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Business & Regulation Profession, Vaccines

Why You Don’t Need a Five-Year Career Plan

Credit: Interviewee supplied

You started out as a nurse but then moved to pharma. Why?

I started nursing at the University Hospital in Philadelphia and got my master's at the University of Pennsylvania. I started working on clinical research in the catheterization laboratory. I loved being in the academic center, and I never really planned on moving into pharmaceuticals, but we worked with many companies, including Merck, Sharp and Dohme (MSD) and J&J – which exposed me to the industry. I became a member of the university’s institutional review board and I remained in the hospital environment for 10 years. But then MSD recruited me to work with them. I remember one of the physicians saying to me, “Well, if you have to go to the pharma world – the enemy, at least you are going to MSD – one of the best.”

How did you find the jump to big pharma?

Though I ended up staying at MSD for 10 years, I didn’t like the corporate world at all when I first started! When you’re working in a hospital, you can’t fake things. You either know what you’re doing or you don’t. You have to work as a team and it’s okay not to necessarily be the expert in the room. There are serious situations and you have to use the data you have at the time – and sometimes use your gut and make decisions on the fly.

In the corporate world, someone may call for a committee or subcommittee when you need to make a decision. I found that crazy! Why did we need all these committees when it wasn’t a life or death decision? There were also a lot of egos. Egos are often left at the door in a hospital – not so in the corporate world.

The first few months were hard, but then I realized that my background in nursing and experience with clinical trials was highly valuable. In my career, I'm always asking myself, what's the angle that makes sense here? How can I actually be of value? How can I use the information that I have? When I started doing this, I felt valued and successful. And I really started enjoying the role.

What drives you?

It's the impact of the work that we do for patients. I also teach a class on good clinical practices as an adjunct professor at Temple University. I take students back to the Declaration of Helsinki and the Nuremberg Code; unfortunate tragedies have happened to patients that weren't informed about studies or didn’t volunteer. We cannot get drugs on the market for patients unless we do clinical studies, but it is critical to protect the rights and safety of the patients in those studies. I am always encouraging people to ask, what would make sense for the patient? What are we trying to do here?

How did you join the MRI?

After MSD, I was recruited by Shire – an amazing company that no longer exists. At MSD, I received great foundational training on how to do clinical research – but in the MSD way. Shire tapped into talent from all over the industry and taught me how people could have different interpretations and different risk-tolerance levels. I also had some really inspiring female leaders at Shire.

Shire moved to the Boston area and I didn’t want to relocate at the time – even though they kept asking me to! I did some consulting for a while – and somebody I was working with knew the Bill & Melinda Gates Foundation, which led to me receiving a call in May 2017 about how the Foundation wanted to open a not-for-profit pharmaceutical company in Cambridge to serve the underserved. I told them I wasn’t interested in moving, but they asked if I could help them with aspects like setting up quality assurance. I did that – and then, to cut a long story short, I had conversations with more people and I realized that this was a cause bigger than myself. How could I say no?

I got an offer letter for the job in October and we opened our doors in January 2018.

How have things changed since the MRI first opened its doors?

When we started, there were just six of us. Today, we have around 162 full time staff, but we are a wholly outsourced company so we use a lot of external service providers. For the first year, we focused on setting up all of the processes and writing SOPs. The programs that we work with come from the foundation, so we had to think about how we would communicate and build our relationship with the foundation. We had to think about our processes for clinical trials and the countries we wanted to work with. In the second year, we had the first patient in one of our trials. We draw such amazing talent from the industry and everybody really is about the mission. I feel really good about what we’ve accomplished!

When we were first created, translational discovery was our focus but we’ve now moved into the product development space. Something I love about the MRI is that there is constant evolution and always something different. It’s now six years since we started and we are running studies in low and middle-income countries (LMICs) – and we are doing it well.

