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Cannabinoid Research & Pharmacology: A Q&A with Dr. Linda Klumpers

By Cannabis Industry Journal Staff
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Dr. Linda Klumpers has a Ph.D. in clinical pharmacology of cannabinoids. Originally from the Netherlands, she began much of her career in studying cannabis there. She now lives and works in the United States, where she has worked on a number of projects, started her own company and is continuing her research on cannabis as an effective medicine.

After studying neuroscience at the University of Amsterdam, she went on to train at the Centre for Human Drug Research and Leiden University Medical Center, where Dr. Klumpers obtained a clinical pharmacology degree and a Ph.D. in clinical pharmacology of cannabinoids. She has been researching cannabinoids in humans since 2006. Dr. Klumpers co-authored a number of peer-reviewed cannabinoid publications and she has received five honors and awards for her work, including the BJCP Prize from the British Journal of Clinical Pharmacology.

Dr. Linda Klumpers

In 2016, she moved to the United States and founded Cannify, an online tool that helps patients and clinicians with product matching and providing legitimate cannabis education based in sound science. In 2018, Dr. Klumpers joined forces with Dr. Michael Tagen, another clinical pharmacologist, to launch Verdient Science, a consulting partnership. Their work at Verdient Science includes helping clients set up human studies, advise on FDA submissions, creating course materials, adjusting product pipelines and product development strategies, among other areas of focus.

Right now, Dr. Klumpers is waiting to hear back from a grant application they submitted to study THC and CBD ratios for medical efficacy in chronic pain patients. We sat down with Dr. Klumpers to hear her story, what she is working on now and how she hopes to continue researching cannabis as an effective medicine.

Cannabis Industry Journal: Tell us about your background as a research scientist. How did you get involved in cannabis? 

Dr. Linda Klumpers: During my Ph.D. work, we studied the effects of so-called cannabinoid receptor antagonists that block the effects of THC – I prefer to say “we”, as research is always done by multiple people. The problem with studying these compounds in healthy volunteers is that you can’t observe acute effects, which means that you won’t measure any effect after a single dose. To circumvent this issue, we applied a trick and developed a ‘challenge test’: after you give the ‘invisible’ blocking compound, you stimulate the cannabinoid system by giving people THC. If the subjects don’t feel the effects of THC, you know that the blocker worked. One thing lead to another and we ended up studying various administration methods, such as intrapulmonal (via the lungs) with vaporization, oral and sublingual. We studied the behavior of cannabinoids in the body and how the body responded to them.

CIJ: Can you share some information on the projects you are working on? What is Cannify and what is Verdient Science?  

Dr. Klumpers: Cannify was founded in 2016 after I saw that too many people had opinions about cannabis that were more based on emotion than fact. Besides, I noticed that a majority of the scientific literature on cannabis pharmacology was left unnoticed and unapplied to the people getting exposed to cannabis, such as patients, the cannabis industry – that was in a very different stage at that time – healthcare providers and regulators. With my Ph.D. in cannabis pharmacology, I wanted to add a level of objectivity to cannabis education and research. Cannify’s goals are to understand the science of cannabis, and share this with others.

The way we do this is multi-fold:

  1. Cannify Quiz: Patients with an interest in cannabis often want to know the science about cannabis and their condition. Our quiz helps these people by asking in-depth questions and showing them relevant scientific literature in a personalized report. After that, an overview is given with products and product matching scores. Our account system allows users to track their progress over time. Product manufacturers, dispensaries and other companies can use the quiz for their websites and their stores to help out retail employees and save them time, and to receive insight with our analytics on customer desires and behavior. Needless to say, an educated customer is a better customer. It is important that customers come and leave stores well-informed.
  2. Education: Speaking of education, our website contains educational articles about everything cannabis: from plant to patient and from product to mechanism of action. We regularly publish educational quizzes for people to test their knowledge level. With a free Cannify account, you can find all of our educational quizzes and save your results. We also provide customized courses, and have educated a wide audience varying from industry professionals to CME-accredited courses for healthcare providers. On top of that, our educational videos in dispensaries (in collaboration with our partner, Enlighten) reach customers and retail employees.
  3. One of Cannify’s educational graphics, showing the difference between topical and transdermal product administration

    Research: To expand the knowledge on cannabis, performing and especially sharing research is essential. We have already performed and published some of Cannify’s results on descriptive statistics and effect prediction during conferences, as well as a review paper on cannabis therapeutics in a peer-reviewed journal and a book chapter. This year, we expect to co-publish the results of a survey in different sleep patient groups. We collaborated with the Centre of Excellence for Epilepsy and Sleep Medicine in the Netherlands on a peer-reviewed paper from which we expect new research to follow to benefit these patients. We have also co-submitted a grant to study THC and CBD ratios in chronic pain patients: fingers crossed! Another important next step is to test a healthcare provider-specific version of Cannify’s quiz in the clinic once COVID dies down. I want to add that after working in a clinical lab for many years, it is important to combine the results of clinical trials to what people do in real life, which is what we do with Cannify.

