Richard Roy is API’s VP of Product Development & Scale-up. Hear from him what makes API’s work important, his background, and what some of his proudest accomplishments are.
What are some of the challenges that companies face with technology transfers and setting up new facilities?
When making products such as pharmaceutical drugs, biologics, medical devices, diagnostic tests, etc., a major consideration are risks to human health and safety. Hence, these products are highly regulated.
It can be daunting to figure out, not only the scientific/technical hurdles, but the quality and regulatory requirements as well. To set up a manufacturing facility, there are various things to consider, from the types of products targeted, the relevant regulations which lead to designing and designating rooms for activities, equipment that’s needed, material and personnel flow, utilities required – the list goes on!
That is why it’s important to have the right team and right ecosystem to support this detailed process.
COVID-19 has further emphasized the need to have vaccines and other medications manufactured locally. What would having larger-scale manufacturing capabilities in Alberta mean for the province and the life sciences sector?
Securing the domestic supply of vaccines and other related products is crucial to ensure we do not run into a shortage crisis.
I have experience at companies that source products internationally, and ones that manufacture domestically themselves. It was scary when reputable international companies declared that they cannot supply anything in the near term and indicated to me to ask again months down the line.
Alberta has so much potential to develop this sector. Having manufacturing capabilities is vital to that development. With such amazing educational institutions and an ever-growing ecosystem that API is supporting, I predict great things for this sector in the future!
Why do you work in the life sciences?
I have always been intrigued by the sciences, specifically biology. I started my post-secondary education in biology at McGill University, however, I found myself leaning toward the applied sciences, so I switched to chemical engineering with a focus on biotechnology.
After graduation, I pursued a Masters in Biotechnology at the University of Toronto. This program was quite unique in that it combined both advanced science with business studies.
I got my first experience in the pharmaceutical field through this program, including various engineering positions at companies like Aventis (Sanofi) Pasteur, and Allelix/NPS Pharmaceuticals (now Takeda), and Merck KGaA: Genpharm (now Mylan).
In those roles, I developed my expertise in the GMPs which led me to specialize in Quality and Regulatory Affairs.
What brought you to Edmonton?
I first came to Edmonton about 17 years ago to work at Nucryst Pharmaceuticals, a University of Alberta spin-off company working with nanocrystalline silver for medical applications. After Nucryst, I joined an Edmonton-based medical device company, PRIMED Medical Products, where I had a unique opportunity to be in charge of product development, regulatory and quality.
It was an exciting role offering medical devices to customers in Canada and other countries around the world.
Why did you choose to join API?
After a temporary relocation to Ontario – working for international companies like AmerisourceBergen and ICON PLC – I returned to Edmonton because it had all of this potential in the life sciences space. I wanted to be a part of that vision – to develop and expand the ecosystem in Edmonton and beyond.
API’s vision and mandate lined up perfectly with what I’d been thinking about! An amazing role heading up Product Development and Scale-Up caught my attention. After some fruitful and exciting calls with the CEO and other members of the team, I decided to join.
Tell us about your proudest career achievements:
I am most proud of the products I helped launch in the marketplace, such as pharmaceutical drugs and medical devices, and a number of regulatory audits that I successfully hosted for the Food & Drug Administration, Health Canada and other entities.
During Covid and to this day, I’ve also seen personal protective equipment I helped develop being used by healthcare practitioners and patients. For those medical products, I oversaw the product development, regulatory and quality aspects of their development.