New R&D President Kelly Warfield: Energized to Drive Vaccine Innovation for Global Health

Kelly Warfield

Sabin Vaccine Institute’s new President of Research & Development (R&D) Kelly Warfield provides insight into her background, her role, and how she hopes to contribute to the organization and its mission.

Tell us about your career journey and what led you to focus on vaccine R&D.

After completing my doctoral studies at Baylor College of Medicine, I began my career as a National Research Council fellow at the United States Army Medical Research Institute of Infectious Diseases. My subsequent role at Integrated Biotherapeutics involved bridging the gap between promising technologies and clinical candidates. At Unither Virology, which was later acquired by Emergent BioSolutions, I expanded my role from being an individual contributor to leading a global team of more than 300 R&D professionals.

In my more than 20 years as a scientist, I have worked on a diverse range of products for prevention and treatment of diseases. However, my true passion lies in vaccine development, having worked on various platforms from viral vectors to live attenuated strains. After safe drinking water, vaccination is the most impactful public health intervention, having saved hundreds of millions of lives over the years. That knowledge motivates me each day.

What are some of the key milestones or achievements in your career that you are most proud of?

I’m particularly proud of milestones where our work directly impacted patient care. Recent notable achievements include facilitating the transition of NARCAN® to over-the-counter status, securing licensure from the Food and Drug Administration (FDA) for the CYFENDUS™ anthrax vaccine, advancing a chikungunya virus-like particle vaccine through Phase 3 clinical trials, and obtaining funding from the Biomedical Advanced Research and Development Authority (BARDA) to enhance the availability of the Ebanga™ Ebola monoclonal antibody.

What were some of the most challenging and rewarding aspects of your role as senior vice president for science and development at Emergent BioSolutions?

Developing products into clinical candidates and licensed products requires meticulous coordination with internal teams, development partners, and regulatory agencies. Building and nurturing these relationships can be challenging but fiercely rewarding. I tackle all my work — from product development and collaboration to leading teams — with a service mindset, and seeing this approach yield positive results gives me enormous satisfaction.

What motivated you to transition from the pharmaceutical industry to the non-profit sector?

My career has been focused on addressing neglected medical needs through public-private partnerships with organizations like the National Institute of Allergy and Infectious Diseases, BARDA, the Defense Threat Reduction Agency, and CEPI. While I have primarily supported U.S. government biodefense needs, I’ve been most energized by vaccine development programs targeting diseases like Ebola, Marburg, Lassa, and chikungunya viruses. Sabin’s mission to improve vaccine access, enable innovation, and expand global immunization aligns perfectly with my goal of saving lives worldwide, not just in the U.S.

As the inaugural R&D president at Sabin, what are you most excited about? What are your primary goals and vision for the organization’s future?

I’m honored to be Sabin’s first R&D President and contribute to our mission of advancing life-saving vaccines and ensuring global vaccine equity. My primary goals include advancing our Marburg and Sudan vaccines to licensure and collaborating with the U.S. government and other partners. If approved, our Marburg and Sudan vaccines could prove critical to saving lives among at-risk populations in Africa, where these diseases strike first and most. I also plan to work with our R&D team, executive leadership, and Board of Trustees to develop a strategic roadmap for the Sabin R&D division. Identifying critical unmet medical needs along with affordable and effective technologies, and new development partners will be important next steps as we grow our global health impact in the coming years.

Can you elaborate on your experience with novel regulatory pathways and how this might benefit Sabin’s vaccine candidates?

I’ve worked on vaccine candidates that benefitted from using non-traditional regulatory pathways, including FDA licensure for the CYFENDUS™ anthrax vaccine via the Animal Rule and seeking accelerated approval for a chikungunya virus-like particle vaccine candidate now under regulatory review by FDA and the European Medicines Agency. Additionally, I’ve helped secured Orphan Drug and PRIME designations that expedite the regulatory review of products targeting rare diseases and life-threatening conditions in the U.S. and Europe respectively. My experience has been that regulatory agencies are willing to work with sponsors to design innovative pathways for developing and approving critical, life-saving vaccines, such as those being developed by Sabin.

Where do you see the greatest opportunities for innovation at Sabin?

Sabin has numerous opportunities for innovation, not just in scientific research but throughout the vaccine value chain. This includes advancements in alternative delivery methods, public-private partnerships, use of novel regulatory pathways, and accessibility strategies. I would say the biggest challenge will be in prioritizing these opportunities effectively to best serve our mission.