Tag Archives: systems

From MedTech to Cannabis: A Q&A with Jennifer Raeder-Devens

By Aaron G. Biros
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Project Yosemite, a cannabis product innovation and brand development company, announced earlier this month the appointment of Jennifer Raeder-Devens as their new Chief Scientific Officer. Raeder-Devens is a veteran of the MedTech industry, working for companies like Becton Dickinson, Cardinal Health, Medtronic and 3M.

Prior to joining Yosemite, she was the Vice President of Research & Development at Becton, Dickinson, where she oversaw product development and technology strategies to launch infection prevention products including the ChloraPrep first-in-the-US sterile solution patient preoperative topical antiseptic. She was previously the Vice President of R&D, Strategy and Innovation at Cardinal Health. She’s also held roles at Medtronic, 3M Drug Delivery Systems and 3M Skin Health Division and she has a number of patents in drug delivery and medical devices.

Jennifer Raeder-Devens, Chief Scientific Officer at Project Yosemite

In November of 2018, Project Yosemite launched their first product, OLO, which is an infused, controlled-release sublingual strip. Part of Raeder-Devens’ new role at the company is the continued development and expansion of the OLO sublingual strip technology platform. Andrew Mack, CEO and founder of Project Yosemite, says he’s thrilled to have Raeder-Devens on the team. “Jennifer is an extremely accomplished scientist and engineer with extensive experience driving innovation and R&D in the pharmaceutical and medical device industries,” says Mack.

We caught up with Jennifer over the phone to talk about her background in the MedTech space, why she decided to jump ship to join the cannabis industry and what she’s excited to work on now.

Cannabis Industry Journal: Can you tell us about your background, including your work with 3M and Medtronic? 

Jennifer Raeder-Devens: I’m coming directly from Becton Dickinson, a global med tech company, where I supervised the development of drug-device combination products for topical antiseptics. I spent about 10 years there, mostly in topical drug and combination product development. Prior to that, I was at 3M and Medtronic working in drug-device combination products. At 3M, I was supervising a team of technology developers for the 3M Drug Delivery Systems business. I had experience working with designing and manufacturing transdermal, nasal, buccal and inhalation drug delivery mechanisms for pharmaceutical partners.

I worked on implantable drug delivery systems at Medtronic, which included working on the biocompatibility of things like pacemakers and drug infusion pumps and optimizing them to reduce infection and enhance healing after the implantation procedure.

CIJ: What made you consider joining the cannabis industry? 

Jennifer: With my work in topicals, transdermal and inhalation drug delivery, I had an easy understanding of the different routes of administration we see today in the cannabis industry. And so, from the technology standpoint, I thought this was a place I could contribute to immediately. And then what got me really excited about it was thinking about cannabis, and just like any other drug, with oral drug delivery, you’ve got first class metabolism and side effects from the 11-Hydroxy-THC that are undesirable and you’d rather not have delivered through the gut.

OLO sublingual strips have a 10-minute onset time

I got excited when I saw the development of things like sublingual strips that were focusing on alternatives to smoking that would preserve that relatively fast onset and mitigate some of the side effects of edibles.

The other thing I really like about the cannabis industry: Previously I have been very focused on known drugs that are already approved and repurposing them into a new delivery system. What really interests me about the cannabis industry is the active cannabinoids and terpenes are somewhat known and somewhat unknown, so there is this really interesting challenge there of trying to separate the wheat from the chaff in terms of producing therapeutic effects.

It is a really interesting space where the indications of certain molecules are evolving along with the delivery technology. So, it is a really exciting and eye-opening way to take the next step in my career and have this wide-open space in front of me, both in terms of the different cannabinoids, their effects and the delivery systems we can use.

CIJ: How might you be prepared, given your background, for some of the challenges in the cannabis space?

Jennifer: I think the challenges in cannabis delivery are not different from the challenges in pharmaceutical drug delivery. It’s just that we have this additional complexity of the entourage effect. We can be engineering not just the main ingredient of THC, but also all the other cannabinoids and terpenes. So, for example, with my background in infection prevention, we build a product that we know reduces the risk of infection, but we are really challenged to actually prove it reduces the risk of infection. We have a similar situation in the cannabis industry, where we can get the THC, or CBG or CBN where we want it to go, but then we are really challenged to figure out how we can find, what we call in the pharmaceutical industry, a surrogate end point for efficacy, so that we can test that product and really believe that when we put the product on the market, even though we haven’t tested thousands of users or conducted large randomized clinical trials, that the effect will be shown. We are networking and partnering with a good scientific community to build the right product and do some testing at a small scale that really demonstrates the product achieves the effect that we are really looking for.

CIJ: Can you tell us a little about your new role with Project Yosemite?

Jennifer: My job description falls into three buckets: The first part is that we are forming a scientific advisory board and we are working with some of the leading cannabinoid researchers around the country and around the world. These are the people identifying whether or not certain cannabinoids could reduce cancer cell metabolism or whether cannabinoids contribute to weight loss or diabetes control and other things of that nature. We are trying to reach as far upstream as we can to grasp the emerging understanding of the performance of cannabinoids and terpenes in the endocannabinoid system. So, part of my job is to chair that scientific advisory board, get the thought leaders together in the room and have them bring their knowledge and explore with our own knowledge what cannabis can really do.

