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Calls for more testing have been a watchword of both cannabis reform advocates and opponents alike for many years.
However, now is a really good time for cannabis companies to consider sponsoring medical trials across Europe for their cannabis products. This is why:
The Current Environment On The Ground
Germany is Europe’s biggest consumer of both prescription medications and medical devices dispensed by prescription. It is, as a result, Europe’s most valuable drug market. And ground zero for every international cannabis company right now as a result.Targeting Germany for your latest pharmaceutical product is difficult no matter who you are.
Here, however, are a few problems that face every pharma manufacturer, far beyond cannabis. Targeting Germany for your latest pharmaceutical product is difficult no matter who you are.
- The vast majority by euro spending on all drugs and devices dispensed by prescription must be pre-approved. To add to this problem, before they can be prescribed, new drugs must get on the radar of doctors somehow. To put this in stark relief, the entire prescription drug and medical device annual spend is about 120 billion euros a year in Germany. Only 20 billion euros of that, however, may be obtained relatively easily (without pre-approval from an insurer). Preapproval also only comes when there is trialor other scientific evidence of efficacy.
- There are strict rules banning the advertising of prescription drugs to patients and highly limiting this outreach to doctors.
- There are strict rules prohibiting the use of the word “cannabis” to promote anything.
- There is a strong reliance on what is called “evidence-based medicine.” That means that large numbers of doctors and insurance company approvers need to see hard data that this drug or device actually works better than what is currently on the market.
How then, is a new drug supposed to get on the radar of those who prescribe the drug? Or patients?
If this sounds like an impossible situation to navigate, do not despair. There is a way out.
The Impact of the European Medicines Agency
This agency has been much in the news of late. Namely, the British do not want to exclude themselves from the regulatory umbrella of this organization.
Largely unknown outside Europe, this agency actually has a hugeinfluence on how drugs are brought into the region. Specifically, this is the EU-wide agency (aka the EMA) that both regulates all drugs within Europe, but has also, since 2016, been making clinical reports submitted by pharmaceutical companies, available to anyone who asks for them. That includes doctors, members of the public and of course, the industry itself.
In the middle of July, the agency also published a report on the success of its now three-year-old program, including the usage of its entry website. Conveniently written in English, it is possible to easily search new trial data, which, also now must be made public.
Medical trial data, in other words, that can be created by sponsored cannabis company backed trials.
It remains the best way to get patients, doctors and insurance companies familiar with new drugs. Or even new uses for old drugs in the case of cannabis.
Will Trials Move Legalization Discussions?
However,there are no other cannabis companies in the position of GW Pharma – namely with a monopoly on a whole country (the UK), where it alone can legally grow cannabis crops and process the same into medication and further for very profitable export. In addition, even more disturbingly, and clearly an era that is coming to an end, the vast majority of British patients have been excluded from access to cannabis except in the case of GW Pharma products.
The current row over expanded medical use in the UK, in fact, was triggered by two things. The failure of the latest GW Pharma trial for drug resistant epilepsy in Eastern Europe. And the deliberate importation by several desperate families, of good old cannabis (CBD) oil into the UK. No medical processing required.
However, that is the UK.
Other cannabis companies can take a page out of the company’s handbook. All that is required for faster market entry, is a slightly altered recipe.
By sponsoring cannabis-related trials in each country they want to enter, starting with Germany, cannabis companies can literally put themselves on the medical map.
Because doctors, patients andother researchers will be easily able to see and access country-specific medical data on each use of cannabis covered by a trial, per EU country. All made possible, of course, by the new open door policy of the EMA.
Growing the Medical Market
While this may sound like an “expensive” proposition, there are really few other alternatives. And with no advertising budget, plus a marketing budget that must include outreach to everyone in the supply chain including doctors, distributors and even pharmacies, the trial approach in the end may be the most efficacious in broadening both the demand and market. Not to mention the cheaper option.
How such a trial strategy might be coordinated at a time when domestic cultivation is still on hold is still a question. However for those companies considering market entry and cultivation bid if not domestic processing strategies for their products is an industry strategy that will pay off in spades.
Its role in the legalization of cannabis as medicine, as well as the speedier introduction of new drugs overall into the European system,cannot be underestimated, even if it is currently underutilized by the cannabis industry specifically now.
The post The Importance of Medical Cannabis Trials In Europe appeared first on Cannabis Industry Journal.read more
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The National Cannabis Industry Association (NCIA) announced earlier this week the release of two white papers at their Cannabis Business Summit in San Jose, California. The first white paper, dedicated to cannabis testing policy, offers recommendations for state’s addressing cannabis testing, advising them on how to write rules for the testing market.“As wonderful as cannabis is, we’ll face a crisis together as an industry way too soon. When it happens, the key will be how we respond to it,” says Moss.
