By Barbara R. Fallon

A new ‘wave’ is heading to the Sunshine State which will essentially double the number of licensed Medical Marijuana Treatment Center (MMTC) license holders over the next 16 months. The Florida Department of Health’s Office of Medical Marijuana Use (OMMU) is currently processing the 2nd cycle of MMTC licenses, authorizing these companies to start their infrastructure buildout process to help serve the 719,366 qualified patients (active ID cards as of May 13th, 2022 OMMU webpage).

As with the current 22 Florida MMTC license holders, the new wave of companies will be required to cultivate, process, and dispense (retail) low-THC cannabis and medical marijuana. However, unlike a typical retail outlet which can simply open a store and purchase product directly from another company, the MMTC must be proficient at all product phases: grow-process-test-package before any product arrives at their own branded retail location. The term is commonly referred to as ‘vertically integrated’ or ‘seed to sale.’

To a current or new MMTC license holder, ‘seed-to-sale’ means ‘a lot of infrastructure.’ This is where SR Construction Services (SRCS) fits in as a scalable 3rd party partner of their organization. Early and consistent collaboration amongst the design & architectural team, contractor, and equipment vendors is key to avoiding costly and time-consuming design alterations during construction.

Partnering with a Florida-based, statewide, cannabis-experienced GC, familiar with all phases of large-scale indoor cultivation, processing, and retail construction, and aware of the many Department of Health (DOH) requirements is vital to ensure your infrastructure plan is successfully executed, delivering market share and return on investment (ROI).

Florida cannabis construction is unique compared to any other state. Many of the original 22 license holders have learned this truth the ‘expensive way’. Due to the diverse and intricate set of codes, Florida compliance regulations, and existing property conditions, it takes more than a tool belt to design and construct successful cannabis infrastructure in the Florida market.

Having completed over 80+ retail dispensaries, offering 60-day, fast-track turn time options on retail construction, and finishing numerous indoor and outdoor cultivation facilities, SRCS clearly understands the challenges within the medical cannabis space and emphasizes a culture of ‘communication’ and ‘transparency’ which provide synergy and balance to our client relationships, according to Ryan Seddon, Principal of SRCS.

Building Relationships

“Our most valuable asset is the talented and experienced SRCS staff who contribute – both as individuals and team members – to the ultimate goal of a job well done,” Seddon explains, “and that’s what brings our customers back.”

By the Numbers

According to the OMNU webpage, Florida has a total of 429 authorized retail dispensary locations statewide (May 13th, 2022 OMNU webpage). When you consider the active patient count makes up only 3.34% of Florida’s population & future recreational use ruling, it is obvious MMTC companies are just getting started.

SR Construction Services is a turnkey, Division 1, vertically integrated, multi-licensed Florida contractor with years of active experience in the commercial retail and industrial cannabis market. Their diverse business model is focused on industrial, hospitality, retail tenant improvement, medical, and large-scale new construction and renovations.

 For more information, visit www.s-r-construction.com/industrial, call (561) 290-0402 or email ERIC@S-R-Construction.com.

All referenced OMNU data found at https://knowthefactsmmj.com/




By Dr. Jeff G. Konin

In some of my previous columns I have discussed the importance of cannabis education to many different stakeholders if we are to see advancement in this space. While the term “education” seems simple to understand for most if not all of us, the diversity and quality of what is being taught in the numerous platforms can leave some even more confused than when they started. What about for those of you who already have a solid baseline of understanding of cannabis and are seeking continued professional development? Where do you go for educational opportunities? How do you decipher between quality and propaganda?

First and foremost, peer-reviewed and published scientific literature is always a reliable source. Yes, you should still evaluate and critique all published work, but the mere fact that a paper has already gone through some review process is a good starting point for a minimal level of assurance. Keep in mind the key term “peer-reviewed.” Just because something is published doesn’t mean it has been reviewed by others for quality, accuracy, and an absence of bias.

From the perspective of live or online courses, they abound! And – they can be expensive! There is no single formula that can help predict how good the educational content will be when signing up to learn about cannabis. However, like all other conferences, there are a few guidelines that you can follow to better evaluate the course content ahead of time. Of course much of this also depends on the level of knowledge that you are starting with and what your overall goals are toward learning about a specific aspect of cannabis.

The first simple step is to review the promotional materials: website, flyers, save the date cards, etc. Look for professional quality, images, typos, etc. These are basic things that should raise a red flag. If you find careless wording or blurred photos, you might want to just wonder if the same lack of attention to detail will be presented in the course delivery. You should also look carefully for the following components related to the course on the promotional materials:

Program and/or Course Title: As simple as it sounds, the title of a program and its inclusive presentation topics may provide you with a sense of the quality and competence of the course. Titles can give you a glimpse into the scientific level of the content as well as the “low key laid back” approach to the delivery. This is not to say that you should always judge the book by its cover, but it is an easy starting point for a review process.

