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Marguerite Arnold
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Paradox Or Paragon? A Non-Techie Look At Blockchain and Cannabis: Part III

By Marguerite Arnold
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Marguerite Arnold

Disclaimer: Marguerite Arnold has just raised the first funds for her blockchain-based company, MedPayRx in Germany (and via traditional investment funding, not an ICO). She will also be speaking about the impact of blockchain on the cannabis industry in Berlin in April at the International Cannabis Business Conference.


Part I of this series was an overview discussion of blockchain, cryptocurrencies and cannabis and Part II dove into some of the pitfalls of ICOs in the cannabis space. This is the third and final piece of this series.

Beyond raising money or tying a tradable altcoin to cannaproduct, there are many places where blockchain technology can (and will) be used to great effect in the cannabis industry.

In fact, ICOs and cryptocurrency are only part of the blockchain discussion for the cannabis industry. In general, the technology will disrupt the vertical just like it is upending other businesses right now. However, for the moment at least, it will prove most useful in the most complicated and challenging technical and regulatory areas – supply chain product tracking being the lowest hanging fruit (which is still fairly high off the ground for a number of reasons). If evaluating blockchain tech is too onerous (which it usually is for the average investor or even senior cannabis exec), there are other options. Look for innovative mobile DApps (distributed apps that use blockchain for a specific purpose) and smart business cases.

The fascinating reality is that where there are service models that can be adapted to regulatory guidelines, blockchain promises, in fact, to remove the red tape and paperwork holding the industry back internationally. The impact on research and testing will also be huge.The rules are certainly changing with regards to public companies and cannabis.

The technology, or even the regulations, in other words, is not necessarily all to blame for the many issues budding blockchain entrepreneurs currently face. This space-age techie stuff, no matter how mind-blowing, is still “just” a tool. As the late Peter Drucker famously said, the raison d’etre of every successful business is one that solves a critical need for their customer. Find one for the industry that happens to use the technology, and you might just retire early. But there is a lot of road between that reality and now. And there probably will not be an ICO on that path. Not in most jurisdictions, and certainly not without complications in every one of them.

With an internationally stock-listed Canadian cannabis business now developing, the rules are certainly changing with regards to public companies and cannabis. For all the press that Cronos recently received for getting listed on the NASDAQ, AbCann got (relatively quietly) listed in Frankfurt last summer. Canopy and Aurora have also just become two of the hottest stocks in Sweden.

That said, these are public companies with regular stock issuances. What that means for ICO issuances related to the cannabis industry in Canada specifically is anyone’s guess at the moment. In Germany presently, this is mine-strewn territory. But even here, that will be driven as much if not more by banking law than canna-reform, just like everywhere else.

Not to mention this of course: Given the choice of investing in a public cannabis company already in business with its stock conveniently listed and purchasable via a regular exchange, what would most people choose? It’s just a whole lot easier than taking a flier on a cannabis-themed ICO offering for a concept that may be a great idea, but will never materialize. Or find a bank. Even in Europe or Canada.

The End Game Is Rosy Even If The Path Is Unclear

Despite all the caveats, the impact on the cannabis industry of this technology will be large – far beyond finance in other words – and in ways that are not necessarily all understood even now. The potential impacts on research, compliance and even further reform, however, are already clear. And for the most part, potentially very positive.

For that reason, there is no such thing as a blanket “yes” or “no” at any part of this discussion. Regulatory environments regarding both cannabis and blockchain are changing everywhere. Go slow and with caution is the watchword of the day. Look for interesting beta projects and track them.This is a rapidly changing territory in every direction.

Mentioning cannabis and blockchain if not cryptocurrency in the same breath is also legit, now. As little as 2 years ago, the idea or any combination of the two terms in fact, for whatever reason, was widely dismissed as just another iteration of Silk Road.

When combining this technology and cannabis, in other words, expect either amazing results or fantastic explosions that create a lot of heat and noise but go nowhere. There is more room, in other words, for a cannabis.io to become the industry’s NextGen Pets.com than Google or Facebook. That said, there are experiments going on now, in several countries where the banking and insurance questions are being addressed early (Germany, Canada, Australia and Israel all being such locales) where such issues have begun to be addressed up front.

In summary? Stay tuned and watch this space. This is a rapidly changing territory in every direction.

