Biden Executive Order Establishes National Biotechnology and Biomanufacturing Initiative

Today, President Biden signed an executive order launching a National Biotechnology and Biomanufacturing Initiative. The order concentrates on supply chains and biomanufacturing, but it also aims to “Drive Research and Development (R&D) to Solve Our Greatest Challenges.” The White House has not given details about additional funding for life sciences R&D, but the initiative’s goals strongly suggest increases in grants for R&D as well as contracts related to bioproducts and biomanufacturing.

Expanding the pipeline, from R&D to prototypes to technology and products

Regarding R&D, the White House’s statement about the executive order explains:

Focused government support for biotechnology can quickly produce solutions, as seen with the first-of-their-kind mRNA vaccines during the COVID-19 pandemic. This Initiative directs Federal agencies to identify priority R&D needs to translate bioscience and biotechnology discoveries into medical breakthroughs, climate change solutions, food and agricultural innovation, and stronger U.S. supply chains.

The executive order is clear that basic science is a priority:

For biotechnology and biomanufacturing to help us achieve our societal goals, the United States needs to invest in foundational scientific capabilities.

It also places special emphasis on genetic engineering:

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 advance the science of scale‑up production while reducing the obstacles for commercialization so that innovative technologies and products can reach markets faster.

To address the proliferation of new technologies and drugs, the initiative also sets this aim:

improve the clarity and efficiency of the regulatory process for products of biotechnology so that valuable inventions and products can come to market faster without sacrificing safety.

Boosting biomanufacturing and consumption of biobased products

Regarding manufacturing, the full executive order specifies these needs:

improve and expand domestic biomanufacturing production capacity and processes, while also increasing piloting and prototyping efforts in biotechnology and biomanufacturing to accelerate the translation of basic research results into practice.

It also broadens government requirements on government agencies to use biobased products.

Bigger, better databases, but will businesses be shut out?

Of course a great deal of life sciences R&D depends on large data sets. Accordingly, the executive order establishes a Data for the Bioeconomy Initiative (Data Initiative) to “ensure that high-quality, wide-ranging, easily accessible, and secure biological data sets can drive breakthroughs for the United States bioeconomy.”

It specifies that these databases should include “genomic and multiomic information” as well as other data “most critical to drive advances in health, climate, energy, food, agriculture, and biomanufacturing, as well as other bioeconomy-related R&D.”

The executive order did not specify who would be able to access government databases and how such data could be used in public-private partnerships.

New business opportunities in biotechnology security and education

The life sciences industry has concentrated on the development of new drugs and medical devices, but biotech security may become fertile territory for businesses.

The executive order sets out several imperatives including these:

• “reduce biological risks associated with advances in biotechnology”;
• “invest in and promote biosafety and biosecurity to ensure that biotechnology is developed and deployed in ways that align with United States principles and values and international best practices, and not in ways that lead to accidental or deliberate harm to people, animals, or the environment”; and
• “safeguard the United States bioeconomy, as foreign adversaries and strategic competitors alike use legal and illegal means to acquire United States technologies and data, including biological data, and proprietary or precompetitive information, which threatens United States economic competitiveness and national security.”

Similarly, new business opportunities may arise as the United States governments expands “training and education opportunities for all Americans in biotechnology and biomanufacturing.”

Companies outside the US will not be left out

While the initiative has been launched as an effort to renew the life science-based capacities of the US, the executive order makes space for “international engagement”:

The Department of State and other agencies that engage with international partners as part of their missions shall undertake the following actions with foreign partners… [firstly, to] enhance cooperation, including joint research projects and expert exchanges, on biotechnology R&D, especially in genomics…

As Biden’s initiative uplifts the US bioeconomy, it can be expected to expand opportunities for life science R&D and business for others nations within the US sphere of influence.