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Arunima Nath: Leading Quality Control and Quality Assurance in the emerging Psychedelic Industry

Arunima Nath | Director of Quality and Compliance
Arunima Nath | Director of Quality and Compliance

The bounds of the medical sector are stretching of the views and are exploring innovative ways to cure humankind. To ensure that the results from the trial and error process are safe, it is quintessential to have a firm backbone of regulatory processes.

While the government system of checks is the superior and ultimate organ of this process, it is also necessary to streamline the process at the intermediate levels. In order to achieve this, leaders like Arunima Nath are devising practical approaches to ensure quality assurance and quality control are supervised effectively and lead to a safer health ecosystem.

She is the Director of Quality and Compliance at Psygen industries which is the world’s first manufacturer dedicated exclusively to the synthesis of GMP-compliant psychedelics, headquartered in Calgary. Established in 2018, the company solved a severe bottleneck for developing novel treatments using psychedelics and ultimately for patient health and well-being.

As a professional with a history of working in the Pharmaceuticals and Cannabis industry and holding a master’s degree in Industrial pharmacy, she leads the company’s quality assurance department and helps it to get quick regulatory approvals from the USFDA and Health Canada.

Her role is enabling in replacing stigma with curiosity and ignorance with evidence. As a leader and an expert in the industry, she, along with her team, has played a pivotal role in granting Psygen a letter of authorization from Health Canada to supply patients with Psilocybin through the Special Access Program.

As there is more to her story and Psygen’s innovative approaches, let us uncover all of them by going through the interview highlights below!

Arunima, could you kindly tell us about your inspiration behind venturing into the healthcare sector?

Since high school, I have always wanted to contribute to saving lives and impacting patients’ well-being. My zeal led me to study pharmaceutical sciences in my undergraduate degree. Later, I studied for a master’s program in Industrial Pharmacy. My career in the pharmaceutical world started in 2011 in the Quality department for the formulation of oral dosage forms. Eventually, the scope of my work expanded to include tablets, soft gels, capsules, suspensions, and actives. I worked on new product launches for the Canadian and US, Europe, LATAM, and APAC regions taking care of the entire life cycle of the pharmaceutical product – from inception to launch.

My career took an interesting turn in 2018 when I started working in the Cannabis Industry. Since 2021, I have led the Quality Assurance, Quality Control, and regulatory teams at Psygen. I feel lucky to be in such a supportive workplace, with an incredible team of professionals who are passionate about the industry, open to learning, and contributing to a common goal.

Please tell us about your journey, highlighting your contribution to Psygen’s success.

I started reading about Psygen in early 2021. The company was aiming to be the world’s first manufacturer dedicated exclusively to the synthesis of GMP-compliant psychedelics, headquartered in Calgary. A position in the Quality department steered me to join Psygen. I met Danny Motyka and Dr. Peter van der Heyden, Psygen’s cofounders, and their goals resonated with me deeply.

My team is responsible for establishing the engineering, controls, and qualification of our 17,000 sq. ft facility, developing and implementing the entire Quality management system, and qualification of all associated instrumentation in the Quality Control and Production lab.

Psygen was able to manufacture two GMP batches of Psilocybin in partnership with a third-party licensed dealer, establishing our customer base in Canada and beyond. Psygen is the first manufacturer to receive a letter of authorization from Health Canada to supply patients with Psilocybin through the Special Access Program. This is an incredible accomplishment for us as a team and demonstrates our strong relationship with Health Canada.

Along with my role at Psygen, I am pursuing an MBA program as a full-time student with the Haskayne School of Business, University of Calgary.

Could you please elaborate upon the core values on which Psygen is built and what the mission of the company is?

Psygen envisions a world where psychedelic drugs are recognized as valuable tools to improve mental health and wellness. Psygen will improve access to these medicines by deploying novel technologies to produce psychedelics at an unprecedented scale, ensuring a safe, non-exclusive, and cost-effective source for innovators.

