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Home > Analysis > Opportunities for Advantage: A Competitive and Innovative Industrial Policy for Biotechnology

Background

Public Sector

Biotechnology innovation holds the potential to ensure food security, biosphere safety, sustainability, and the development of a disruptive new class of therapeutics.

The USG has identified biotechnology as an Industry of the Future (IoTF) alongside the following emerging technologies:

  • advanced computing
  • advanced materials, manufacturing, and robotics
  • advanced, next-generation communications technologies
  • artificial intelligence
  • battery technology
  • cybersecurity
  • green products/clean technology
  • plant genetics/agricultural technologies
  • privacy-enhancing technologies
  • quantum information science/quantum computing
  • nanotechnology; and
  • semiconductors/microelectronics technologies

Federal IoTF strategic investments for competitive advantage are structured around the following working definition from the Office of Science and Technology Policy (OSTP) Report on the Industries of the Future Act :

  • Advanced industrial sectors that support innovative, inclusive, equitable, and sustainable growth;
  • Have profound connection with technology R&D and STEM workforce;
  • Require R&D investments to support growth that will lead to transformative impact; and
  • Will significantly benefit future economic prosperity and national security.
  • This definition can be translated into specific industrial sectors, although the specific sectors will change over time and will also vary based on analysts’ judgments of whether specific sectors meet the stated criteria.
  • Based on the definition, this report finds that all of the industrial sectors in the list above have Industries of the Future characteristics.

Another recent USG investment in biotech is the DoD funding for HBCUs to Advance Biotechnology and Materials Science Research.

Private Sector

From a private sector perspective, ARK Investment Management LLC  is an investment firm specializing in thematic investment portfolios and innovation-based ETFs [Exchange Traded Funds]) “to deliver long-term capital appreciation by investing in the leaders, enablers, and beneficiaries of disruptive innovation.” (1)

The ARK Invest team analyzes biotechnology as part of their “Genomic Revolution”  themed investment strategy.  The ARK Invest Genomic Revolution investment strategy “aims to provide exposure to DNA sequencing technology, gene editing, CRISPR, therapeutics, agricultural biology, and molecular diagnostics. These innovations can help us restructure health care, agriculture, and pharmaceuticals, and enhance the quality of life.

This actively managed equity strategy seeks long-term capital growth by investing in the US listed securities, including ADRs [American Depositary Receipts], of companies focused on the genomics revolution. Companies within this strategy aim to capture the substantial benefits of new products and services associated with technological and scientific developments in DNA sequencing, gene editing, targeted therapeutics, bioinformatics, and agricultural biology.” (2)

Biotech is also included in the ARK Disruptive Innovation investment strategy which “aims to provide broad exposure to disruptive innovation. ARK believes innovations centered around artificial intelligence, robotics, energy storage, DNA sequencing, and blockchain technology will change the way the world works and deliver outsized growth as industries transform.

ARK defines ‘disruptive innovation’ as the introduction of a technologically enabled product or service that potentially changes the way the world works. Companies in ARK’s cornerstone strategy aim to capture the substantial benefits of new products or services associated with scientific research in:

  • DNA technologies
  • Energy storage
  • Increased use of autonomous technology
  • Next-generation internet services, and
  • Technologies that make financial services more efficient.” (3)

ARK Invest has done some great work specifically on Agricultural Biotechnology, which they consider “the first genomic industry.”

Regenerate: Biotechnology and U.S. Industrial Policy

What will be the tie that binds all this promising and exciting public and private “deep tech” investment in the bioeconomy- enabling the exponential speed and scale of federal projects, market-based business models, and value creation?  According to Ryan Fedasiuk, a Research Fellow at the Center for a New American Security (CNAS), all ships will rise through the transformation of U.S. industrial policy:

“The United States needs some form of industrial policy to promote its bioeconomy—one that is enshrined in democratic values and focused on improving access to four key drivers of bioeconomic growth:

  • Equipment
  • Personnel
  • Information, and
  • Capital

This report –[Regenerate: Biotechnology and U.S. Industrial Policy]  – attempts to measure the health and outlook of the U.S. synthetic biology industry and broader bioeconomy by examining U.S. access to each of these four resources. It concludes that the United States still possesses an advantage in each of these fields—but that, absent a proactive strategy to ensure resource access, and without a significant infusion of capital, the U.S. bioeconomy risks languishing behind competitors such as China in the decades ahead.”

