Artificial Intelligence in Life Sciences

AI and advanced data analytics are transforming how therapeutics and medical technologies are discovered, developed, manufactured, and commercialized. Life sciences companies increasingly leverage AI/ML and advanced data analytics for a range of strategic applications — including identifying novel disease targets, optimizing therapeutic design, predicting clinical outcomes, streamlining clinical trial protocols, and enhancing manufacturing and regulatory decision-making.

We advise clients on the legal, regulatory, and risk considerations that arise at each stage of AI-enabled development — helping them deploy these tools responsibly while maximizing strategic value.

We advise AI/ML-driven life sciences companies on the full spectrum of strategic transactions, combining deep industry knowledge with sophisticated deal execution. Our team navigates the complex regulatory, IP, data, and commercialization considerations unique to AI/ML-enabled platforms to help clients structure and close transformative partnerships, financings, and M&A transactions with confidence.

AI/ML-enabled discoveries raise complex and evolving issues in patent strategy, inventorship, ownership, and portfolio development. We counsel clients on:

• Patent protection for AI-assisted discoveries and platform technologies
• Inventorship considerations in machine-assisted innovation
• Trade secret protection for models, algorithms, and training datasets
• Data ownership, access rights, and governance frameworks
• Freedom-to-operate analyses for AI-generated compounds and biologics
• Joint ownership and IP allocation in strategic collaborations

Our IP team works with life sciences innovators to craft protection and enforcement strategies for AI/ML-augmented technologies that translate into legally defensible, commercially valuable rights.

Regulatory expectations governing AI use in drug and device development continue to evolve. We guide clients through US and global regulatory frameworks affecting AI-enabled products and processes, including:

• FDA (U.S. Food and Drug Administration) and international regulatory guidance relating to AI/ML
• Use of AI in preclinical research and clinical trial design
• Model validation, documentation, and data integrity standards
• GxP (good practice) considerations in AI-supported development and manufacturing
• Regulatory implications of AI-generated evidence in IND (investigational new drug) applications, BLAs (biologics license applications), and other submissions

We help clients anticipate regulatory scrutiny, implement defensible validation practices, and integrate AI into development programs in a compliant and strategic manner.

As AI becomes core to therapeutic development, governance and risk management are critical. We advise boards and executive teams on governance frameworks for responsible AI use — including accountability structures, disclosure considerations and investor diligence readiness, risk management practices, and policies that support ethical deployment in scientific and clinical contexts.

Our approach helps clients mitigate regulatory, litigation, and reputational risk while demonstrating responsible innovation to investors and strategic partners.

• insitro – Strategic collaborations with Gilead Sciences and Bristol Myers Squibb.
• Isomorphic Labs – Multitarget research collaborations with Johnson & Johnson and Novartis combining AI-first drug discovery approaches with global pharmaceutical development capabilities.
• Generate:Biomedicines – Collaboration agreement with Amgen to discover and create protein therapeutics across multiple modalities, with significant up-front payments and a potential milestone value exceeding $1 billion.
• Absci – Multiyear collaboration with Genentech to discover novel medicines for challenging targets, with substantial up-front payments and a multibillion-dollar potential milestone value.
• Orionis Biosciences – Strategic collaborations with Novartis and Genentech leveraging Orionis’ AI- and ML-enabled Allo-Glue platform to identify, design, develop, and commercialize novel small molecules, including protein degraders, across multiple therapeutic areas.
• Schrödinger – Multiple collaborations, including agreements with Bristol Myers Squibb, Otsuka, and Eli Lilly and Company, involving up-front payments and significant development and commercialization milestones.

• Noetik – Strategic collaboration and AI model licensing agreement with GSK.
• insitro – Strategic agreements for model development with Eli Lilly and Company.

• Valo Health – Series B financing to scale its Opal Computational Platform, the first-of-its-kind fully integrated end-to-end platform that combines ML-driven computational capabilities and patient data to develop therapeutic programs.
• Nabla Bio – Series A financing to support AI-driven innovation in life sciences.