RFI Response: Bioeconomy

On October 22, 2019, the Johns Hopkins Center for Health Security provided recommendations to promote and protect the US Bioeconomy, in response to a request for information (RFI) posted by the White House, Office of Science and Technology Policy (OSTP). The RFI was released to “identify gaps, vulnerabilities, and areas to promote and protect in the US Bioeconomy that may benefit from Federal government attention.” The recommendations stem from research conducted by the Center, including a meeting with private and public stakeholders active in the US bioeconomy on July 16, 2019. 

The United States already hosts one of the world’s most competitive bioeconomy markets and is a leader in biological innovation and education. However, recent years have seen increased global investment and international competitiveness. As the growth or neglect of the US bioeconomy affects national security, it is critical for the United States to actively develop new mechanisms that leverage advantages in biotechnology for its benefit in the face of greater peer competition.

Response to RFI Questions:

1. What specific actions could the U.S. Government take to reinforce a values-based ecosystem that will guide the transformation and expansion of the U.S. Bioeconomy, in both the short- and long-term? Please consider:
    

   Create a clear regulatory pathway for biologically derived products. Biotechnology companies and researchers require a clear pathway for approval and licensure to explore and produce novel biotechnology products. This is particularly important for products intended for consumption or that will have environmental impacts (eg, environmental remediation or mining). Currently, there is confusion about which federal agency should regulate a given product type (eg, whether FDA or USDA or EPA regulations should take precedence), and some regulations may need to be updated to accommodate newer biotechnologies, particularly for environmental release.

   Develop a national strategy for boosting the bioeconomy. Several federal agencies, including the Departments of Energy and Agriculture, have a strategy to boost the national bioeconomy, but these are largely uncoordinated. An overarching national strategy with a clear vision, plan, and leadership team can align the efforts of various agencies and speed development and growth of the US bioeconomy. Such a strategy should include actions and goals for several agencies, including the Departments of Defense, Health and Human Services, Homeland Security, Commerce, and Veterans Affairs, and should include a mechanism to measure and track progress.

   Track and quantify bioeconomy-pertinent data. The size and scope of the US bioeconomy is currently only estimated by nongovernment experts; it is not specifically tracked by the US government. If it were to be tracked, however, policy actions to boost the bioeconomy could be targeted more effectively. Data needed include workforce information, such as the number of skilled workers and the number of people who receive training in the United States who ultimately leave the country. Additionally, information on the private bioeconomy ecosystem, such as the number of companies, types of products, and gross revenue, can help to identify strengths and gaps. These data could more effectively direct resource allocation and policy initiatives.

   Consider the holistic cost of products for procuring US government contracts and making technology investments, which would demonstrate savings for biotechnological approaches. Biologically produced goods are likely to be more sustainable and allow for distributed manufacturing, so that products can be produced closer to the site of need and can circumvent supply chain disruptions common with petroleum-based products. Distributed manufacturing also has national security benefits, in that it reduces supply chain vulnerabilities. Current methods of assessing costs do not take these other features into account, disadvantaging biotechnology adoption by the US government.

   Create and fund an office responsible for coordinating federal efforts relating to biotechnology, similar to the National Nanotechnology Coordination Office (NNCO). The NNCO provides interagency coordination, technical expertise, administrative support, and public outreach for the National Nanotechnology Initiative (NNI), and a National Academies review found it positively affected nanotechnology research and development in the United States. A synthetic biology/biotechnology office could similarly shepherd companies and researchers and direct them to government resources/policies, act as an interagency coordinator, and be the focal point for private biotechnology companies, research institutions, and venture capitalists. This office would promote access to biologically produced products and coordinate efforts of the government and companies or research institutions to ensure mutually beneficial outcomes. For increased stability over the coming years, such an office (and other biotechnology efforts) should be codified in legislation where possible.
    

2. In what ways can the U.S. Government partner with the private sector, industry, professional organizations, and academia to ensure the training and continued development of a skilled workforce to support the growth of the Bioeconomy?
    

   Prioritize recruitment and retention of biotechnology expertise for work in federal agencies. A lack of expertise in biotechnology, synthetic biology, and related fields in the federal government has been well documented; this lack is a risk to national security and could lead to poor decision making, missed opportunities, and higher costs for the taxpayer. New methods for recruiting biotechnology expertise, such as allowing for positions with short expected tenures, could help candidates serve the nation without degrading their scientific expertise. Increased opportunities for promotion for biotechnology experts in the government should be prioritized, including placing more experts in leadership roles.