The OLO sublingual strips

I have worked in topical, transdermal, buccal, nasal, inhalation drug delivery. In the second bucket of my job, we are trying to understand a given indication or experience that our users want to have, what would be the right route for them. We are challenging our sublingual delivery mechanism to see how fast of an onset we can really get. Right now, we are at 10 minutes for drug delivery in sublingual and we are still trying to get an even faster onset time for the sublingual strip.

For other indications, like chronic pain, we may want to think about a sustained release, so sort of aligning the different indications with which different cannabinoids and terpenes will work for it and see which delivery platform will work for what we are trying to accomplish in each indication.  So, we do not plan to remain solely a sublingual strip company, but will build out additional delivery platforms as we develop new indications.

Right now, we are working upstream with the growers and the processors to get cannabis oil and extracts. Some of the growers are working on different genetics in their cultivars to grow plants that have different ratios of different cannabinoids that we know from the emerging research will have an impact on people’s experience. Now we are working with growers to really get ahead of the curve on how to formulate products with various cannabinoids.

We have an R&D team in house that I supervise. We are always working with our production team to make small improvements such as the faster onset and the dissolution rate and things like flavors, which covers a downstream focus as well.

Aphria, Inc. Implements Quality Management Systems

By Cannabis Industry Journal Staff
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According to a press release published today, Aphria Inc. has implemented Rootstock Software’s cloud Enterprise Resource Planning (ERP) solutions and ComplianceQuest’s Enterprise Quality Management System (EQMS). Aphria, one of the largest cannabis companies in the world, trades on both the Toronto Stock Exchange and the New York Stock Exchange.

Rootstock’s cloud ERP software includes things like order processing, production management, supply chain management, lot and serial number trackability and traceability, compliance reporting, costing and financial management. ComplianceQuest’s EQMS software provides support for GMP compliance and can help improve efficiencies in operations. The EQMS focuses on quality and risk management across Aphria’s business platforms, from sourcing to manufacturing to supply chain management.

Aphria is using the entire EQMS platform, which includes software to handle documents, training, changes, inspections, nonconformance, corrective actions (CAPA) and customer complaints which integrates to Rootstock’s ERP. According to the press release, the company is currently working to roll-out audit, equipment, incident and supplier management functions and will be fully live with the entire quality system in the next few months.

According to Tim Purdie, chief information officer & chief information security officer of Aphria Inc., both platforms delivered on their implementation. “Grounded in the scalability of the force.com platform, CQ transformed our quality management operating capabilities overnight and we are delighted at the fully integrated partnership result,” says Purdie. “We now have fully digital real-time informatics and ability to implement change in a highly transparent manner to meet the demands of our high growth business.”

Adding that Rootstock ERP will help facilitate their company’s production, inventory and supply chain management, Purdie says both platforms will enable Aphria to be increasingly responsive to market needs. “Aphria is setting the standard as a worldwide leader in the cannabis industry through a diversified approach to innovation, corporate citizenship, strategic partnerships and global expansion,” Purdie says. “With these system implementations, we’re now technologically equipped to take our competitive advantage to new levels of market leadership.”

Why the Central Chiller Isn’t So Central to Grow Room HVAC

By Geoff Brown
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There’s a better way to design HVAC for cannabis grow rooms, and it may seem a little odd at first.

Central chillers are a tried-and-true solution for projects requiring large refrigeration capacity. They’re found in college campuses, hospitals, office buildings and other big facilities.

While central chillers are a good default for most large-scale applications, they fall short in this industry. Grow rooms, with their need for tight, variable conditions and scalable, redundant infrastructure, have HVAC requirements that the central chiller model simply can’t deliver on.

Let’s unpack the shortcomings with the central chiller in this niche and explore some possible solutions.

What’s Wrong With Chillers?

Building a scalable HVAC system is essential for the cannabis industry as it continues to ramp up production in the U.S. and Canada.

Many growers are building their large facilities in phases. In Canada, this is common because growers must have two harvests before they can receive a production permit, so they build just one phase to satisfy this requirement and then build out the facility after the government’s approval.

This strategy of building out is less feasible with a central chiller.

solsticegrowop_feb
Indoor cultivator facilities use high powered lights that give off heat, requiring an efficient air cooling system.

A chiller and its supporting infrastructure are impractical to expand, which means it and the rest of the facility needs to be built to full size for day one, even though the facility will be in partial occupancy for a long time. This results in high upfront capital costs.

If the facility needs to expand later down the road, to meet market demand for example, that will be difficult because, as mentioned, it’s expensive to add capacity to a central chiller.

Additionally, the chiller creates a central point of failure for the facility. When it goes down, crops in every room are at risk of potentially devastating loss. Grow rooms are unusual because of their requirement for strict conditions and even a slight change could have big impact on the crop. Losing control due to mechanical failure could spell disaster.

One Southern Ontario cannabis grower met with some of these issues after constructing their facility, which uses a central chiller for cooling and dehumidification. The chiller was built for full size, but the results were disappointing as early as phase one of cultivation. While sensible demands in the space are being easily met, humidity levels are out of control – flowering rooms are up to 75% RH.