Learning Outcomes or Program Goals: A 1- or 2-day course can be themed and focus on a very specific topic such as the endocannabinoid system, or it can have a variety of topics that range from CBD and forms of application to the entourage effect of various cannabinoids. The choice is yours, depending on your goals of learning and levels of interest. While not everyone is an expert in using Bloom’s taxonomy to state course and presentation goals, those who do use such higher level of learning words such as “solving”, ‘detecting”, or “validating” reflect a deeper expectation as compared to words such as “identifying”, “estimating”, or “comparing”. Again, these are examples, but those who present more often and are tasked with writing goals and objectives will be more familiar with using higher level terms. It is easy to search online for an example of Bloom’s taxonomy of words. One thing to also consider is who is identified as the target audience. Be sure that you fit into this category or else you may feel as though you are in the wrong room!

Speaker Credentials: A series of alphabet letters after one’s name does not automatically translate to excellence at the podium. Credentials go beyond letters as they include accomplishments that contribute to the body of work in the area of the content being presented. We have all been to presentations where “heavy-hitting” named speakers disappointed us as well as listening to some of the best presentations delivered by speakers we never previously have heard of. It is also important to correlate the speaker’s presentation and know whether or not the individual has any potential conflicts of interest or biases in any way. This could influence the presentation and not provide you with a true reflection of the facts. Do your homework, ask around, have some familiarity with individuals as best you can to maximize your valuable time.

Registration Fees & Cancellation Policy: This can be a tricky area to consider. Think about it, if a course fee is very low, would you not assume there may be a lack of quality? After all, we equate lower costing items with lesser quality products. Do professional development continuing education programs fall under this similar assumption? Yet, if the course was very high priced – as some are tremendously overpriced especially in the online cannabis space – will it truly deliver a valuable package to you or is it a quick money grab? It is also helpful to view the cancellation policy. Any policies that just simply don’t appear to be “user friendly” would raise a red flag to me. Life happens, and if companies putting on courses are unwilling to recognize this I would likely turn toward another program. Refunds that can be applied elsewhere toward a future course are good options, and refunds minus a reasonable administrative fee are also fare. After all, companies may have spent a respectable amount of funds marketing and promoting the course, agreeing to speaker fees, renting room space and/or AV equipment, etc. But any program that refuses to honor a refund in any manner within a reasonable time for such a request is simply not acting in good faith. Such programs operating in this manner will ultimately lose clients and word of mouth will spread fast.

Professional Credits Offered: One item to consider is whether or not the program offers formal credits such as CME’s or CEU’s. Programs that formally offer credit that has been granted by your professional associations reflect a minimal standard of review and expectations that inform you of a higher level of quality to begin with. This doesn’t mean there may not be less than admirable speakers or some with great knowledge and poor presentation skills. It does mean that some vetting process has occurred at least through a paper review and typically those looking to simply put on a program and make a quick buck will not go through the approval efforts.

This is just a snapshot of some suggestions for reviewing cannabis educational courses. All of us have different experiences and we play a role in helping to bring efficacy not only to the science and clinical aspects of cannabis integration but also to ensure proper, factual, and efficacious education is being transmitted to our stakeholders.

Dr. Jeff G. Konin is a Clinical Professor in the Department of Athletic Training in the Nicole Wertheim College of Nursing and Health Sciences at Florida International University (FIU) where he directs the Global Initiative for Cannabinoid Research and Education. To learn more about FIU’s cannabinoid research and education initiative you can visit their website at https://go.fiu.edu/GlobalCannabis. Views represented in this column do not reflect that of Florida International University and are solely attributed to Dr. Jeff G. Konin.

 




Clearmind aims to initiate clinical trials with CMND-100 by year’s end

VANCOUVER, May 26, 2022  — Clearmind Medicine Inc. (CSE: CMND, OTC Pink: CMNDF,FSE: CWY0) (“Clearmind” or the “Company“), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, has completed a highly constructive Pre-Investigational New Drug Application (“pre-IND“) meeting with the U.S. Food and Drug Administration (“FDA“) to discuss the development of the Company’s MEAI- based proprietary compound CMND-100.

“The FDA’s interest in CMND-100 as a potential therapy for alcohol use disorder was extremely encouraging,” said Dr. Adi Zuloff-Shani, Clearmind’s CEO. “Their feedback to the proposed development program was positive, and we are working diligently towards initiating the clinical trials with CMND-100 by the end of 2022.”

