Background
Artificial Intelligence (“AI”) has been utilized by innovative companies across the array of industry spaces, but its impact on biotech (and human health in general) could become the most significant among all sectors.
AI is being leveraged across the drug development spectrum to accelerate inherently burdensome tasks including the identification of targets and leads,
Introduction
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This initiative formalizes the agency’s long-building effort to incorporate New Approach Methodologies (NAMs) into regulatory review and follows the release of draft guidance
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Key Takeaways:
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Introduction: Harnessing Cellular Machinery for Precision Medicine
Targeted protein degradation (TPD) is transforming drug discovery by leveraging the cell’s natural protein disposal systems to eliminate disease-causing proteins. Innovators are making rapid and successful advancements in the field of targeted protein degradation, leaving intellectual property (IP) protections and strategies in hot pursuit. Unlike traditional inhibitors, which only
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Introduction
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to enhance the efficacy and accuracy of the drug approval process, ensuring that applications incorporating AI meet rigorous