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Researcher Profiles

Recalculating drug risks as new data flows in


Louisa Smith

Her role is to help the FDA recalculate biologics’ risks, updating risk-benefit ratios as new patient data flows in.   

As a 7th grader in Cumberland, Maine, Louisa Smith says she vividly remembers learning about Ebola and thinking “epidemiology was cool.” After studying community health and comparative literature at Brown University, Smith enjoyed teaching grade schoolers for several years but decided that, while education was important, health was “at the root of everything.” 

So Smith set off on the road to a master’s degree in epidemiology from the University of California at Berkeley. Inspired, she moved on to the Harvard T.H. Chan School of Public Health, where she earned a master’s in biostatistics and a doctorate in population health sciences. 

“It was hard getting answers to questions I wanted to ask,” Smith says, given the challenges inherent in gathering data on big groups of people. Among the obstacles are measurement error, confounding, and selection bias, which can creep into a study’s design and obscure the link between a toxin or pathogen and a disease. As part of her dissertation, she devised ways to assess the impact of a study’s multiple types of biases, each one a threat to the integrity of its results. 

Meanwhile, when the pandemic struck, Smith joined a research team to conduct online surveys of pregnant women affected, or not, by Covid-19. Coronavirus infection in the third trimester seemed to pose the greatest risk of preterm delivery, but Smith identified potential biases baked into the data, such as the inclusion of only women with internet access. 

In the summer of 2021, doctorate in hand, Smith looked into postdocs from Harvard and universities in Colorado, New York, and Stockholm, but the lure of Maine, her home state, won out. Today she’s a postdoc in Portland at Northeastern’s Roux Institute, funded by the FDA’s BEST (Biologics Effectiveness and Safety) program, which monitors the safety of in-market biologic treatments, including vaccines. Her role is to help BEST recalculate biologics’ risks at a brisker pace, updating risk-benefit ratios as new patient data flows in. 

On the job, Smith is building on her data skills, which she notes can be transferred to all sorts of problems in health research, and to industry. But she’s found her sweet spot in academia. “It’s where I can teach and mentor and keep learning,” she says, “asking questions that impact thousands or millions of lives.” 

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