This article is brought to you by MediPharm.
With big changes to the world of legal cannabis imminent, demand for high-quality purified cannabis concentrates has never been higher. But how does a company stand out in the increasingly crowded marketplace?
MediPharm offers an example. The company specializes in purified, pharma-grade cannabis oil and cannabis concentrates, and they're midway through a big year. In April, they announced the formation of a Science Advisory Committee, a group of expert scientists, researchers and medical professionals who will advise the management team.
We spoke with MediPharm about the Science Advisory Committee, the steps they're taking to be ready for the next stages of cannabis legalization, and the future of the cannabis industry.
How long did it take for MediPharm to assemble its Science Advisory Committee? How will the SAC affect the way MediPharm operates?
Pat McCutcheon began formally working on the MediPharm Labs business plan in 2015 with co-founder Keith Strachan, but had long before imagined its possibility. While working in the pharmaceutical industry he understood how assembling a team of expert scientists and researchers working in a world-class facility could focus and work to develop much-needed treatments for different medical conditions and diseases. Pat believed in the potential of cannabis for its therapeutic qualities and so educated himself through every means possible.
In 2015, Pat attended MJBizCon in Vegas where he met Matt Archibald. Matt had worked as a consultant to the natural products and pharmaceutical industries and more recently in cannabis, helping with commercialization of processes and products and in infused product formulations. They struck up a great friendship as well as a business relationship, and eventually Matt introduced Pat to Dr. Leslie Brown, a UK-based scientist and entrepreneur specializing in Centrifugal Partition Chromatography equipment for the isolation of organic compounds at an industrial scale.
In 2017, Pat and Keith attended the Emerald Scientific conference in San Diego, California, the most technical cannabis science conference in the industry. It was there that they first met Dr. Jerry King and Dr. Markus Roggen, both returning speakers at this conference and renowned globally for their cannabis extraction research and expertise. The two were initially hired on individual consulting contracts but would ultimately become members of the Science Advisory Committee, along with other experts from pharmaceutical, natural products and cannabis industries.
Pat also drew from his personal circles to build a medical and pharmacy perspective into the SAC. Miriam McDonald, the Director of Pharmacy at Health Sciences North, had been a client and collaborator in his role leading the Hospital Division for Renal and Mental Health products at Janssen Canada (one of the Pharmaceutical Companies of Johnson & Johnson). Miriam became a mentor and friend to Pat so she was the first one he called to join MediPharm Labs’ board of directors and the SAC.
As well, Dr. Arshad Hack was a friend of Pat’s and an early investor in MediPharm Labs. As a past hospital administrator and now general practitioner, Arshad brought a patient and physician focus to the SAC, being quite involved in patient advocacy and the politics of medicine.
The Science Advisory Committee’s mandate is to collaborate with MediPharm Labs management team on advancements in the emerging fields of cannabinoid extraction and cannabinoid-based derivative science. This work will serve to continually enhance the company’s manufacturing platform and research practices, assist management in evaluating commercial opportunities related to technologies, testing and methodologies and provide guidance on partnerships with globally preeminent academic and medical institutions for cannabis research.
The SAC will help to keep MediPharm Labs on the forefront of the industry, achieving its goals of being the trusted global leader in high-quality, industrial-scale manufacturing of cannabinoid-based derivatives.
How will the SAC help us plug gaps in cannabis research? What does filling those gaps mean for the cannabis industry and cannabis consumers?
There are really two types of research that MediPharm Labs (and its SAC) are involved in.
Firstly MediPharm is developing technology and methodology to successfully extract cannabinoids from plant material – using methods that are effective and efficient resulting in the highest possible quality while also working at industrial scale. MediPharm Labs is at the forefront of this. Although the majority of its operations and revenue today are derived from primary extraction of crude resin which is utilized by its clients to formulate diluted cannabis oil and for the production softgel capsules, the focus of MediPharm Labs will be on refined cannabis distillates in the near term and on fractionation of individual and novel cannabinoids in future years.
As regulations change in the fall of 2019 to include an expanded line of concentrate-based products such as vapeables, edibles/beverages and topicals, these new consumer product categories will demand a more highly purified distillate as well as different formulation which might include full spectrum product with reintroduced terpenes, water-soluble, dry powdered, and/or tasteless/odourless concentrates.
MediPharm Labs is involved in all kinds of research and development, from equipment testing & modification, parameter testing for optimal methodologies, as well as formulation research. Along with our suppliers and consultants, we are forging the next generation of cannabis science, technology, methodology and practice.