Our current CEO, Emilio Emini, is retiring this summer. He is our second CEO so the next stage will be Version 3.0 of the MRI! Emilio brought a level of science and rigor that really benefited our programs. I’m excited to see what comes next. We have shown that we can get out there and run phase III studies in LMICs, serving the underserved. It’s been a huge success!

How did the pandemic affect the early days of the institute?

When the pandemic hit, we were in our second temporary space. We had found a more permanent space, but then we all had to work from home so it was about a year before we could finally enter our beautiful office!

Pre-pandemic, we had very limited remote staffing, but this has now changed. Around 25 percent of our staff is now considered remote, but once a month we have institute weeks in which we encourage all staff to be in the office, and we also have collaboration days during which we encourage teams to meet in person. I think that remote working is a challenge. Work does get done, but coming into the office, building relationships, and having conversations can avoid a lot of misunderstandings. 

What projects are you working on now?

We have a phase I study for a malaria vaccine, a phase IIb for TB therapeutics, and a phase 3 for a probiotic supplement. We’ll also soon be starting a phase III trial for our TB vaccine M72 (named for its molecular weight of 72 kDA!), which is really exciting because we will have up to 60 sites in 7 different countries and I feel we have a great quality management system that supports it.

In all of our programs, access is important. From the moment the MRI started, we wanted to ensure that the medicines get to the right people. Cost is also important – and we take this into consideration right at the beginning to help make our therapeutics cost effective.

You still teach. What is it about teaching that keeps you motivated? And what advice do you give to your students?

I’ve been teaching for 20 years and I love it! I teach graduate students – most of whom come from pharmacy school or the industry. It really forces me to stay up to date on the policies, procedures, and thought process from regulators, and I am also learning from my students. I don't have all the information and I can't keep up on everything, so it becomes a dialogue and I really enjoy learning from them. They definitely keep me on my toes!

Many students ask me about female leadership – a really hot topic. I feel very proud and privileged to work at the MRI where there are a lot of female leaders. I’m often asked about career development. I tell people to focus on the opportunities that are out there; don't worry so much about the promotions and the title, but do fill up your toolbox – you want as much in there as possible. This means you should learn from anybody and everybody. 

I always joke that I don't want to be the smartest in the room – instead, I want to go in and learn from folks. Perhaps it is naïve, but I really believe that if you focus on learning and growing then it will take you somewhere. As a leader, I want people to feel valued and to feel that this is the best environment for them to deliver on their work. I also think we should support one another. 

Many would say that senior leadership across the pharma industry is still dominated by men, but are things starting to change?

I read something a while ago that showed that the number of women in the C suite is increasing, which is great. Do I think it's where it needs to be? No, of course not.

I tell folks that it is important for women to show up authentically and to be who they are. When it comes to me, I am very direct and very transparent. Some leaders – both male and female – will remark, “Oh, Debbie is direct!” But I decided a long time ago that this is who I am, and I'm going to show up and be like that.

When I was at Shire and they asked me to take over GMP QA, it was very uncomfortable. I had never worked in GMP before, I was surrounded by men, and I didn’t understand the manufacturing space. But the female leader that wanted me to take the job told me that she wasn’t hiring me for my subject matter expertise; she was hiring me because of my ability to collaborate, put teams together, and problem solve. Now, I tell people to focus on what they are bringing to the table. The science in this industry can be complicated. I joke with my colleagues that I’ve been sitting in our meetings for six years and I still don’t totally understand the science. But I don’t beat myself up about it because that’s not what I’m here to do. I’m here to help them operationalize their scientific knowledge. If you walk into a room and focus on what you’re not bringing, you will fail. 

What advice would you give to your younger self?

One job interview question I hate is: “Do you have a five year plan?” Although I think everyone should have a guide, I don’t believe they should have a plan. You have to be open to opportunities. When I was a nurse, I didn’t have a lot of confidence. If you had told me then that I could become the COO of the Bill & Melinda Gates Medical Research Institute, there’s just no way I could have planned the path I needed to take. Be open to experiences, be open to meeting people, and build your toolbox. You will get ahead.

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