And here’s some information on Verdient Science:

Verdient Science is a consulting partnership I have with clinical pharmacologist Dr. Michael Tagen. We provide clinical and translational pharmacology expertise to improve the quality of product development & clinical testing. While both working as independent consultants, we decided from 2018 to start working together to offer better services. Since then, our work has been very variable and includes helping clients set up human studies, advise on FDA submissions, creating course materials, adjusting product pipelines and product development strategies to make them more efficient and cheaper, performed scientific due diligence and much more. When clients want additional services that are beyond our expertise, we are typically able to introduce them to various people per expertise area, or refer them to our partner companies, Complex Biotech Discovery Ventures (CBDV) with Dr. Markus Roggen, and Via Innovations with Dr. Monica Vialpando. A benefit of working with the same partners includes smooth handovers and the feeling of a one stop shop.

CIJ: How does Cannify match available products to consumer needs? Is there an algorithm you developed that matches moods or feelings to cannabinoids or chemical profiles?

Dr. Klumpers: That is a great question and the core of what we do! So back to the Cannify quiz: there are three steps:

  1. Users fill in questions;
  2. A personalized report is generated with the relevant science;
  3. The user gets a product overview with product matching scores.
Another Cannify educational graphic, showing THC distribution throughout the body over time

The report and the matching scores are generated using algorithms that are regularly updated. These algorithms are based on various data sources:

  1. Literature: There is a lot of available literature, and we make sure to select the most relevant and reliable studies;
  2. Raw data: There is only so much one can find in the literature, and lots is hidden in the raw data. Therefore, we piled up data from studies done at various research institutions, including the University of Kentucky and Johns Hopkins University, and used them in our algorithms;
  3. Internal studies: From the thousands of users filling in their results, there is a lot of information that we should learn from. This feedback loop helps us to better understand how the lab relates to real life situations.

CIJ: The world of cannabis research has been historically stymied by red tape, DEA interference and a host of federal regulations. How have you managed to work through all that? Do you have a DEA license? What did it take to get it? 

Dr. Klumpers: Luckily, a majority of our research was and is done outside of the US. You still need to obtain the appropriate licenses, but I was perhaps lucky to have filled in every form very thoroughly and we got the licenses within months. The process is quite meticulous, as you need separate licenses for almost every step from manufacturing to administration. An additional complication is that our cannabis is not stored in our own building, but in the hospital pharmacy across the street, involving transport via the public road. Despite the roadblocks, including a legal procedure about this matter that was going on in parallel, I had no major issues getting our work done. For our research in the US, we were lucky to have been working with partners that already have the required license.

Also with publishing, I have never had an issue with the cannabis stigma. Generally, in my field of science, good quality science is very much welcomed and appreciated, and this was even before the time that there were four different cannabis-related journals, as is the case nowadays.

CIJ: Looking to the future, where do you hope to focus your research efforts? Where do you think the cannabis community should be focusing their efforts in the next 5-10 years?

Dr. Klumpers: Besides continuing to analyze the data generated from Cannify, I keep my fingers crossed for the grant application I mentioned earlier on THC and CBD ratios in chronic pain patients. Although we know that CBD is able to influence THC-induced effects, it is not known at what dosages, which ratios and how the effects are related to each other. For example: is CBD able to decrease certain side-effects of THC without decreasing pain-relieving effects?

Whatever is done, wherever in the community: good quality data are keyNext to that, I am also interested in other neurological and psychiatric disorders, and, of course, my Ph.D. love: the cannabinoid antagonists. Sadly, all the research efforts on this compound group were halted more than a decade ago. However, there is a renewed interest. I would love to help turn these compounds into effective and safe medicines.

Regarding the cannabis community: 5-10 years sounds really far away for an industry that is relatively new to many, but a lot has already changed since I started cannabis research more than 14 years ago and time has flown by. Some changes have been positive and others less so. Whatever is done, wherever in the community: good quality data are key. Many companies gather data and even publish them in peer-reviewed journals, but that does not always mean that the data are useful or that the studies were done well. Only a few minor changes to how and which data are gathered, and so much more can be done. What can help with achieving this is to let the right people do the right thing: many call themselves a ‘cannabis scientist’ or ‘cannabis expert’, but that does not mean anything. What has someone truly achieved and what is their exact expertise? A Ph.D. in chemistry is not going to help you in setting up effect studies, neither will I be able to improve your product’s shelf life or extraction yield. Getting the right people in the right place is key. Lastly: the cannabis community should stay critical. The length of one article in Cannabis Industry Journal wouldn’t be enough to lay out all the misconceptions that people have about cannabis. Make sure that those misconceptions do not live on and do not be afraid to admit you don’t know something, irrespective of the branch you work in: only then, can the cannabis community progress to the benefit of all.

Why Employee Training is Your Key to Financial Success

By Shannon Tipton
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So, there you are, pondering your finances, there are many expenses and costs that go into running your business and when your budget is already tight, should you add or increase training to the expense list? Why frustrate yourself, looking for ways to train people, when you could be focusing on things like technology, product development or sales that help with business growth?

We all know that product development and sales are important. But what differentiates training from other expenses is that while on the surface training might appear as an expense, it’s not.

Think about this analogy: We know one achieves a greater plant quality and yield by using advanced cultivation practices. That said, the quality of the plants also greatly depends on the lighting, the nutrients and the nurturing they receive. The training and development of your people depends on the quality of effort you give them. Therefore, it is not so much a cost as it is an investment in the growth of your people, and when your people grow, you experience business growth.

Why invest in continual training?

The answer as to why continual training is important can be summed up in four points:

  1. Well trained employees = happy and loyal employees.
  2. Happy employees = educated and happy customers.
  3. Happy and educated customers = customer loyalty.
  4. Customer loyalty = increased business revenue

Any break in the chain breaks the relationship with the customer. There isn’t any business right now that can afford to lose a customer over something as intuitive as keeping people knowledgeable and happy.

