Pharmaceutical regulatory affairs and quality operations is a dynamic field that has undergone many adaptions during this pandemic. With the immediate need of vaccines and diagnostic devices to curb the spread of the COVID-19, regulators have been diligent to keep up with the demand. As innovations in medical devices abound, how do regulators strike a balance in meeting regulatory standards while being mindful of the urgent requisition of these devices?
In this month’s speaker series, Burce Isik, a technical associate intern takes us through her experience working within BTNX Inc.’s regulatory department. BTNX Inc. is a global biotechnology company that is primarily focused on creating rapid point of care medical diagnostics. The company has seen its operations expand as demand for its Rapid Response™ branded products have increased during the pandemic.
Through this written interview, we learn about Burce’s journey into the regulatory world and hear her unique perspective as an intern at a company at the forefront of rapid tests. Burce shares both the challenges and rewards of this profession and provides insight into the important work regulators do every day.
Please enjoy this interview!
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Burce Isik is a technical associate intern at BTNX Inc. where she is currently completing the co-op portion of the Pharmaceutical Regulatory Affairs and Quality Operations program at Seneca College. She moved to Canada from Istanbul, Turkey in 2012 to join the undergraduate life sciences stream at the University of Toronto. After graduating in 2018 with her HBSc in Genetics, and a minor in Biology and German studies, she began working in different industries, including hospitality and education, before exploring careers in the medical devices sphere. As an intern at BTNX Inc., Burce has had the rare opportunity to expand her knowledge of regulatory affairs and quality assurance in the context of a pandemic. Additionally, her time at BTNX Inc. is providing her with insights into the dynamic approval and deployment process of Rapid Response™ tests and medical devices. Outside of work, Burce loves to sample international cuisines and travel. She is looking forward to crossing more countries off of her list once it is safe to do so.
Can you tell us a bit about yourself including your studies and career path?
My name is Burce Isik and I originally came to Canada from Istanbul, Turkey in 2012 to begin my undergraduate studies at the University of Toronto. I was in the Human Biology department majoring in Genetics and minoring in Biology and German studies.
During my undergrad, I had the chance to shadow doctors and work as a student researcher during my summers in Turkey. I fell in love with research, and I wanted to continue on this path. However, upon graduating, I immediately joined the workforce in order to gain a permanent resident status. So, for a year after graduation, I worked at one of busiest restaurants in downtown Toronto as a line cook. This environment was intense and fast-moving. My experience as a line cook taught me how to lead a team, manage my time, and how to problem-solve on the spot. I became agile, detail-oriented, and my confidence grew.
After receiving my permanent residency, I decided to go back to school to further my studies. I applied and was accepted into the Pharmaceutical Regulatory Affairs and Quality Operations program at Seneca College. It is a one-year program with a co-op term at the end. Currently, I am completing the co-op portion of my program with BTNX Inc. as a technical associate intern within the regulatory affairs and quality control department. It’s been five months since I started, and I’ve learnt a lot so far.
What interested you in regulatory affairs and quality assurance?
My interest in regulatory affairs and quality assurance was sparked by a conversation I had with a friend whose father owns a pharmaceutical company. She had brought up the topic about approving and importing medication in the Canadian space. I was really intrigued by the topic and realized that it was something that I never thought about. I realized that many drugs that are over and behind the counter are from all over the world. What is the process behind acquiring these drugs, testing them, and approving them? I conducted personal research on careers in the pharmaceutical industry and that is how I learned of the regulatory affairs and quality assurance program at Seneca. This field appeals to me because it allows me to use my science background and apply it in a context that can positively impact the health and wellbeing of many people.
I realized that many drugs that are over and behind the counter are from all over the world. What is the process behind acquiring these drugs, testing them, and approving them?
What is BTNX Inc. and its overall mission?
BTNX Inc. is medical device company that produces Rapid Response™ point of care diagnostic devices. Our main product line consists of in vitro diagnostic (IVD) tests for laboratories, clinics, hospitals, and physician offices. BTNX’s overall mission is to supply Canada and the rest of the world with these devices. With the onset of COVID-19, the need for these devices is ever more important and BTNX Inc. is here to fulfill that demand and continue innovating within the Rapid Response™ test space.
What are some of your day-to-day duties as a technical associate intern?