The NCIA Policy Council is like a think tank for helping for and shape state and federal level policy related to cannabis. Kurshid Khoja, principal at Greenbridge Corporate Counsel and member of the Policy Council, says this release of the testing policy recommendations demonstrates how we can help shape policy on the state level. “As both an NCIA Board member and a member of the Policy Council, I am really excited about the Council’s work,” says Khoja. “Somewhat under the radar, the Policy Council is establishing itself as the think tank for the cannabis industry. On topics ranging from tax policy to pesticides to international competition, the Policy Council is churning out quality papers to raise awareness and educate policy makers in DC. With the release of its testing policy recommendations this week, the Policy Council is demonstrating that it could also help shape policy on the state level.”
The second white paper is meant to provide guidance to businesses dealing with crisis communications. The manual describes best practices in crisis communications, showing businesses how to identify and avoid potential public communications issues in the cannabis industry.
Jeanine Moss, Crisis Manual Subcommittee Chair of NCIA’s Marketing & Advertising Committee, says the creation of a crisis manual is meant to preempt problems we might face soon in the cannabis industry. “As wonderful as cannabis is, we’ll face a crisis together as an industry way too soon. When it happens, the key will be how we respond to it,” says Moss. “That’s why we think it is so important for NCIA members to have an easy and practical guide that can not only help protect businesses during a crisis, but also the industry as a whole. This manual will help businesses prevent problems, keep issues from spiraling out of control, and share positive messages during times of stress.”
The guides will be presented this week at the NCIA’s Cannabis Business Summit & Expo in San Jose, California.read more
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Peer to peer payment technologies are on the rise with trustworthy apps such as Venmo, PayPal and Zelle. It’s a tough business to be a part of when you don’t have the numbers or the credibility, as demonstrated by Snapchat which will soon be terminating Snapcash.
TechCrunch made this discovery thanks to a code buried on the Snapchat Android app, which stated that Snapcash will no longer be available after an unknown date. The website contacted Snapchat for comment and the company replied confirming that Snapcash’s services would on August 30th, and so would their partnership with Square Inc.
“Yes, we’re discontinuing the Snapcash feature as of August 30, 2018. Snapcash was our first product created in partnership with another company – Square. We’re thankful for all the Snapchatters who used Snapcash for the last four years and for Square’s partnership!”
Aside from the low amount of users that Snapchat has been reporting, TechCrunch claims that Snapcash had a reputation for being used to pay for erotic content and for the services of adult performers. These rumors are unconfirmed but closing a service to avoid a PR scandal sounds like a good explanation behind this decision.
Snapchat is still trying to survive, developing it’s services and trying to become a more commerce oriented application. While the company has been forced to let go of employees, it’s still planning to introduce new features that allow users to shop within the app. Snapchat’s Android code contains a feature called “Eagle”, which would gives users the ability to scan a barcode with the app’s camera, showing them the results on Amazon. It’s not known if this feature will debut any time soon.
The post Snapchat Is Having A Rough Time And Is Forced To Shut Down Snapcash appeared first on The Fresh Toast.read more
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After a rough year that prevented Bitcoin investors from sleeping soundly, the cryptocurrency finally found its footing again, making a comeback that now values the coin at over $7,000. All of those investors can continue to annoy people by telling them that “Bitcoin really is the investment of the future.” Until it flops again, which it most certainly will.
Mashable reports that even though users of Reddit, Twitter, and all sorts of places were celebrating, it was only last December that Bitcoin was valued at $19,000. And now, less than a year later, it’s worth less than half of that price.
bitcoiners look at this sort of thing and think “this is good. this proves that bitcoin is good. this really proves the detractors wrong. this is natural and organic. satoshi please strip the flesh from my bones” pic.twitter.com/BsvRCXWDxx
— Buttcoin (@ButtCoin) July 17, 2018
No one knows how to predict Bitcoin and what to do when the price soars, but it’s important for those investors and Bitcoin believers to tread carefully. Or not. As billionaire Marc Lasry says, “Bitcoin investors will be making 5 to 10 times their money in 3 to 5 years.” John McAfee — another Bitcoin believer and the guy who created the anti-virus software that has existed since the beginning of time — agrees with this sentiment. He believes Bitcoin will hit the $1 million mark by 2020.
Related Story: HTC Is Developing Phones That Are Blockchain Friendly
Where does all of this certainty comes from? Most people don’t know. For now, Bitcoin has yet to find stability even though it’s been around for nine years. At the very least, it has survived another day.read more
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Editor’s Note: The views expressed in this article are the author’s opinions based on his experience working in the laboratory industry. This is an opinion piece in a series of articles designed to highlight the potential problems that clients may run into with labs.