This approach does, however, come with a caveat. Your training needs to be amazing and it needs to stick. You need to be willing to give your people the tools they need to succeed, and amazing training doesn’t come with a low-price tag. It requires not only a monetary investment but the investment of time and energy of the entire team.

Consider this, according to a Gallop research paper, happy and well-trained employees increase their value, and dedicated training and development fosters employee engagement, and engagement is critical to your company’s financial performance.

In short, this means your happy people will be earners for you. They will help you exceed industry standards, sell more and hang around longer. This means lower turnover costs.

Who doesn’t want that?

Educated and loyal employees lead to increased financial results

According to another Gallup study, businesses that engaged workgroups in continual development saw sales increase and profits double compared to workgroups that weren’t provided with development opportunities. The pressure to succeed among competitors of the cannabis industry is intense and rewards high. Having a good product is a start, but if your customer does not trust you or your employees…then what?

You can have the best product in the world, but if you can’t sell it, you still have it.

Can your business survive without trained people and loyal customers? The growth rate for legalized cannabis will be $73.6 billion with a CAGR of 18.1% by 2027. Plus, total sales of illicit cannabis nationwide were worth an estimated $64.3 billion in 2018, projections call for the U.S. illicit market to reduce by nearly $7 billion (11%) by 2025.

Those customers are going somewhere, will they be coming to you? Are you and your people prepared to earn potential customer trust and build critical relationships? Can you afford to miss being a part of this growth because your people were not carefully trained and your customers were uninformed about you, your product and your services?

A common adage is, “What if I train them and they leave? What if you don’t and they stay?” – where does your business stand?

Time for non-traditional approaches for high-impact training

With the rapid growth of the industry with ever changing regulations, new types of edibles, better product with exponentially more options – your customers will demand higher quality standards and expect your people to be in-the-know. This requires “just-in-time” knowledge as opposed to formalized training delivery.

Disappointingly, only 34% of businesses feel their overall training is effective. So, as the industry continues to evolve, it is important to know how to make your programs as effective as possible for your people. The traditional training that has failed corporate America is not the answer for this non-traditional cannabis industry. The need for new and non-traditional training methods will be critical for your people to be efficient, productive and adaptable to react to fluctuating business needs.

Six areas to focus your non-traditional training

1) Build a strategy

As the gap begins to widen and the competitive “cream of the crop” starts rising to the top, you will need to take the initiative in training and upskilling employees. This means planning future training efforts and reimagining current ones.

The steps involved in creating a training plan begins with establishing business goals. Ask yourself what business factors and objectives you hope to impact through training? You will also need to decide what critical skills are needed to move the business forward. Start your training focus with high-impact skills. These are the skills, if mastered, that will lead to customer loyalty and education. Ultimately impacting your bottom-line.

2) Target skills that build relationships

Building relationships is often placed in the category of, “soft skills.” However, this is a misnomer; “soft-skills” are core strengths you will need for your business to stand apart from your competition. This goes beyond smiling at the customer. Your business requires adaptable, critical thinkers who can problem solve and communicate effectively. Soft skill training is never “finished.” Therefore, consider how reinforcement is going to be delivered and how coaching will evolve.

3) Personalize training to individuals

Many traditional training programs approach people with a “one size fits all” mentality. Just put all the people in all the classes. This is a common failed approach. Each person on your team has individual skills and needs that require attention. This means creating and planning the delivery of training programs to address specific strengths and skills challenges. Not everyone will be at the same level of knowledge. If you are hiring for culture (which you should) rather than specific skills this means providing ongoing support at different times. This requires developing a training plan that allows people to choose their training path.

4) Create digital learning spaces

Ensuring employees make time for learning was the number one challenge talent development teams faced in 2018. One way to combat this challenge is putting training in the hands of people through platforms they are already using. Most notably, their cell phones and mobile applications.

Training should be created and delivered through multiple platforms (mobile and on-demand), where the training can be personalized, and offer ongoing job support. For example: Consider training to be delivered through mobile apps, text messaging or instant messenger. This type of training is targeted, direct, can be tracked and supports “just-in-time” delivery of help. Help when the people need it and when the business needs them to have it.

5) Make training interesting through gamification

There is a general misunderstanding about how gamification and training programs work. Many business owners discard the idea of gamification because they believe it means turning training programs into video games. Understandably, owners do not want critical and regulatory compliance training to be like a game of Candy Crush. What is important to realize is that gamification is a process of building a reward system into training that imitateschallenge games. Allowing people to “level-up” based on skill or knowledge acquisition. The use of badges, points and leaderboards encourage participation in online experiences. Thus, making training interesting and more successful.

6) Plan to educate your customers

As stated, providing customer training around your products or services is a fantastic way to differentiate yourself from competitors. It also boosts customer engagement, loyalty and enables them to gain more value from you.

Customer training is now considered a strategic necessity for businesses in every industry and within the cannabis industry, education programs will play a critical role in attracting new customers. Although, keep in mind your new customers do not need “training.” They need educational awareness. Consider the education you are providing customers as an onboarding process. Thoughtfully designed educational content can help customers make the right decisions for them, and you are there every step of the way.

