Tag Archives: topical

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

By Cannabis Industry Journal Staff
No Comments

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.

The Secret to Marketing Cannabis to Women

By Jacquie Maynard
2 Comments

The world is changing, and women are the ones changing it. Classic methods of advertising to women just don’t work anymore, and worse, make you seem outdated and out of touch.

According to a 2017 study by BDS Analytics, 45 percent of cannabis users are women and that number is quickly rising. It could be even higher since according to Van Der Pop’s Women & Weed survey, 66 percent of women hide their cannabis use. No one seems to be able to agree on the exact figure, but experts do agree that women are the fastest growing market in the cannabis industry.

Harvard Business Review reported in their 2009 article “The Female Economy” that worldwide, women control nearly $30 trillion in household spending and make the majority of purchasing decisions in the family. If they’re not directly purchasing something with their $18 trillion in collective income, they are influencing others’ purchasing decisions. Often, they are the primary caregivers in their family circles, making them responsible for buying things for their children, or on behalf of their elderly loved ones.

Gender can often be a marketing blind spot, even though it’s the biggest influence on consumer behavior, according to a 2017 report from The Journal of Business and Management. Now that the number of women working in the cannabis industry is at 36 percent and rising, they are using their experiences and perspectives to market effortlessly to women, and it shows. If your brand is ignoring this powerful demographic, you’d better catch up quick.

Why do women use cannabis products?

Women are into cannabis wellness, but like to get high, too.

In Headset’s 2019 report entitled “What Women Want in Cannabis: Shopping Trends Among Female Cannabis Consumers,” some of the most popular cannabis products among women are still classics like flower and pre-rolls, but women are more likely than men to try capsules, topicals and sprays. They are fascinated by the concept of CBD helping them with issues like menstrual cramps, body and muscle pain, and even sensitive skin, but enjoy products with THC as well.

In general, women’s purchases in the cannabis industry end up being more centred towards wellness, but it’s not all about spa treatments and relaxing.

Sex sells, but not in the way you think.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

There has been a growing interest in using cannabis and CBD for women’s sexual health. Researchers haven’t quite caught up with the science yet, but researchers at the Center for Sexual Health at Saint Louis University think that cannabis and CBD can help women overcome pain and anxiety during sex. Foria Wellness is a brand that sells CBD suppositories and lubricants that help women have a better sex life. Not only are their products seemingly effective, but they provide loads of education to their audience and work with influencers to build their community.

Beauty is Pain.

Being a woman is hard. Or at least, painful. Between walking in heels, getting in an intense workout, and feeling the stress of general life, women end up with quite a few aches and pains. Topicals and bath bombs seem to be leading the way in this area. Celebrity stylists have been using CBD lotions on the feet of starlets before a long night on the red carpet, and more brands are marketing their products to fitness buffs.

Market to specific kinds of women.Skincare is another burgeoning market. Van Der Pop reports that 60 percent of women are interested in cannabis skin care. Again, the science hasn’t quite caught up, but anecdotally it has been shown to have anti-bacterial and anti-inflammatory properties when applied to the skin. Women with psoriasis, eczema and other skin troubles are also finding relief with CBD. A bunch of large retail brands have already jumped on the bandwagon and indie brands are starting to pop up as well.

Life is Stressful.

A report from Spate and Landing International found that there has been a 24 percent increase in consumer interest in anxiety. Young people these days are under more pressure than ever, and they are turning to their products to solve it. The American Psychological Association says that 12 percent of millennials are officially diagnosed with an anxiety disorder, so it’s no surprise that anxiety and depression are the fastest-growing search terms associated with CBD.

Does this make me a bad mom?

Being a mom is stressful, and a lot of moms have been toking since before their kids were born, so after the kids are asleep they relax on the porch with a joint. It’s right for them, but the stigma is still there and they can feel it. Over 70 percent of women believe that there is still a stigma attached to cannabis use. The answer is not only marketing to Mary Jane moms but also using marketing to help end the stigma around cannabis consumption.

What do women look for in cannabis brands?

Women use cannabis for different reasons than men, so it makes sense that they would look for different things in a cannabis brand.

