBC is known to block pain and inflammation, and CBG is known for its use as a potential anti-cancer agent1.
Along with these compounds that provide medical benefits, there are psychoactive compounds that are used recreationally, such as THC.
“It will definitely be an advantage to have cannabis-based medications with clearly defined and constant contents of cannabinoids,” says Kirsten Müller-Vahl, a neurologist and psychiatrist at Hannover Medical School in Germany.
Creating a Standard Through Centrifugal Partition Chromatography
To obtain purified compounds from cannabis, researchers need to use technology that will extract the compounds from the plant.
Many manufacturers use some sort of chromatography technique to isolate compounds. Two popular methods are high performance liquid chromatography (HPLC) and flash chromatography. These methods have their places in the field, but they cannot be effectively and cost-efficiently scaled to isolate compounds. Instead, HPLC and flash chromatography may be better suited as analytical tools for studying the characteristics of the plant or extract. As cannabis has more than 400 chemical entities4, compound isolation is an important application.
This method is highly effective for achieving both high purity and recovery.Although molecules such as CBD can be synthesized in the lab, many companies would rather extract the compounds directly from the plant. Synthesized molecules do not result in a completely pure compound. The result, “is still a mixture of whatever cannabinoids are coming from a particular marijuana strain, which is highly variable,” says Brian Reid, chief scientific officer of ebbu, a company in Colorado that specializes in cannabis purification.
Currently, there is only one method available to researchers that completely allows them to isolate individual compounds: centrifugal partition chromatography (CPC).
The principle of CPC is similar to other liquid chromatography methods. It separates the chemical substances as the compounds in the mobile phase flow through and differentially interact with the stationary phase.
Where CPC and standard liquid chromatography differs is the nature of the stationary phase. In traditional chromatography methods, the stationary phase is made of silica or other solid particles, and the mobile phase is made of liquid. During CPC, the stationary phase is a liquid that is spun around or centrifuged to stay in place while the other liquid (mobile phase) moves through the disc. The two liquid phases, like oil and water, don’t mix. This method is highly effective for achieving both high purity and recovery. Chemists can isolate chemical components at 99 percent or higher purity with a 95 percent recovery rate5.
“CPC is ideal for ripping a single active ingredient out of a pretty complex mixture,” says Reid. “It’s the only chromatographic technique that does that well.”
The Need for Pure Compounds
High levels of purity and isolation are necessary for cannabis to be of true value in the pharmaceutical industry. Imagine relying on a medication to decrease your seizures, and it has a different effect every time. Sometimes there may be traces of psychoactive compounds. Sometimes there are too much or too little of the compound that halts your seizures. This is not a safe practice for consumers who rely on medications.“It’s hard to do studies on things you can’t control very well.”
Researchers working with cannabis desperately need a technology that can extract compounds with high purity rates. It is hard to run a study without knowing the precise amounts of compounds used. Reid uses a Gilson CPC 1000 system at ebbu for his cannabinoid research. With this technology, he can purify cannabinoids for his research and create reliable formulations. “Now that we have this methodology dialed in we can make various formulations —whether they’re water-soluble, sublingual, inhaled, you name it —with very precise ratios of cannabinoids and precise amounts of cannabinoids at the milligram level,” says Reid.
Kyle Geary, an internist at the University of Illinois at Chicago, is currently running a placebo-controlled trial of CBD capsules for Crohn’s disease. This consistent isolation is helpful for his research, as well. “Ideally, the perfect study would use something that is 100 percent CBD,” says Geary. “It’s hard to do studies on things you can’t control very well.”
The State of the Industry
While CBD is not considered a safe drug compound under federal law in the United States6, 17 states have recently passed laws that allow people to consume CBD for medical reasons7. Half of medicinal CBD users solely use the substance for treatment, a recent survey found8. As the industry quickly grows, it is crucial that consumer safety protocol keeps pace.
In June, the US Food and Drug Administration (FDA) approved the first drug that contains a purified drug substance from cannabis, Epidiolex9. Made from CBD, it is designed to treat Dravet Syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy. FDA Commissioner Scott Gottlieb said in the news release that although the FDA will work to support the development of high-quality cannabis-based products moving forward, “We are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
The industry should be prepared to implement protocols to ensure the quality of their CBD-based products. The FDA has issued warnings in recent years that some cannabinoid products it has tested do not contain the CBD levels their makers claim, and consumers should be wary of such products10. It’s hard to know when or if the FDA will begin regulating CBD-based pharmaceuticals. However, for pharma companies serious about their reputation, there is only one isolation method that creates reliable product quality: CPC.
National Institute on Drug Abuse. (2015, June 24). The Biology and Potential Therapeutic Effects of Cannabidiol. Retrieved from https://www.drugabuse.gov/about-nida/legislative-activities/testimony-to-congress/2016/biology-potential-therapeutic-effects-cannabidiol
Atakan, Z. (2012). Cannabis, a complex plant: Different compounds and different effects on individuals. Therapeutic Advances in Psychopharmacology,2(6), 241-254. doi:10.1177/2045125312457586
Gilson. (n.d.). Centrifugal Partition Chromatography (CPC) Systems. Retrieved from http://www.gilson.com/en/AI/Products/80.320#.WzVB2lMvyMI
Mead, A. (2017). The legal status of cannabis (marijuana) and cannabidiol (CBD) under US law. Epilepsy & Behavior, 70, 288-291.
