Interview with Roderick Szarka
Rod is an industry professional with a successful track record in research and development, sales team management, business development and corporate marketing. His first 16 years of his career were in Research & Development developing pharmaceuticals, vaccines and medical devices with ChemBioMed, Cytovax Technologies and Alberta Research Council respectively. Rod is an inventor on 2 medical device patents and author on 13 peer-reviewed scientific papers. Following his successful tenure at the bench, the next 15 years, Rod took on increasing roles of Business Development at Global IQ, a CRO conducting human clinical trials, QSV, a GMP manufacturer for biologics and as VP of Business Development for Exciton Technologies, a medical device company developing silver wound bandages. At Keystone Labs, he was grown the cannabis business through regulated testing services and development of KEY-BOX across Canada and leads the company’s corporate marketing initiatives.
Rod holds a BSc degree (Specialization in Biochemistry) from the University of Alberta.
1. You are the Vice President of Keystone Labs. Can you tell us more about Keystone Labs and what you do?
Keystone Labs Inc. is a Health Canada accredited laboratory focused on providing quality third-party microbiological and analytical testing located in Edmonton, Alberta. Established in 2005 with a Health Canada Good Manufacturing Practices (GMP) Drug Establishment License (DEL), Keystone’s initial focus was to meet the requirements for regulated testing for the Pharmaceutical, Biotechnology, and Nutraceutical industries. Our regulated testing and validation meets the requirements of regulatory boards in Canada (Health Canada), the EU, Japan and the United States (FDA). In August 2015, Keystone Labs acquired a Health Canada Controlled Substance License to conduct cannabis testing for authorized and regulated cannabis sources. The unique combination of a Health Canada Controlled Substance License combined with a Health Canada DEL, is formal validation that Keystone has built a reputation for providing reliable, trustworthy data on the quality of cannabis products which are sold to consumers. At this time, there are very few testing facilities across Canada with the same accreditations as Keystones Labs to address the highly-regulated testing requirements for cannabis, especially for exportation of cannabis products to Europe. Our goal is to meet the regulated testing needs of both producers and consumers by offering all users the knowledge, confidence and insurance that their cannabis and cannabis products are safe.
As VP, Business Development and Marketing, the primary responsibility in this role is to seek and establish opportunities to facilitate business growth, with the new expanding Canadian regulated cannabis industry and exportation of cannabis products to Europe. This growth will focus and continue with Health Canada continuing to move forward with approval of Micro-Production cannabis facilities and the legalization of topicals, edibles and concentrates by October 2019.
2. Keystone developed a real-time test for medical cannabis. How does it work and what benefits does it provide? What are the different challenges that you meet in developing it?
To meet the untapped market of personal growers, in September 2016, Keystone Labs commercialized the KEY-BOX test kits to meet the demand for Cannabinoid testing of dry flower and extracted oils. Through marketing efforts, national and local distribution agreements, KEY-BOX sales have grown each year. The kit contains all the supplies needed to conduct a simple chemical procedure to isolate the cannabinoids from the dry flower into a sample liquid. The client returns the sample to Keystone Labs. Once received, the sample is analysed and the results are sent back to the client by e-mail. The KEY-BOX test kit now offers the terpene analysis along with the cannabinoid profile for each sample. These two tests analysis the complete profile for each cannabis sample and provide the information needed to specify unique strains and profiles especially for medical patients requiring specific components for their treatment.
We continued to get requests from our clients for a Real-Time cannabis test kit to provide the same quality of results with no turn-around time. The Real-Time technology platform is based on “Lab-on-a-Chip” technology which will allow cannabis production facilities, personal growers and users the ability to measure the cannabis potency within minutes. The device will use state-of-the-art microfluidic solid-state technology for detection. These microchips will be incorporated into a cassette and onboard microfluidics technology will allow interaction of the client’s sample with the microchip technology. The cassette will be inserted into a hand-held amplification device which will detect and quantitate the cannabinoids. The information will be sent to a smartphone interactive App via Bluetooth for analysis and data display results. The product launch is scheduled for September 2020.
3. How do you see the Canada-wide legalization of cannabis impacting your business?
The legalization of Cannabis in Canada has greatly impacted Keystone Labs in a very positive way. Before legalization on October 17, 2018, Keystone Labs acquired a Health Canada Controlled Substance License to test legal medical Cannabis. There was a need for regulated testing facilities to analysis the cannabis for contaminates before release to medical cannabis patients. At that time, there were approximately 10-12 approved Licensed Producers (LP), currently there are 141 LPs across Canada. After legalization, all cannabis products, dry flower and oils, require extensive analysis for contaminates and potency before release for sale. For Keystone Labs, there are three key market segments – Domestic Licensed Production, Health Canada’s expanded licensing program and export to the World-wide market. We continue to develop the domestic LP market. Health Canada’s Expanded Licensing program includes new categories: Standard and Micro Processing, Micro Production and next year will also include edibles, topicals and concentrates. With the combination of a Health Canada GMP DEL and Controlled Substance Licenses, Keystone Labs’ testing services are sought after to meet the high-level requirements for exporting cannabis products to Europe. Canada is the first G7 country in the world to legalize cannabis, exporting will be critical to grow the cannabis industry globally. Each of these new categories represent a new opportunity for business at Keystone Labs.
4. In contrast to the Canadian situation, only medical cannabis is legal in Germany. You are currently working together with the German company Mildendo GmbH. How do different legal frameworks influence international partnerships?
The different cannabis legal frameworks in the two different countries will not be an issue. The focus is to develop the microfluidics and chip development with Mildendo. All the product development with cannabis testing will be conducted in Canada in the licensed Keystone Labs facility. Once the product is commercialized, there will be no restrictions on the product for global sales as it is a personal test kit with no illegal materials.
5. How do you see the future of the cannabis industry and related markets evolving? What technological developments do you expect, or hope, to see in the near future?
As stated earlier, Canada is the first G7 country to legalize Cannabis and the world is watching. This gives Canada an incredible opportunity to be a leader in this new industry in all aspects of cannabis. This would include development of new technologies, products and development of clinical studies to produce key data for the medical community. Germany may be the next G7 country to legalize cannabis. This may be a great opportunity for the two countries to collaborate and become co-leaders in all aspects of this new industry.