Choose a different path for your training efforts

Your business needs a non-traditional training plan to help your people to be better, smarter, faster than your competitors and to gain customer trust and loyalty. Cannabis is a non-traditional industry, why box your business into traditional corporate training models proven to be unsuccessful? Your business and your people deserve better.

Contact Learning Rebels to learn more about what we can do for you to help you develop training tools and resources that will make your people stand above the rest.

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Destination Cannabis Europe: Employment in the Industry

By Marguerite Arnold
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It is obviously not just at conferences but now on the ground in Germany and across Europe that Americans are heading to the industry here. And it is not just the “new” cultivation guys at Demecan in Berlin (currently hiring), or in Guernsey, but in truth, throughout the industry.

Wish you were here? Here is the broad skinny to actually getting (and keeping) a job in the industry in Europe.

Get A Job Before You Come

By far, the easiest and safest way to come to a new country, like Germany (or the UK for that matter) is to have pre-arranged employment. That is also beginning to happen, as large companies set up grow and manufacturing facilities throughout Europe. That said, these are hard to come by (there are many Germans and other natives vying for the same jobs). However so far, certain kinds of experience in the U.S. (or Canada) beats anything that has gotten going here so far from the cultivation side and many other aspects of the biz.

But – and this is a big one – you have to have the kind of experience that counts. Regulated industry participation is a must on your CV if this is your preferred route of travel. Pharmacists in particular, could have a fascinating career path here not open in the United States at all yet. So will doctors – but that certification has to be earned here to practice.

It is also far easier to deal with the paperwork that is required than it used to be ironically – in that there are new qualifications being set out for the same in both the UK and Germany at the moment. Understanding them, however is another matter, and interpretation at the immigration office is not something you want to sign yourself up for. In any language.

european union states
Member states of the EU, pre-Brexit

However, immigration law is just the beginning on the regulation front. Regulations across the cannabis industry are also changing fast – and not just under the heading “cannabis.”

Nothing, really is “easy” about being an expat. You have to want to do this.

There are now starting to be numerous European job postings in the industry on Linked In. It is a great place to start. Having B1 Deutsch (third level, very hard to pass, intensive German language certification) is usually a must for employment (not to mention getting around in the country).

Disclosure: This journalist failed A1 German in Germany (introductory level) twice. Starting from scratch is not recommended, because the rest of your class (usually with previous German training) will kick your butt in numbers bingo by the end of the first week. Learning – including punctuation and spelling 50 new vocabulary words a week is pretty standard. And that is before the grammar. All taught in German too! Four hours a day, five days a week.

Yes, your class will laugh at you, even if they think you are otherwise cool as a North American.

It also helps if you have taken at least one German language course (as in college semester level) before you come. Otherwise you will hit unbelievably intimidating compound words that take up a great deal of space on a page and four different tenses that even native Germans do not really understand by the end of the second week (and it is mind-blowing). You learn to appreciate Mark Twain’s humour about the dratted language very quickly, not to mention that the umlaut is really the only thing you have any freedom of expression with.

Be prepared to sign up for language courses when you land with the local VHS (Volkshochschule) – which is sort of like German community college for anything you want to take classes in. It is also the cheapest deal on language courses around. The private ones are pricey.

That said, master the lingo, even passably, and Germans are super pleased about the same. No matter how badly you mangle the language, they are just happy to hear you try.

Student Visas and the Educational Path

By far, the easiest path to starting your journey overseas, is luck. The second one however, is actually one way to go if you are prepared to work yourself to the bone, and do it while learning German intensively. Plus get a university level or graduate degree along the way.

If Cannabis Europe is your dream job and vocation, you will make it happen. Just don’t expect it to be easy, or just like anywhere else.Go first as a language student. That gets you two years, fairly easily, as long as you have €8k in your bank account at all times, and do not work at a German job. That is verboten. However, as an American, particularly in Germany, you still have the right to come here and learn.

There is also about to be a fairly ground-breaking immigration law that comes into effect as of March in Germany that allows highly skilled foreigners to earn their way to citizenship. There is a list of requirements that go along with this, of course. The path to being able to stay includes getting a higher German degree or special German training. Expect pretty much the same thing from post-Brexit Britain too – just in the same language.

You also have to have health insurance and a lot of other things taken care of. It is not a sudden move or jump. For all the amazing things that come with this, also be prepared to think about looking in the mirror at least a few times and thinking “am I stupid, what on earth have I done?”

Then there is location. A Kreuzburg address may impress the folks back home, but those are not cheap these days, and extremely hard to come by. Rent, in general, and not just in Berlin, is beginning to be a real issue in every German city. Finding an accommodation that you can afford in “starting out” circumstances – is not easy right now anywhere.

But it’s not just about rent or the buzz you might have heard. Don’t just put Berlin on the map (or even Munich, also a growing professional scene). Both cities are far from the center of the cannabis scene in Europe, much less Germany although there is a lot going on all the time there. Dortmund, and the Ruhrgebeit in the former “Rust Belt” of Germany are much cheaper, full of students, and popping with cannabis reform all over. Cologne is also a very interesting city right now. So are Bremen and Stuttgart.

The Differences Are Large Besides the Language

No matter what you think you can expect, the only thing you can rely on is that just about everything will not be the same. Yes, German beer fests and bratwurst are comfortingly familiar to be accepted easily. But when it comes to really immersing yourself in a country well enough to think of it as “home”, let alone understanding the vagaries of this business in particular? Just about everything is different. This ain’t Kansas, (or Colorado, for that matter) Dorothy.