Fedasiuk and his collaborators over at the CNAS make “nearly two dozen policy recommendations for the United States to undertake in support of a more robust industrial policy.  Each is focused on improving access to the [four key drivers itemized above].

Equipment

A U.S. strategy to promote the bioeconomy should focus on improving access to equipment at the core of the bio revolution:

  • computing and data sources used in genomics, and
  • hard infrastructure used in DNA synthesis and fermentation.

Congress should pass the America COMPETES Act of 2022, which authorizes the creation of a National Engineering Biology Initiative. The initiative should pool and subsequently distribute access to data used in biotechnology discovery applications for investigators and biotechnology startups.

The National AI Research Resource Task Force should formalize a National Research Cloud for distributing access to cloud computing power for researchers and enterprises.

The White House should launch a bioeconomy opportunity tax credit. Biotechnology startups should not have to worry about affording crucial resources like cloud-based computing, one-time gene sequencing fees, or expensive licenses for industrial control software.

The National Institute of Standards and Technology should establish and update clear definitions, interoperability parameters, and technical specifications for fermentation units used in the large-scale cultivation of microorganisms, as well as novel, genetically engineered materials and devices for medical use, to ensure that these products remain safe and interoperable with one another.

Personnel

A diverse and well-trained workforce is undoubtedly the United States’ single largest bioeconomic strength relative to any other country. There are several tools at the U.S. government’s disposal to grow and enhance its pool of human talent in conjunction with allies and partners.

The White House Office of Personnel Management and Budget should establish a BioCorps Scholarship for Service program modeled after the CyberCorps Scholarship for Service, which would support stipends, tuition, and allowances for Ph.D. students in the general area of biotechnology.

Congress should pass the America’s College Promise Act, the proposal to fully fund associate degrees for low-income students at community colleges across the United States.  Supporting community college education and laboratory certification programs can create alternative career pathways that support the U.S. bioeconomy.

The Department of Education’s Office of Elementary and Secondary Education should establish a Bio-Competition Grant Program to cover the cost of after-school training, materials, and travel for teams participating in the International Genetically Engineered Machine competition and other regionally and nationally recognized biotechnology competitions.

The Department of State should replicate or otherwise institutionalize the Quad STEM Fellowship run by Schmidt Futures, which grants Ph.D. funding to 100 students from Quad countries each year.

The Department of State’s Lower Mekong Initiative should fund Agricultural Centers of Excellence across Southeast Asia. By working with regional groupings like the Indian Ocean Rim Association and the Bay of Bengal Initiative for Multi-Sectoral Technical and Economic Cooperation, the United States can fund a network of research centers that solve regional challenges and contribute to environmental resilience and socioeconomic mobility.

Congress should vote to codify the recent expansion of the STEM Optional Practical Training program (STEM-OPT) led by the Departments of State and Homeland Security. Expanding STEM-OPT and supporting longer-term immigration pathways will support continued U.S. leadership in biotechnology.

Congress should double the H-1B visa cap from 65,000 to 130,000 visas each year. Amid global crises from climate change, the COVID-19 pandemic, and the Russian invasion of Ukraine, the world’s best and brightest talent is increasingly mobile and willing to work in the United States. Bold action is necessary to transform these crises into opportunities.

Information

Expanding access to genetic data, harmonizing intellectual property protections, and upholding a flexible and transparent regulatory environment are crucial to sustaining growth in the bioeconomy.

The National Institutes of Health (NIH) should establish a National Gene Bank equipped for 21st-century genomic research. Creating a system that is updated in real time, with authorities and incentives to motivate private- and public-sector participation, is necessary to sustain U.S. progress in biotechnology research.

