When a start-up decides to commercialize a medical device, the process inevitably involves working in tandem with regulatory bodies, such as the U.S Food and Drug Administration (FDA). Working in a start-up is like jazz music, loose compositions coming together for a finale through improvisation. Conversely, working within a regulatory environment is like a symphony, controlled compositions with set movement forms, assigned roles, and a known finish.
How does one working at the intersection of these areas bring them together to form third stream music: a wholly unique composition that draws on the foundations of each but is neither? This is the challenge that Emily Birthisel tackles at Nutromics as Senior Clinical Research Associate (CRA).
Balancing improvisation and symphony, one chord at a time
Emily always knew that Clinical Affairs was the pathway for her. “I never wanted to be a scientist or physician, but I wanted to be in the business of medicine”, Emily says. In the first few years of her career, Emily is focused on gaining experience across this spectrum.
Prior to Nutromics Emily worked at a consulting firm focusing on pharmacovigilance, that is monitoring and evaluating adverse effects for medications already in the market. Elaborating on why she applied for the CRA role at Nutromics, Emily said “Clinical research was at the opposite end of what I was doing and seeing the other side of the pipeline was really attractive to me. I was also ready to move from a more corporate environment to a start-up.”
Emily feels that working in a start-up has given her opportunities to grow professionally by leaps and bounds. A year into a role, she has helped organize and manage multiple clinical studies, both on-site and with collaborators and establish a Human Research Ethics Committee which is registered with the Australian National Health and Medical Research Council. As one of the early hires in the team, she had an opportunity to contribute to shaping its processes.
“In my view, work at start-up is all about process development. In our team it was about developing quality systems, deciding how we wanted to manage our processes and procedures, and building something that worked and evolved with the company rather than being limited by archaic systems”, she said reflecting on her early experiences.
These instances of “learning by doing” as are the norm in start-ups, were balanced with an immersion in the structured regulatory side of things. Through Nutromics Emily had the opportunity to attend ACRP 2023, a conference for clinical research professionals in the USA. Here she had a chance to get greater insight into regulatory requirements, processes, and changes in the US, Nutromics’ first market. Furthermore, she also receives regular mentorship from her manager and Nutromics’ Chief Medical Officer, Tahir Yahya, who earned his stripes at Abbott.
The cumulative sum of these learnings and experiences is a growing body of knowledge that serves as a foundation for Emily as she helps Nutromics work towards securing regulatory approvals for its DNA-based sensor.
From comfort zone to crescendo
Jazz musicians are unique in that they make music by focusing on how they play a song rather than what they play. They develop such mastery over their music that an improvised change in groove, chords, or tempo creates a new song. To some musicians this may be daunting but for others it is an embodiment of freedom and teamwork. When it comes to start-ups, the people who work in them share this sentiment. This is precisely what drew Emily to their world.
“Your decision to join a start-up depends on your risk appetite. For me it was at a time when I was finishing my Masters and it felt like the right time to take a risk and try it out”, she reflected.
Nutromics was Emily’s first foray into the world of start-ups. Her ideas of what it would be like were largely shaped by social media. However, the first thing she was struck by, besides the dog-friendly office, was how big the realm of opportunity was. “While you come into a role, what you can do and where you can go is more mobile. We had team members who had tried a few different things before transitioning into areas they enjoyed more. This would be harder at a more established company”, she said.
There were some stereotypes about start-ups that held true for Emily, “Start-ups, I think the perception of being higher pressure and having a bigger workload. This is true. You have a lot more to prove because you’re trying to get people to believe in what you’re doing. There are a lot more expectations and you have a lot of variety in the kind of tasks you have to deal with.”
However, this aspect of start-ups excites Emily. She loves the opportunities it creates for her, her teammates, and her stakeholders to innovate and come together as a team. This has helped her grow in her work. Nutromics’ culture that emphasizes collaboration and trust beyond work builds on this and contributes to Emily’s personal growth. Elaborating, she said, “At Nutromics we have a very diverse team with different life experiences and expertise. This is really cool, and we celebrate this diversity well. Outside of the nine-to-five, we spend a lot of time engaging with each other whether it is at drinks after work or at an activity. When you have a lot of different personalities you find people that you get along with.”
“At Nutromics you have a lot more opportunities to meet and build connections with people from different departments. Even though I’m the only person from my team in Australia, I’ve been able to build connections with teams like Research and Development, Public Relations etc.“, she continued. “The structure also facilitates connections upwards. The Founders and senior leaders also have an open-door policy, and they take on feedback with an open mind. In terms of how opinions are valued, my experience at Nutromics has been very different to previous experiences”, she said with a smile.
When asked what helps people thrive in a start-up, Emily believes that whether you’re early in your career or an experienced professional, dynamic thinking and a desire to push yourself beyond your comfort zone are key.
Emily also stated that agility and creativity are crucial to blending regulatory knowledge and start-up work demands. “Agility and creativity are top priorities at a start-up. I don’t necessarily consider myself a creative person but when you’re in a start-up you have to be able to go beyond what you have traditionally done, pivot to new directions, and develop new paths and solutions in time.”, she said.
At Nutromics, Emily is helping compose a sheet of music that will ultimately create a timeless melody: one of greater good where real time diagnostic data will help save millions of lives.
“It’s opening a whole new door of medicine, which is really cool”, she said emphatically.