In the last two articles, I discussed the laboratory’s first line of defense (e.g. certification or accreditation) paperwork wall used if a grower, processor or dispensary (user/client) questioned a laboratory result and the conflicts of interest that exist in laboratory culture. Now I will discuss the second line of defense that a laboratory will present to the user in the paperwork wall: Quality Control (QC) results.
Do not be discouraged by the analytical jargon of the next few articles. I suggest that you go immediately to the conclusions to get the meat of this article and then read the rest of it to set you on the path to see the forest for the trees.
QC in a laboratory consists of a series of samples run by the laboratory to determine the accuracy and precision of a specific batch of samples. So, to start off, let’s look at the definitions of accuracy and precision.QC Charts can provide a detailed overview of laboratory performance in a well-run laboratory.
According to the Standard Methods for the Examination of Water and Wastewater:
Accuracy: estimate of how close a measured value is to the true value; includes expressions for bias and precision.
Precision: a measure of the degree of agreement among replicate analyses of a sample.
A reputable laboratory will measure the Accuracy and Precision of QC samples in a batch of user samples and record these values in both the analytical test report issued to the user and in control charts kept by the laboratory. These control charts can be reviewed by the user if they are requested by the user. These control charts record:
Accuracy (means) chart: The accuracy chart for QC samples (e.g., LRB, CCV, LFBs, LFMs, and surrogates) is constructed from the average and standard deviation of a specified number of measurements of the analyte of interest.
Precision (range) chart: The precision chart also is constructed from the average and standard deviation of a specified number of measurements (e.g., %RSD or RPD) for replicate of duplicate analyses of the analyte of interest.
Now, let’s look at what should be run in a sample batch for cannabis analyses. The typical cannabis sample would have analyses for cannabinoids, terpenes, microbiological, organic compounds, pesticides and heavy metals.
Each compound listed above would require a specific validated analytical method for the type of matrix being analyzed. Examples of specific matrixes are:
- Cannabis buds, leaves, oil
- Edibles, such as Chocolates, Baked Goods, Gummies, Candies and Lozenges, etc.
- Vaping liquids
- Topicals, such as lotions, creams, etc.
Running QC analyses does not guarantee that the user’s specific sample in the batch was analyzed correctly.
Also, both ISO 17025-2005 and ISO 17025-2017 require the use of a validated method.
ISO 17025-2005: When it is necessary to use methods not covered by standard methods, these shall be subject to agreement with the customer and shall include a clear specification of the customer’s requirements and the purpose of the test and/or calibration. The method developed shall have been validated appropriately before use.
ISO 17025-2017: The laboratory shall validate non-standard methods, laboratory-developed methods and standard methods used outside their intended scope or otherwise modified. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application.
Validation procedures can be found in a diverse number of analytical chemistry associations (such as AOACand ASTM) but the State of California has directed users and laboratories to the FDA manual “Guidelines for the Validation of Chemical Methods for the FDA FVM Program, 2nd Edition, 2015”
The laboratory must have on file for user review the following minimum results in an analytical statistical report validating their method:
- limit of quantitation,
- precision,The user must look beyond the QC data provided in their analytical report or laboratory control charts.
- linearity (or other calibration model),
- confirmation of identity
- spike recovery.
- limit of detection,
- measurement uncertainty,
The interpretation of an analytical statistical report will be discussed in detail in the next article. Once the validated method has been selected for the specific matrix, then a sample batch is prepared for analysis.
Sample Batch: A sample batch is defined as a minimum of one (1) to a maximum of twenty (20) analytical samples run during a normal analyst’s daily shift. A LRB, LFB, LFM, LFMD, and CCV will be run with each sample batch. Failure of any QC sample in sample batch will require a corrective action and may require the sample batch to be reanalyzed. The definitions of the specific QC samples are described later.
The typical sample batch would be set as:
- Instrument Start Up
- Calibration zero
- Calibration Standards, Quadratic
- Sample used for LFM/LFMD
- Samples (First half of batch)
- Samples (Second half of batch)
The QC samples are defined as:
Calibration Blank: A volume of reagent water acidified with the same acid matrix as in the calibration standards. The calibration blank is a zero standard and is used to calibrate the ammonia analyzer
Continuing Calibration Verification (CCV): A calibration standard, which is analyzed periodically to verify the accuracy of the existing calibration for those analytes.
Calibration Standard: A solution prepared from the dilution of stock standard solutions. These solutions are used to calibrate the instrument response with respect to analyte concentration
Laboratory Fortified Blank (LFB): An aliquot of reagent water or other blank matrix to which known quantities of the method analytes and all the preservation compounds are added. The LFB is processed and analyzed exactly like a sample, and its purpose is to determine whether the methodology is in control, and whether the laboratory is capable of making accurate and precise measurements.