Bottom line? If Cannabis Europe is your dream job and vocation, you will make it happen. Just don’t expect it to be easy, or just like anywhere else.

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The Face Of Cannabis Education In Europe

By Marguerite Arnold
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margueriteICBC

More than a few cannabis “education companies” – mostly from Canada and the U.S. but some with Israeli ties, plus German and British efforts have targeted Europe as the next logical expansion plan in their global roadmap.

These include most recently Cannvas Medtech Inc., and several initiatives funded by Canopy Growth, including teaching children about the drug. It also includes training programs for frontline staff, launched by Organigram (although in this case it appears to be geared towards “brand education.”)

There are also doctor training programs launching in the UK.

In Germany, there are several efforts underway, helmed by both doctors and cannabis advocates generally, in several cities around the country.

But how effective is all of this “education” in both preventing illegal use, and promoting legitimate sales?

Particularly if such “education” platforms are exported from a foreign market for use in Europe?Canopy_Growth_Corporation_logo

Education Is Desperately Needed, But So Is Channel Penetration

Nobody is arguing that “education,” as well as trials and more information for payers and doctors are not required. The problem is that some education is more effective than other campaigns. And most of the talk in most places is more a discussion of the need for further regulatory reform, more trials and more investigation.

That has to get paid for somewhere.

That, at least in Europe is also tricky, as both early educational movers Weedmaps and Leafly have both found out, especially in medical only markets in the EU. Why? There are also highly limited opportunities for advertising either a drug, or to doctors.

Different Regulatory Environments Cause Bigger Issues

Even in Canada and the United States, there is an ecosystem of supplying the demand that has very much grown up customized by the strange paths to reform if not the first mover discussion.

That is not going to be the case in Europe, which in effect creates a brand-new ecosystem to educate, with new players, and every ecosystem participant group has a different kind of educational needs.

Here is one example of where this shows up. So far, in most countries, doctors are still highly resistant to prescribing the drug. Nurses, on the other hand, in both the United States and Canada at least, have proven to be a much more reliable source of converts for the cannabis cause. That approach of course is not possible in places like Germany where only doctors may issue prescriptions, including of the cannabis (and narcotic) kind.

european union statesAccess issues also play a big role in just about every country- from cost to privacy. And on the privacy front, it is not just foreigners who are getting used to new rules. So are German doctors.

The pharmacy discussion is also very much in the room – and this is not “just like” approaching a “dispensary” from North America. They are regulated chemists. Which causes a whole new set of issues and a serious need for new kinds of educational materials.

In Germany, for example, pharmacists are being recruited and trained by not only staff recruiters specializing in the same, but also sent on special training courses funded by the big Canadian companies (Tilray being the noticeable one recently). The brick and mortar vs. online discussion is also a big topic across Europe. Notably, where it is allowed and where it is, as in Deutschland, verboten.

And, of course, the big green giant in the room everywhere in Europe, in particular, is payer/insurance approvals, which are based on a kind of education called proven medical efficacy.

And that, so far, is in markedly short supply.

In the UK, it is so far the main reason that NHS patients (for example) cannot access coverage for the drug to treat conditions like chronic pain.

In the meantime, the most widespread “education” that is going on, is still mostly at the patient level. Especially when patients sue their insurers, or lobby doctors to prescribe.

The cannabis industry may be maturing, in other words, to be able to answer these questions – but there is also clearly a long way to go.

Spotlight on AOAC: New Leadership, New Initiatives In Cannabis & Food

By Aaron G. Biros
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AOAC INTERNATIONAL is an independent, third party, not-for-profit association and voluntary consensus standards developing organization. Founded in 1884, AOAC INTERNATIONAL was originally coined the Association of Official Agricultural Chemists. Later on, they changed their name to the Association of Official Analytical Chemists. Now that their members include microbiologists, food scientists as well as chemists, the organization officially changed its name to just AOAC INTERNATIONAL.

Much of AOAC’s work surrounds promoting food safety, food security and public health. Their work generally encompasses setting scientific standards for testing methodology, evaluating and adopting test methods and evaluating laboratory proficiency of test methods. The organization provides a forum for scientists to develop microbiological and chemical standards.

In December of 2018, they appointed Dr. Palmer Orlandi as deputy executive director and chief science officer. Dr. Orlandi has an extensive background at the U.S. Food and Drug Administration (FDA), serving the regulatory agency for more than 20 years. Most recently, he was the CSO and research director in the Office of Food and Veterinary Medicine at the FDA. He earned the rank of Rear Admiral and Assistant Surgeon General in 2017.

Dr. Palmer Orlandi is the new Deputy Executive Director and Chief Science Officer at AOAC.

Where It All Began With Cannabis

As recently as three years ago, AOAC began getting involved in the cannabis laboratory testing community, with a working group dedicated to developing standard method performance requirements for AOAC Official MethodsSM for cannabis testing. We sat down with Dr. Palmer Orlandi and a number of AOAC’s leaders to get an update on their progress working with cannabis testing as well as food security and food fraud.