Humidity is one of the most important control aspects to growers. Without a handle on it, growers risk losing their entire crop either because there’s not enough and the plants dry out, or there’s too much and the plants get mold disease. This facility has fortunately not yet reported serious crop issues but is mindful of the potential impact on harvest quality.

By going unitary, capital costs scale on a linear basis.If tight control over humidity is what you need, then a chilled water system needs very careful consideration. That’s because typical chiller system designs get the coils cold enough to lower the air temperature, but not cold enough to condense water out of the air as effectively as a properly designed dehumidifier coil.

A chilled water system capable of achieving the coil temperatures needed for adequate dehumidification in a typical flower room will also require full-time reheat to ensure that air delivered to the plants isn’t shockingly cold — either stunting their growth or killing them altogether. This reheat source adds complexity, cost and inefficiency which does not serve growers well, many of whom are under pressure from both utilities and their management to minimize their energy usage.

How Do Unitary Systems Solve These Problems?

Compared to central chillers, a unitary setup is more agile.

A facility can commence with the minimum capacity it needs for start-up and then add more units in the future as required. They’re usually cheaper to install than a central system and offer several reliability and efficiency benefits as well.

The real business advantage to this approach is to open up the grower’s cash flow by spreading out their costs over time, rather than a large, immediate cost to construct the entire facility and chiller for day one. By going unitary, capital costs scale on a linear basis.

Talltrees
One of the flowering rooms in an indoor set up (Image: Tall Trees LED Company)

Growers can have more control over their crop by installing multiple units to provide varying conditions, room-by-room, instead of a single system that can only provide one condition.

For example, flowering rooms that each have different strains of crop may require different conditions – so they can be served by their own unit to provide variability. Or, rooms that need uniform conditions could just be served by one common unit. The flexibility that growers can enjoy with this approach is nearly unlimited.

Some growers have opted for multiple units installed for the same room, which maximizes redundancy in case one unit fails.

A cannabis facility in the Montreal area went this direction when building their HVAC system. Rather than build everything in one shot, this facility selected a unitary design that had flowering rooms served independently by a series of units, while vegetation rooms shared one. The units were sized to provide more capacity than currently required in each room, which allows the grower to add more plants and lighting in the future if they choose.

This facility expects to build more grow rooms in a future phase, so it was important to have an intelligent system that could accommodate that by being easy to add capacity to. This is accomplished by simply adding more units.Multiple, small systems also have a better return-on-investment.

The grower, after making a significant investment in this facility, was also averse to the risk of losing crop due to mechanical failure, which is why they were happy to go with a system of independent grow room control.

Multiple, small systems also have a better return-on-investment. Not only are they easier to maintain (parts are easier to switch out and downtime for maintenance is minimal) but they can actually be more efficient than a large, central system.

Some units include heat recovery, which recycles the heat created by the dehumidification process to efficiently reheat the unit’s cold discharge air and keep the space temperature consistent, without needing expensive supplementary heaters. There’s also economizer cooling, which can be used to reduce or even eliminate compressor usage during winter by running the unit on dry outside air only.

Demand for cannabis continues to increase and many growers are looking to expand their businesses by adding new facilities or augmenting existing ones. Faced with the limitations of the traditional chiller system, like the lack of flexibility, scalability and redundancy, they’re looking for an intelligent alternative and the unitary approach is earning their trust. It’s expected this option will soon become the leading one across North America.

Aphria Fights Shortseller Allegations Of Insider Double Dealing

By Marguerite Arnold
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Two reports published by short selling stock firm Quintessential Capital Management and forensic investor research firm Hindenburg Research on December 3, charges that Canadian LP Aphria, has bought overinflated assets in Latin America and in Florida from shell companies owned by company insiders. Added to the lingering controversy is the purchase of the German Nuuvera this spring (a company also partly owned by Aphria brass), and the reports went over like a bombshell. Globally.

However, the story has already spread far beyond one company. And the response in the market has rocked the industry for most of December.

Aphria’s shares tanked, and dragged everyone down with them. Several class action law firms in the United States began promptly looking for aggrieved shareholders.

The response by the firm? A promise of an immediate line-by-line rebuttal, due out in the second week of December. So far, however, despite news of an additional Aphria purchase in Paraguay, the rebuttal report has not been issued.

Why Is This So Damaging? Or Is It?

Aphria’s stocks promptly took a dive that halved their value although they began to recover after Aphria management appointed an independent third party firm to review the claims.

Worse, however, the entire industry saw a hit too. This report affected investor confidence across the industry. And although the hit appears to be temporary, the unfolding scenario is a perfect example of why volatility in the market is scaring away not only more conservative female retail investors but larger institutional ones that the industry is now courting assiduously as medical cannabis begins to be integrated into health systems particularly in Europe.

Why?

Bottom line? As the big cannabis companies are listing on the larger, foreign exchanges, including the NYSE and Deutsche Börse, the scrutiny is getting more direct and granular.Despite the stratospheric market caps of all the major Canadian LPs in particular, not to mention enormous expenditures for the last several years (on property and other acquisitions), the revenue picture, as other stock analysts and publications such as the normally neutral Motley Fool recently pointed out, at least so far does not justify the same. Bulk sales to a hospital, establishing a cultivation or processing facility or even getting import licenses may set one up to do business however, but it is not an automatic route to ongoing and expanding sales. And that is the key to high valuations that are rock solid and beyond the scope of such allegations.

