Reading Room Production — page 469

Draft of individual firms to make investments in newer approaches. One such example is the continued use of chicken eggs for the growth of influenza virus for use in vaccines. In recent years, however, as biomedical research and drug development have become more expensive, biomedical research has become more of an information science, technical barriers to information sharing have declined, cultural shifts favoring large-scale collaborations have occurred, and biotechnology and pharmaceutical firms have explored new ways to partner with each other and with government to solve common problems and make the leap to new technology and practices. Such collaborations and partnerships are based on shared goals that are critical for progress but that cannot be monetized (i.e., exploited as stand-alone profit-making opportunities) and cannot feasibly be achieved by a single organization. In such circumstances, "precompetitive" collaborations and partnerships have been established to reduce cost and risk to individual partners while pursuing advances that benefit all participants. Such collaborations and partnerships have a considerable track record. They have been used to develop new standards and tools, to generate or aggregate data, and to create new knowledge or develop products by accessing resources and capabilities across organizations. Consortia have been established to foster process innovation, to enable discovery, and to serve as innovation incubators. Pooling resources to invest in sector-wide process and technology improvements leverages the investments of and minimizes risk for individual partners while enabling downstream processes that create market value and unlock creative capital and dormant intellectual property. A convergence of factors has also led to the emergence of more robust and innovative publicprivate partnerships in various domains of biomedicine. These factors include the flattening of NIH budgets in recent years, the declining productivity of freestanding research and development programs within the biotechnology and pharmaceutical industries, the escalating complexity of biomedical science, the challenges posed by regulatory processes, and the emergence of viable collaborative models. Precompetitive collaborations that have enhanced public-private partnerships include (among others) the Biomarkers Consortium, which is managed by the Foundation for NIH and includes NIH, FDA, CMS, PhRMA, BIO, non-profit organizations, and multiple biotechnology and pharmaceutical firms as partners, and the partnerships and consortia supported through FDA's Critical Path Initiative that engage NIH, patient organizations, academia, and multiple biotechnology and pharmaceutical firms to facilitate advances in regulatory science, including innovation in product development, safety assessment and clinical trials. These diverse efforts provide models of collaboration likely to be very helpful in advancing relevant biodefense and public health focused projects. Through existing U.S. Government networks and alliances here and abroad, such partnerships could be extended internationally, to include allied nations as well as overseas clinical trial sites and other valuable components of the product development pathway. As a part of the initiative to transform our countermeasure enterprise, the U.S. Government will work with industry partners to leverage existing or to create new public-private partnerships to propel much-needed advancements in pharmaceutical product discovery, development, and manufacturing. Input from industry partners will focus the capabilities and operating concepts of these partnerships so that they meet the needs of all participants. These partnerships will foster advances in enabling science and technology that facilitate the development of countermeasures against public health threats, and they will be guided by the multi-use principle in concentrating resources on those that will have broader application for other products.