From Big Pharma to Non-Profit

What inspires you to do what you do every day?
 

I love this job. I've been working in the vaccine industry since the beginning of my career with Merck, where I got to work on a number of different products doing technical or lifecycle management support. One of them was the MMR vaccine. If you look at the incidence of measles before and after that vaccine was introduced, it plummeted in the US. I then moved to Takeda, where I was able to work on the development of other vaccines, including the vaccine for dengue. The work was very satisfying. 

Joining the Bill and Melinda Gates Medical Research Institute (Gates MRI) has allowed me to focus on low and middle income countries, and branch out beyond vaccines. My whole career has been in vaccines, but at Gates MRI the focus is on disease areas for which there is limited investment incentives. There is no platform technology for our products. It’s technically challenging, but also incredibly rewarding.

Is there anyone from history who inspires you?

When I first joined Merck, the measles vaccine developer Maurice Hillemann was retired but occasionally made appearances. He was certainly somebody who was held in high regard for the way he developed so many life-saving vaccine products.

How has your academic background helped shape your career today?

I started out as an English major, but I pivoted fairly soon after graduating from college. I decided I wanted a more technical role and I had taken a lot of technical classes as an undergraduate, which led me to chemical engineering. My idea at that point was to focus on environmental work. I had my first child in graduate school and I wanted an opportunity that would have a positive societal impact and wouldn't require a lot of travel. After I joined Merck to work on vaccines, I've never really looked back.

What attributes should a good leader have?
 

Leadership is a topic we talk a lot about. A good leader in this industry needs strong technical skills, alongside an ability to lead through influence. All of our work happens through partners – internal partners and the external partners who develop the products. We continue to work with the original developers. Leadership and collaboration skills allow you to do that effectively, and in a way that enables you to learn from them as you drive a particular program forward. Being able to manage those relationships is very important. As a nonprofit, we have pretty tight caps on our budget, so making sure that we're working as effectively as possible is critical.

How do leadership positions at big pharma companies differ from the nonprofit arena?
 

A lot of things are similar. We’re set up as a biotech so the organizational structure feels very similar and we have the same quality management systems. The differences lie in investment incentives. Our partners are more willing to work with us because we don't have a commercial or profit-orientated target. People understand that we are doing this to get products to people who need them.

How vital is your role to the vaccine manufacturing process?
 

My team’s responsibilities are producing the products of our studies, from preclinical to phase III. Without CMC, we don't have any product to test.

We’re also responsible for developing effective and robust manufacturing processes and analytics so our products can be produced at the required volumes and costs. Because the Gates MRI focuses on low and middle income countries, the cost element is very important, and the potential demand for the products is huge. Malaria and TB, for example, affect so many people, so we need to make products that can be produced at huge scales.

What challenges or barriers have you faced and overcome in your career?
 

There are always technical challenges in these roles that you have to anticipate and overcome – especially when working on a novel product. As a leader, making sure that there is the support for the work we do adds extra pressure. When I started, CMC was a very small organization, so there was a lot of risk that we wouldn't be able to produce our products on time and in the way needed.

It took some time to build the team, but I had a lot of support. Sometimes, CMC can be a little bit of an afterthought, so making sure that this part of the organization wasn’t neglected was important.

How does CMC augment the drug development process?
 

One area of focus involves identifying a regimen of drugs for tuberculosis that can treat the disease in much less time than the current standard of care, which is six months. Trying to find a set of drugs that, in combination, can bring that timeline down to two or three months is an enormous challenge, but it would have an enormous impact. With a six-month treatment timeline, there are challenges with adherence to the drug regimen, which can result in relapse and sometimes multidrug resistance can develop. In CMC, we support the effort to find a shorter treatment by producing the drugs used in those clinical studies.

It’s also about exploring new technologies. One specific example is long acting injectables, which could allow treatment with a single shot rather than through daily oral therapy. These pose a challenge from a formulation perspective, but our CMC team is evaluating different formulation approaches that could make this powerful technology a reality for our TB drugs.

How do strategic partnerships help to overcome these challenges?
 

In the TB space particularly, a lot of companies are developing drugs. Sometimes very impactful drugs, but they don't necessarily work in isolation. Treating TB with one drug is a recipe for resistance. We need a multidrug approach. No one company is going to be able to do that because the investment incentives are pretty limited, but what we can do is bring those pieces together and use partnerships to accelerate new treatments for TB. The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) is a consortium of drug developers coming together, using drugs developed by multiple companies.

I hope we can continue to build upon the work we're doing in the TB space. In ten years' time, we may find ourselves in a very different world. We are currently working on a vaccine that protects people with latent TB from getting active TB. That vaccine is now in a phase III trial that’s going really well.

Can you envision a world where TB doesn’t impact 20 percent of the world’s population? Organizations coming together is what will enable that to happen.

Outside of work, what else do you enjoy?
 

I've always been a runner. I'm much slower than I used to be, but I still love to get out and run! I also love to read and now I combine both by listening to books while running.

It's also important to take a step back and make sure you're taking care of yourself. I have four things I try to do: eat well, exercise, get enough sleep, and do something that nurtures your spirit.