Battelle, IBM, Merck Team for UPMC’s 21st Century Biodefense (21CB)

March 15, 2010

Building on its extensive efforts to establish a flexible vaccine development and production facility to strengthen the nation’s biosecurity, UPMC has been joined by Battelle, and Merck & Co in this first-of-its-kind initiative. These industry and non-profit leaders are supporting UPMC and GE Healthcare in pursuing the construction of this facility, which UPMC proposes to operate in a unique partnership with the federal government.

“With this powerful coalition of partners, we will finally address a critical gap in the nation’s defenses against bioterrorism and infectious diseases,” said Robert J. Cindrich, UPMC’s chief legal counsel and chairman of the initiative, known as 21st Century Biodefense (21CB). “Through this collaboration, we are poised to deliver the urgently needed advances in vaccine development and manufacturing as recently called for by President Obama in his State of the Union address.”

Battelle, the world’s largest, independent research and development organization, has agreed to provide comprehensive pre-clinical research and development services, including infectious disease model development and product safety and efficacy evaluations in a Good Laboratory Practice (GLP) environment. These services will support the licensure of new vaccines and therapeutics by the U.S. Food and Drug Administration. Battelle also will provide project management support and senior leadership to 21CB’s advisory board. “We are committed to solving the most critical problems in human health and stand ready to be a full partner in this impressive public-private initiative,” said John Wade, vice president for Battelle.

IBM will provide innovative information technology, such as IBM’s new POWER7 systems, to create the infrastructure that will support 21CB manufacturing processes and operations. This infrastructure will be able to handle extreme volumes of data and scale quickly to adapt to changing demand. “IBM brings leading technology to 21CB, as well as access to teams of life sciences researchers at each of our eight research labs around the world,” said Dan Pelino, general manager, IBM Healthcare and Life Sciences. “We’re pleased to bring our deep skills and pharmaceutical industry consulting expertise to support 21CB and its important mission.”

Merck, a global pharmaceutical company, has agreed to provide drug-development and bioprocess counsel as part of a planned consortium of other biopharmaceutical companies. Merck also will provide senior leadership to 21CB’s advisory board and training for facility staff when 21CB begins
operations. “As a global company with a long history of dedication to public health, Merck is pleased to share its technical expertise with 21CB in this innovative approach to enhancing our nation’s biodefense capabilities,” said Diana Lanchoney, executive director, Merck Research Laboratories.

These new 21CB partners join GE Healthcare, which announced in October 2009 that it would provide manufacturing design and development expertise, as well as production equipment, consumables, and manufacturing processes for 21CB. GE Healthcare’s leadership in bioprocessing and its innovative disposable manufacturing technologies will enable 21CB to rapidly and flexibly produce vaccines for the U.S. government’s dynamic biosecurity needs. The new facility would be designed to produce multiple vaccines simultaneously and would have the ability to quickly switch production from one vaccine to another to respond in a crisis.

In his State of the Union address on Jan. 27, President Obama announced a new initiative to respond faster and more effectively to bioterrorism and infectious diseases. The Administration said it plans to pursue “a business model that leverages market forces and reduces risk to attract pharmaceutical and biotechnology industry collaboration with the U.S. government.” Department of Health and Human Services Secretary Kathleen Sebelius has launched a comprehensive review of the nation’s public health countermeasure enterprise with the goal of providing “a modernized countermeasure production process where we have more promising discoveries, more advanced development, more robust manufacturing, better stockpiling, and more advanced distribution practices. In other words, we want to create a system that can respond to any threat at any time.”

With the expectation that the government will allocate money for this public health priority, UPMC and its partners plan to compete for the funds to build a vaccine facility. Through 21CB, UPMC would share in the necessary private funding and own and operate the facility under the direction of the federal government as a public-private partnership, thus ensuring that the plant focuses on national health priorities. The initiative would create 1,000 jobs directly and up to 6,000 indirectly, while increasing the nation’s pool of scientists and engineers.