Regulatory & Statutory Developments

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In a previous posting, we flagged how the BIOSECURE Act (enacted as Section 851 of the Fiscal Year 2026 National Defense Authorization Act) reflects a growing focus on biotechnology supply chains within federal procurement. The statute is designed around a simple premise: Biotechnology risks rarely appear at the level of the final product. Instead, the risks tend to emerge through tools, platforms, and service providers embedded in the performance of federally funded work.

Nowhere is that observation more apparent than in industries adjacent to biotechnology that rely heavily on biological data, specialized testing infrastructure, or outsourced research capabilities. Examples include pharmaceutical and biologics developers, medical device and diagnostics manufacturers, contract research organizations (CROs) and specialized laboratory providers, healthcare and academic research institutions participating in federally funded programs, and technology companies supporting biological data analytics or laboratory automation. For these sectors, biotechnology may not define the business model, but it plays a quiet yet significant operational role in how products are discovered, validated, and manufactured. The BIOSECURE Act brings those operational dependencies into sharper focus.Continue Reading The BIOSECURE Act and the Expanding Life Sciences Supply Chain: Practical Considerations for Research-Driven Industries

“I felt a great disturbance in the Force, as if millions of voices suddenly cried out in terror and were suddenly silenced.”

When Obi-Wan Kenobi says this in Star Wars: Episode IV – A New Hope, he senses that something profound just changed in the galaxy. A powerful presence has vanished. The balance of power shifting in ways that will ripple far beyond the immediate moment. As Yoda later describes the Force: “Life creates it, makes it grow. Its energy surrounds us, binds us.” In this way, artificial intelligence (AI) is beginning to play a role for the US Defense Industrial Base (DIB) not unlike the Force itself—quietly enhancing the capabilities of engineers, analysts, and compliance professionals across thousands of organizations supporting national defense programs.

So what could happen if a major AI player suddenly disappears from the board?Continue Reading Orbiting A.I.-deraan? A Disturbance in the Force for the Defense Industrial Base

Remember in Coming to America when Eddie Murphy’s Prince Akeem shows up in Queens full of charm, optimism, and big dreams and somehow it all works out? Fast-forward 38 years (yes, it’s been that long) and European companies looking to sell into the US Department of Defense (DoD) and Department of Homeland Security supply chains will need much more than charm. Instead, they’ll need real strategy, a focused structure, and readiness for regulatory scrutiny that doesn’t end with an award notification. In the current climate, with a heightened domestic preference policy, new executive directives such as the “Prioritizing the Warfighter in Defense Contracting” executive order, and renewed focus on supply chain security and performance, it is essential for foreign companies and their counsel to clearly understand the terrain before landfall.Continue Reading Coming to America (the Government Contracting Edition): Ownership, Compliance, and Shifting Policy