We continue to see the U.S. government setting policy priorities that underscore the importance of both building a robust American bioeconomy and strengthening domestic pharmaceutical supply chains – two core pillars of Antheia’s business and technology.
ln 2021, the Administration released the Supply Chains Executive Order, which outlined the need for “resilient, diverse, and secure supply chains to ensure our economic prosperity and national security.” The executive order outlines four critical supply chains that have a direct and significant impact on both economic and national security: high-capacity batteries, semiconductors, critical minerals, and notably, active pharmaceutical ingredients (APIs).
Jumping forward to 2022, President Biden released the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The bioeconomy executive order called for sweeping investment and bolstering of domestic biomanufacturing technologies and infrastructure that can transform industries as varied as pharma, energy, and agriculture.
As a company leveraging synthetic biology to solve urgent supply chain problems for key starting materials and active pharmaceutical ingredients, we are uniquely positioned at the intersection of two executive orders that have catalyzed action across the U.S. government. The following reports are a product of these executive orders and represent a comprehensive analysis of the opportunity and path forward to establish a world-leading biomanufacturing ecosystem and onshore critical supply chains:
- The White House Office of Science and Technology Policy along with several agencies, including the DOE, DOD, HHS, Commerce, and USDA released its Bold Goals for U.S. Biotechnology and Biomanufacturing. These goals aim to guide policymakers and the private sector for the next two decades as they together establish R&D priorities that will be critical to advancing the bioeconomy. The report highlights the vast potential of biology, noting that, “Recent global disruptions, geopolitical conflicts, and weather events exposed the vulnerability of U.S. supply chains critical for industrial production,” and citing synthetic biology as a solution, “to replace existing production processes, such as for precursor materials, and to create new products, resulting in new opportunities for diversifying production pathways and alleviating supply chain chokepoints. For example, realizing biomanufacturing breakthroughs for active pharmaceutical ingredients (APIs) has the potential to create environmentally sustainable, domestic alternatives to API production, which is currently heavily concentrated abroad.”
- The Senate Committee on Homeland Security and Governmental Affairs explored the pharmaceutical supply challenges we face as a country in a new report: Short Supply: The Health and National Security Risks of Drug Shortages. From 2021-2022, new drug shortages increased by nearly 30% with a record five-year high of 295 active drug shortages at the end of 2022. The average drug shortage lasts about 1.5 years and more than 15 critical drug products have been in shortage for over a decade. The report states that, “Overreliance on foreign and geographically concentrated sources for critical drugs and their key starting materials and limited domestic manufacturing capabilities create health and national security risks.” This report reinforces the Supply Chains Executive Order, which recognizes APIs as one of four critical U.S. supply chains. While the other three supply chains have been addressed with legislative bills (e.g., the CHIPS and Science Act and the Inflation Reduction Act), APIs still require a legislative push that will direct resources to the public and private entities that can transform these pharmaceutical supply chains, onshore production, and end shortages of essential medicines. This is an urgent problem and will require legislation that drives increased investment in domestic advanced manufacturing – such as biomanufacturing – for critical drugs.
- Antheia was proudly involved in the development of a strategic action plan from the Special Competitive Studies Project. Co-founder and CEO, Christina Smolke contributed to the development of The National Action Plan for U.S. Leadership in Biotechnology, which outlines a series of policy recommendations to ensure American leadership in this critical industry. The recommendations range from incentivizing commercialization to developing the key biomanufacturing infrastructure to cultivating the next generation of biotechnologists. A desired end state from the report includes, “An agile, rapidly-scalable, distributed biomanufacturing base that efficiently produces the majority of essential medicines and makes affordable medicines available to everyone who needs them,” stating that, “modernization of pharmaceutical supply chains drives more equitable health outcomes globally.”
As a company, we remain steadfast in our mission to transform pharmaceutical supply chains and ensure more equitable access to essential medicines. From establishing a thriving U.S. biomanufacturing infrastructure to building more resilient pharmaceutical supply chains, Antheia sits squarely at the intersection of several of the U.S. government’s key imperatives.
We are proud to see such close alignment across two of the Administration’s executive orders and several recent reports that reinforce the importance of fermentation as the leading manufacturing technology of our generation. We look forward to seeing continued action from these agencies and departments that will help propel our efforts in building resilient pharmaceutical supply chains with synthetic biology.