Tag Archives: clinic

Cannify Adds 1,500+ Products to Database

By Cannabis Industry Journal Staff
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According to a press release sent out this week, Cannify has added a new feature to their website, which allows users to check out more than 1,500 cannabis products available in the United States and save the ones that interest them.

Cannify’s mission is to “bring relevant cannabis science closer to the users, and vice versa, by extracting relevant data from hundreds of studies and making them easy to understand.” Dr. Linda Klumpers, one of the few clinical cannabinoid pharmacologists in the world, founded Cannify back in 2016. Cannify developed a science-based algorithm that helps patients learn which cannabis products are best suited for their personal needs. When patients take the Cannify quiz, it asks them in-depth questions and shows them relevant scientific literature in a personalized report. After that, they are given an overview showing which products match their reports best.

“Making your product database available is nothing new,” says Klumpers. “Making sure that it is actually useful, is a different story. The product list is easy to navigate, even for cannabis novices. Users can filter products by location, administration method, or compound: are they interested in THC, CBD, or both? It might sound so simple, but it turned out to be a rare feature on the market.”

This new addition to the Cannify platform aims to help enhance the overall utility and versatility of the system.

Cannify wants to collect, analyze and publish its data, which they hope will contribute to the advancement of cannabis research. In addition to the Cannify quiz and the product database features, the company also has plenty of educational materials, educational quizzes and customized cannabis courses available on their website.

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.

Will Australia’s Cannabis Program Follow Canada’s Lead?

By Marguerite Arnold
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The news is intriguing in a world overwhelmed with pandemic news. THC Global, a Canadian-Aussie company now raising money and signing global deals, has just bought a “clinic network” of 30 prescribing physicians that will be able to supply up to 6,000 Australian patients this year.

In doing so, this entity is clearly beginning to establish a pattern of expansion in a new medical market not seen so far outside of Canada. Namely being able to obtain the all-important prescription for one’s brand at the doctor or prescriber’s office which is affiliated with a certain producer. Pharmacies and dispensaries downstream have no discretion for any other product to sell if the brand is written right on the prescription itself.

And this marks a new step in an industry frustrated with the high prices and high levels of red tape in other international environments where more widespread medical cannabis reform has come.

The Situation in Germany
Germany represents, so far at least, the destination market of choice for Canadian cannabis firms (for the last several years at least). This is for several very sound business reasons (at least in theory).

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Photo: Ian McWilliams, Flickr

The German medical market is the largest in Europe. Health reforms which swept the country at the time of reunification also created a system that is in its own way a hybrid of the more European (and British) NHS and American healthcare. Namely, 90% of the German population is on the system, but it is tied to employment and income. Freelancers, even of the German kind, must use private healthcare as must all non-passport foreigners. If you make over a certain amount of money (about $65,000), you must also pay for private healthcare. As the cannabis revolution rolls forward, many cannabis patients are caught in changing rules and a great reluctance by public health insurers to allow fast entry of any new drug, including this one. This is based on “science” but also cost.

Bottom line? Yes, the market is lucrative and growing, and yes, cannabis is covered under public health insurance, but the ability of any producers to be able to maintain a reliable, steady market of “prescribers” is highly limited. Furthermore, unlike anywhere else in the world, pharmacists play an outsized role in the process – namely because there are no chains (more than four brick and mortar outlets are verboten). Prices and availability vary widely across the country.

There are also no “online” drug stores where patients can send prescriptions in the sense that this vertical has developed in other countries.

Hospital dispensation is, for all the obvious reasons, highly expensive and generally prohibitive for the long term, if not serving much larger numbers of patients.

The Problem in the UK
Like Germany, the UK decided to launch medical “cannabis” – or at least cannabinoid-related drugs under the purview of the NHS, but there are several issues with this.

Epidiolex-GWThe problems start with the fact that the system remains a monopoly for one British company, GW Pharmaceuticals. The medication produced by them, including Sativex and Epidiolex is expensive and does not work for many patients that it is produced “on label” for (such as MS or childhood epilepsy).

And then of course, the largest group of cannabis patients anywhere (chronic pain) have been explicitly excluded from the list of conditions cannabis can be prescribed for under public health guidelines in the UK. This, like Germany, has created a highly expensive system where those patients who obtain the drug on a regular (and legal basis) have to have both private healthcare and obtain help through private clinics. While there are several chain clinics now forming in the UK, this is not the same thing as “buying” patients in the thousands – the model seen in Canada from the beginning of 2014.

The market has a lot of potential, in other words, but like Germany, via very different paths to market than seen in Canada, in particular.

