United States: Life Sciences, Biotechnology & Nanotechnology

National security considerations are rapidly reshaping the life sciences industry, with evolving U.S. and European regulations affecting research, clinical trials, supply chains, investment, data governance, and commercialization. This webinar examines the latest developments across the U.S. and European national security landscape, including countries of concern, investment controls, human 'omic data restrictions, and AI-related risks.

Expert testimony is often the center of gravity in life sciences and technology disputes because patent, licensing and other commercial cases often turn on specialized scientific or technical questions. Yet the traditional method of presenting expert testimony—one side presents its expert, the expert is examined and cross-examined and, days later, the opposing expert goes through the same process—is not always well suited to resolving these questions. By the time the second expert addresses a point made by the first, the tribunal is comparing testimony delivered at different times, in response to different questions and sometimes using different terminology or assumptions. And much of what the experts have to say is really not in dispute.

The FDA is advancing significant changes to drug manufacturing oversight through proposed PDUFA VIII commitments, new registration pathways for distributed manufacturing, and enhanced inspection protocols. These developments aim to strengthen supply chain transparency, streamline facility readiness assessments, and reinforce good clinical practice standards in an increasingly globalized clinical trial landscape.