For the moment, that pressure, particularly in global medical markets, is falling first on patients if not doctors. Not the industry.

That said, this has been a major building year. Recreational cannabis has just become legal in Canada. And in Europe, reform is still in the process of happening.

It is also a charge if not frustration that has been growing, however, against all the public cannabis companies as valuations shoot into the stratosphere. Forensic and investigative firms, particularly in Europe and the United States have been focusing on the industry for close to a year now. As a result even when firms successfully rebut charges of fraud, they are looking at different valuations from analysts at least in the short term.

Bottom line? As the big cannabis companies are listing on the larger, foreign exchanges, including the NYSE and Deutsche Börse, the scrutiny is getting more direct and granular.

Are “Short Seller” Reports Unbiased?

For all of the focus on short seller reports in this industry, however, no matter the accuracy of some of their claims, here is the next issue:

Short sellers make money by betting against not only individual firms but the industry itself. They benefit financially in other words, from volatility in the market and arbitraging even small changes in price. Even if their reports cause the same.

Such reports as a result are also not “unbiased” as industry coverage in the press is supposed to be, no matter how much more time sometimes goes into the reporting and preparation of the same.

And no matter that this industry is now going into its fifth year, there is still lingering scepticism that, in the case of Aphria, has so far not only fallen on the individual firm in question, but then rebounds across the industry, unfairly hurting all firms in this space.

VinceSebald
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Automation – Planning is Everything

By Vince Sebald
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VinceSebald

Automation of processes can provide great benefits including improved quality, improved throughput, more consistency, more available production data, notifications of significant events and reduced costs. However, automation can also be expensive, overwhelm your workforce, cause future integration problems and magnify issues that you are currently experiencing. After all, if a machine can do work 100 times faster than a human, it can also produce problems 100 times faster than a human. Whether it is a benefit or a scourge depends largely on the implementation process.

There are thousands of possible technology solutions for just about any production problem. The trick to getting results that will work for your company is to use good engineering practices starting from the beginning. Good engineering practices are documented in various publications including ISPE Baseline Guides, but there are common threads among all such guides. What will the system be used for and what problem is it intended to solve?

The key is implementing a system that is fit for your intended use. As obvious as it sounds, this is often the most overlooked challenge of the process. In the grand scheme of things, it is a MUCH better proposition to spend more time planning and have a smooth operation than implement a system quickly and fight it because it isn’t a good fit for the intended use. The industry is littered with systems that were prematurely implemented and complicate rather than simplify operations. Planning is cheap, but fixing is expensive.

The most important step to getting an automated system that will work for you is also the first:

Defining “what” you need the system to do: User Requirements

Automation Runaway
Once automation is in place, it can be a boon to production, but don’t let your systems get ahead of your planning! It can be difficult to catch up.

With decades of experience in the automation industry, I have seen systems in many industries and applications and it is universally true that the definition of requirements is key to the success of the automation adventure. To clarify, the user requirements are intended to define “what” the system is required to do, rather than “how” it will do it. This means that persons that may not be familiar with the automation technologies can still be (and usually are) among the most important contributors to the user requirements document. Often, the people most familiar with the task that you wish to automate can contribute the most to the User Requirements document.

Some of the components of a User Requirements document typically include:

  • Purpose: What will the system be used for and what problem is it intended to solve?
  • Users: Who will be the users of the system and what is their relevant experience?
  • Integration: Is the system required to integrate into any existing or anticipated systems?
  • Regulatory Requirements: Is the system required to meet any regulatory requirements?
  • Functions: What is the system required to do? This may include operating ranges, operator interface information, records generation and storage, security, etc.
  • Performance: How many units per hour are required to process?  What percent non-conforming product is acceptable?
  • Environment: What environment is the system required to operate in? Indoor, outdoor, flammable, etc.
  • Documentation: What documentation is required with the system to support ongoing maintenance, calibration, etc.?
  • Warranties/Support: Will you perform work in-house, or will the manufacturer support the system?

The level of detail in the User Requirements should be scaled to the intended use. More critical operations may require more detailed and formal User Requirements. At a minimum, the User Requirements could be a punch list of items, but a detailed User Requirements may fill binders. The important thing is that you have one, and that the stakeholders in the operation have been involved in its production and approval.Once completed, the User Requirements can be a very good document to have for prospective providers of solutions to focus their attention on what is important to you, the customer.

Equally important to the process is the idea of not over-constraining the potential solutions by including “how” the system will meet the requirements within the User Requirements. If it is required to use specific technologies for integration with other existing systems, it is appropriate to include that information in the User Requirements. However, if use of a particular technology (e.g. “wireless”) is not required, the inclusion may unnecessarily eliminate viable design options for systems that may address the requirements.

Once completed, the User Requirements can be a very good document to have for prospective providers of solutions to focus their attention on what is important to you, the customer. This helps to ensure that they focus their efforts in the areas that match your needs and they don’t waste resources (which translate to your costs) in areas that don’t have tangible benefits to you, the customer. It also gives you a great tool to “value engineer”, meaning that you can consider cutting design options that do not support the User Requirements, which can reduce project costs and timelines, keeping things lean and on track.