Laboratory Fortified Sample Matrix/Duplicate (LFM/LFMD) also called Matrix Spike/Matrix Spike Duplicate (MS/MSD): An aliquot of an environmental sample to which known quantities of ammonia is added in the laboratory. The LFM is analyzed exactly like a sample, and its purpose is to determine whether the sample matrix contributes bias to the analytical results. The background concentrations of the analytes in the sample matrix must be determined in a separate aliquot and the measured values in the LFM corrected for background concentrations (Section 9.1.3).Laboratories must validate their methods.
Laboratory Reagent Blank (LRB): A volume of reagent water or other blank matrix that is processed exactly as a sample including exposure to all glassware, equipment, solvents and reagents, sample preservatives, surrogates and internal standards that are used in the extraction and analysis batches. The LRB is used to determine if the method analytes or other interferences are present in the laboratory environment, the reagents, or the apparatus.
Once a sample batch is completed, then some of the QC results are provided in the user’s analytical report and all of the QC results should be recorded in the control charts identified in the accuracy and precision section above.
But having created a batch and performing QC sample analyses, the validity of the user’s analytical results is still not guaranteed. Key conclusion points to consider are:
- Laboratories must validate their methods.
- Running QC analyses does not guarantee that the user’s specific sample in the batch was analyzed correctly.
- QC Charts can provide a detailed overview of laboratory performance in a well-run laboratory.
The user must look beyond the QC data provided in their analytical report or laboratory control charts. Areas to look at will be covered in the next few articles in this series.
The post Quality Plans for Lab Services: Managing Risks as a Grower, Processor or Dispensary, Part 3 appeared first on Cannabis Industry Journal.read more
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Now that governments are legalizing cannabis around the world, the question looms for cannabis businesses seeking legitimacy in the new industry: what safety standards should apply? This question is more difficult as different jurisdictions grapple with defining and implementing legal requirements and struggle to keep up with the pace of growth.
For visionary cannabis business, it makes sense to anticipate requirements – not only from governments, but also from consumers and partners. Most regulations currently focus on security and basic health issues but, in the long-term, the industry that may offer the best model for cannabis businesses isn’t pharmaceuticals, but food. Cannabis (especially edibles) share similar hazards and traceability challenges with food products, so taking the lead from the food industry will be much more applicable and could offer greater benefits.
Companies that achieve the highest and most flexible certification will enjoy a crucial competitive advantage when it comes to winning market share, popularity and consumer trust. Let’s take a quick look at the different options of food safety (and quality) certifications that cannabis businesses may consider. But first, let’s clarify two important definitions that are necessary to understand the food industry.
Basic Concepts from the Food Industry
The first acronym you should be aware of is GFSI, the Global Food Safety Initiative. GFSI is a food industry-driven global collaboration body created to advance food safety. When it comes to understanding GFSI, the important part to note is that certifications recognized by GFSI (like SQF, FSSC 22000, and BRC) are universally accepted. Companies operating under GFSI-recognized certifications open the most doors to the most markets, providing the highest potential for growth. For this reason, cannabis companies should be aware of and seriously consider seeking GFSI certifications
Secondly, many food safety programs are built around Hazard Analysis Critical Control Points, or HACCP. While many people may talk about HACCP like it’s a certification in and of itself, it is not actually a certification like the others on this list, but rather a methodology that helps companies systematically identify and control biological, chemical, and physical hazards that may arise during food production, handling, and distribution. Companies that adopt this methodology end up with a HACCP plan, which must then be followed at all times to avoid and address health and safety issues. It’s often required for food businesses and is generally required in most of the world, except where ISO 22000 is more common, primarily in Europe and countries whose primary export market is European. Since HACCP plans are also incorporated into most of the other achievable certifications, developing a HACCP program early will build a strong foundation for higher levels of certification.
Certifications for the Cannabis Industry
Now that we understand the basics of GFSI and HACCP, we can see how the certifications that have been developed by and for the food industry may apply to cannabis companies – and which you should consider necessary for your business.
GMP: Good Manufacturing Practice Certification
GMP (or sometimes cGMP) certification requires that companies abide by a set of good manufacturing processes for food and beverage products, pharmaceuticals, cosmetics, dietary supplements and medical devices. Since it really only covers basic sanitation and employee hygiene, it is considered the lowest level of certification in the industry. It is not recognized by GFSI, but GFSI does require all the standard benchmarks of a GMP be met before granting GFSI certification.