CMND-100, Clearmind’s lead product that is based on MEAI, a novel psychoactive compound, exerts a significant reduced desire to consume alcoholic beverages, and the company is developing it as a candidate therapy for the treatment of Alcohol Use Disorder (“AUD“). Clearmind submitted a pre-IND meeting package to the FDA in April; it included an overview of the development program, and questions about the regulatory requirements for opening an investigational new drug (“IND“) application.

Opening an IND is required for conducting clinical trials in the United States and ensures that trials are designed in accordance with the data requirements for FDA marketing approval. The written responses, and the responses provided in a teleconference with FDA representatives, were constructive and supportive

“It’s critical to have such open discussions with regulatory officials. It helps us efficiently and effectively follow the requirements and guidance toward approval,” Zuloff-Shani said.

AUD is a chronic relapsing brain disorder characterized by an impaired ability to stop or control alcohol use despite negative social, occupational, or health consequences. Alcohol is the third most-common preventable cause of death in the United States, where an estimated 5.8% of the population (over 18 million people) struggle with the condition. It is assumed that CMND- 100 suppresses the desire to drink alcohol by potentially innervating neural pathways such as 5-HT1A that lead to “sensible behavior.”

About Clearmind Medicine Inc.

Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.

The Company’s intellectual portfolio currently consists of five patent families. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on the Canadian Securities Exchange under the symbol “CMND“, the Frankfurt Stock Exchange under the symbol “CWYO” and on the OTC Markets under the symbol “CMNDF“.




Pre-clinical trial based on the proprietary combination demonstrates high safety profile in addition to a significant suppressive effect on alcohol consumption

Vancouver, May 24, 2022  — Clearmind Medicine Inc. (CSE: CMND, OTC Pink: CMNDF, FSE: CWY0) (“Clearmind” or the “Company“), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major undertreated health problems, today announced positive safety profile results from its joint pre-clinical trial with SciSparc Ltd. (NASDAQ: SPRC), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system (“SciSparc“).

The trial evaluated the proprietary combination of Clearmind’s proprietary psychedelic molecule MEAI and SciSparc’s CannAmide™ for treating alcohol consumption.

“We are extremely pleased with these positive results that once again strengthen our belief in the potential of our novel propriety psychedelic molecule MEAI,” said Dr. Adi Zuloff- Shani, Clearmind’s Chief Executive Officer. “The results continue to suggest a high safety profile of the joint venture psychedelic combination treatment. We plan to further explore the safety and efficacy of combining our novel technology with Clearmind’s novel molecule.”

Earlier trials successfully showed a significant dose-dependent effect for MEAI treatment in reducing alcohol consumption in mice, with an additional significant effect achieved when combining CannAmide™ with a lower sub-effective MEAI dose. These positive results follow previously announced results showing that alcohol consumption was significantly reduced following treatment with MEAI at a dose of 40 mg/kg and higher (p<0.01) compared to consumption before treatment.

A histopathology assessment was conducted to determine safety of the proprietary combination of MEAI and CannAmide vs. control (mice that were not exposed to alcohol). Several organs (heart, lungs, liver, kidneys, brain, pancreas, spleen, and thyroid gland) were harvested from all experiment groups (n=3-5 per group) and evaluated for impairment. The severity of impairments was scored by a 5-point scale by a qualified blinded toxicologist (Schafer et al., Toxicol Pathol 2018, 46:256-265). Results indicated a high safety profile of the combination treatment with no treatment-related changes observed.

Alcohol consumption was significantly reduced following dual treatment with 25 mg/kg CannAmide™ in addition to MEAI at a dose of 20 mg/kg and compared to consumption before treatment. The mice were provided with 20% alcohol solution for 24 hours, three times a week for seven weeks, and were treated every day with MEAI or MEAI/CannAmide™ during the last two weeks of alcohol treatment. The alcohol consumption was measured by weighing the alcohol bottles before and after; water consumption was measured similarly in parallel.

About Clearmind Medicine Inc.

Clearmind is a biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder, binge eating and depression.

The Israeli-Canadian company holds several patents for the non-hallucinogenic compound MEAI. The company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

The company’s intellectual portfolio currently consists of five patent families. The company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on the Canadian Securities Exchange under the symbol “CMND”, the Frankfurt Stock Exchange under the symbol “CWYO” and on the OTC pink under the symbol “CMNDF”.