“Traditionally, marketing weed to men has either been about projecting fantasy, or appealing to the everyday guy that men feel like they could smoke a bowl with,” Mary Pryor, CEO and co-founder of Cannaclusive, told AdAge. “But women want to know what gets the job done without having to do too much work to know what we’re going to get.”

That means lots of education and support at the customer level. Women are used to a higher level of customer service and will most certainly take their business elsewhere if they feel they aren’t being heard or served effectively.

Women buy things that make them feel good, or items that help them express themselves, so aesthetic is important, too. There was a time in cannabis culture when most cannabis accessories had flames, or skulls, or aliens, and while that may appeal to some women, the majority want a more feminine and streamlined look. Brands like Van Der Pop offer modern designs that will readily fit into the consumer’s decor, and Lord Jones packages their CBD oil with an ornate style that invokes more of a luxury perfume brand than a cannabis product. Women are looking for a product that will look good on their shelf or in their homes.

The Secret? Know Your Audience

The first rule of marketing to women is: don’t market to women.

The absolute best way to reach women is to create authentic content for women, by women, addressing their specific concerns.At least, not women as a mass, general group. Market to specific kinds of women. Like cannabis, women come in many beautiful and exotic varieties, each one more interesting and lovely than the last, and each with their own values and shopping habits. For example, the wellness guru will have different needs from the sun-weathered gardener, who will have different needs from the stressed-out mom with a sore back.

Here are some time-tested generalizations that could help you out, though. The Journal of Business and Management reports that women are more likely to appreciate finer distinctions and enjoy more of a conversational style dialogue. When it comes to problem-solving, women care more about how a problem is solved, and like sharing and discussing it. Similarly, shopping is also a process where women tend to enjoy more interaction and take more pride in finding the best bang for their buck and the best product for them.

According to Bloomberg, you should study women as if they were a foreign market. All groups of women have their own culture, values and even language. The key here is to get to know each and every one of these personas so that you can create a targeted strategy to reach them specifically.

The absolute best way to reach women is to create authentic content for women, by women, addressing their specific concerns. Create a community for them. Formulate products for them that actually work. Hire them, listen to them, hear them and they will choose your brand every time.

Stratos: Quality, Expansion & Growth in Multiple Markets

By Aaron G. Biros
No Comments

Jason Neely founded Stratos in 2014, when he and a small group of people left the pharmaceutical industry in search of a new endeavor in the cannabis marketplace. The concept was straightforward: Apply pharmaceutical methodologyof production to cannabis products. Back then, Stratos offered a range of THC-infused tablets in the Colorado market.

Brenda Verghese, vice president of research & development

Brenda Verghese, vice president of research & development, was one of five people on staff when Stratos launched. Now they have about 30 team members. Consumers were looking for a cannabis product that would be consistent and reliable every time, taking the guesswork out of infused products dosage. That’s where Brenda Verghese found her skillset useful.

Transitioning to the pharmaceutical industry right out of college, Verghese started her career as a chemist and worked her way up to the R&D business development sector. “I specializedin formulations and taking a product from concept to commercialization in the pharmaceutical space,” says Verghese. “Jason Neely approached me with the idea of a cannabis company and focusing on making products as effective and consistent as possible, so really bringing pharmaceutical science into the cannabis space. In the matter of 4 years we grew substantially, mainly focusing on the efficacy of products.”

Behind the scenes at packaging and labeling Image credit: Lucy Beaugard

Soon after the success of their THC products became apparent, Stratos launched a CBD line, quickly growing their portfolio to include things like tinctures and topicals as well. According to Verghese, they are hoping that what’s been established on the THC side of their business as far as reproducibility and consistency is something that consumers will also experience on the CBD side. “Quality and consistency have definitely driven our growth,” says Verghese. “That is what consumers appreciate most- the fact that every tablet, tincture or swipe of a topical product is going to be consistent and the same dose every time.” This is what speaks to their background in the pharmaceutical sciences, FDA regulation has taught the Stratos team to create really robust and consistent formulations.