The Food and Drug Administration (FDA) should establish a process to share its existing research data with scientists at universities and trusted research institutions. The FDA’s expansive collection of data, from both clinical trials for pharmaceuticals and diagnostic research, could spur innovation in basic research if provided to public research centers.

Congress should broadly aim to preserve the U.S. system of intellectual property protection as it relates to biotechnology.

Congress should scale up funding for the U.S. Patent and Trademark Office. The patent office needs to examine and issue patents faster. To do so, it needs to retain and improve training for existing patent examiners who have a history of being hired away by intellectual property firms as soon as they learn their trade.

The U.S. Trade Representative and Department of Commerce should encourage U.S. allies and partners to relax protections of naturally occurring human genes to promote further innovation in the global biotechnology industry.

The FDA, Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) should overhaul their implementation of the Coordinated Framework for the Regulation of Biotechnology. An updated approach should give weight to the expected safety impact of providing a given product or service—irrespective of the technical method used to derive it.

The Small Business Administration (SBA) should enlist the support of the Federal Bureau of Investigation (FBI) and Defense Counterintelligence and Security Agency (DCSA) in offering security guidance to Small Business Innovation Research (SBIR) and Small Business Technology Transfer (SBTR) funding recipients. The SBA should collect survey information about awardees’ experiences with attempted economic espionage, which should be shared with the DCSA and FBI.

Capital

While private-sector investments have paid the largest dividends, government can play a much more active role in allocating capital and helping early-stage companies bridge the “valley of death”.  See also:  Deep Tech, the “Valley of Death” and Innovative Technologies for the Warfighter

Congress should authorize significant increases in the budgets of several biotechnology industry incubators, including a 50 percent increase in the SBIR and STTR programs run by the USDA, FDA, and EPA; research grants issued by the NIH; funding for Defense Advanced Research Projects Agency’s Biological Technologies Office, and In-Q-Tel’s biotechnology research portfolio.

The Department of Defense should request to expand the remit and budget of BioMADE, and the Office of the Undersecretary of Defense for Research and Engineering should create redundant initiatives for specific biotechnologies, including novel sources of bioenergy and biomaterials.

Congress should establish the Industrial Finance Corporation of the United States, a new investment mechanism for public-private partnerships, which will act as a magnet for capital in strategic industries.

The White House should work with state and local governments to establish a network of Biotechnology Industrial Opportunity Parks. These special economic zones would include favorable federal and local tax structures, modeled after the oil industry’s Foreign Trade Zones along the Texas coast, but for biorefineries across middle America.

The U.S. Trade Representative and Department of Commerce should advocate for relaxed restrictions on U.S. genetically modified agricultural exports at the EU-U.S. Trade and Technology Council and amid negotiations over the Indo-Pacific Economic Framework. (4)

What Next?

The CNAS recommendations are impressive:  robust, well researched, and really attentive to private sector investment efforts in tandem with governmental subsidies.

Still, questions remain:

  • What would an expert panel from industry add to this list of CNAS bioeconomy recommendations?
  • Would industry experts agree with the four main drivers identified by the CNAS report (equipment, personnel, information, and capital)?

We will get garner feedback from industry leaders in the months ahead.   We will also continue to track the macro-level evolution of the bioeconomy and any specific uptake of and announcements about any of the CNAS industrial policy recommendations offered in the report.

In the meantime,  strategic issues around the compromise of biotech-based data will be an ongoing challenge – as well as the formal efforts by Russia and China using human targeting – amongst other tools- to achieve security advantage in key emerging technologies including biotechnology by 2030.

Further Resources:

The full CNAS Report:   Regenerate: Biotechnology and U.S. Industrial Policy

OODA Special Report: Executive’s Guide To The Revolution in Biology

https://oodaloop.com/archive/2020/10/21/ooda-special-report-executives-guide-to-the-revolution-in-biology-2/

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Daniel Pereira

About the Author

Daniel Pereira

Daniel Pereira is research director at OODA. He is a foresight strategist, creative technologist, and an information communication technology (ICT) and digital media researcher with 20+ years of experience directing public/private partnerships and strategic innovation initiatives.