While GMP certification is often required, it is far below the standard that should be upheld by any serious businesses. It doesn’t cover many of the different types of hazards associated with food production – that I have argued will become increasingly relevant to cannabis producers – and doesn’t provide a systematic approach to identifying and controlling hazards like a HACCP program would. It’s really just about providing the basic procedures and checks to ensure that the facility is clean and that employees aren’t contaminating the products.
Final Verdict: Recommended, but as the bare minimum. GMP is not sufficient on its own to adequately control the risk of recalls and foodborne illness outbreaks, and it limits a company’s market potential because it lacks the GFSI worldwide stamp of approval.
Some companies consider GMP certification a good place to start if you’re on a tight deadline for distribution in markets where only GMP is required by regulators. I would argue that striving for the minimum standards will be costly in the long run. Health, safety and quality standards are the foundations upon which winning companies are built. It’s critical to develop a corporate culture that will lead to GFSI-recognized programs without major organizational overhaul. Start on the right foot and set your sights higher – obtain a certification that will stand the test of time and avoid the pain and risks of trying to change entrenched behaviors.
SQF: Safe Quality Food Program Certification
SQF is my number one recommendation as the best certification for the cannabis industry. One of the most common certifications in North America, SQF is a food safety management system recognized by retailers and consumers alike. It is administered by the Food Marketing Institute (FMI) and, importantly, recognized by GFSI, which gives companies a huge competitive edge. SQF focuses on the whole supply chain.
SQF was also the first to develop a cannabis program and is currently the leader in this market segment. It is also the scheme that best integrates food safety with quality. Since it is recognized worldwide, SQF provides the greatest leverage to accelerate a company’s growth. Once obtained, products with SQF certification can often jump the queue to enter different regulatory markets.
Final verdict: Highly recommended. A cannabis company with an SQF certification has the greatest advantage because it offers the broadest worldwide reach and keeps companies a step ahead of competitors. It’s also achievable – just this past April, Curaleaf Florida ostensibly became the first cannabis company to achieve SQF certification. It is tough, but fair and practical.
Other Certification Standards
SQF is the top certification that should be considered by cannabis companies, especially outside of Europe. However, the food industry has several other major types of standards that, at this time, have limited relevance to the cannabis industry today. Let’s take a quick look.
When considering GFSI-recognized programs, the main choice for food companies is between SQF, which we’ve covered, and BRC (the British Retail Consortium Certification). BRC has the most in common with SQF but, while SQF was originally developed for processed foods, BRC was developed in the UK for meat products. Today, they are quite similar, but BRC doesn’t focus quite as much on the quality component as SQF does. While BRC could be a good option, they don’t have a program for cannabis and, thus far, do not appear to be as friendly toward the cannabis industry.The food industry has a lot to offer cannabis companies that are anticipating future regulatory changes and market advantages
Across the pond, there are a few other certification standards that are more common than SQF. One of these is ISO 22000, which is the certification for the food-related standard created by the International Organization for Standardization (ISO) in Europe. It is not recognized by GFSI but is the primary system used in Europe. If your market is exclusively in the EU, it might be a good choice for you in the future. However, to date, there is no indication that any cannabis company has achieved ISO 22000 certification. Some cannabis companies have attained certification for other ISO standards like ISO 9001:2015, which specifies requirements for quality control systems, and ISO/IEC 17025 for laboratory testing. These are generally more relevant for the pharmaceutical industry than food and beverage, but still apply to cannabis.
There is the perception that cannabis is more accepted in EU countries like the Netherlands, but the regulatory attitude to cannabis is complicated. In the Netherlands, for example, cannabis isn’t actually legal – “coffee shops” fall under a toleration policy that doesn’t include regulation. Medical cannabis in the Netherlands is all produced by one supplier and several countries in the EU allow for licensed distribution and import, but not domestic production. Various EU countries are trying to keep up with the legalization trend, however. The Czech Republic, Germany, and others all recently introduced legislation for domestic production of cannabis for medical use. For companies with their eye on the EU, it is crucial to watch which regulatory requirements will be implemented in each market and how.
The last certification standard to mention is the result of a compromise between ISO and the more HACCP oriented programs like SQF. FSSC 22000 (Food Safety System Certification) tries to address the gaps between ISO 22000 and GFSI-recognized certifications by introducing another component called PAS 220. Since it is recognized by GFSI, FSSC 22000 is starting to get more traction in the food industry because it makes products a bit easier to export to the EU. FSSC 22000 satisfies the EU ISO standards but isn’t as closely tied to HACCP. We will be keeping an eye on this one.
The food industry has a lot to offer cannabis companies that are anticipating future regulatory changes and market advantages – but it’s difficult for cannabis companies to understand all the options available and how each apply to their specific products. While markets adjust beyond the preliminary issue of legality, it’s crucial for companies to look forward and comply with safety and quality standards like SQF. Companies who strive for SQF certification (or other GFSI-recognized certifications as they become available) will find themselves far better prepared to seize market share as cannabis markets blossom.
