Game Changing Approach to Solving the Essential Medicines Shortage in the U.S.

Medication shortages have impacted the U.S. healthcare systems for more than a decade, prompting the American Medical Association in 2018 to declare an urgent public health crisis in the U.S. The problem originates in U.S. reliance on foreign pharmaceutical manufacturers, especially for active pharmaceutical ingredients supply.

These shortages became exacerbated by the COVID-19 pandemic, which put further pressure on an already fragile global supply chain of essential medicines and exposed vulnerabilities. The pandemic compromised not only patient care and treatment availability across hospitals in the US, but also the government’s ability to respond to the crisis.

The problem is that domestic manufacturing of highly commoditized essential medicines is simply not cost-effective. Consequently, in the last few decades, increasing costs due to labor shortages and regulatory shifts pressured organizations to move the production of active pharmaceutical ingredients (APIs) overseas. With more than 80% of APIs being produced outside of the U.S., primarily in China and India, interruptions caused by public health threats, political unrest, trade wars, weather catastrophes, and other events seriously disrupted the supply of essential ingredients and medicines.

Developing the U.S.-based manufacturing capabilities to create a reliable supply of high-quality and affordable essential medicines to ensure uninterrupted access for all Americans and the ability to compete against foreign suppliers requires the use of advanced manufacturing processes. Phlow Corp. was founded with the mission to overcome these challenges and leverage state-of-the-art flow chemistry and advanced manufacturing processes to reimagine the domestic production of key starting materials (KSMs), APIs, and finished pharmaceutical products that are all critical to the health and well-being of Americans while also reconstructing our essential medicine supply chain.

To help further compete against foreign pharmaceutical manufactures in the highly commoditized essential medicines industry, Phlow is developing strategic partnerships and networks of innovation, implementing smart end-to-end supply chains, creating new chemistry processes, and implementing advanced manufacturing technologies, including continuous manufacturing. These capabilities, which constitute a change in paradigm, will be resilient, but also flexible and adaptable, to meet the speed of changes driven by external factors.

At the core of this approach are technologies and data analytics capabilities that will enable Phlow to make timely decisions, provide Phlow with market insights, promote innovation, and establish mechanisms to manage environmental uncertainty. The implementation of novel information and communication technologies will permit Phlow to work more effectively with its partners and overcome the technical boundaries that often exist between organizations and thwart networks of innovation.

The introduction of disruptive Industry 4.0 technologies, such as cyber-physical systems, multi-cloud environments, artificial intelligence (AI), machine learning (ML), mobility and the Internet of Things (IoT) will provide high levels of process automation including streamlining the workforce, improving time-to-market, boosting productivity, and increasing product quality.  Importantly, 4.0 technologies will also create connections and interdependencies between the strategic partners that will facilitate a continuous exchange of actionable data essential to creating synergies that accelerate innovation.

It is important to consider that these complex digital value chains and their heavy dependency on integrated information systems and technology will also potentially increase the company’s level of cybersecurity exposure. Industry 4.0 digitized manufacturing and hyper-connected systems that enable smart factories also, unfortunately, open the door to new vulnerabilities that could be exploited by cyber-criminals. These vulnerabilities can negatively impact the continuity of business operations, lead to theft of confidential information, and cause reputational harm. The number of interconnected paths of communication in the firm’s hyperconnected networks of innovation will extend the company’s landscape across physical and trust boundaries creating highly dynamic “micro-borders” and exposure to larger threat vectors.

To mitigate these issues, Phlow will extend network and security policies to cover the firm’s distributed architectural model. Phlow will also implement an agile micro-granular security approach to individually manage and protect identity, traffic, and workloads. By incorporating a modern cybersecurity posture, Phlow will be leveraging a combination of the defense-in-depth and zero trust paradigms with a defensive and offensive approach. Defensive approaches, which are the more common methodology implemented today, require a thorough understanding of the organization, its systems and infrastructure, and use reactive strategies focused on protection, prevention, detection, response, and recovery. Offensive approaches use ethical hacking concepts to identify, predict, and eliminate vulnerabilities before they can be identified and exploited by a potential intruder.

Successfully reconstructing the essential medicines supply chain from molecule to bedside to create supply chain resiliency will rely heavily on strategic partnerships,4.0 technologies, and advanced data analytic capabilities.  As Phlow works to secure our nation’s public health, best-in-class digital innovation and cybersecurity will protect the organization and facilitate unwavering focus on ensuring that all Americans have access to critical essential medicines.

Juan Piacquadio, MBA MSIT
VP, Information Services @ Phlow
Member Board of Directors @ Cystel
Adjunct Faculty @ Colorado Christian University, California Baptist University and Columbia International University
DBA Doctoral Candidate @ University of Liverpool, UK

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