Ask The Expert: Exploring Cannabis Laboratory Accreditation Part 4

By Aaron G. Biros
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In the first part of this series, we spoke with Michelle Bradac, senior accreditation officer at A2LA, to learn the basics of cannabis laboratory accreditation. In the second part, we sat down with Roger Brauninger, A2LA Biosafety Program manager, to learn why states are looking to lab accreditation in their regulations for the cannabis industry. In the third part, we heard from Michael DeGregorio, chief executive officer of Konocti Analytics, Inc., discussing method development in the cannabis testing industry and his experience with getting accredited.

In the fourth and final part of this series, we sit down with Susan Audino, Ph.D., an A2LA lead assessor and instructor, laboratory consultant and board member for the Center for Research on Environmental Medicine in Maryland. Dr. Audino will share some insights into method validation and the most technical aspects of laboratory accreditation.

Susan Audino, Ph.D.

Susan Audino obtained her Ph.D. in Chemistry with an analytical chemistry major, physical and biochemistry minor areas. She currently owns and operates a consulting firm to service chemical and biological laboratories. Susan has been studying the chemistry and applications of cannabinoids and provides scientific and technical guidance to cannabis dispensaries, testing laboratories and medical personnel. Dr. Audino’s interest most directly involves cannabis consumer safety and protection, and promotes active research towards the development of official test methods specifically for the cannabis industry, and to advocate appropriate clinical research. In addition to serving on Expert Review Panels, she is also chairing the first Cannabis Advisory Panel and working group with AOAC International, is a member of the Executive Committee of the ASTM Cannabis Section and has consulted to numerous cannabis laboratories and state regulatory bodies.

CannabisIndustryJournal: What are the some of the most significant technical issues facing an accreditation body when assessing a cannabis-testing laboratory?

Susan: From the AB perspective, there needs to be a high level of expertise to evaluate the merits and scientific soundness of laboratory-developed analytical test methods. Because there are presently no standard or consensus test methods available, laboratories are required to develop their own methods, which need to be valid. Validating methods require a rigorous series of tests and statistical analyses to ensure the correctness and reliability of the laboratory’s product, which is– the test report.

CIJ: When is method validation required and how does this differ from system suitability?

Susan: Method validation is required whenever the laboratory modifies a currently accepted consensus or standard test method, or when the laboratory develops its own method. Method validation is characterized by a series of analytical performance criteria including determinations of accuracy, precision, linearity, specification, limit of detection, and limit of quantitation. The determination of system suitability requires a series of deliberate variations of parameters to ensure the complete system, that is all instrument(s) as well as the analytical method, is maintained throughout the entire analytical process. Traditionally, method validation has been referred to as “ruggedness” and system suitability as “robustness.”

CIJ: What are the most important aspects of method validation that must be taken into account? 

Susan: In keeping with the FDA guidelines and other accepted criteria, I tend to recommend the International Conference on Harmonization (ICH), particularly Q 2A, which is a widely recognized program that discusses the pertinent characteristics of method validation. This include: method specification, linearity, range, accuracy, and precision (e.g., repeatability, intermediate precision, reproducibility). As mentioned earlier, system suitability is also a critical element and although related to method validation, does require its own protocol.

CIJ: What three areas do you see the laboratory having the hardest time with in preparing for accreditation? 

Susan: My responses to this question assume the laboratory employs appropriate instruments to perform the necessary analyses, and that the laboratory employs personnel with experience and knowledge appropriate to develop test methods and interpret test results.

  • By and large, method validation that is not appropriate to the scope of their intended work. Driving this is an overall lack of information about method validation. Oftentimes there is an assumption that multiple recoveries of CRMs constitute “validation”. While it may be one element, this only demonstrates the instrument’s suitability. My recommendation is to utilize any one of a number of good single laboratory validation protocols. Options include, but are not limited to AOAC International, American Chemical Society, ASTM, and ICH protocols.
  • Second is the lack of statistically sound sampling protocols for those laboratories that are mandated by their governing states to go to the field to sample the product from required batches. Sampling protocols needs to address the heterogeneity of the plant, defining the batch, and determining/collecting a sample of sufficient quantity that will be both large enough and representative of the population, and to provide the laboratory an adequate amount from which to sub-sample.
  • Third, sample preparation. This is somewhat intertwined with my previous point. Once an appropriate sample has been collected, preparation must be relevant to the appropriate technology and assay. It is unlikely that a laboratory can perform a single preparation that is amenable to comprehensive testing.