According to Scott Coates, senior director of the AOAC Research Institute, they were approached three years ago to set up a working group for cannabis testing. “We created standards that we call the standard method performance requirements (SMPR®), which are detailed descriptions of what analytical methods should be able to do,” says Coates. “Using SMPRs, we issued a series of calls for methods and looked for methods that meet our standards. So far, we’ve completed four SMPRs- cannabinoids in plant material, cannabinoids in plant extracts, cannabinoids in chocolate (edibles), and one for pesticides in cannabis plant material.” AOAC doesn’t develop methods themselves, but they perform a comprehensive review of the methods and if they deem them acceptable, then the methods can be adopted and published in the AOAC compendium of methods, the Official Methods of Analysis of AOAC INTERNATIONAL.

Deborah McKenzie, senior director of Standards and Official Methods at AOAC

Deborah McKenzie, senior director of Standards and Official MethodsSM at AOAC, says the initial working group set the stage for really sinking their teeth into cannabis testing. “It started with methods for testing cannabinoids in plant dried material and plant extract,” says McKenzie. “That’s where our previous work has started to mold into the current effort we are launching.” McKenzie says they are looking forward to getting more involved with methods regarding chemical contaminants in cannabis, cannabinoids in various foods and consumables, as well as microbial organisms in cannabis. “We are pretty focused on testing labs having reliable and validated analytical solutions as our broad goal right now.”

Moving Forward, Expanding Their Programs

Coates says the work they’ve done over the past few years was more of a singular project, developed strictly for creating standards and to review methods. Now they are currently developing their Cannabis Analytical Science Program (CASP), which is expected to be an ongoing program. “We are looking to fully support the cannabis analytical community as best we can, which will potentially include working on reference materials, proficiency testing, education, training and ISO 17025 accreditation, all particularly as it applies to lab testing in the cannabis industry,” says Coates. “So, this CASP work is a much bigger and broader effort to cover more and to provide more support for labs doing the analysis of cannabis and its constituents, as well as hemp.”

According to Dr. Orlandi, they want this program to have a broad reach in the cannabis testing community. “As Scott pointed out, it’s not just strictly developing standards and methods,” says Dr. Orlandi. “It is going to be as all-encompassing as possible and will lead to training programs, a proficiency testing program and other areas.” Arlene Fox, senior director of AOAC’s Laboratory Proficiency Testing Program, says they are actively engaging in proficiency testing. “We are in the process of evaluating what is out there, what is possible and what’s needed as far as expanding proficiency testing for cannabis labs,” says Fox.

Regulatory Challenges & Obstacles

The obvious roadblock to much of AOAC’s work is that cannabis is still considered a controlled substance. “That creates some challenges for the work that we do in certain areas,” says Dr. Orlandi. “That is why this isn’t just a one-year project. We will work with these challenges and our stakeholders to address them.” AOAC had to put some limits on participation- for example, they had to decide that they cannot look for contributions or collaborations with producers and distributors, so long as cannabis is still a Schedule I controlled substance in the US.

Arlene Fox, senior director of AOAC’s Laboratory Proficiency Testing Program

Muddying the waters even further, the recent signing of the Farm Bill puts a clear distinction between most types of cannabis and industrial hemp. David Schmidt, executive director of AOAC realizes they need to be realistic with their stakeholders and in the eye of federal law.

While scientifically speaking, it’s pretty much the same plant just with slightly different chemical constituents, AOAC INTERNATIONAL has to draw a line in the sand somewhere. “As Palmer suggests, because of the Farm Bill being implemented and hemp being defined now as a legal substance from a controlled substance standpoint, industrial hemp has been given this exclusion,” says Schmidt. “So, we are trying to be realistic now, working with our stakeholders that work with hemp, trying to understand the reality of the federal law. We want to make clear that we can meet stakeholder needs and we want to distinguish hemp from cannabis to remain confident in the legality of it.” Schmidt says this is one of a number of topics they plan on addressing in detail at their upcoming 9thannual 2019 Midyear Meeting, held March 11-14 in Gaithersburg, Maryland.

Uniformity in Methodology: The Future of Cannabis Testing

Dr. Orlandi says his experience at the FDA has prepared him well for the work being done at AOAC. “The role that I served at the FDA prior to joining my colleagues here at AOAC was very similar: And that is to bring together stakeholders to accomplish or to solve a common problem.” Some of their stakeholders in the CASP program include BC Testing, Inc., the Association of Food and Drug Officials (AFDO), Bia Diagnostics, Bio-Rad, Industrial Laboratories, Materia Medica Labs, PerkinElmer, R-Biopharm AG, Supra R & D, TEQ Analytical Laboratories, Titan Analytical and Trilogy Analytical, among others.

David Schmidt, executive director of AOAC

“The underlying reason behind this effort is to create some level of harmonization for standards and methods,” says Dr. Orlandi. “They can be used in the near future to stay ahead of the curve for when regulatory agencies become involved. The idea is that these standards for analytical methods will already be established and as uniform as possible.”

When comparing cannabis to other industries in the US, Scott Coates mentions that most standards are signed off by the federal government. “When we started looking at pesticides in cannabis, it became really clear that we have a number of states doing things differently with different limits of quantification,” says Coates. “Each state, generally speaking, is setting their own standards. As Palmer was saying, one thing we are trying to do with this CASP program eventually will be to have some harmonization, instead of 30 different states having 30 different standards and methods.” So, on a much broader level, their goal for the CASP program is to develop a common set of standard methods, including hemp testing and even the Canadian market. “Hopefully this will be an international collaboration for standards for the methodology,” says Coates. They want to create a common set of standards, setting limits of quantification that will be accepted internationally, that will be accurate and repeatable and for the entire cannabis industry, not just state by state.