The post Which Safety Standards Work Best for the Cannabis Industry? appeared first on Cannabis Industry Journal.read more
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The projected growth of the legal cannabis market is astounding. According to a report from BDS Analytics, the industry is expected to grow from $9.2B to $47.3B in 2027 in North America, with medical cannabis contributing 33% of that overall growth. While this number is impressive for an industry still in its infancy, I have reason to believe it can be much higher.
In the pharmaceutical industry, treatment of pain and insomnia represent an annual revenue exceeding $140B; concurrently, studies have shown cannabis to be an effective treatment for both conditions. If medical cannabis can capture 10% of that revenue over the next ten years, it essentially doubles the current estimates mentioned above.
So, what stands in our way? Education.
To gain acceptance from the medical community, physicians need to better understand the plant and its therapeutic benefits. To do so, they need more substantial data to prove cannabis’ efficacy before prescribing it to their patients. However, federal illegalities have prevented government-mandated clinical studies, but I believe there’s another way.
By adopting a collaborative health care model, patients and caregivers can work together to track the effectiveness of their cannabis treatments and share their learnings with the larger medical community. With the right tools in place, we can fast-track the research process and provide physicians and politicians with the information they need to make this medicine more approachable and accessible to those who could benefit from it.
By harnessing the power of the community, we can apply learnings from one patient’s cannabis use to help countless others.The Spine Patient Outcomes Research Trial (SPORT) was a five-year study consisting of approximately 2500 patients with back and spine conditions. Participants entered qualitative data into an online portal, including post-surgical results and patient outcomes, to provide a comprehensive insight into treatment methods and their efficacy. Today, others suffering with those same conditions can enter their personal information into an online calculator and receive a prospective treatment plan. Together, patients and their doctors can view results and build a customized plan using more informed decisions about the available treatment options.
Another example comes from OpenNotes– an exploratory study that provides patients with full access to their medical files and the opportunity to input comments about their doctor visits and prognosis and make corrections related to the care they received. Results showed that this process helped patients retain a better understanding of their condition which improved their decision making and resulted in increased adherence to treatment plan protocols because they had greater trust with their doctors.Not only will this improve the patient experience by providing a safer, more sustainable treatment option, it also provides a very significant financial opportunity.
I believe the cannabis industry can take a leadership role in empowering patients to become active participants in their own treatment, while also sharing knowledge with the larger patient and physician communities. In fact, this core belief was the reason I founded Resolve Digital Health. Data-empowered patients not only make better decisions but also enjoy a greater feeling of control over their treatment. The power of collaborative healthcare grows exponentially when the data is shared to educate a broader group. By harnessing the power of the community, we can apply learnings from one patient’s cannabis use to help countless others.
Businesses within the cannabis industry can also leverage this data to create new products and services. For example, insights as to what products work best for certain conditions can help LP’s improve their product offerings and guide recommendations from dispensaries. Through product innovation, companies can make cannabis more accessible to a larger group of patients, who may be currently taking pharmaceuticals. Not only will this improve the patient experience by providing a safer, more sustainable treatment option, it also provides a very significant financial opportunity.
Ultimately, knowledge is power. When patients are empowered to make educated decisions about their health care and doctors are more tuned into the patient-tested cannabis treatment options, it’s a win-win for everyone.
The post Collaborative Health Model to Advance Cannabis Research appeared first on Cannabis Industry Journal.read more
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Are you a product designer in the edible cannabis market? Well, you live at the intersection of the food and pharmaceutical industries and need to know both worlds, utilizing best-practice product development principles, regardless of which industry you are working in. In the cannabis industry, this means knowing your chemistry principles, food science, food safety, Good Manufacturing Practices (GMPs, applicable to the food industry) along with the more intense records and documentation requirements of the pharmaceutical industry.
California is the most recent state to implement legal recreational cannabis. It is estimated to deliver $7.7B in sales by 2021, including a reduction of medical use cannabis and an uptake of adult recreational use. How often do you live at the inception of such a potentially enormous market? Not often, so product developers, here is an opportunity. However, with that opportunity comes the responsibility. A recent emergency legislation adopted by the California Cannabis Safety Branch states:
Operational Requirements Licensees must have written procedures for inventory control, quality control, transportation, security and cannabis waste disposal. Descriptions of these procedures or Standard Operating Procedures (SOPs) must be submitted with the annual license application. Cannabis waste cannot be sold, must be placed in a secured area and be disposed of according to applicable waste management laws. Good manufacturing practices must be followed to ensure production occurs in a sanitary and hazard-free environment, cannabis products are contaminant free and THC levels are consistent throughout the product and within required limits. Extractions using CO2 or a volatile solvent must be conducted using a closed-loop system, certified by a California-licensed engineer. Volatile, hydrocarbon-based solvents must have at least 99% purity. Finally, volatile solvent, CO2 and ethanol extractions must be certified by the local fire code official.
