Fred Hutch Cancer Center biostatistician Peter Gilbert, PhD, received the 2025 Marvin Zelen Leadership Award in Statistical Science from Harvard University.
The award recognizes Gilbert’s contributions to public health and vaccine research. A professor in Fred Hutch’s Vaccine and Infectious Science Division (VIDD), Gilbert specializes in improving the design and analysis of clinical trials for vaccines against HIV, SARS-CoV-2 and other infectious diseases, as well as defining the biomarkers that predict whether a new vaccine or therapeutic will work.
“This is really an award to a huge number of people,” said Gilbert, who leads the Statistical Data Management Center (SDMC) of the HIV Vaccine Trials Network (HVTN), headquartered at Fred Hutch. “No one’s research can bear fruit in isolation; this is a testament to the gifts given to me, and to the people who worked with me and supported my career.”
The Zelen Award honors Marvin Zelen, PhD, whose leadership shaped the field of biostatistics. The annual award recognizes an individual in government, industry or academia whose leadership has greatly impacted the theory and practice of statistical science.
“Peter has been a fantastic contributor to VIDD and Fred Hutch, both in the science and the administration of the population aspects of VIDD,” said Fred Hutch colleague and professor emeritus Ross Prentice, PhD, who previously received the Marvin Zelen Leadership Award for his contributions to public health research. “He is well known for methods development and the application of methods, both for vaccine development and for vaccine trial evaluation, with emphasis on approaches that support a causal interpretation of results.”
After receiving his PhD in biostatistics at the University of Washington, Gilbert moved to Zelen’s department at Harvard, focusing on analyzing and designing clinical trials to test treatments for HIV. From the beginning, he integrated students into his research, a theme that would continue throughout his career.
In 2001, Gilbert’s doctoral mentor, UW biostatistician Steven Self, PhD, enticed him back to Seattle to support the rapidly expanding statistical science developments at Fred Hutch. He joined the SDMC to develop statistical methods for the design and analysis of ambitious HIV vaccine trials.
The HVTN is the world’s largest publicly funded collaboration to assess vaccines and interventions designed to prevent HIV infection. The SDMC is essential to its mission to fully characterize the safety, immunogenicity, and efficacy of HIV vaccine candidates.
Since 2004, Gilbert has headed or co-headed the SDMC and guided the design and analysis of clinical trials that measure HIV vaccine immunogenicity and efficacy, as well as interventions, like monoclonal antibodies, developed to help treat or prevent HIV infection. He also directs statistical science activities for COVID-19 vaccines and chaired Fred Hutch’s Program in Biostatistics, Bioinformatics and Epidemiology from 2013 to 2019.
HVTN trials have spanned the gamut from early-phase trials that test how well a vaccine stimulates the immune system to enormous, thousands-strong Phase 3 trials that test how well vaccines or monoclonal antibodies prevent infection.
Under Gilbert’s leadership, the SDMC has spearheaded the development of new trial designs, such as Phase 2b trials, and continues to innovate in response to new developments in the field of HIV prevention. The SDMC team has created methods to measure vaccine immunogenicity, the persistence of monoclonal antibodies, viral sequence and structural characteristics that influence vaccine efficacy, and define biomarkers that reveal how effective a vaccine will be.
Synchronized with the HVTN research, Gilbert has also led development of new statistical methods to improve assessment of vaccines against dengue and malaria.
As the SDMC’s leader, Gilbert guides the team as they create innovative new approaches and communicates their findings and strategies to the regulatory bodies in charge of vaccine approval.
His primary role, he said, is to attract the expertise and experts needed to advance the work, and to orchestrate the teamwork toward research outcomes. Biostatistics on its own isn’t enough; to advance science, biostatisticians must integrate available knowledge and technology, Gilbert said. He sees himself positioned at the hub of a wheel, its spokes extending into other areas of expertise.
“I go out on the ‘spokes’ to find expertise, bring it in, and synthesize it,” he said. “I aim to make sure we appropriate new expertise, while staying focused on biostatistics’ core areas of rigorous study design and quantification of uncertainty.”
Gilbert has attracted experts with knowledge in statistical theory and deep learning, sequencing and immunoassay technology, and the ability to communicate with regulators regarding the pathways and standards for approving vaccines and monoclonal antibodies.
In his own research, Gilbert focuses on two major themes. First, he develops methods that allow scientists to determine “correlates of protection,” or the molecular shorthand that quickly reveals a vaccine’s efficacy. His second focus is sieve analysis, which enables scientists to assess which features of a virus are involved in vaccine efficacy.
Correlates of protection are a critical ingredient for vaccines that will be regularly updated, like those against flu and SARS-CoV-2. Efficacy is usually measured in very large, placebo-controlled Phase 3 trials, but a molecular shorthand can make it faster, cheaper and easier to test the efficacy of vaccine updates.
During the COVID-19 pandemic, Gilbert and his team defined the correlates of protection for the Moderna vaccine against SARS-CoV-2. Continuing these efforts, they secured an award from the Center for Biomedical Advanced Research and Development Authority, or BARDA, to establish correlates of protection for next-generation COVID-19 vaccines being tested as part of Project NextGen. They will also assess the effectiveness of new decentralized trial designs that could make future vaccine trials faster, cheaper and easier to participate in.
Gilbert’s work on correlates of protection has informed the scientific bar that vaccine developers must clear to convince the Food and Drug Administration that their vaccines are effective. In addition to his work at HVTN, Gilbert advises pharma companies’ plans of statistical analysis for correlates of protection as they work to gain regulatory approval.
Sieve analysis can also improve vaccine development. If scientists understand the most important viral characteristics that trigger a protective immune response, they can use them to design the most protective vaccine possible.
Though he never collaborated with Zelen, Gilbert still remembers Zelen’s generosity — and a cryptic comment that has resonated with Gilbert over the decades.
“I was walking down the hallway, and Marvin was coming the opposite direction,” Gilbert remembered. “Without stopping, he turned to me and said, ‘Keep your eye on the ball.’”
Zelen didn’t expand on his exhortation, which encouraged Gilbert to draw his own meaning, he said.
“I interpret its meaning for myself as seeking to be a 'synthesizing prism' that listens intently to all available knowledge from diverse disciplines, with the objective to synthesize all this knowledge toward pursuing elegant solutions to clearly posed scientific questions — elegant in their incisiveness, mathematical rigor, and in the manner of communicating the solutions,” Gilbert said.
Sabrina Richards, a senior editor and writer at Fred Hutch Cancer Center, has written about scientific research and the environment for The Scientist and OnEarth Magazine. She has a PhD in immunology from the University of Washington, an MA in journalism and an advanced certificate from the Science, Health and Environmental Reporting Program at New York University. Reach her at srichar2@fredhutch.org.
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