Why Is Canada Different?
The development of the medical market came through federal change in the law around the turn of the century. Namely, after patients won the right to grow for themselves, via Supreme Court legal challenge, patient collectives gradually formed to grow and sell cannabis that was more “professionally” cultivated. This, in turn, became the right of private companies and indeed household names in the Canadian market saw buying patient pools as their path to financing on the equity markets as of 2014.

This is not widely popular within the industry. Indeed, the last legal challenge mounted by the industry to ban non-profit patient collectives fell apart in 2016 – the year that the larger Canadian companies began to look abroad to Europe.

It is also undoubtedly why, beyond the red tape they face in Germany and the UK if not across Europe, Canadian firms are looking to hybridize a model which worked well for them at least in the early days of capitalization of the private industry. And maybe Australia will be “it.” Stay tuned.

UKflag

The Rise of The Cannabis Clinic Model In Europe

By Marguerite Arnold
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UKflag

The opening of the UK’s first cannabis clinic is certainly cause for cheer. The effort, backed by a growing UK powerhouse that includes European Cannabis Holdings, has just opened its first private cannabis clinic in the UK, with two more on the way, including one in London by the end of the year.

The clinic will see patients who can afford to pay, in other words those who are privately insured and not covered by the NHS. The clinics will also serve those with chronic illnesses including chronic pain and epilepsy.

This development will also undoubtedly begin to increase the number of actual legal British cannabis patients, which is significant in and of itself. That count now, close to five months after cannabis became technically available via Schedule II prescription last year, is a shocking four patients. This is not a typo.

Presumably, this means that patients who enter the market this way will also be able to access newly imported Dutch cannabis which has just started to enter the country in bulk. Not to mention be able to find pharmacies who stock the drug.

For the backers of ECH (which include SOL Global), these are strategic moves indeed, which also bode well for those who can afford access.

But does this herald a new shift in the way that cannabis will be prescribed for the mainstream in the UK if not across Europe? That is not so clear.

The History of Cannabis Clinics… In Israel and Beyond

From the medical side of the world, it has been cannabis specialty pain clinics that have moved the conversation forward and served patients in places like Israel. In the latter part of the last decade, Israel slowly began to liberalize access not via dispensaries, as in the American model, but rather via specialty pain clinics paid for by the government. It was only when patient attendance at such prescription and dispensation points became flooded by applicants that the government, just a few short years ago, began to allow regular doctors to prescribe the drug and regular pharmacies to carry it.

What does this say about a British market where reform has just come, and only four patients?There are currently various initiatives sprinkled around Europe- mostly in the form of collectives of doctors who try to help get their patients cannabinoid treatments. See, for example, Kalapa Clinic in Spain. Or the “self help” group of patients in Germany loosely associated with Dr. Grotenhermann (one of the country’s best-known cannabinoid doctors).

Yet in Germany, the first country in Europe to liberalize medical use, there are as yet no cannabis clinics of either the private or public kind (although there have also been several unsuccessful attempts to do just this since 2017 in cities like Berlin and Munich). Part of the reason for the failure of the model in Germany at least is due to the fact that while specialty doctors are needed to help guide patients through the complicated approvals process, the payment for the same from the insurance companies (even private insurers) is so low it is not yet economically feasible to set up a clinic based on this model.

That said, it is clearly an idea that has occurred to more than a few entities. In Germany, however, land of (at least) 40,000 patients, this model has yet to take off. What does this say about a British market where reform has just come, and only four patients? Even as early as spring 2017, when the German government changed the law mandating insurance coverage, there were 800 German patients in the system.

Why The UK Is Likely To Be Different

Image: Flickr

Cannabis patients may actually be some of the best situated patients to ride out the Brexit crisis that will hit all drugs. Why? From the start, the strange classification of the drug is requiring bespoke solutions for niche patients. While it may not be fair, this in turn will at least start to create a core group of medical users.

Creating at least that first critical mass is also unbelievably important for greater access and reform, if not speeding it on its way. And the backers of the new clinics are well aware that impetus on this front will not come from the much-beleaguered NHS but rather private initiatives like the ones now being launched in the UK.


Disclaimer: ECH is a sponsor of the MedPayRx go to market pilot trial.

Epidiolex-GW

GW Pharma’s Epidiolex Gets Encouraging FDA Assessment

By Aaron G. Biros
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Epidiolex-GW

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

GW logo-2The drug is targeted to treat Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) a rare early-onset type of epilepsy found in children, according to Reuters. FDA staff said the drug “reduces seizure frequency in patients with drug-resistant LGS or DS while maintaining a predictable and manageable safety profile.”

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

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

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