Well intentioned but flawed: The US National Biotechnology and Biomanufacturing Initiative

On September 12th, the Biden administration issued an executive order to enhance the development and commercialisation of biotechnology in the United States.

This order promises the investment of 2 billion US dollars into subsidizing the biotech industry and to improve the regulatory framework to bring its products to market faster. While this is well-intentioned and certainly in the interest of the biopharmaceutical industry, the initiative shows a flawed thinking that could damage the reputation of the industry and thwart its mid-term market potential.

A key passage at the beginning of the Presidential order states: “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.”

The assumption that we can “write circuitry for cells” and “predictably program biology” shows a dangerous ignorance of living organisms. We can create and program electric circuits because their relevant behaviour is fully described by Maxwell’s equations. They can therefore be used to implement Boolean logic on the computer chips. But we have no synoptic equations for living organisms that allow us to perform predictable interventions in complex living organisms. Instead, we need to try thousands of therapeutic ideas in vitro and then hundreds in vivo using animals before we can dare to use a novel biopharmaceutical in humans. We are complex driven systems, the reaction of our bodies to new pharmacological interventions cannot be predicted. If we use a primitive mechanistic view of biology as the foundation of our industry, we will soon and drastically fail with devastating safety issues and a bitter lack of efficacy. This would destroy our reputation and growth perspectives.

We must adhere to the well-established principles of biopharmaceutical research and development that have been established because living organisms are no mechanical items, but complex driven systems.

With Cognotekt, you can see how to leverage the subsidies and deregulation which the order promises without hurting reputation and growth perspectives.

Register here for our Cognotekt Biopharma Series brought to you every week by Cognotekt.


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Dr. Raija Kramer
+49 221-643065-10