Regulatory and public health expertise will advance the development of and global access to innovative new solutions to important global health needs
NEW YORK – JANUARY 18, 2022 – IAVI is very pleased to announce the appointment of Marion F. Gruber, Ph.D., M.S., as Vice President, Public Health and Regulatory Science.
Dr. Gruber is a preeminent vaccine expert with 30 years of experience in the development and regulation of vaccines and related biologics. Most recently, she served as Director of the U.S. Food and Drug Administration (FDA) Office of Vaccine Research and Review, where she led the FDA’s vaccine evaluation and licensure function and oversaw approval and authorization of vaccines for SARS-CoV-2, Zaire ebolavirus, and other global health challenges and emerging infectious disease threats. During her long tenure at the FDA, Dr. Gruber also contributed to global vaccine development, policy, and safety oversight by serving as expert advisor to the World Health Organization (WHO) and as a member of the WHO Global Advisory Committee on Vaccine Safety. She has also been a champion of regulatory capacity strengthening efforts in low-income countries.
“IAVI is thrilled to welcome Dr. Gruber, with her considerable regulatory expertise and leadership experience,” said Mark Feinberg, M.D., Ph.D., IAVI president and CEO. “Throughout her career, Dr. Gruber has demonstrated a strong commitment to using innovative regulatory strategies to ensure that life-saving vaccines meet the highest standards of safety and efficacy, thereby maximizing their benefit for the people in the U.S. while also working to facilitate their availability in low- and middle-income countries where vaccine availability is often limited by economic and other factors. Dr. Gruber is a tremendously dedicated public health leader who is globally respected and cherished by all those who have had the opportunity to work with her. We are honored to have her on the IAVI team and look forward to having her expertise and leadership inform the regulatory and global public health strategies for IAVI’s vaccine and antibody products.”
Dr. Gruber said, “I joined IAVI because I share their vision of a world where all people have equitable access to innovative vaccines and therapeutics — a critical need underscored by the COVID-19 pandemic. I bring to this role more than two decades of knowledge in regulatory science, product assessment, and licensure; but most importantly, I bring a commitment to creating pathways for widespread availability of vaccines and biologics. I look forward to applying my experience and the hard lessons of COVID-19 to ensure that the urgently needed products IAVI is developing become a reality.”
Dr. Gruber will lead IAVI’s strategic engagement with key external organizations and stakeholders working to shape scientific, regulatory, and public health policies to advance global health product development and access-enabling efforts. These engagements will be essential in elucidating regulatory science approaches for complex and, in some instances, currently unclear pathways to develop innovations for a number of important global health threats, including those focusing on the prevention of HIV acquisition and emerging infectious diseases. In addition, she will devise regulatory science and public health strategies to maximize the efficiency, effectiveness, and probability of success for IAVI’s own product development and implementation efforts. Beyond IAVI’s own programs, she will foster dialog, collaboration, and innovative solutions with external partners in public health and regulatory science to develop new approaches to address unmet global health needs related to endemic, epidemic, and pandemic diseases that disproportionately affect people living in low-income countries.