Making an Impact through Regulatory Affairs

Making an Impact through Regulatory Affairs

Some days, Northeastern University-Toronto student Dione D’cruz pores over lengthy technical documents and Food and Drug Administration (FDA) regulations. Other days, she may spend time chatting with her mentor, a quality and regulatory medical device consultant. There are also moments when Dione gets up close to the technology for which she is developing a quality management system (QMS). Those times require Dione, a student in Master of Science in Regulatory Affairs (MSRA) program in the College of Professional Studies, to collaborate with interprofessional teams. Eventually, Dione’s work will culminate in her drafting the QMS’s standard operating procedures, templates, and documents required for each phase of design and development of the medical device. These responsibilities are part of her co-op placement turned part-time job at health systems start-up Insight Medbotics. Dione’s efforts are also her contribution to preparing a FDA premarket submission for the new medical device to get a FDA regulatory clearance — one that has the potential to save lives.

Beyond being an opportunity for real-world application and networking, Dione’s experience and impact at Insight Medbotics provides a glimpse into the 360-degree benefits of cultivating strong relationships between industry and academia.

“The Master of Science in Regulatory Affairs program at Northeastern University – Toronto is known for its co-op, and that is one of the main reasons I chose it,” says Dione, who is set to graduate in July 2022. “It’s also the only Masters of its kind in Canada, and focuses specifically on the development and commercialization of drugs, biologics, and medical device products. The last six months at Insight Medbotics have been a great learning experience and networking opportunity. Co-op is definitely a stepping stone to get ahead in your career.”

Dione entered the program with a Master’s degree and extensive experience as a pharmacist and product manager. Having worked at two major Indian multinationals, she was even involved in launching India’s first oral Hepatitis C drug. At Northeastern Toronto, her focus is twofold: gain insight into the lifecycle of getting products into the Canadian market and acquire Canada-specific experience. The MSRA program’s built-in co-op allows for both. At Insight Medbotics, she also augments classroom learnings while applying her skill set in a meaningful way.

That’s because Insight Medbotics focuses on developing novel MRI-guided diagnostic and therapeutic approaches to treat cancer. The company’s lead product, the Image Guided Automated Robot (IGAR), enhances precision and accuracy for early detection of breast cancer​. It is the IGAR that’s been the focus of Dione’s regulatory work at Insight Medbotics.

“I’ve always worked with big multinationals but working with a start-up has given me hands-on experience in many other areas,” says Dione. “The company has given me a platform to speak with different consultants in areas like engineering, regulatory, and quality. I felt prepared for the role because I had a lot of knowledge from my courses but since starting, I’ve further developed my technical and soft skills.”

Paul Chipperton is Insight Medbotics’ president and CEO. He says Dione’s contribution makes her instrumental in the platform’s development, approval, and launch into the market.

Industry Connections with 360-Degree Benefits for Co-op Placements

Dione’s experience is exactly the kind that Montse Sanzsole hopes co-op students will have during their time in the real world. As Northeastern University-Toronto’s Director of Strategic Partnerships, she oversees the university’s interactions with employer partners in ways that involve much more than student co-op placements.

Research, for example, is one important collaboration avenue. Northeastern University boasts more than 40 innovative research laboratories. Annually, Northeastern researchers receive approximately $100 million in research awards. Students collaborate alongside expert faculty in numerous areas such as sustainability, health informatics, data analytics, regulatory affairs, global health, and urban public policy.

“When I engage with employers for our various partnership opportunities, I look for synergies,” says Montse. “Employers have needs and we can meet their needs — whether that is talent, upskilling their own staff, or network growth — but we can only learn from each other when we know each other.”

Another unique opportunity for industry are the Program Advisory Committees (PAC). Made up of professionals of program-specific fields, PACs, says Montse, ensure programs are current and relevant to industry, business, and society by offering feedback and program direction. They also become a crucial link between the university and the external community by giving a voice to the professionals who will end up hiring the university’s graduates. In fact, it was Paul’s involvement in the Regulatory Affairs PAC that led to Dione securing her co-op position.

“When he saw Dione’s resume, he made an effort to connect with her,” Montse says. “It was his first time hiring a co-op student from our program. It’s a great example of how our PAC members give back and also gain from their interactions with us. When you combine the various ways that we build relationships with industry partners with our curriculum and experiential opportunities, our students hit the ground running when they graduate. They are ready to contribute to the Canadian economy.”

For Dione, her current contribution also goes much deeper. It is lifesaving work. MRI is widely-regarded as the superior diagnostic imaging modality for monitoring and diagnosing women with a heightened genomic and phenomic risk for breast cancer. That’s where MRI-guided techniques such as the IGAR, which recently underwent two clinical trials, come in.

“It is definitely a rewarding experience to work with a lifesaving device especially in the field of breast cancer,” Dione says. “Being a part of the process where the device goes through different phases of design and development, and ultimately gets regulatory approval, is going to be enriching. I am grateful to have a chance to work with a novel device like this.”

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