AI and Genomics: A New Era of Personalized Medicine
Robert J. Hilton, Ph.D. & Bailey R. Arenberg
Advances in AI and genomic analysis will allow medical providers to tailor treatment for individual patients at the genome level, but challenges exist for protecting AI-assisted inventions.
IP Considerations Following FDA Announcement on Flexibility for Cell and Gene Therapies
Makoto Tsunozaki, Ph.D. & Kenneth O. Aruda, Ph.D.
Manufacturing processes of cell and gene therapies (CGTs) may remain fluid well into development and even after FDA approval, and therefore sponsors of CGTs may benefit from patent strategies that account for innovations that emerge later and carry independent value from an earlier process.
Greater regulatory acceptance of iterative manufacturing changes by the FDA may increase the value of innovation beyond final commercial configurations.
In IP diligence and landscape analyses, practitioners should be mindful that regulatory flexibility may permit multiple manufacturing pathways to support a single approved product, each with potentially distinct IP considerations.
New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the U.S.
Michael L. Fuller & Phillip J. Minnick, Ph.D.
New FDA guidance released on February 23, 2026, and March 9, 2026, signals a continued shift toward regulatory flexibility aimed at accelerating approval of biosimilar treatments for rare and ultra-rare diseases.
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