Novartis, Duke sign deal to develop pandemic flu vaccine

The Duke Human Vaccine Institute today announced a collaboration and strategic agreement with Novartis Vaccines and Diagnostics to enable the rapid development of a vaccine and accelerate preparedness in case of a pandemic virus threat such as pandemic influenza. The team, composed of Duke and Novartis investigators, will utilize resources of the National Institute of Allergy and Infectious Diseases-sponsored Regional Biocontainment Laboratory at Duke, and resources of Novartis' state-of-the-art, cell-based vaccine manufacturing facility located in Holly Springs, N.C.

The five-year agreement calls for all parties and facilities - located only 30 miles apart in central North Carolina - to be activated and operational within 24 hours of a decision to move to emergency pandemic status based on information provided to vaccine makers by the Centers for Disease Control and Prevention, the World Health Organization and others.

"This is a uniquely important collaboration as it will facilitate immediate and optimal management of scientific demands and response to a pandemic while all parties are at the same table - from start to finish - due to our proximity," said Barton Haynes, M.D., director of the Duke Human Vaccine Institute and the Center for HIV/AIDS Vaccine Immunology. "This project encompasses the best elements of both academic and pharmaceutical company translational research for the benefit of society."

"This collaboration brings together the state-of-the-art facilities in the Regional Biocontainment Laboratory at Duke, faculty at Duke who are members of the Southeast Regional Center of Excellence in Biodefense and Emerging Infections (SERCEB), and the vaccine development expertise at Novartis to respond quickly to infectious disease threats-a consortium that will benefit North Carolina and society in general", said Fred Sparling, director of SERCEB and professor at the University of North Carolina-Chapel Hill.

The agreement also creates a robust research collaboration between the partners to take vaccine research in new directions. Together, the Duke Human Vaccine Institute and Novartis investigators will tackle both basic and translational vaccine studies.

"The agreement lays the groundwork for creating an ongoing, thriving research collaboration between Duke and Novartis," said Thomas Denny, M.Sc., chief operating officer for the Duke Human Vaccine Institute. "While we all hope we never need to respond to an emergency pandemic threat, there will be no shortage of opportunities to collaborate on vaccine-based research endeavors."

The key facilitators of this agreement include Novartis' new cell-culture vaccine manufacturing facility in Holly Springs, N.C. The cell-culture method provides for a more rapid pandemic response than egg-based vaccines, which take longer to produce and can cause allergic reactions in some people.

Duke's Regional Biocontainment Laboratory - one of only 13 National Institute of Allergy and Infectious Diseases-funded Regional Biocontainment Laboratories in the U.S. - is equipped to facilitate the work of isolating and sequencing pandemic strains of influenza and other viruses, evaluating those viruses in pre-clinical models, and ultimately, producing viral seed strains that could form the basis for new vaccine development by Novartis.

"The Regional Biocontainment Laboratory provides high-level containment of pathogens and the specific technologies needed to develop vaccines safely and quickly," said Richard Frothingham, M.D., director of the RBL at Duke. "The public health goal is compelling, because during the H1N1 influenza pandemic the vaccines weren't generally available until the pandemic was in a declining phase. Production of H1N1 vaccines was delayed due to reliance on older (egg-based) technologies, but with this partnership we have the opportunity to deliver new types of vaccines more rapidly."

"Highly collaborative partnerships among those in academia, industry and the government are the only way that we can meet the complex, potentially dangerous and rapidly evolving challenges presented by emerging pandemics," Haynes said. "We believe this collaboration will establish best practices for emergency public health preparedness."

Source: Duke University Medical Center