   Develop standards for certification of biotechnology proficiency. The American National Standards Institute (ANSI) standards have provided pathways to demonstrate proficiency in fields like cybersecurity, which has allowed federal agencies to develop requirements for promotion or hiring. Developing similar standards for biotechnology would develop pathways for hiring and advancement in the field of biotechnology. This opportunity should also be used to expand current training in biotechnology to increase biotechnology expertise in the government.

   Enable experts trained in the United States to stay in the country to contribute to the US bioeconomy—or “staple green cards to PhDs.” There is a brain drain in biotechnology; people trained in the United States in graduate school or postdoctoral training leave the United States, in accordance with the limits on their student visas. Immigration should be streamlined for biotechnology researchers so the investment in these individuals and their talent and expertise are not lost.

   Incentivize cross-disciplinary training. US funding agencies, including the National Science Foundation (NSF), should create incentives for cross-disciplinary training in bioinformatics and biotechnology. NSF already gives priority to interdisciplinary work. Funding agencies should incentivize training programs that promote multidisciplinary research and training, but more can be done. Several countries, including China and India, have embedded bioinformatics into the required coursework for programs in biotechnology and synthetic biology to encourage coding and assessing data. Other disciplines that should be considered for interdisciplinary work include material sciences, chemistry, artificial intelligence, and engineering.

   Provide incentives for biotechnology companies to partner with community colleges to prepare students to become part of the biotechnology workforce. Programs could train students for laboratory work and could serve as a certification for companies. Partnerships would be mutually beneficial and could spread the benefits of a growing bioeconomy across the United States. Such a partnership was created at the Portland Community College when Genentech and Welch Allyn helped create curriculum covering material needed for the workforce at a nearby plant. The program has been successful at placing graduates in jobs at biosciences companies, and companies have continued to serve on the program’s advisory board to ensure students are trained in relevant and useful skills. Another possibility is to encourage STEM education. Encouraging community laboratories to open across the country and providing incentives for taxpayer-funded researchers to support these facilities would increase the opportunities for local students and community members to foster innovation and encourage STEM education.

   The National Science Foundation and the National Institutes of Health should be given increased funding for synthetic biology research. Programs that provide longer-term grants can provide stability across years and encourage more innovation and research.
    

3. In what ways can the U.S. Government partner with the private sector, industry, professional organizations, and academia to establish a more robust and efficient Bioeconomy infrastructure?
    

   Add specificity for acquisition of biotechnology and biologically produced products. Biology is more flexible than other technologies and may be able to serve US government needs, but without a demand signal, companies will not deliver. The US government needs to be more specific and precise about their desired end products, so that companies can better meet its needs.

   Improve and streamline contracting for biotechnologies. Many biotechnology companies are small startups that need investors or large contracts, and these companies struggle with government contracting. Government liaisons could shepherd companies through the federal government contracting process, and there should be incentives for government program managers to award contracts. One positive example of success is the “Air Force Pathfinder” program, which, if emulated, could facilitate mutually productive government contracts and develop a workforce prepared to support a growing bioeconomy. In addition, programs that encourage bio-investment, like the “BioPreferred Program” at the US Department of Agriculture, could be strengthened, and Small Business Innovation Research (SBIR) programs for biotechnology companies could be expanded. Use of “opportunity zones” for tax credits to companies that build facilities in areas that are traditionally underrepresented in the field could be created.

   Support biotechnology small business and startups with nondilutive capital, matched by venture capital investments. Creating partnerships among startup companies, the government, and venture capitalists (VCs) could be a viable pathway to nurture biotechnology companies and enable and sustain innovation in the long term. The government could invest in the early stages of biotechnology companies with nondilutive capital to offset the risk to venture capitalists who can then invest in the company in the longer term. This framework would give the US government first access to products and encourage outside investment in companies, ultimately supporting the development of a long-term provider for US needs and boosting the nation’s overall economy. Nimble forms of financing are also needed so that the US government can ensure that biotechnology companies critical to the US bioeconomy are not purchased by other nations’ funds.

RFI Response: Bioeconomy was prepared by Lane Warmbrod, Marc Trotochaud, Tom Inglesby, and Gigi Kwik Gronvall.