Part of this emergency legislation for all California cannabis product manufacturers is the newly published GMP requirements, which appear to be a combination of food, supplements and HACCP requirements. Helpful resources to learn more about this new California emergency legislation impacting cannabis product manufacturers can be found at the California Manufactured Cannabis Safety Branch with the details of the emergency cannabis regulations.
Once developers have decided on a product, research and education to develop a good understanding of the regulatory environment is a must. For example, in order to develop compliant cannabis edibles, compliance with state, and in some cases local regulations, for food and cannabis must be met. Proactive compliance is a big part of designing a successful product in the most efficient manner.The attention to detail here will create a safe and satisfying experience for consumers as they receive a consistent product every time.
As a product developer you must first know the incoming cannabis plant characteristics to determine what type of cannabinoids they contain to determine what types you wish to source. This requires a strong and well documented supplier program that can identify reliable suppliers of high purity and consistent cannabis raw materials, the same principles that are typically required of food manufacturers. When looking for examples of credible ingredient supplier programs, looking at those used by the food industry is a good start. Make sure supplier management programs apply to all the raw materials and direct-contact packaging that you plan to use in your new product.
Once reliable sources of raw material have been secured, the next challenge is to conduct periodic tests of cannaboids levels found in your incoming cannabis. With this information, you need to adjust blending amounts to reflect the correct cannaboid dose in the finished ready-to-eat (RTE) product. Like any other medicinal product, the active ingredient dosage will directly impact the effect on the consumer, thus it is important that you, the manufacturer, are completely aware of the exact cannaboid levels in your incoming ingredients, your blending amounts and your final product levels. This will require a robust either in-plant or commercial laboratory testing program. There is a great deal of technology and chemical analyses available to help dose the product accurately. This must also include robust testing and verification steps. If a consumer of your product were to over-consume from “normal” consumption rates of your cannabis-based food product, the liability, both financial, civil, ethical and criminal would fall on your company. The attention to detail here will create a safe and satisfying experience for consumers as they receive a consistent product every time.
design your products with commercial manufacturing viability in mindOnce regulatory responsibilities for manufacturing and marketing a cannabis-based food product have been met, so that you may sell a compliant and consistent product, it is time to add some creative juices and make the product interesting and enjoyable to consumers. With cannabis edibles, for example, explore what sort of food is appealing to consumers. Consider when, where and with whom your potential customers would be eating that food. Evaluate the best packaging design and size to suit the occasion. Ensure the packaging is child resistant yet practical for adult consumers. And above all manufacture a food that is delicious. Curiosity will attract your customers for the first time but quality and consistency will keep them coming back.
Product developers are usually fantastic at developing great lab scale products, but part of a developer’s job is to ensure that the design and manufacturing process is scalable for consistent and compliant commercial manufacturing. So design your products with commercial manufacturing viability in mind. Try to minimize the number of ingredients whilst still making a consumer-desirable product. Finally, rationalize your ingredients across your portfolio to avoid overcrowding the warehouse and risking expired ingredients.
If successful, your consumers will desire your product, your compliance team will be satisfied, your manufacturing partners will be thankful, the State of California will determine that you are fully compliant and your sales team’s job will have great business and professional success. In the end, you will have developed and launched a successful legacy product!
The post Designing the Perfect Cannabis Edible in California appeared first on Cannabis Industry Journal.read more
THE MOST POWERFUL & POTENT HEMP PRODUCTS ON THE MARKET
Have you paused to consider that quality assurance is a moving target rather than a destination? It is culture within a company that requires constant improvement and change, rather than the work of a select few to reach one defined end goal. Quality, therefore, is not a box that must simply be checked but an overarching and driving force propelling organizations forward.
For those within the cannabis industry and specifically cannabis testing labs, quality assurance is critical to having a successful and thriving business within the rapidly evolving industry. Dr. Kim Ross, who earned her Ph.D. at the University of Colorado in Molecular Biology, and also has worked with multiple cannabis labs, says, “It is not that often that you get a new testing industry born these days and people are scrambling to borrow processes from other industries and apply these to the cannabis industry.” Those within cannabis testing labs are looking towards established industries like water and food testing labs to serve as a quality assurance beacon. Ross elaborates:
The cannabis industry is operating in the absence of federal oversight. If you think about it, the water, food, and pharmaceutical industries have federal oversight. In lieu of that, it is up to states to adopt regulatory practices and enforcement strategies to uphold a level of compliance and data defensibility that these types of regulators have seen in their careers working in the FDA, EPS, NELAC or ISO.