As a technical associate intern, my role is to learn as much as possible, so I have made it a personal goal to interact with colleagues across all departments at BTNX Inc. I provide support on many diverse projects and tasks. My main duty in terms of quality control is to diligently check over labeling and quality control reports. These are received from our international suppliers. I ensure everything is correctly labelled for each country’s requirements. If all looks well, I approve the labels and quality control reports and notify the team. Additionally, I ensure that the devices meet our internal and external quality control requirements.
What has your experience been working for a company at the forefront of COVID-19 Rapid Response™ Antigen testing?
My experience has been amazing so far as I have been exposed to regulatory bodies and processes during a time when the field is quickly evolving. Given the current affairs, I feel that the work that I’m doing is impactful and novel as BTNX Inc. is pioneering the next generation of Rapid Response™ testing. Specifically in the case of COVID, the pandemic and the situation surrounding this event has increased the workload and responsibility of each person in the company. Despite this, I believe I’ve grown a lot and had the chance to overcome a steeper learning curve that has allowed me to use the theoretical knowledge I gained at Seneca. Additionally, being connected to the responsibility for individuals receiving Rapid Response™ testing is an exciting part of the job.
How was BTNX Inc. able to mobilize Rapid Response™ testing for COVID?
When approving medical devices, there is a process that must be followed in order to ensure that standards are met. In the perspective of a new product, this innovation comes from our research and development team whose goal is to develop the most reliable technology for COVID-19 testing.
Once the new product has gone through sufficient testing and clinical trials, licensing and further approvals must begin. Applications must be submitted to Health Canada as well as international governments if this product is to be distributed globally. Additionally, our suppliers must also receive approvals from their respective regulatory bodies.
In the case of COVID-19, regulations are evolving and professionals in the space must attend seminars by these regulatory bodies to stay updated with the most recent information. Additionally, the packaging design must ensure that important legal terms and labels are included, so that is another step in this process. There are many teams working together to move these devices along the approval pipeline. The process is detailed and dynamic as we are ensuring these devices are of the highest quality and accuracy.
What were some challenges faced by the BTNX Inc. team when mobilizing these tests?
Some major challenges faced by the BTNX Inc. team when mobilizing these devices during the pandemic are the increased workload, time-sensitivity, and meeting the growing demand, not only in Canada, but around the world. As mentioned, fulfilling this urgent need and ensuring all regulatory and quality standards are met have meant a greater workload than usual. Despite these challenges, we are motivated by the importance of our work and our contribution to helping the world receive accurate Rapid Response™ testing.
What has been the most rewarding experience so far in your role as a technical associate intern?
Personally, the most rewarding experience so far in my role as a technical associate intern has been learning more about the industry. Through my work, I’m learning about the stringent measures within the approval process and the level of detail and diligence that is required. This first-hand experience has strengthened my trust in existing and developing regulatory guidelines. Additionally, I’ve gained a big picture perspective of the industry and a greater understanding of how scientific discoveries are translated into life-saving treatments.
I’ve gained a big picture perspective of the industry and a greater understanding of how scientific discoveries are translated into life-saving treatments.
What are BTNX Inc.’s goals for COVID-19 testing as the pandemic continues to evolve?
Earlier on, our goal was to receive approval for antibody and antigen testing for COVID-19, and this was recently achieved. Our distant goal is an over-the-counter self-testing COVID-19 device that individuals can use at home. Our aim is to provide users with a reliable, accurate, and real-time diagnosis without having to visit testing centers.
How do you envision Rapid Response™ testing post-COVID in terms of other healthcare applications?
I think the pandemic highlights the importance of Rapid Response™ testing and the need for individuals to know whether they have a positive or negative response in real-time. In the case of COVID-19 and the resulting pandemic – real-time results are crucial to curb the spread of the virus. This pandemic has challenged healthcare and governmental bodies and has also pushed for innovation in this field. I believe that the need for Rapid Response™ testing, not only for COVID-19 but other diseases, will continue to grow with increasing demand. Furthermore, I believe the next evolution in this field would be Rapid Response™ testing that you can do at home in a safe, fast, and accurate way. As we know, when one is sick, the diagnostic time is imperative and allowing individuals to do these tests at home can lead to greater efficiencies. It is without a doubt that the technology will continue to improve, as will our regulatory requirements, and I’m excited to see what’s next.