Connecting Science and Strategy in Biopharma

Merrill Birkner (B.S. ’00, biological sciences) applies her numerical and statistical insights to the complicated business of drug discovery and development.

Merrill Birkner (B.S. ’00, biological sciences) has a passion for the science of numbers.

“I love being able to use numbers to solve complex problems and provide insights,” she explained. “I’m a statistician at heart.”

As vice president for portfolio strategy and analytics at the biopharma giant Gilead Sciences, Birkner applies her numerical and statistical insights to the dynamic and often complicated business of drug discovery and development. Working at the intersection of clinical processes, research, commercial analytics and portfolio management, Birkner helps Gilead’s leadership team decide which new drugs to take from the lab to the market.

“Gilead’s portfolio spans across multiple therapeutic areas including virology, oncology, and inflammation. In my role, I help advise leaders within our company make quantitative-based decisions on what drugs to invest in,” Birkner explained. “Pharma is an expensive business, and you have significant uncertainty throughout the lifecycle of a therapy—for example, only approximately one in 10 therapies that enter into clinical trials actually succeed to marketed therapies—so you have to be able to understand and assess uncertainty and risk, which is what our team does.”

For Birkner, Gilead is the latest stop in a 20-year career that put her on the front lines of biotech and the biopharmaceutical industry, working with major companies including Gilead, 23andMe and Genentech to advance innovative therapies for a variety of medical conditions.

“What I've always been really passionate about is this connection between science and strategy,” Birkner said. “Drawing from my background in biology and also my training in statistics, it’s been very rewarding being able to link that to our company’s corporate strategy and objectives. What are the corporate goals of our company, and what do we want to deliver to patients?”

Growing up with UMD

The University of Maryland and its commitment to academic excellence were part of Birkner’s life long before she enrolled there as a student. She grew up in nearby Bethesda with a dad who was a professor in the A. James Clark School of Engineering.

“My dad, Francis Birkner, taught civil and environmental engineering at UMD, so I grew up in a very academic framework as a kid,” Birkner recalled. “Education wasn't just a phase of life that you go through; it was a mindset, focusing on the challenges, the curiosity and building confidence that you can walk into unfamiliar situations and you can learn to succeed.”

Early on, Birkner thought she would be an engineer like her dad. But her coursework and the College Park Scholars program shifted her focus in a different direction. 

“I took organic chemistry, and what I loved was really understanding all the building blocks and the biological implications of that,” Birkner recalled. “There was also a microbiology course that I loved, and the topics were so challenging, it made me realize, what am I capable of? I think that was really my jumpstart to getting into biology.”

A senior-year internship studying pathogens in blood at the Walter Reed National Military Medical Center gave Birkner her first hands-on experience doing biology in a real-world setting. Then, after graduating from UMD, she spent a year working on international public health topics at the U.S. Agency for International Development before earning her Master of Public Health degree in epidemiology and biostatistics and her Ph.D. in biostatistics (with a focus on computational biology) at the University of California, Berkeley.

“When I went to graduate school, I thought more about public health and bringing my science in that direction,” Birkner said, “but what I became very passionate about is using my numerical expertise to solve biological application questions, and I fell in love with that.”

A graduate school internship at Genentech helped Birkner land a full-time position there after graduation as a senior biostatistician, applying statistics to decision-making in cancer drug development and eventually becoming a leader in the company’s business operations. 

“What I started getting excited about was that link from the science to the strategy. How do you make decisions on therapies, on what to invest in and where to go with the therapy? And, to do that, I wanted to expand beyond statistics. I wanted to learn the whole lifecycle of drug development and commercialization,” she explained. “So, I took a risk and learned the commercial side of things, and then I pursued portfolio management, which is what I'm focused on now, making decisions and being able to really decide between one path and another for a drug, and what inspires me about that is how you can really impact patients' lives.”

One of Birkner’s proudest achievements is her work with Perjeta and Herceptin, biologic therapies from Genentech that are approved by the Food and Drug Administration for use in combination with chemotherapy to treat patients with HER2-positive breast cancer.

“I worked as a statistician on designing that trial, and I was so grateful and fortunate to see that all the way through to approval. Perjeta and Herceptin made an impact for patients with HER2 positive breast cancer, and just seeing that impact was so rewarding,” she said. “At the end of the day, we can make all sorts of decisions, but there's so much more behind the numbers, and that's what really matters.”

A blast from the past

In 2016, Birkner left Genentech for a leadership role at 23andMe, growing the company’s portfolio management and business operations and leading novel drug research and development in collaboration with GSK. Then in early 2020, Birkner got an unexpected blast from the past—an intriguing call from Merdad Parsey (B.S. ’85, biochemistry and microbiology), a fellow Terp she had worked with at Genentech years earlier who was the chief medical officer at Gilead. 

“Merdad called me out of the blue, and he said, ‘We're starting a portfolio strategy team; would you be interested?’” Birkner recalled. “And I thought, I've probably done all I can do here at 23andMe, and I really respect him as a leader—so I interviewed on the day California went into shelter-in-place, and then I had to build a team from scratch during COVID.”

In the last six years, Birkner has led a team that advises on decisions about new drugs in the company’s pipeline, recommending which to move forward or hold back.

“We actually look at the portfolio of therapies together and assess attributes such as the technical risk and value, like the opportunity it has for patients, but also the risk and investment that you're incurring along with the drug,” Birkner explained. “You want to look at each investment like you would with a financial advisor, but also incorporating the key scientific insights, and then say, ‘What's the potential value of this therapy, and what are the trade-offs? And what is the right mix of investments for the portfolio”  

And all these years later, she’s still leveraging skills and experience from her years as a biological sciences major at Maryland.

“I was just talking about a specific therapy within our portfolio with someone on my team, and we were talking about technical risk, and I reflected on the scientific mechanism and technical risk. My understanding of the science and the technical components, and the critical thinking skills, that’s really the foundation Maryland gave me. You can't just know the business case; you have to understand what the drug does,” Birkner said. “Both the biologic training and some of the early quantitative training I got at Maryland have made me better at my job today and better at being able to understand the complexity of the really dynamic and uncertain business of pharma.”

For Birkner, every new challenge is another opportunity to make a difference.

“I really love what I’m doing,” she said. “I really am passionate about my team, and about what I do, providing objective information to facilitate quantitative decision-making and bring promising new drugs to market. At the end of the day, that’s why I’m at Gilead and why I'm in pharma—it's about the impact that we can make to change patients' lives.”