The Importance of Trust in Vaccine Development

Edna Choi (MBP '05) is associate director for business operations at Kite Pharma, and although her company is not focused on a vaccine for COVID-19, she has unique insights into the potential care and prevention of the novel coronavirus.

The parent company of Kite is Gilead, the manufacturer of remdesivir, which received emergency use authorization by the US Food and Drug Administration to treat COVID-19. Beyond that, Choi previously worked at Novavax, a biotech company focused on vaccine development. 

"My past employment at Novavax and my experience in biologics enable me to explain to friends and families the vaccine development and approval process," Choi said. "I feel there is a lot of mistrust and misunderstanding, creating fear and further distrust in safety and validity of COVID-19 vaccines."  

Choi, a member of the Industrial Advisory Board for Northwestern Engineering's Master of Biotechnology program (MBP), recently sat down to talk about her work, vaccine development, and why MBP students are uniquely qualified to be leaders within the biotechnology arena. 

"The (biotechnology) industry suddenly got thrust into the spotlight. It is being seen as the only hope back to normalcy." - Edna Choi 

How do you like to describe your role and responsibilities?

I am a business operations lead for my site, which is one of Kite's six manufacturing sites globally, and one of the company's two clinical manufacturing sites in the world. My responsibilities include owning the Operational Excellence (OE) program, strategy development and execution, portfolio management, change management, and performance management for my site. I am also the chief of staff for the site head, managing all key business activities including site budgeting, site goal setting, facilitating site leadership meetings, site performance reporting, leadership communication preparation, and site operating model deployment.

How has COVID-19 impacted you?

Personally, working from home with a child learning remotely was very challenging in the beginning. I bounced between homemaker and professional responsibilities from the time I woke up until I went to bed with no break in between. On the upside, we have some new family routines, like one hour of movie time after dinner on weeknights!

Professionally, I became a lot more flexible with my schedule. Instead of 9-5, I may start work earlier with more breaks in the middle of the day and hop back on work after dinner and bedtime to balance work and life. Thankfully, Gilead and Kite have been great in helping employees through COVID-19 with expanded COVID benefits and campaigns to ensure employees stay connected like regular company meetings, monthly webinars to educate employees on what different departments do, patient stories, culturally-relevant events, and regular COVID-19 business updates, as well as pulse surveys on employee engagement.

How, if at all, do you think the public's perception of biotechnology has changed since the pandemic started?

The industry was suddenly thrust into the spotlight. It is being seen as the only hope back to normalcy, yet there is a lot of public distrust in Operation Warp Speed's ability to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021. I hope there will be more opportunities for the industry to educate the public on topics like how vaccines can be made so fast or the Investigational New Drug (IND) to Biologics License Application (BLA) process. I believe the pandemic is also creating an interest for the younger generation to pursue this field as they see how important it is.

Having worked at Novavax, which prides itself on creating vaccines at rapid speed for emerging disease, I understand the struggle of the business model. There is no money in making a vaccine for an emerging disease that may or may not become a pandemic. Funding was hard to come by. And now, more than ever, governments around the world finally woke up and realized the importance of funding vaccines for emerging diseases.

I also think there is a renewed interest in vaccines. Vaccines were less sexy of a biologics product as compared to monoclonal antibody (mAB), cell and gene therapy (C&GT) or informational RNA (iRNA). With this pandemic and all the leading vaccine candidates and treatments, the speed of which they are being developed highlights the technological advancement in vaccines. Vaccines can be a hot item again!

What role do you think biotechnology will play in helping society move past COVID-19?

I don't believe COVID will pass necessarily. At best, I believe a viable and effective vaccine will at least turn COVID into just another seasonal virus like the cold and flu that we have to deal with, because it will continue to circulate in the population and mutate constantly. A viable and effective vaccine enables socialization again. There is an opportunity here for the industry to proactively educate the public on vaccine technology and FDA approval processes to help build trust. Without trust, the public will not take the vaccine even when one becomes available, and we'll be dealing with COVID-19 for a lot longer. 

How do you think MBP is preparing students to succeed in today's complex and ever-changing world?

We talked about ensuring the MBP curriculum and co-ops are morphing with macro and micro trends. MBP provides all the tools that students need to navigate the VUCA (volatility, uncertainty, complexity, and ambiguity) world we live in. While bioprocessing still has a place, dabbling in things like C&GT and iRNA will ensure students stay relevant with the technological advancement of our industry.   

What advice would you give to a prospective student considering MBP?

Be comfortable with the VUCA world as that is the only constant life can guarantee. The COVID-19 pandemic proves just that. So diversify your skill set and knowledge base during your time in MBP, stay alert on macro and micro trends, and then go out and get some real world experience. The learning will continue as your career develops. Having your eyes and ears open to trends will help you become an early adopter of emerging opportunities.