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Extending Federal Stewardship of the U.S. Bioeconomy

Fruits of the Bioeconomy

In 2020, the National Academies of Sciences, Engineering, and Medicine released theÌý, which provided a recommended guiding definition for the U.S.:Ìý

The U.S. bioeconomy is economic activity that is driven by research and innovation in the life sciences and biotechnology and that is enabled by technological advances in engineering and in computing and information sciences.

Activities includeÌýagricultural, biomedical, bioindustrialÌýapplications along with tools, kits, and services.ÌýSome of the most dynamic bioeconomy-based innovations includeÌý, topical fertilizers with reprogrammed microbes; to infinitely recycle all types of plastic- and textile-based polyethylene terephthalate waste;Ìý into high quality leather alternatives;Ìýcreating from plant-based products; andÌý through biomimicry-based design of long-term drug delivery systems.Ìý

Highlights of Federal Leadership in the Bioeconomy

Shaping, growing, and protecting the bioeconomy has been a notable federal priority since the publication of theÌýÌýby the Obama Administration in 2012. The Trump Administration hosted aÌýÌýin 2019, and most recently, in 2022, the Biden Administration directedÌýÌýin addition to re-establishing the National Security Council Directorate on Global Health Security and Biodefense.

A multi-pronged approach across federal agencies has yielded significant advancements across the regulatory, commerce, research, and defense spaces. Efforts include:

  • In the regulatory space, theÌýOffice of Biotechnology Products at the Food and Drug AdministrationÌýworks to review, regulate, and research biological products and biosimilar biological products
  • In the commerce space, theÌýDepartment of Commerce, theÌý, theÌý, theÌýÌýand theÌýatÌýall jointly promote innovation and industrial competitiveness by advancing measurement science, standards, and technology to enhance economic security
  • In the research space, theÌýDepartment of Veteran AffairsÌý(VA)Ìýmaintains theÌýand theÌýwhich both offer guiding data and research
  • In the defense space, theÌýDepartment of Homeland SecurityÌýsupports the safeguarding of the bioeconomy through initiatives including theÌýÌýand theÌý

Some of the more recent, high-profile bioeconomy development efforts have included:Ìý

  • WithinÌýHealth and Human Services (HHS), the creation of theÌýAdvanced Regenerative Manufacturing Institute (ARMI)Ìýin 2020 established the U.S.’s first foundry for biotechnology and the forthcoming creation of theÌýAdvanced Research Projects Agency for Health (ARPA-H)Ìýthis year to bring the ARPA model of innovation and commercialization to theÌýNational Institutes of Health (NIH)
  • WithinÌýDepartment of Defense (DOD), the creation of theÌýBioindustrial Manufacturing and Design Ecosystem (BioMADE)Ìýto enhance the U.S.’s domestic bioindustrial manufacturing and biomanufacturing workforce capacityÌý

Transdisciplinary Action Is Required to Maximize the Bioeconomy Impact

, bioeconomyÌýdevelopment is enabled by life science, artificial intelligence (AI) and machine learning (ML), high-performance and next-generation computing, and effective cybersecurity. Coordinated federal action in these sectors is required to fully harness the bioeconomy to advance health, climate, and the overall economy, while protecting national security.Ìý

Based on original research and analysis conducted, here are our recommendations:

Life Sciences

Research and development in theÌýbioeconomy is undergoing a paradigm shiftÌýas the translation of research to end products becomes a central driver, making extensive knowledge in a variety of increasingly complex fieldsÌý—includingÌýquality, safety, and regulatory science—even more essential to success. Moreover, the increasing velocity of discovery emphasizes the need to be familiar with data generation, sharing, and provenance; high-throughput data analysis; and strategic allocation of resources, which are this era’s hallmark innovations inÌýtechnology and standards for experimental design.

The federal government should create interagency fellowship programs at leading biotechnology agencies to train diverse cohorts of experts who will catalyze future, transdisciplinary advancements as bioeconomy generalists. To guarantee talent is available and equitably distributed to fill the bioeconomy jobs of the future, the government must develop regional public-private partnerships for workforce upskilling. Finally, the government must increase funding to recruit and retain the bioeconomy-based knowledge of its own workforce to ensure innovations areÌýsafely developed, properly regulated, protected, and utilized.