About SciSparc (NASDAQ:SPRC):

SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. Our focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the company is currently engaged in the following drug development programs based on THC and/or non-psychoactive cannabidiol (CBD): SCI-110 for the treatment of Tourette syndrome, for the treatment of obstructive sleep apnea and Alzheimer’s disease and agitation; SCI-160 for the treatment of pain; and SCI-210 for the treatment of autism spectrum disorder and status epilepticus.




May 10, 2022 – Emerging industries require a skilled workforce to function. Sometimes, the industry begins to boom before employers can hire a sufficient number of skilled employees. That was the case for many employers in the medicinal plant industry, which includes crops like hemp, kava and kratom. Faculty from two University of Florida colleges worked together to help meet that demand with a new course.

Developed by the UF/IFAS College of Agricultural and Life Sciences and the UF College of Pharmacy, the course addresses the skill sets required to help launch new, emerging crops. Labs taught students skills in propagation, germination, extraction and analysis and everything in between.

“Employers in emerging industries have issues finding employees that understand plant production and extraction for medicinal use,” said Brian Pearson, a UF/IFAS assistant professor who developed and taught the course. “There is a major gap of potential employees with this skill set, and it is impacting producers. This course teaches a different skill set from what current course offerings prepare students for.”

Driven by industry need and student interest, Pearson and UF College of Pharmacy Professor Chris McCurdy teamed up to establish and teach the course. The partnership provided faculty expertise on both the plant production and medicinal side of the industry.

“UF is in a unique position to offer such a course because we have UF Health and UF/IFAS all under one umbrella which is a great strength,” said McCurdy. “To be able to offer the horticulture and cultivation training would be something that could happen at any agricultural program, but to add in-depth understanding of the medicinal properties, compounds responsible for biological activity in animals and/or humans is a unique opportunity that gives our students an advantage over others in the field.”

Students enrolled in the course varied in their interests and goals but found inspiration from the course content and the ability to interact with many expert faculty.

“I believe that botanical medicine offers a wealth of untapped potential, especially in terms of offering alternative treatment options for those who may not respond to conventional therapies,” said Daniela Perez Lugones, a graduate student studying horticultural therapy. “I hope to work with individuals recovering from substance-use disorder. While it is not the job of the horticultural therapist to prescribe medicines, I believe that any insight I can gain on how plants can offer these additional therapeutic benefits and how their secondary metabolites interact with the human body will facilitate better understanding and connection with my clients.”

Another student – who is a current grower and master’s student – took this course to help him reach future business goals.

“My goal is to one day create a restaurant centered around medicinal plants to help people eat a bit healthier, without sacrificing flavor,” said Jansen Mitchell Gedwed. “I would also like to use this knowledge to help integrate medicinal cooking and plant production into community gardens and other community focused organizations. The education provided to students in this course is critical for furthering the safe growing, consumption and processing of medicinal plants.”

While this course may be new, the research partnership between UF/IFAS and the College of Pharmacy is well established.

The two teams already unite on projects such as research in the chemistry and pharmacology of plant-produced chemicals with plant cultivation and growing techniques that influence the production of these chemicals. These cross-functional research projects help scientists understand the best ways to grow medicinal plants to benefit farmers and the consumers who will ultimately purchase the products these plants become.

“This is the most exciting time in my career,” said McCurdy. “This work with UF/IFAS gives us the potential to really understand how to cultivate these plants as a crop that could benefit the farmers in our state while helping to treat the population of our state that needs this plant. We use kratom in our research, but this could be just the tip of the iceberg for additional projects with more medicinal plants.”

Crop diversification is important for farmers and sometimes helps replace other crops that are experiences losses or a decrease in value due to market fluctuations.

“There have been decreases in crops that have a long legacy in Florida and being able to support these new emerging industries that can help a grower’s bottom line is critical,” said Pearson.

Special thanks to Roseville Farms and AgriStarts, who provided tours of their facilities and plant products to use in the lab that gave students hands-on experiences in the industry.

“We’re really thankful for the industry support we received for this course,” said Pearson. “Students did research, provided UF/IFAS Extension to growers from the research they conducted all while learning. All three missions of the land grant mission worked together to make this course a huge success.”

 

ABOUT UF/IFAS
The mission of the University of Florida Institute of Food and Agricultural Sciences (UF/IFAS) is to develop knowledge relevant to agricultural, human and natural resources and to make that knowledge available to sustain and enhance the quality of human life. With more than a dozen research facilities, 67 county Extension offices, and award-winning students and faculty in the UF College of Agricultural and Life Sciences, UF/IFAS brings science-based solutions to the state’s agricultural and natural resources industries, and all Florida residents.