Further steps in the project are built around the User Requirements including system specifications provided by vendors, testing documentation and the overall turnover package. An appropriately scaled User Requirements document is a low cost, easy way to ensure that your automated system will serve you well for years to come. Alternatively, the lack of a User Requirements document is an all-too-common indicator that there may be challenges ahead including scope creep, missed deadlines and unacceptable long term performance.


Feel free to reach Vince at vjs@sebaldconsulting.com with any questions you might have.

Is There a Looming Supply Bottleneck in California?

By Aaron G. Biros
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California’s regulated adult use cannabis market has been up and running for around four months now and rumors of a potential supply bottleneck on the horizon are beginning to circulate. There are a number of factors that could have an impact on the cannabis supply in the market, most of which stem from changes in the distribution channels now that the state is implementing new regulations.

Those include a slow rollout in licensing cannabis businesses, new testing requirements, the supply carryover period prior to January 1stas well as new labeling and packaging regulations. In this piece, we are going to examine some of those rumors, see if there might be some truth to them and provide some guidance for what businesses can do to prepare for this.

A Slow Start to Licensing

This one is perhaps the most obvious factor to impact the supply chain in California. Much of the delays in licensing cannabis businesses came from the issue of local control, where businesses needed to get approval from their municipality before getting a state license. In the first month of the new market, it took Los Angeles weeks longer than other counties to begin licensing dispensaries. Whereas San Diego retailers saw a massive influx of customers right away, forcing them to buy up product to meet the high demand. Smaller producers also had trouble getting licenses as quickly as some of the larger ones.

Basically it all boils down to a slow start for the new market, according to Diane Czarkowski, co-founder of Canna Advisors. “The state is requiring businesses to get their local licenses before they can get their state license and that will create a delay in operators being able to bring products to market,” says Czarkowski. She says this is pretty typical of new markets, or when a market experiences dramatic changes quickly. “It could be a brand-new market, like in Hawaii, where the operators were ready with product, but there were no labs to test the products, which caused delays.” In addition to the licensing roll out being slow to start, the temporary licenses initially awarded to businesses are set to expire soon, by the end of April.

Stricter Rules to Come

The same logic goes for the testing regulations. New testing and labeling requirements, according to the Bureau of Cannabis Control regulating the market, will be phased in throughout 2018.

CA cannabis testing chart
California’s plan for phasing in testing requirements.

The state has already phased in cannabinoids, moisture content, residual solvent, pesticide, microbial impurities and homogeneity testing to some extent. On July 1st, the state will add additional residual solvent and pesticide testing as well as foreign material testing. At the end of 2018, they plan on requiring terpenoids, mycotoxins, heavy metals and water activity testing. All of those tests cost money and all of those tests could impact suppliers’ ability to bring product to market. “Oftentimes regulations require different types of testing to be done to products without recognizing that adequately completing those tests requires different methods, equipment, and standards,” says Czarkowski. “Most labs do not have all of the necessary components, and they are very costly. Producers could wait weeks to get test results back before they know if they can sell their products.”

Back when we spoke with Josh Drayton, deputy director of the California Cannabis Industry Association, about the upcoming changes to the California market, he voiced his concerns with the coming testing rules. “A lot of testing labs are concerned they are unable to test at the state’s threshold for some of these contaminants and pesticides; the detection limits seem very low,” says Drayton. “The testing portion will take years to work out, I am sure we will remove and add different pesticides and contaminants to the list.” California’s testing industry is, however, capable of adapting to changing rules, as they’ve done in the past on more than one occasion. It should be noted that many labs in the state are on the cutting edge of testing cannabis, working with The Bureau to implement the new rules.

roybingham
Roy Bingham, CEO of BDS Analytics

Cannabis products made prior to December 31st, 2017, did not need to comply with the stricter testing rules that are coming in the next few months. This carryover period allowed dispensaries to have products on the shelves when the new market launched in the beginning of 2018. Retailers knew this rule meant they needed to stockpile product in the event of a supply bottleneck, and it appears much of that product is now sold and running out, according to Roy Bingham, founder and chief executive officer of BDS Analytics. “The true impact of licenses is starting to be felt since the carryover from December buying prior to the licensed market has been sold,” says Bingham. “Some of the major brands have consciously not applied for licenses. Some of that has to do with the flexibility the government has given them to wait.”

A fourth reason for a potential bottleneck could also come from packaging and labeling rules. “There will have to be many modifications to products to ensure they follow the new potency regulations, and many formulations will have to be modified in order to meet new regulations,” says Czarkowski. Distributor licenses, according to The Bureau, have a number of compliance documentation requirements, such as arranging for all product testing, quality assurance and packaging and label accuracy. Everything has to be packaged before it gets to a dispensary, which is a new rule California businesses need to comply with.

Pricing is the Indicator

There are a handful of reasons why prices could increase; some of them are more defined than others, the biggest factor being the tax burden passed on to consumers, where reports showed up to a 40% increase from last year. A price increase in the future could also come from The Bureau implementing testing regulations throughout 2018, as mentioned previously.

If prices were to surge enormously and very quickly, that might be an indicator that a shortage is fast approaching. A dramatic increase in price over this year could squeeze margins for smaller producers, forcing retailers to pass that burden on to consumers as well.“So yes, the rumors are true.”