Outside of advancing our commercial operations, MediPharm Labs is also involved in supporting international research in cannabinoid-based medicine. We have partnered with Dr. Yasmine Hurd at the Icahn School of Medicine at Mount Sinai Hospital in New York, in supporting a multi-year clinical trial dedicated to developing a non-addictive oral gelcap medication (hemp-derived CBD combined with a proprietary formula provided by our partner Timeless Herbal Care Inc.) for the treatment of opioid use disorder through anti-anxiety intervention. This will be a U.S. and international large-scale, multi-site clinical trial that will include at least 500 patients spanning the United States, Canada, Australia, Europe and Jamaica. One of the reasons MediPharm Labs was selected above other competing Canadian Licence Holders was due to the deep pharmaceutical industry experience of the company’s senior leadership team and its Science Advisory Committee. The Science Advisory Committee is currently vetting other research trials for potential participation.
You mentioned the EU GMP certification - can you expand on the importance of preparing for a global market?
While Canada’s cannabis industry is governed by Good Production Practices (GPP), this is essentially an agriculture designation unique to Canada and focused on quality systems and cleanliness standards of fresh and dried cannabis, cannabis plants and seeds, and cannabis oil prior to making it available for sale. But this designation is not recognized in other parts of the world and so MediPharm Labs is seeking EU Good Manufacturing Practices (GMP) certification which is more rigorous and is regarded as the highest international designation for pharmaceutical standards. Achieving this higher standard certification will allow MediPharm Labs the opportunity to have its advanced cannabinoid-based derivative products accepted for sale and consumption in other legal jurisdictions around the world.
From the beginning, Pat and Keith planned for MediPharm Labs to be a pharmaceutical-like company in the cannabis industry. They designed and built their laboratory and manufacturing facilities to include a GMP workflow in ISO-built standard clean rooms and controlled environment. They hired many of their team from the bio-pharmaceutical industry who had experience working in disciplined manufacturing operations and producing at scale. They supplemented this core science/production team with legal and regulatory affairs specialists who helped to build MediPharm Labs’ respected governance practices and standard operating procedures. Now as we build out our Australian operations, all of that early rigorous work from our Canadian operations is being adopted in Australia to ensure the same high quality is delivered in every link of our global supply chain.
How will medical patients and recreational consumers benefit from individual cannabinoids in the years to come?
Early clinical trials and volumes of patient feedback show potential therapeutic benefits from cannabis. And now we turn to the international scientific research and medical communities to substantiate these hopes through bona fide research studies. As cannabis extraction science advances, MediPharm Labs aims to fractionate cannabis distillate through centrifugal partition chromatography into individual cannabinoids at a purity of 99.9% at commercial scale. These isolates can then be studied in isolation or in combination with other cannabis compounds – terpenes, flavonoids and cannabinoids – to appreciate therapeutic benefits and/or negative effects, and what’s understood as ‘the entourage effect’, how some organic components of cannabis might act synergistically to accentuate benefits or mitigate negative effects of the plant. Ultimately it is MediPharm Labs vision that these outputs can be utilized as API – Active Pharmaceutical Ingredients for cannabis medicines.
There is an understanding that aspects of cannabis have therapeutic benefits for a number of medical conditions and diseases. Health Canada provides internationally peer reviewed information for physicians about potential therapeutic uses for 62 different medical conditions.
As extraction and advanced cannabinoid-based derivative science advances, patients and consumers alike will benefit from the creation of new specialized products and delivery systems that offer purified, safe, and precisely-dosable cannabis medicines and consumables. Rigorous standards in manufacturing, such as those that are utilized at MediPharm Labs, will provide consistent, predictable cannabis experiences and effects.
These sorts of moves are essential to prepare for the cannabis industry of tomorrow. What do you think the Canadian and the global industry will look like in 10 years?
There is already tremendous momentum with more than 50 jurisdictions around the globe adopting some form of legalized or de-criminalized use of cannabis. Most are for medical consumption of course, with Canada being the leader for legalized adult recreational use. Within ten years, we believe that stigma of usage will be reduced, adult use will be more widespread and, particularly in areas of the world where cannabis is currently outlawed (like Asia) we’ll see legalized medical use. Over the next ten years we anticipate phenomenal advancements in medical cannabis research and therefore growing acceptance of cannabinoid-based medicines for indication treatments.