Artificial Intelligence and Machine Learning

Life sciences and biotechnology research is fueled by extracting knowledge, detecting complicated patterns, and making predictions fromÌýincreasingly larger volumes and varieties of data. Artificial intelligence and machine learning catalyze connections between our understanding of proteins, organisms, ecosystems, and biomes more rapidly than possible in isolation.ÌýTherefore,Ìýto accelerate the comprehensive development of the bioeconomy, national AI capabilities need to be developed and integrated into every facet of research.ÌýData sets must be .ÌýThey must also cover the key domains of the bioeconomy: from human health records for developing clinical care improvements to plant and microbial genomics for agriculture and energy applications.Ìý

The U.S. government must invest in initiatives for propelling bioeconomy research and development through the accessibility of impactful data sets and democratization of AI/ML use. Data sets should be developed through government research programs,Ìýcreated via synthetic data generators, and made available through sophisticated privacy-preserving data mining techniques. For example, the federal government should continue to champion innovative research programs like theÌý, while simultaneously funding additional grand initiatives across life sciences and biotechnology so that bioeconomy-related data is available to researchers.Ìý

Finally, theÌýwidespread application of AI/ML to these data sets should be enabled by the greater availability of scalable compute resources (e.g., cloud computing environments) and AI as a service and ML as a service platforms. These platforms should provideÌýAI operationsÌýtools and processes to reduce the development time and increase the likelihood of success for delivering AI solutions.

High-Performance and Next-Generation Computing

Today, scientific data is being produced at a scale and rate never seen before. To unlock breakthrough insights across diverse data types and datasets, scalable computing environments (e.g., cloud computing) and specialized hardware (e.g., graphics processing units) are needed.Ìý

Projects that look toÌýincrease the efficiency of laboratory data operations or to expedite the development of new, synthetic small molecules for drug design via protein folding will directly benefit bioeconomy-related research and development.Ìý

These can accelerate informatics and advanced analytics tools, kits, and services capable of extracting granular knowledge. Continued development and greater use of next-generation computing techniques, includingÌýedge computingÌýandÌýquantum computing, will further disrupt the status quo of life science research—for example, through platforms that can transform smart devices into data-collection devices capable of transmitting, processing, and sharing information in the field independent of the cloud or a network for data processing.ÌýIn addition to addressing cybersecurity risks posed by these next-generation computing techniques, the .Ìý

Cybersecurity

Maintaining and protecting intellectual property, research, and large and sensitive health data sets, requires robust security measures. Indeed, intellectual-property theft of bioeconomy assets has increased dramatically in the last decade.Ìý

Hacking and data leakage also put privacy at risk. For example, genetic databases could be hacked, .Ìý

Scientific research is intrinsically collaborative, requiring data sharing across networks and the cloud. Standardized enterprise solutions often lack the nuance necessary to meet the specialized needs of secured scientific environments. Thus, protecting valuable bioeconomy information assets will require new and innovative approaches such asÌýzero trustÌýandÌýAI-enhanced cybersecurity.

The federal government should prioritize embedding cybersecurity subject matter experts into all life-sciences-based organizations and agencies so that native cyber solutions can be created precisely for the unique needs of the bioeconomy. In addition, bioeconomy experts should be employed by federal cyber agencies to ensure that bioeconomy-specific cyber threats are being appropriately assessed and triaged from the top.Ìý

Strategic Action to Protect, Shape, and Grow the Domestic Bioeconomy

The bioeconomy is set to transform every element of humanity’s collective experience through biotechnology innovation. The federal government—with itsÌýmulti-pronged approach across regulation, commerce, research, and defense—has nurtured domesticÌýbioeconomy development, but there is still significant work to be done to secure U.S. leadership in the realm. Maintaining the nation’s competitive posture will require concerted action across life sciences, artificial intelligence, high-performance computing, and cybersecurity.Ìý