For cannabis testing labs, the stakes are high. First, there is the need to keep up with the rapidly evolving industry climate as more and more states and governing bodies are setting requirements and expectations for quality and compliance. It is in nobody’s best interest to fall behind or be a late adopter to the increasingly regulatory compliance environment.
Additionally, untrustworthy data sets can have detrimental impacts on people and patients. Medical applications of cannabis require specific results in order to ensure the safety of patients, many of which are immunocompromised. Beyond damage to people and patients, businesses themselves can be hurt if a cannabis testing lab were to present inaccurate or flawed data sets. Ross shared hypothetical examples of potential negative impacts:
If, for example, you fail a product for microbiology based on false-positive results then it incurs damages to the client because now their product can’t go to market. Additionally, falsely inflated THC results are also a huge problem in the industry, and can result in downstream problems with edible dosing or consumer satisfaction.
A quality assurance system can minimize risk and maximize adherences to proper procedure, resulting in reliable data. Recalls, product issues and lawsuits cost organizations tremendous amounts of time and money, both to manage the problem at hand and prevent future incidents. Not to mention, the immeasurable damage done to the brand & industry by being viewed as untrustworthy–especially as a consumable product. “Ensuring data defensibility and data integrity protects the laboratory from lawsuits,” says Ross. “That is a really important piece of a quality assurance system for a laboratory.”
One common misconception is viewing quality assurance as a cost center rather than a profitability maximizer. A robust quality assurance system is a competitive advantage–especially for those who are not yet mandated to be compliant to a particular standard, like ISO/IEC 17025, but choose to pursue that accreditation knowing it reflects reliability. In many ways, quality assurance can be summarized as “say what you do, and do what you say”, with a willingness to allow third-party confirmation of your commitment and practice. “Accreditation gives an unbiased stamp of approval that helps ensure data defensibility in the laboratory,” affirms Ross.
Accreditation as a result of quality assurance ultimately leads to reliable and trustworthy data sets. Ross shared:
It might appear to be easy to buy expensive instrumentation, accept samples, and produce data. There are so many ways to do that, some of which are incorrect, and therefore accreditation is really an opportunity to have professionals evaluate methodology and post-analytical data processing to ensure that it is scientifically sound. It is an opportunity for a laboratory to be confident that their processes and reporting procedures are robust and error free.
Remember: this is a new industry. There aren’t firmly established methods and procedures like other legacy industries. “We are operating in a time and space where there is no standard methodology and that makes oversight by a third party even more important,” shares Ross. When a company opts to pursue accreditation they are indicating a willingness to be honest and transparent with their business processes, procedures, outcomes and data. Accreditation, therefore, is necessary for this emerging industry. Having a robust, inclusive quality assurance system in place will ease and quicken their pursuit of accreditation.The stress on an audit day when there is a digitized system is vastly lower than a system that is printed and physically maintained.
Not all quality assurance systems are created equal. There are still some companies seeking to implement systems that lack the modernization necessary to truly propel them forward towards continuous improvement and scalability. Quality assurance software with widespread use and adaptation across organizations is both scalable and in support of continuous improvements. Binders, rows of filing cabinets and complicated excel spreadsheets are not a scalable backbone for a quality system.
Beyond the accessibility and traceability that a digital system creates, it also protects. “We can protect that data with credentialed logins for key personnel and have information at our fingertips to reduce the regulatory stress on all personnel,” says Ross. The stress on an audit day when there is a digitized system is vastly lower than a system that is printed and physically maintained.
For those in the cannabis industry, specifically cannabis testing labs, there is an unequivocal advantage to implementing a system that supports continuous improvement, reliable data sets and the very best in business practices. Doing so will help sustain and grow the industry, and could be pivotal in transforming the production, market and research of cannabis.read more
THE MOST POWERFUL & POTENT HEMP PRODUCTS ON THE MARKET
According to a press release, the U.S. Food and Drug Administration (FDA) approved GW Pharma’s drug Epidiolex for the treatment of rare forms of epilepsy. Just a few months ago, news broke of a very encouraging FDA panel assessment, which indicated a positive outlook for the drug’s approval.
In the press release, FDA Commissioner Scott Gottlieb, M.D appeared to indicate an open willingness to explore the medical benefits of cannabis. “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” says Gottlieb. “And, the FDA is committed to this kind of careful scientific research and drug development.” He went on to add:
Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.
According to the press release, the drug was studied in three randomized, double-blind, placebo-controlled clinical trials with 516 patients who have either Lennox-Gastaut syndrome or Dravet syndrome, the two rare forms of epilepsy the drug is now approved to treat. 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.read more