According to Roy Bingham, there has been a significant increase in pricing in all categories at the retail level. “In January and February, we are seeing about 10% increases per month in average retail prices,” says Bingham. “If we look at concentrates in California during 2017, they averaged about $34 by the end of the year, whereas it was about $31 at the start of 2017. So in January, prices have increased up to $38, which is a bit above trend, but in fact we were seeing a trend upwards before January 1st as well.” Comparing that with edibles pricing, Bingham says we see a clear jump at the start of 2018. “It was basically flat in 2017, averaging $14 roughly almost straight-line across, dipped in December, then in January it jumped to $17 and then to $18 in February, a big increase and significantly more than concentrates,” says Bingham. He also says flower was hovering around $9 per gram in December 2017, but surged above $10 in February 2018.

According to Cannabis Benchmarks, the California wholesale averages surged in the summer of 2017 up to $1,631 by September, then reached their lowest point in December, with their spot index at $1,368. The Cannabis Benchmarks report underlines some important reasons for the changes in pricing, but they also attribute it to the new licensing system.

“Increasing operating expenses for businesses preparing to enter California’s licensed system in 2018 were key to propping up supply side rates in the first six months of 2017. New compliance requirements were being instituted to varying degrees by local governments, while market participants warily eyed draft regulations from state officials for guidance as to how to prepare their sites and facilities to meet under-construction regulatory mandates.”

Their report highlights some very important aspects of the supply chain. “Again, it is likely that the increased costs faced by operators up and down the supply chain exert some upward pressure on wholesale rates, preventing them from steep year-over-year declines that were observed in some of the other major Western markets,” reads the Cannabis Benchmarks report.

So How Can Businesses Prepare?

Well to start, producers should make sure their operations and product are clean and safe. Making sure your product will pass a pesticide test should be top of mind. Dispensaries should also be wise in selecting their suppliers, performing supplier quality audits or some form of verification that they meet your standards is key in a consistent supply chain.

Dr. Jon Vaught, chief executive officer of Front Range Biosciences, believes tissue culture could be a viable solution for some California producers. Using tissue culture, as a form of propagation instead of mothers and clones can be cleaner, cheaper and more efficient, thus allowing growers to keep up with demand and prevent a shortage.

Dr. Jon Vaught headshot
Dr. Jon Vaught, CEO of Front Range Biosciences

Dr. Vaught says growers could look to tissue culture as a means to “mitigate risk to their supply chain and mitigate the risk of potential loss and improve their ability to efficiently grow their plant.” Maintaining a disease-free, sterile environment is a huge advantage in the cannabis market. “The real use of tissue culture is to provide disease free, clean, certified material, that has gone through a QA program,” says Dr. Vaught. “In greenhouses, the ability to control your environment is also critical because your margin of error is high. Variations in sunlight, weather, humidity all of these things have an impact in your plants. Technology can help monitor this.”

We’ve covered the basics of tissue culture previously on CIJ, with Dr. Hope Jones chief science officer of C4 Laboratories. She echoes many of Dr. Vaught’s points, firmly believing that, having existed for decades, tissue culture is an effective propagation tool for advanced breeders or growers looking to scale up.It is a complex supply chain that requires systems thinking.

It is important to note they don’t think growers should try this at home. Work with professionals, get the necessary funding, the training and facilities required if this is a project that interest you. “There’s a pretty big barrier to entry there,” Dr. Vaught urges. “The ability to manage thousands or millions of plants in a greenhouse increases risk, whereas in the lab, you’ve got a safe, secure, sterile environment, reducing risk of disease, making things easier to manage. The producers most successful at large scale are controlling those variables to the T.”

Ultimately, one segment of the market can’t prevent a bottleneck. It is a complex supply chain that requires systems thinking. Regulators need to work with producers, manufacturers, retailers, distributors, patients, consumers and laboratories to keep an eye on the overall supply chain flow.

Diane Czarkowski says the California market should prepare for this now if they haven’t already. “We have seen supply issues in every market going through a change. Other potential bottlenecks will occur because former distribution channels will be required to change,” says Czarkowski. “So yes, the rumors are true.”

Soapbox

When the Company’s Revenue Drops, Who’s to Blame?

By Dr. Ginette M. Collazo
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The ultimate goal of any business is to produce and generate revenue. Now, when the company’s revenues drop, who’s fault is it? This question, though silent, is in the minds of everyone in an organization, especially when things start to become difficult.

Working as a consultant in productivity with different industries around the world, I have come to realize that question is not openly discussed, but everyone wants to know the answer. To answer it, we will explore the most common areas of opportunity related to this problem.

When we talk about productivity, we are talking about final tangible results, because of the production process and the effort made by each one; when speaking of income, we are talking about the difference between the purchase price and the cost of entering the market. Seeing these definitions, we might conclude that the increase in income is directly related to the increase in productivity.

On the other hand, we must not lose perspective that the increase in productivity is also directly related to the decrease of losses.

First, we have to put into perspective the goals and objectives that a business or organization may have. Many companies go on believing that everyone is clear about the goals and organizational objectives and what is expected in each one of those roles that compose the organization. The reality is that, if we do not know where we are going, the chances of reaching the goal decrease.

When organization’s objectives are properly communicated, and documented, in such a way that the evaluation of the performance is directly linked to the expected results, the chances of success increase substantially.