Quality in manufacturing starts at the source for Stratos: their suppliers. They take a hard look at their supply of raw materials and active ingredients, making sure it meets their standards. “The supplier needs to allow us to do an initial audit and periodic audits,” says Verghese. “We require documentation to verify the purity and quality of oil. We also do internal testing upon receipt of the materials, verifying that the COAs [certificates of analysis] match their claims.”

Process validation in action at the Stratos facility
(image credit: Lucy Beaugard)

Verghese says maintaining that attention to detail as their company grows is crucial. They implement robust SOPs and in-process quality checks in addition to process testing. They test their products 5-6 times within one production batch. Much of that is thanks to Amy Davison, director of operations and compliance, and her 15 years of experience in quality and regulatory compliance in the pharmaceutical industry.

Back in August of 2018, Amy Davison wrote an article on safety and dosing accuracy for Cannabis Industry Journal. Take a look at this excerpt to get an idea of their quality controls:

Product testing alone cannot assess quality for an entire lot or batch of product; therefore, each step of the manufacturing process must be controlled through Good Manufacturing Practices (GMP). Process validation is an aspect of GMPs used by the pharmaceutical industry to create consistency in a product’s quality, safety and efficacy. There are three main stages to process validation: process design, process qualification and continued process verification. Implementing these stages ensures that quality, including dosing accuracy, is maintained for each manufactured batch of product.

Fast forward to today and Stratos is looking at expanding their CBD products line significantly. While their THC-infused products might have a stronger brand presence in Colorado, the CBD line offers substantial growth potential, given their ability to ship nationwide as well as online ordering. “We are always evaluating different markets and looking for what suits Stratos and our consumer base,”says Verghese.

New Drug Delivery Mechanisms For Cannabis Products

By Aaron G. Biros
No Comments

Next Frontier Biosciences announced the launch of their new product line, Verra Wellness, in the Colorado market this week. The products are designed with relatively new concepts for the cannabis market, including nasal, sublingual and topical administration.

The company claims their product is the first-ever cannabis nasal mist. Co-founded by biotech executives Marc Graboyes and Dr. Paul Johnson, Ph.D, Next Frontier Biosciences is developing this product line with three formulations, each with a different ratio of THC and CBD. According to a press release, Next Frontier Biosciences is focused on developing cannabis products with these new drug delivery methods, and even offering a microdosing option.

“We believe that leveraging science and research is the key to optimizing product development,” says Dr. Johnson, one of the co-founders. “With the introduction of our Verra Wellness line of products, we are reshaping the cannabis industry by offering trusted products that provide uniform composition, formulation and dosing in highly consistent modes of administration.”

Their topical salves in the Verra Wellness product line are “designed to permeate skin and muscle tissue deeply without penetrating the blood stream or causing psychoactive effects,” reads a press release. In addition to the nasal mist and topical salve, they also launched a sublingual spray.

Marc Graboyes, chief executive officer and co-founder of Next Frontier Biosciences

According to Marc Graboyes, chief executive officer and co-founder of Next Frontier Biosciences, drug delivery mechanisms like a nasal mist are superior to smoking, vaporizing and edible administration. “Nasal administration is among the most effective delivery technologies due to the extensive vascularization and large surface area of the nasal cavity, allowing for rapid uptake and reliable results,” says Graboyes. “The cannabis nasal mist is a novel technology that other brands have not yet tapped into.”

He says this drug delivery mechanism is efficient, fast acting and a healthy alternative to smoking. “For many, nasal delivery is a desirable alternative delivery mechanism because it does not present the health risks associated with smoking,” says Graboyes. “In addition, as previously mentioned, the large surface area of the nasal cavity permits high drug absorption, and the fine-mist sprayer allows for accurate, consistent dosing and an excellent safety profile. Further, nasal delivery avoids first-pass metabolism by the liver, where a large fraction of orally delivered cannabinoids are inactivated.”

While the Verra Wellness product line is available in Colorado starting this week, the company has plans to expand into a number of other states as well. “We are executing a multi-state expansion, with plans to move into the California, Oregon, Washington and Nevada markets in the coming year,” says Graboyes.