Daniel J. Larkins, MS

Daniel J. Larkins is an accomplished regulatory affairs leader with more than 30 years of experience guiding pharmaceutical products through global development and registration. He brings deep expertise in U.S. and international regulatory strategy, health authority engagement, and cross-functional leadership, with a strong focus on inflammatory and gastrointestinal diseases.

Most recently, Mr. Larkins served as Director and Global Regulatory Lead at Teva Pharmaceuticals, where he was part of the team developing duvakitug (anti-TL1A), a novel therapy currently initiating Phase 3 development for both ulcerative colitis and Crohn’s disease. At Teva, he led global and U.S. regulatory strategies for early- and mid-stage specialty programs in gastrointestinal and inflammatory diseases.

Previously, Mr. Larkins held senior regulatory leadership roles at AbbVie, where he was a member of the upadacitinib (RINVOQ) development team supporting its Phase 2/3 programs in ulcerative colitis and Crohn’s disease. He also provided regulatory support for risankizumab (SKYRIZI). Earlier in his career, he held regulatory roles at Merck & Co., Inc., contributing to development and approval programs across immunology, infectious disease, vaccines, oncology, and women’s health, with direct engagement with the FDA and other global health authorities.

In addition to his industry leadership, Mr. Larkins has served as an Adjunct Professor of Regulatory Affairs and Quality Assurance at the Temple University School of Pharmacy since 2008. He holds a Master of Science in Quality Assurance and Regulatory Affairs and a Bachelor of Science in Biology from Temple University.