On many occasions, I have heard phrases such as: “we work hard, we spend many hours, all sacrifice ourselves… we should be more successful”. The question then is: what are we encouraging, efforts or results?

It is hard for organizations to translate or differentiate between organizational goals and individual objectives (expected results) for each of those roles in the company. We all agree that we want to be the first in sales, the best in service and produce the highest quality, but how is that done?

To be the first in sales, what do I have to do as a seller? Get three customers in a three-month period? As secretary, process the orders in the first three days of receiving them? As a carrier, suggest three ideas be more useful in daily deliveries? How does that translate into individual performance?

We focus too much on telling people what they must do, but we forget to be clear on what we expect them to achieve. Hence, the effort versus result dissonance. The success of an organization is the collective behavior that arises from the conduct of individuals. If we align people, we align the organization.

Other elements that we must ponder, and that are directly related to productivity, are: how much of what we do holds value? How much of what we do does not have value? Moreover, how much of what we do, though it has great value, shall be performed by the requirements of law or regulation?

An analysis of productivity is critical, particularly in a time when we want to do more with less. Lately, an area of great success for many organizations is to streamline processes to make them more simple, efficient and with less risk of error. Human errors generated many losses. Defects, the re-process, the handling of complaints and lawsuits are costing companies money equivalent to the salary of 7,200 employees every day (according to statistics in the United States).

Human errors can be avoided. The idea that to err is human has led us to ignore this problem. We think that we can do nothing and lose an infinite number of opportunities for improvement that can help us to increase our income, reducing losses.

Only 16% of organizations measure the cost of human error. The remaining 84% do not measure it and are paying a high price without knowing it. In Puerto Rico, there are no statistics that could shed light on how many local companies lose because of human error, but it is very likely that the numbers are alarming. Human error can be reduced by 60% in less than a year when an intervention is done on systems. Approximately 95% of human errors are due to the design of the company’s systems, and they can be the simplest errors even in the most complex processes.

Today, we have more information, and we know that errors are symptoms of deeper problems in the processes created by the organizations. People play a crucial role regarding how robust methods are, but, we must not lose perspective that human beings operate according to the policies, procedures, and instructions which the same organization designs. Then, if people work according to the designs of the organization, is it not easier to modify designs than eliminating people?

So, who’s fault? Organizations are responsible for providing clear guidance to individuals in the right direction, and individuals have the responsibility of translating their efforts into results. Both have to work with the same objective in mind, and both employers and employees should communicate openly about these objectives. Only by working in partnership will achieve success. Forget who is to blame and focus on the processes and goals that help us be successful.

ASTM International Launches Cannabis Committee

By Aaron G. Biros
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According to a press release published March 1st, ASTM International formed a committee focusing on “creating technical standards and guidance materials for cannabis and its products and processes.” ASTM, founded in 1898, as the American Section of the International Association for Testing Materials, predates other standards organizations such as IEC (1906), ANSI (1918) and ISO (1947). ASTM International is a non-profit organization devoted to the development of international standards. For more than a century, ASTM has served as a leading venue for consumers, industry and regulators to work collaboratively under a balanced and consensus–based process to craft voluntary consensus standards.

Logo_of_ASTM_International,_Oct_2015ASTM International meets the World Trade Organization (WTO) principles for developing international standards, and maintains the attributes outlined in the National Technology Transfer and Advancement Act (NTTAA) for a voluntary consensus standards development organization. ASTM International is known throughout a variety of industries for creating voluntary consensus standards for products, systems, services and materials. ASTM standards are used globally in research and development, product testing, quality systems, commercial transactions, and more.

Lezli Engelking
Lezli Engelking, founder of FOCUS

On January 18th, 2017, the American Public Health Association hosted thirteen industry stakeholders representing state laboratories, standards developers, research institution, academia, cultivation centers, auditors and software compliance providers, according to Lezli Engelking, founder of the Foundation of Cannabis Unified Standards (FOCUS), who is involved and familiar with the process. The planning meeting discussions included a summary of where the request was initiated, why a standards activity was necessary and the results of ASTM’s exploratory efforts. At the conclusion of the planning meeting, it was decided by vote, that ASTM should move forward with the activity.

On February 28th, 2017, roughly 60 stakeholders and cannabis industry representatives met at ASTM International’s headquarters in Conshohocken, Pennsylvania. The volunteer committee on cannabis, designated D37 by ASTM, is a result of inquiries flooding the company regarding cannabis since 2015, states the press release.

The committee will focus on six technical areas, forming subcommittees:

  • Indoor and outdoor horticulture and agriculture,
  • Quality management systems,
  • Laboratory,
  • Processing and handling,
  • Security and transportation, and
  • Personnel training, assessment, and credentialing.

Dr. Ralph Paroli, immediate past chairman of the board and director of R&D in measurement science and standards at the National Research Council of Canada, was voted to serve as the committee’s first chairman. “With its decades of experience in industries such as pharmaceuticals, medical devices, packaging, agriculture, pesticides, and more, ASTM International is the perfect place for standards development for the cannabis industry,” says Paroli.