Our team offers unparalleled knowledge and manufacturing capabilities from over 50 years of experience in manufacturing psychedelic medicines.

The values of generosity, gratitude, curiosity, and connection drive and motivate our team to be the seeds of change we hope to see. We believe it is time to replace stigma with curiosity and ignorance with evidence.

Kindly shed some light on the services and the immersive benefits that make Psygen stand out from the competition.

Psygen is one of the few dedicated psychedelic manufacturers globally. Our competitive advantage stems from more than 50 years of combined experience synthesizing psychedelics, as well as our state-of-the-art GMP production lab. When Psygen was founded in 2018, no dedicated manufacturer of GMP psychedelic APIs existed – a serious bottleneck for the development of novel treatments and, ultimately, for patient health and wellbeing.

Psygen is a Health Canada licensed dealer capable of producing and selling restricted drugs. Our scientific team develops innovative production methods to both meet the requirements of the industry, as well as generate IP around these novel production methods for our customers.

The legal counsel at Psygen and the Regulatory team have expert working knowledge of the Controlled Drugs and Substances Act and the associated regulations that strengthen the strategic partnerships with all our clients and support their project requirements.

Please elaborate on the technological developments and the patented technologies that the company incorporates when catering to the dynamic needs of the healthcare sector.

Technological developments in CMC (chemistry, manufacturing, and controls) are constantly evolving. Although CMC is sometimes overlooked in favor of clinical development, it is a key driver of significant advancements in drug development, inventing cutting-edge pharmaceutical technologies, reducing development costs, and increasing access to GMP-grade psychedelics.

Psygen is focusing on In-house research and development to modify current chemistry for scalability for different molecules. In the psychedelic space, there have been significant challenges to patent reviewers.

We are leveraging our deep knowledge of the space, in collaboration with our in-house IP counsel and have several patents pending. Psygen will codevelop technologies with strategic partners as we provide commercial opportunities for certain production technologies. Our IP strategy is to identify valuable innovations while improving our trade-secret manufacturing processes.

Psygen has a novel process for the synthesis of Psilocybin, that leverages new technologies in the field of synthetic chemistry. We also have a patent pending psilocin recovery protocol (increasing the overall reaction and recovery yield of Psilocybin by 50%).

Being an experienced leader, what is your intuitive advice for budding youngsters venturing into healthcare?

You need to pick a profession that you enjoy both studying and working in. Be driven, diligent, and hardworking. There is no shortcut to success, and even if there were, maintaining it would be much more difficult. Young people who are interested in the healthcare and pharmaceutical industries must define their areas of interest. It’s a vast industry with several distinct divisions you can lead and plenty of ongoing and unfinished research.

Focus on learning from scratch and maintaining a good foundation of learning. Always strive to see the wider picture of your assignment, maintain the accuracy and integrity of the task you have been given, and consider how that action or task is assisting your company in reaching a certain milestone. Keep yourself apprised of the regulatory updates by the agencies, i.e., Health Canada, FDA, ICH, etc., to have an insight into regular updates in the industry.

Apart from your journey, how do you envision further strengthening Psygen’s stronghold in 2022 and beyond?

The year 2022 has been a year of highs and lows for the psychedelic pharmaceutical industry, beginning with much excitement and investment and ending with consolidation and attrition in demand. As the market for traditional psychedelics (e.g., Psilocybin and DMT) waned and interest in the more patentable Novel Chemical Entities (NCEs) grew, Psygen recognized new opportunities to support drug developers.

For my team, the focus is on validating the production of various psychedelic compounds (e.g., LSD and MDMA) to support our customers’ ongoing clinical trials around the world and receiving a Drug Establishment License from Health Canada. To maintain our position as an industry leader Psygen will focus on our innovation project, executing a partnership for the development and deployment of novel technologies that will aid both drug discovery and production, two critical components of our customers’ drug development plans.

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