ProCon.org. (2018, May 8). 17 States with Laws Specifically about Legal Cannabidiol (CBD) – Medical Marijuana – ProCon.org. Retrieved from https://medicalmarijuana.procon.org/view.resource.php?resourceID=006473
Borchardt, D. (2017, August 03). Survey: Nearly Half Of People Who Use Cannabidiol Products Stop Taking Traditional Medicines. Retrieved from https://www.forbes.com/sites/debraborchardt/2017/08/02/people-who-use-cannabis-cbd-products-stop-taking-traditional-medicines/#43889c942817
U.S. Food & Drug Administration. (2017). Public Health Focus – Warning Letters and Test Results for Cannabidiol-Related Products. Retrieved from https://www.fda.gov/newsevents/publichealthfocus/ucm484109.htm
According to Kermit the Frog, it’s never easy being green. It is also tough to be “first” in the cannabis biz. Anywhere.
One of the most remarkable features of the first years of state-level legalization in the U.S. was the sheer number of mistakes by the authorities in issuing licenses and bids for state-sanctioned cultivation and dispensation once the voters had forced legalization. There were several state-level “redos” and lots of legal mumbo jumbo thrown around as the green-rush kicked off at the state level.The real news? There is going to be a completely new one.
Fast-forward a couple of years and it is clear this is not just an issue of the confused state of legalization in the U.S.
Canada too, on a federal recreational level, has moved forward in fits and starts. And even though a fall start date to the market has now been enshrined into law, the continued moving target of the same has been a topic of fraught conversations and bargaining ever since the country decided to move ahead with full Monty recreational.
Across the pond, things are not going smoothly on the cannabis front. In the first week of July, the much stalled medical cultivation bid in Germany finally came to a limpid end. It remains to see if there will be any legal “bangs” as it whimpers away.
The real news? There is going to be a completely new one.
A Do-Over
According to documents obtained by Cannabis Industry Journal, the Bundesinstitut für Arzneimittel und Medizinprodukte (or BfArM) issued letters to original bid respondents in the first week of July. The letters appear to have been sent to all parties who originally applied to the first bid – far from the final top runners.
The translation, from German reads:
“We hereby inform you that we have withdrawn the above-mentioned award procedure…and intend to initiate a new award in a timely manner.”
The letter cited the legal decision of March 28 this year by the Düsseldorf Higher Regional Court as the reason the agency cannot award the contract. Specifically, because of “necessary changes to the tender documents…inparticular with regard to time, we have decided to cancel the procedure altogether and initiate a new award procedure.”
Per the letter, the new procedure will be published in the Official Journal of the EU. No date was mentioned.
An Expensive Surprise and a Global Response
Conventional wisdom in the industry about the fate of the first bid has been mixed since last September when the first hint of lawsuits against the procedure began to circulate. Highly placed sources within the industry have long had their doubts about the bid’s survivability, although nobody will talk on the record. The bid process is supposed to be secret.However, it is clear that another bid will be issued
Furthermore, for the last 9 months, BfArM has maintained that the agency would go full-steam ahead with the original tender. None of the major firms contacted by CIJ about this notification would confirm that they had received a similar letter, nor would they comment.
However, it is clear that another bid will be issued. Further, this time, it is also obvious to the extent that it was not before, the applicants will indeed hail from all points of the globe. On top of that, those who are qualified to respond and who missed it last time are unlikely to sit the bid out this time around.
German Parliament Building
It remains unclear of course, what the response of the finalists to the first bid will be. Including, theoretically,legal action forpotential damages. BfArM was, technically, held at fault by the court. This means that all the companies who made it to the previous “final round” have now suffered at a minimum, an expensive time delay where other outlays of cash were also required. That includes the leasing and retrofitting of high security real estate, but of course,is not limited to the same. If any of these firms do not obtain the bid in the second go around, will they sue?
At press time, there were no cannabis industry companies willing to comment on the matter as this is still a “secret” process – even if it now apparently has come to an end for this round.
Who Is Likely To Be a Major Contender This Time?
German firms who were sleeping the last time this opportunity arose (or brushed it off as a “stigmatized” opportunity) are not likely to sit the second tender offer out. Especially given advancements in legalization if not the industry both in Europe and globally in the period of time the bid has stalled.
Add to that Canadians, Dutch, Israeli and Uruguayan firms, and the mix of applicants this time is likely to be the who’s who of the global cannabis industry. Americans are still not qualified to participate (with experience at least). Why? No federal reform.Domestic cannabis will not be harvested in Germany until at least 2020.
It is also likely to be even more expensive. Not to mention require easy and quick access to European-based or at least easily confirmable pools of cash. It is conceivable that successful applications this time around will not only have to prove that they have a track record in a federally legal jurisdiction but will also have to be able to quickly access as much as 100 million euros. And there are not many cannabis companies, yet, who can do that, outside of the presumed top 10 finalists to the bid.
Will Bid Respondents Be Limited To “Just” the Cannabis Industry?
It is, however, absolutely possible that this time around the bid could include a more established pharmaceutical player or two who realizes that the medical market here has absolutely proved itself. Within the space of a year, according to the most recent “market report” on the industry (from the perspective of one of the country’s largest statutory insurance companies – Techniker Krankenkasse), there are now just over 15,000 patients.
Cannabis, in other words, is no longer an “orphan drug.” It is also still, however, considered a narcotic. For that reason, seasoned European and German players may upset the market even more with an entry via this tender bid.
Here is what is certain for now. Domestic cannabis will not be harvested in Germany until at least 2020. And until that time, it will be a growing, but import-based market.
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Through the Lambert Center for the Study of Medicinal Cannabis and Hemp, Jefferson is the first major university in the US to provide a comprehensive academic resource for the medicinal, medical and industrial applications and business of cannabis and hemp. The Lambert Center, the first of its kind in academia, provides “expert-developed, unbiased information to clinicians and patients about medical cannabis and cannabinoid-based therapies,” according to their website. They want to “support the development of entrepreneurial and socially responsible business and clinical approaches within the emerging medical cannabis industry and explore and develop new ways to use hemp in medical, industrial, and consumer products,” reads the website.
