CSC's DVC Unit Takes Unique Approach to Vaccine Development
 CSC is regarded as one of the world's leading IT services firms, yet there are many other areas in which the company is making significant strides. One example is biotechnology, where DVC LLC, a CSC company, is taking a novel approach to the advanced development and licensure of essential medical products, including biodefense and influenza vaccines. This approach, in which DVC plays the role of biotechnology integrator, is helping establish the company as a leader in the management of U.S. government vaccine programs.
For more than eight years, DVC has overseen the management and development of biodefense vaccine and therapeutic biologic programs for various U.S. government entities, including the Department of Defense and the National Institute of Allergy and Infectious Diseases (NIAID). On May 4, the company was awarded a contract from the Department of Health and Human Services (DHHS) Office of Public Health Emergency Preparedness to develop seasonal and pandemic influenza vaccines as part of a five-year agreement valued at $242.5 million.
DVC will lead a collaborative effort with Baxter Healthcare Corporation to develop cell-culture-derived influenza vaccines, with DVC managing the clinical trials, as well as the overall project. Under the contract, Baxter will utilize its proprietary vero cell technology platform to develop the vaccine, complete process development and manufacture clinical material to be used in clinical testing of the vaccines; this development supports the licensure of a seasonal vaccine, and the completion of clinical trials for the pandemic vaccine. Ultimately, Baxter will serve as the U.S. Food and Drug Administration (FDA) license-holder for the seasonal vaccine. This landmark contract illustrates DVC's ongoing transformation from a company that chiefly served the U.S. military's biodefense needs to a leading biotechnology industry player that develops products benefiting all citizens.
Integration expert
Just as CSC excels as an integrator of IT services, DVC is achieving success as a lateral integrator within the complex process of biopharmaceutical development. Whereas biotech firms typically perform product development in-house, DVC serves as a biotechnology integration expert, selecting "best of breed" companies in areas such as manufacturing, non-clinical research, testing, distribution and clinical trials. In addition to building an integrated product team, DVC draws upon its industry expertise to manage the entire process.
DVC president and chief scientific officer Dr. Robert V. House says DVC's approach is somewhat unique in the industry. "The fact that we are integrated laterally means that we are able to use the best providers of each individual piece of a complex process." DVC incorporates an integrated risk management framework into every program it manages, continually monitoring budget and scheduling impacts. The company also uses a proactive approach to problem solving, and to date, more than 50 best practices have been identified and shared, resulting in significant process improvements and cost savings to DVC's clients. Dr. House says DVC differs from other biopharmaceutical companies because, "we are always inventing new methodologies for developing vaccines. What this does is allow us to be very flexible with our thinking. By necessity, we have to be creative."
In recent years, DVC has managed the development of a wide range of significant products, including vaccines for plague, botulinum neurotoxin, tularemia and Venezuelan equine encephalitis. In 2005, the FDA approved DVC's Vaccinia Immune Globulin (VIGIV), an intravenous immune globulin used to treat certain adverse reactions to the smallpox vaccination.
Fighting the flu
The recent cases of avian flu reinforce the fact that the possibility of a global disease outbreak, or pandemic, is real. An especially severe influenza pandemic could lead to high levels of illness, death and global economic loss. For example, during the Spanish Flu pandemic in 1918 and 1919, approximately 20 to 40 percent of the worldwide population became ill, and between 20 and 50 million people died, including more than 500,000 in the United States. A recent study by the Congressional Budget Office concluded that a severe influenza pandemic could infect 90 million people in the United States and cause the deaths of more than two million.
The DHHS contract combines Baxter's extensive influenza vaccine development experience with DVC's government vaccine program management experience. Under the terms of the agreement, DVC and Baxter will develop two influenza vaccine candidates: one for seasonal influenza and one for pandemic influenza. The vaccines being developed will be cell-culture-derived, as opposed to the more common egg-derived vaccine. Traditionally, flu vaccines are manufactured via a cumbersome process in which the flu virus is grown in special types of hens' eggs for many months. Cell-culture-derived means the cell is grown in a synthetic environment. The use of advanced genetic techniques associated with cell-culture technology has a number of benefits, one being that it removes the burden of needing to have millions of eggs readily available.
Regardless of the technology used, it still takes several months for a vaccine to be made widely available. Dr. House says, "Our work on a vaccine for influenza fits in exceptionally well with our overall paradigm of protecting humanity with preventive vaccines. I think we're poised to do exceptionally well to address the needs of not only the United States, but also the world at large to meet the challenge of a pandemic influenza outbreak."
Dr. House insists that people must never take for granted the service to humanity companies such as DVC provide. "Vaccines have been responsible more so than any medicine that's ever been developed for preventing disease and extending the quality of human life," he says. "I think that fits in with DVC's mission because we're doing something we believe is exceptionally important."
DVC LLC is part of the Enforcement, Security and Intelligence organization within CSC's federal sector business unit and employs more than 100 professionals at its headquarters in Frederick, Maryland.
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