On Sept 12th 2022, the White House, under the Biden-Harris administration, issued the Executive Order on Advancing Biotechnology and Biomanufacturing or referred to as the acronym EOABB in this article. The goal of the EOABB is to fuel activity around biotechnology and biomanufacturing in the form of services and products to grow the economy and workforce of the United States. In publishing this EO, the federal government is committing to an investment of 2 billion USD. The language of the executive order emphatically mentions investing in better data management and software tooling. Some key excerpts include statements like
we need to develop genetic engineering technologies and techniques to be able to write circuitry for cells and predictably program biology in the same way in which we write software and program computers; unlock the power of biological data, including through computing tools and artificial intelligence
AND
foster a biological data ecosystem that advances biotechnology and biomanufacturing innovation, while adhering to principles of security, privacy, and responsible conduct of research
Since then, the White House has passed multiple additional executive orders that directly benefit the field of biotechnology and biomanufacturing. The EOs have been rightly cause for celebration for people building in the biotechnology space. But at the same time, the legislative power of an executive order, and its tangible impacts remain somewhat ambiguous. In this essay we try to untangle what this executive order means for the future of the bioeconomy.
What is an executive order?
An executive order (EO) is a set of instructions published by the President of the United States to funnel the actions of executive agencies and government officials. It can be also used as a way to direct creation of policies for the executive branch to follow. Executive orders are fairly common and every US president has issued one or more of these since George Washington was president in 1789. An easy way to describe executive orders is ‘insta-law’ but they do not qualify as legislation and for this reason they can be somewhat controversial. After the issuance of an EO, the Congress has the power to pass counter-legislation that can block, impede or completely overturn it.
Historically some of the bolder EOs passed over the last century in the US have had rapid and immediate impact. The New Agency under the New Deal passed by Roosevelt in 1935 was a historic EO that provided jobs and resulted in relief for millions of citizens after the Great Depression. Some other famous EOs include the facilitation of the Manhattan Project in 1941 and pardon of Nixon in the 1970s. Suffice it to say, EOs are serious, disruptive and have been iconic in propelling the economy of the United States in the past.
How long does it last?
The duration of the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy is not specified in the order itself. However, like all EOs, it will remain in effect until it is revoked or superseded by a subsequent EO or legislative action.3
The duration of an Executive Order issued by the White House can vary depending on a number of factors. Generally, an Executive Order remains in effect until it is revoked or replaced by a subsequent Executive Order or legislative action. EOs issued by the President can be revoked by the President who issued it or by a succeeding President. They can also be revoked by Congress through legislative action, such as passing a law that negates the Executive Order. Additionally, the courts can declare an Executive Order unconstitutional or unlawful, which would nullify its effects.
What does it say exactly?
A strategic framework published on March 2023 titled Bold Goals for U.S. Biotechnology and Biomanufacturing provides a glimpse into the future impacts of the EOABB. It uses active language to describe key goals and how they will be achieved via federal investment. The framework includes the following key goals:
Accelerate the development and deployment of new biotechnology products to address important national challenges, such as improving public health and national security.
Build a robust and resilient domestic biomanufacturing industry to ensure a reliable supply of critical products, including vaccines, therapeutics, and diagnostics.
Foster innovation and entrepreneurship by creating a supportive environment for biotechnology startups and small businesses.
Develop a skilled workforce equipped with the knowledge and tools necessary to succeed in the biotechnology industry.
Promote responsible and ethical biotechnology practices to ensure public trust in the industry.
To achieve the bold goals set out for U.S. biotechnology and biomanufacturing, progress in several areas beyond research and development is necessary. This will ensure that innovation leads to safe, effective, and equitable products that will grow the bioeconomy across US and globally. To advance the goals, departments and agencies are working on initiatives such as establishing a Data Initiative for high-quality, easily accessible, and secure biological information; expanding domestic biomanufacturing infrastructure; growing training and education opportunities for the biotechnology workforce; improving regulatory clarity and efficiency for biotechnology products; creating a Biosafety and Biosecurity Innovation Initiative to reduce risks; and pursuing international cooperation through joint research projects and data sharing while mitigating risks and upholding democratic values.
Can you give us some specifics, please?
Part of the issue with understanding this EO is that is was mostly hype, government hype, which is the least penetrable of them all. The initial press release for the executive order was more a gantt chart of when we would have more detail about the different facets. For example, the nebulous ‘Harnessing Biotechnology and Biomanufacturing R&D to Further Societal Goals’ section was released 180 days after the order. In the governmental gantt chart there were some surprising initiatives such as the fairly comprehensive ‘Data for the Bioeconomy Initiative’. This initiative is set to aggregate multiomic data across health, climate, energy, food, agriculture, and biomanufacturing, as well as other bioeconomy-related R&D while making it findable, accessible, interoperable, and reusable (FAIR Data Principles) in ways that are equitable, standardized, secure, and transparent, and that are integrated with platforms that enable the use of advanced computing tools’. What we’re thinking this means is a Basecamp Research X Lamin Labs X Form Bio - for free! However, accomplishing all these together seems to be a formidable task, especially with the existing issues with the NCBI database such as accessing and retrieving data, data quality issues, limited data sharing, bias, and maintenance and updates. We’re watching this space as there are certainly capabilities here that the government doesn’t have which might make selling bio software to government a more significant revenue stream. If they’re really aggregating all this information, we wonder if they’re thinking about how to build biological foundation models for the whole industry? This could potentially be one of the most valuable public goods they could give society.
Human and tumor digital twins is a space that’s been garnering a lot of interest recently with Roche launching the Institute for Human Biology. We’ve also seen inroads being made by DeepLife, Turbine Bio, and Syntensor. However all of these are for humans - but there could be tremendous value in making foundation models of chassis for high value product production which be achievable and monetized much faster (e.g. Pichia pastoris, Bacillus subtilis, etc).
A fundamental part of the EO is the emphasis on biobased products procurement. This requires the government to have training appropriate staff (including contracting officers, purchase card managers, and purchase card holders) be trained on (and presumably encouraged) biobased product purchasing. There are many parallels here to the underwriting of the electric vehicle industry, subsidizing Tesla (>$5bn) and allocating over $7.5B for electric vehicle charging infrastructure. This is where things start to get exciting for the bioeconomy! Speak to anyone in the industry and issue with bio-based commodities is cost parity with petroleum based products. Well, yeah - when fossil fuel subsidies are around 6% of GDP ($5.9 trillion), things look cheaper than they actually are. This is why there’s a black hole for every industrial biotech company to reach therapeutics, because the margins are high enough to garner success. In the electric vehicle industry as well, we all understand that the cars are expensive now because we’re still figuring out the tech and infrastructure, but for some reason, people have not been so charitable to the bioeconomy, until now. With government buy-in and subsidy the bioeconomy, we hope people will talk about it in the way we talk about electric cars - working out the kinks but an eventuality.
In this eventuality, the government plans to upskill the workforce by providing more ‘career and technical education, and expanded career pathways into existing degree programs for biotechnology and biomanufacturing. This is really key - a car technician can be excellent without needing a university degree, neither will a biomanufacturer in the future. Part of the reason why the bioeconomy hasn’t pierced the collective consciousness because it is gate-kept by university degrees and ivory tower dialects. It’s odd that lab work has a white-collar feel when it’s actually apprenticeship and vocation. We’re glad the government sees the need to transition and upskill workers, especially in the rust belt where jobs will be made obsolete as we transition away from fossil fuels.
To read another great article on this topic, check out
Lipman’s Substack post predicting how $2b in federal funding could be spent for biomanufacturing.