Late last month, the Obama Administration released the National Bioeconomy Blueprint. The report outlines steps that federal agencies will take to drive the bioeconomy—economic activity driven by research and innovation in the biosciences—and details ongoing efforts across the federal government to realize this goal. A key part of these efforts are ways to improve innovation, development, and regulation of pharmaceuticals.
Origins of the bioeconomy
In 2010, the Obama Administration included in its science and technology priorities as part of federal agency budget submissions a priority for federal agencies to “support research to establish the foundations for a 21st century bioeconomy.” In September 2011, President Obama announced that his Administration would release a National Bioeconomy. Modeled after the Administration’s 2011 Blueprint for a Secure Energy Future, the 2012 National Bioeconomy Blueprint has two purposes: to lay out strategic objectives that will help realize the full potential of the US bioeconomy and to highlight early achievements toward those objectives.
The report recognizes the importance of biotechnology not only in healthcare but in other sectors. “The bioeconomy emerged as an Administration priority because of its tremendous potential for growth and job creation as well as the many other societal benefits it offers,” says the report.” A more robust bioeconomy can enable Americans to live longer and healthier lives, develop new sources of bioenergy, address key environmental challenges, transform manufacturing processes, and increase the productivity and scope of the agricultural sector while generating new industries and occupational opportunities.”
The Bioeconomy Blueprint outlines five strategic imperatives: support R&D investments; facilitate the transition of bioinventions from research laboratories to market, including an increased focus on translational and regulatory sciences; reduce barriers to increase the speed of regulatory processes; update training programs and align academic institution incentives with student training for national workforce needs; and identify and support opportunities for the development of public–private partnerships and precompetitive collaborations.
In laying out a plan to increase R&D investment, the report emphasizes the need to increase coordination of federal bioeconomy-related research activities to improve the efficiency and effectiveness of R&D investments. The report also emphasizes the importance of multiagency collaborations for emerging foundational technologies, such as synthetic biology, biology-related information technologies, and proteomics and the integration of disciplines. The report says that the Administration will prioritize additional multidisciplinary efforts in physics, chemistry, engineering, computer sciences, and mathematics, to support the bioeconomy. The report also calls for federal agencies to further explore the use of new or modified funding mechanisms in and across agencies to stimulate the discovery of new bioinventions with potential to grow the bioeconomy.
In facilitating the transition of bioinventions from research laboratory to market, the report emphasized an increased focus on entrepreneurship, translational sciences, regulatory science, and technology transfer, including strategic, coordinated investments in translational and regulatory sciences to accelerate progress. To capitalize on the promise of the newly reauthorized Small Business Innovation Research (SBIR) program, the report said that federal agencies should evaluate and update SBIR programs. Some relevant objectives include reducing application response times, hiring/training program staff to enhance relevant in-house experience, and increasing the use of industry experts as peer reviewers to evaluate industry proposals. The report also stressed the importance of enhancing entrepreneurship at universities and using federal procurement to encourage the development of biobased products.
The blueprint calls for regulatory reform by reducing barriers, increasing the speed and predictability of regulatory processes, and reducing costs while protecting human and environmental health. When an emerging technology enters the regulatory process, federal agencies are asked to have a robust framework that identifies lead agency responsibilities, clarifies supporting agency roles, and delivers timely, specific guidance for applicants. The report also calls for stakeholder collaborations to identify needs and reduce impediments.
The report also calls for updating training programs and aligning academic institution incentives with student training for national workforce needs. At the K-12 and undergraduate levels, the report cites progress in developing approaches to improve science, technology, engineering, and mathematics (STEM) education and increasing the number and diversity of STEM students. The report points to the Educate to Innovate campaign, launched in 2009, to move American students from the middle to the top of international rankings in STEM achievements over the next decade. The report says that by building upon and expanding these efforts, particularly with regard to graduate-level training enhancements, would help to align academic institution incentives with training for future workforce needs.
The blueprint also calls for increased partnerships between employers and educational institutions, including incentives for academic institutions to enhance entrepreneurship and restructure training programs. Following reengineering of training programs, the report says that agencies should consider convening industry stakeholders from various sectors to assess the success of training programs to meet the needs of employers.
The report also calls for identify and supporting opportunities for the development of public–private partnerships and precompetitive collaborations—where competitors pool resources, knowledge, and expertise to learn from successes and failures. “Many companies do not invest in early ideas because they are unlikely to pay off immediately. This is one place where the government can play a crucial role,” says the report. Moving forward, the report emphasizes that federal agencies provide incentives for public–private partnerships and precompetitive collaborations.
In laying out a blueprint, the report also identifies areas of progress, including those relating to pharmaceuticals and biomedical innovation. One area cited by the report is the need to improve the information technology infrastructure of FDA and the access to this information to “transform FDA archives into a driver of discovery and development,” says the report. It notes that FDA currently houses one of the largest known repositories of clinical data, including safety, efficacy, and performance information, and an increasing amount of postmarket safety surveillance data. Integrating and analyzing these data, with appropriate patient privacy protections, is one way to advance biomedical research, notes the report. The report points to FDA efforts to rebuild its information technology and data analytic capabilities and establishing “science enclaves”— virtually networked IT environments where multidisciplinary teams can work together to analyze large sets of data extracted from the FDA data resources while complying with applicable law concerning proprietary information and patient privacy. The enclaves can also be used to design new software that should enhance the quality, efficiency, and accuracy of FDA regulatory reviews.
Other projects cited by the report are the recent launch of Intramural Center for Regenerative Medicine (CRM) at the National Institutes of Health (NIH) to support induced pluripotent cell technology. NIH CRM and its partners are exploring the development of iPS cell therapies to treat blood-related diseases, such as leukemia and metabolic diseases, including lysosomal storage diseases that affect children. In addition, researchers will investigate whether iPS cells can be used to develop blood products that could help meet the demand for blood transfusions during medical emergencies and surgeries. NIH also recently embarked on a major effort to use iPS technology to advance research into neurodegenerative diseases. That effort already has developed and made widely available neural cell lines for Parkinson’s disease, amyotrophic lateral sclerosis, and Huntington’s disease.
Also, the NIH’s newest center, the National Center for Advancing Translational Sciences (NCATS), recently teamed up with Eli Lilly to create a step-by-step playbook to help researchers from all sectors translate their basic findings into potential treatments for patients. The Assay Guidance Manual will be available as a free e-book in early May.