Food Authenticity & Fraud

One of the other activities that AOAC just launched recently is the food authenticity and fraud program. As the name implies, the goal is to start developing standards and methods and materials to look at economically adulterated foods, says Dr. Orlandi. That includes non-targeted analyses looking at matrices of food products that may be adulterated with an unknown target, as well as targeted analytes, identifying common adulterants in a variety of food products. “One example in the food industry is fraudulent olive oil,” says Dr. Orlandi. “Honey is another commodity that has experienced adulteration.” He says that in most cases these are economically motivated instances of fraud.

AOAC INTERNATIONAL is working in a large variety of other areas as well. All of these topics will be explored in much greater detail at their upcoming 9thannual 2019 Midyear Meeting, held March 11-14 in Gaithersburg, Maryland.

Deibel Cannabis Laboratories Launches Cannabis-Specific HACCP Program

By Dr. Laurie Post
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Manufacturers of cannabis products need a program tailored to the cannabis industry that helps assure the safety of cannabis products with respect to known hazards such as pesticides, residual solvents, microbial impurities, heavy metals and mycotoxins. Deibel Cannabis Laboratories has developed a course that that will teach those manufacturing cannabis products how to manage known product safety hazards using a Hazard Analysis and Critical Control Point (HACCP) system.

HACCP has a long history of use in the food industry based on preventing potential hazards from occurring rather than reacting to issues when they arise. This program was started in the US but is globally recognized, used by food companies around the world to help produce safe products for consumers. Deibel Cannabis Laboratories applies the same prevention based system of HACCP to the creation of safe and wholesome cannabis goods whether they be edible, medicinal or topical. They also explore ways cultivators can use HACCP principles in their operation.12

Deibel Labs was founded by Dr. Robert Deibel in the 1970’s. Dr. Deibel is one of the original pioneers of HACCP, expanding the program from its original three HACCP principles to the seven principles we recognize today. Dr. Deibel developed the first “HACCP Short Course,” teaching this prevention-based program to food industry leaders in the 1970s.

According to Charles Deibel, president of Deibel Labs, this is an important step for the cannabis space. “Deibel Labs is proud to continue in our historic role as leaders in HACCP training by providing the cannabis industry with a training course developed by Deibel Labs associates who are International HACCP Alliance accredited lead instructors with years of experience in crafting and implementing HACCP plans for the food industry.”

They are launching a pilot two-day Cannabis HACCP Class to select clients at the end of January in Santa Cruz, CA. The full Cannabis HACCP course schedule for 2019 is currently in development. Accreditation by the HACCP Alliance is expected by early January, assuring that a standardized and internationally recognized training curriculum is provided by accredited instructors.

The course is forward-thinking, anticipating that sometime in the near future cannabis manufacturers will be required to control and document the safe production, handling and preparation of products according to state or even federal regulatory standards. Participants will be able to develop their own model HACCP program in an interactive group learning environment.

Attendees will:

  • Understand how Prerequisite Programs provide the foundation on which HACCP programs are built including GMPs, Sanitation and Pest Control Programs
  • Be able to identify where and how product safety problems can occur using a Hazard Analysis that considers Biological, Chemical and Physical Hazards
  • Gain the skills, knowledge, and tools necessary to develop effective Critical Controls, formulate corrective actions, conduct program verification and validation activities
  • Learn how to document activities and maintain records

Stay tuned for more information on when the 2019 course schedule is announced and how to register.

Basic Training for Employers and Employees in the Cannabis Industry

Basic Training for Employers and Employees in the Cannabis Industry

By Lindsay Engle
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Basic Training for Employers and Employees in the Cannabis Industry

The cannabis industry is evolving as more states begin to legalize; as the legalization of cannabis grows, the industry will need more well-informed dispensaries and dispensary employees.

Unfortunately, there are employees in dispensaries without proper training and some are put in positions to recommend specific strains to patients that may not be accurate. Getting proper training is important, no matter which cannabis job you want to pursue.

More Training Is Needed

Currently, there are no national standards for training dispensary employees, there is not even a licensing code. Therefore, it is important for owners to investigate state laws and understand legal minimums for worker education.

There are states, like Massachusetts, which requires a $500 fee for employee registration. There are other states that require cannabis employees receive a certain number of education hours on specific topics, like patient confidentiality.

Overall, more than fifty percent of cannabis dispensary staff has reported receiving some type of formal training and only twenty percent of staff members have received medical cannabis training.Basic Training for Employers and Employees in the Cannabis Industry

Dispensary staff should receive training on how and when to make appropriate suggestions to patients. Any successful dispensary owner will acknowledge that employee education pays off in reduced loss, increased sales and avoided fines. There are more benefits to employee training than just these and there are steps owners can take to ensure they are getting the most out of their business and employees.

Setting up a System

When a dispensary has protocols in place that show how the business operates, the company will have consistency and organization. No matter the task, all team members must follow specific procedural protocols.

Mostly, mistakes are made when steps are missed or misunderstood by new employees, but with proper and thorough training, this can be avoided. Owners should be investing in a POS software system that is straightforward; this will reduce training time and make it easier for new staff to be familiar with the system.Having budtenders that can educate and connect with the customers on a personal level is invaluable

Teaching budtenders to adopt a soft sell technique will be the most effective when it comes to increasing sales. Many customers seeking relief using cannabis are not going to respond to a hard sell technique, as this comes off pushy or aggressive.