Pending ASTM International board of directors’ approval (anticipated late April 2017), a shift of standards development efforts has been made from FOCUS to the ASTM International technical committee D37 on cannabis and its products and processes.FOCUSlogo

“FOCUS could not be more pleased by ASTM’s decision to further the development of internationally harmonized cannabis standards,” says Engelking. “This is desperately needed, and an enormous step in the right direction of legitimizing the cannabis industry. We are thrilled FOCUS standards will be included, and honored to be a part of this exciting process.” During this transition period, interested stakeholders can get directly involved through the FOCUS website and then follow directions provided by FOCUS.

According to Engelking, third-party, cannabis-specific certifications for cultivation, retail, extraction, infused products and laboratories are provided by FOCUS for cannabis businesses committed to providing safe, consistent and quality products. FOCUS certification helps businesses decrease liability and risks, maximize efficiency, reduce costs and differentiate their brands.

“FOCUS encourage all stakeholders to participate in this important process,” says Engelking. “ASTM has an incredible standards development system in place that allows for many different levels of participation.” During 2017, ASTM is offering free temporary memberships. After 2017, stakeholders will need to join as a participating member.

Cannabis, Soil Science and Sustainability Part II: The ‘Roots’ of Sustainable Cultivation

By Drew Plebani
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The modern chemical agricultural approach is based on the assumption that chemical science has discovered all facets of plant nutritional requirements. It is clear that the traditional NPK approach to plant/soil systems has its limitations, both from an ecological perspective and in terms of its ability to create nutrient-dense food.

Soil and plant systems have existed together for millions of years and have evolved the capacity to coexist in a way that is mutually beneficial. Plants have been fed and evolved with these biological and environmental stimuli over millennia.

Looking to the geologic record for evidence, we can see that it shows that invertebrates, fungi and early vascular plants appeared on land roughly 400 million years ago, the first seed bearing plants about 360 million years ago and the first flowering plants 130 million years ago. What does this mean? The soil food web has been in existence for millions of years and significant evidence exists that plants and soil biology have co-evolved together for millennia.

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The Geologic Time Scale

Between mineral rich soils and the soil food web, this natural system has been able to create and provide significant plant available nutrients, certainly enough to facilitate the successful life cycle of many species. Clearly from an evolutionary context this system has been able to facilitate maximum genetic expression and the ongoing evolution of biologic species.

In the not-too-distant past, agricultural fertilization practices were based on the existence of a diversity of plant and animal byproducts, animal manures, green manures, etc. These were reintroduced to the system and combined with the appropriate biologic populations, resulting in the decomposition of these organic material inputs and their conversion into plant-available nutrients.

An overview of traditional farming practices provides substantial evidence that farming has been occurring for at least 10,000 years. Why, with such a long history of symbiotic interactions between biologic species, are we now witnessing the mass deterioration of arable land, and agricultural commodities containing lower nutritional value?

Mycelium, the vegetative part of a fungus bacteria colony, seen breaking through rock.
Together, indigenous mycelium and plant roots seen turning rock into soil

An interesting common question among the conventional farming community, when the topic of organics or sustainability comes up, is “how are you going to feed the world?” Well that goal certainly will not be well served by the development of shelf stable, but low nutrient-dense foods. A greater volume of low nutrient-value foods certainly does not seem like a winning approach. Supporting agricultural systems that encourage the development of sustainable systems via locally produced, nutrient-dense food is a good start.

And the same holds true for cannabis. In fact, the parallels between the production of high quality nutrient dense foods and high quality cannabis products are quite significant.

Nutrient density in crops results from balanced, mineral rich soils, and a diversity of organic materials and biologic life, these elements provide the framework to facilitate the creation of a highly functional, biologic nutrient cycling system. A highly functional soil system results in more nutrient-dense crops, which contain measurably larger quantities of different phytonutrients, vitamins, minerals, flavonoids, and terpenes as compared to a system operating at a lower level of biologic efficiency.

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Nutrient-dense cannabis flowers

Benefits that have been observed from nutrient-dense crops are: more pest and disease resistance in the vegetative and fruiting stages, greater yield, more complex and intense flavors and a longer shelf life.

Ultimately advancement in any cultivation system means finding and defining limiting factors in the given system. The objective should be ensuring the maximum biologic vitality of the components of said system and its outputs. Practically speaking, in order to enable the full genetic potential of biologic species, this means identifying and working toward the removal of limiting factors. Minimizing or entirely alleviating the factors that limit maximum plant growth will undoubtedly net positive gains and must be an integral component to any sustainable cultivation strategy.

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Cannabis growing in a polyculture

The Earth has provided us with a highly successful, multi-million-year-old biologic system, capable of providing abundant plant available nutrients on demand, a dynamic which must be integral to appropriate and intelligent systems design.

In the pursuit of sustainability, perhaps it is time to return to our roots and begin to pursue dynamics that are mutually beneficial to all forms of biologic life.

In the next article, we will take a step back from viewing sustainability through the lens of soil and plant specific cultivation methodologies, and focus on the broader context of sustainability in cultivation systems. We will look at sustainability from the context of operational efficiency, and provide a case study from a 400-light commercial indoor cannabis operation. The case study will provide evidence that, in order to achieve higher levels of sustainability, both cultivation strategies and operational efficiency must be factored into the equation. As we will see, true sustainability is created through the efficient design, incorporation, use and management of system elements, all of which can, when appropriately designed, work together to create improved efficiency for the system.