Stop the Shortages

Phlow Corp.’s Statement on Essential Medicines Supply Chain and Manufacturing Resilience Assessment

May 26, 2022 | Corporate Statements

Phlow Corp. is pleased to see the release of the Essential Medicines Supply Chain and Manufacturing Resilience Assessment, an action plan developed by the National Forum to Secure America’s Supply Chain for Essential Medicines. Phlow, a U.S.-based essential medicines public benefit company, was honored to participate in the forum with our industry partners, led by HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) and the Advanced Regenerative Manufacturing Institute (ARMI)/the Next Foundry for American Biotechnology (NextFAB). Together, key pharmaceutical supply chain stakeholders, including government health authorities and leaders from the pharmaceutical industry, shared perspectives for creating a resilient U.S. supply chain to ensure that essential medicines are available in the event of a crisis as well as for daily acute patient care.

“The United States has an opportunity to completely re-imagine our supply chain through continuous flow and other advanced manufacturing technologies in order to protect America’s health, safety, and national security through a robust supply of our most vital medicines,” said Eric Edwards, M.D., Ph.D., co-founder, president, and CEO of Phlow. “The Essential Medicines Supply Chain and Manufacturing Resilience Assessment is yet another critical step forward for the nation as we revitalize our domestic competitiveness and strengthen the supply chains required for lifesaving, priority medicines in the U.S.”

The National Forum to Secure America’s Supply Chain for Essential Medicines was assembled in response to Executive Order 14017 on supply chain resilience by the White House in February 2021 to ensure better preparedness for future pandemics and a more stable U.S. manufacturing environment. The Executive Order included a directive for key federal agencies, including ASPR and the U.S. Food & Drug Administration (FDA), to conduct a 100-day supply chain review, titled Building Resilient Supply Chains, Revitalizing American Manufacturing, and Fostering Broad-Based Growth. In response to this review, the National Forum to Secure America’s Supply Chain for Essential Medicines set out to develop an action plan to address pharmaceutical supply chain vulnerabilities identified in the 100-day supply chain report. The process included interviews, a series of surveys and workshops with groups of both clinicians and industry stakeholders, public feedback, and extensive evaluation of more than 100 sources. The resulting report comprises nearly two years of collaboration by the Administration and healthcare industry stakeholders to create a set of long-term strategies to overcome current pharmaceutical supply chain vulnerabilities.

To achieve increased supply chain resilience, industry leaders like Phlow contributed actionable steps to develop a balanced approach to essential medicine manufacturing capacity, supply, and distribution. Examples of strategies for achieving resilience include identifying, promoting, and investing in advanced technologies and processes that can improve the quality and safety of essential medicines. The assessment also emphasizes purchasing and stockpiling essential medicines, with a focus on domestic capacity and manufacturing of active pharmaceutical ingredients to enable targeted and efficient distribution of supplies in response to demand fluctuations or shortages.

Phlow, along with its partners, has already delivered to the U.S. Strategic National Stockpile millions of doses of essential medicines used to treat COVID-19 patients. Phlow is also building the United States’ first Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), a long-term, national stockpile to secure key ingredients used to manufacture the most essential medicines on U.S. soil, reducing America’s dependency on foreign nations to support its drug supply chain. Using predictive analytics and demand-side data, Phlow and its partners are positioned to quickly convert APIs from the SAPIR into finished pharmaceutical products in response to world events such as trade disputes, natural disasters, or public health threats.

“Phlow is committed to securing our nation’s health and enhancing our national security by helping to create a dynamic supply chain in the U.S. and preemptively preparing for demand spikes. The shared perspectives in the Essential Medicines Supply Chain and Manufacturing Resilience Assessment are what’s needed now to protect America’s medicine cabinet in the future,” said Edwards. “The assessment demonstrates that it is possible to not only address – but fix – the structural weaknesses in international supply chains that have threatened America’s economic and national security for decades. It’s collaboration like this that will reduce the nation’s reliance on imports from foreign nations. With continued cooperation across healthcare sectors and the government, along with bold thinking, we can help the United States maintain and strengthen its innovative leadership and rebuild its productive capacity for essential medicines and medical countermeasures now and for future generations. Working together, private industry and government stakeholders can chart a new path forward resulting in resilience, reliability, and enhanced national public health security.”

###