There are going to be customers who are unsure of what products they want; theses customers will need guidance, and training employees to make suggestions based on what the customer is looking for is the best sales practice.

Having budtenders that can educate and connect with the customers on a personal level is invaluable; dispensaries that do this will have repeat customers.

More States Legalizing, More Dispensaries and More Employees

As the United States heads towards cannabis legalization, slowly but surely, we need to be prepared to train workers. When you have a dispensary that you have already spent millions of dollars on the application process, you don’t have time to be messing around with employees that are not serious.

There are many different options anyone in the cannabis industry can seek out to educate themselves more in the business.Those distributing cannabis must take their duties as seriously as pharmaceutical technicians, because in a sense that is what they are doing. They are giving information on the prescription or drug to a customer that is using it for an intended a purpose.

Cannabis users come in many different ages and aliments. It is important for budtenders and dispensary owners to understand the backgrounds of each customer to increase their up-sale potential.

While compassion isn’t something you can learn online or in a classroom, it is always a good idea to remind others to be compassionate. The budtender that asks the right questions, takes time with each patient to care for them and goes over practical products for the client will be the budtender with the most sales revenue.

Higher Learning

There are many different options anyone in the cannabis industry can seek out to educate themselves more in the business.

Some platforms are available online and are filled with important content that can teach you about different aspects of the cannabis plant and industry. These classes can prepare employees or owners for success.The most important training will be the training of patients

There are courses that can educate you in how to cook and healing with cannabis. You can also learn about laws on a state-by-state basis when you are enrolled in a cannabis-training program. The cannabis industry is large and growing; entrepreneurs, lawyers and caregivers can learn about the growing movement and expand their knowledge on this topic.

Patient Training

The most important training will be the training of patients, who will be navigating between the world of western medication and the new option of medicinal cannabis.

There are obviously many positive things that will come from the legalization of cannabis, one of the biggest being more options for pain management patients. There is a misconception that people are using medicinal cannabis as an excuse to get high; however, many patients in most states are over the age of 50.

In 2016, it was estimated that 650,000 Americans were using cannabis in compliance with the laws of their state. As legalization grows to a national level, we are going to need to be educating patients.

It is important for citizens to talk to their doctors about methods they believe will work best for them. It is necessary to communicate strains that are ineffective or unsatisfying. Keeping a cannabis journal is a good way to know what dose and strain you benefit from the most.

There are many ways patients can be educated in the cannabis industry, and dispensaries that encourage patient education will grow customer loyalty. The person who knows the facts and is confident in their information will be more successful than the person who guesses.

Be sure you, your staff and your customers know the laws, strains and can accurately answer questions about cannabis.

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Food Safety Consortium To Address Cannabis Safety, Edibles Manufacturing

By Aaron G. Biros
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The 6thAnnual Food Safety Consortium Conference & Expo will feature an entire track dedicated to cannabis. As announced in May of this year, the Cannabis Quality series will feature presentations by subject matter experts in the areas of regulations, edibles manufacturing, cannabis safety & quality as well as laboratory testing.FSC logo

The Food Safety Consortium is hosted by our sister publication, Food Safety Tech, and the Cannabis Quality series will be co-hosted by Cannabis Industry Journal. A number of cannabis-focused organizations will participate in the series of talks, which are designed to help attendees better understand the cannabis edibles market, regulations surrounding the industry and standards for manufacturers. Some highlights include the following:

  • Ben Gelt, board chairman at the Cannabis Certification Council (CCC), will moderate a panel where leaders in the edibles market discuss supply chain, production and other difficulties in manufacturing infused products. Panelists include Leslie Siu, Founder/CEO Mother & Clone, Jenna Rice, Director of Operations at Gron and Kristen Hill, MIP Director, Native Roots Dispensary, among others. “The Cannabis Certification Council believes consumer education campaigns like #Whatsinmyweed are critical to drive standards and transparency like we see in food,” says Gelt. “What better place to discuss the food safety challenges the cannabis industry faces than the Food Safety Consortium”
  • Radojka Barycki, CEO of Nova Compliance, will discuss the role of food safety in the cannabis industry and identify some biological and chemical hazards in cannabis product testing in her talk, “Cannabis: A Compliance Revolution.”
  • Larry Mishkin, counsel to Hoban Law Group and partner at the law firm, Silver & Mishkin, which serves cannabis businesses in Illinois, will provide insights during the conference.
  • Cameron Prince, vice president of regulatory affairs at The Acheson Group, will help attendees better understand key market indicators and current trends in edibles manufacturing during his talk on November 15. “With the current trend of legalizing cannabis edibles, medicinal and recreational suppliers alike are looking to quickly enter the edibles market,” says Prince. “Understanding the nuances of moving to food production relative to food safety, along with navigating the food industry’s regulatory environment will be critical to the success of these companies.”
  • Tim Lombardo and Marielle Weintraub, both from Covance Food Solutions, will identify common pathogens and areas where cross contamination can occur for edibles manufacturers.

The Food Safety Consortium will be held November 13–15 in Schaumburg, Illinois (just outside of Chicago). To see the full list of presenters and register for the conference, go the Food Safety Consortium’s website.

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Raising the Standard for Dispensary Education: Building a Better Budtender

By Maureen Smyth
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Maureen Smyth headshot

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.”