Odette Hauke is a global regulatory affairs leader and exhibiting artist who builds approval-ready regulatory architectures for first-in-class therapies, rare disease and immunology programs, neuroplastogens, and psychedelic modalities, where evidence is still emerging and policy hasn’t caught up to the science. She works at the thresholds of development: the moments when data are incomplete, risk is real, and the narrative must be both scientifically rigorous and humanly defensible.

With 13+ years across IND/CTA/NDA/BLA/MAA submissions and global health-authority engagement, Odette is known for designing risk-managed strategies that accelerate development, anticipate agency concerns early, and hold up under scientific and statistical scrutiny. Her work blends deep submission craftsmanship with executive-level decision framing: what to do next, what to defend, what to concede, and how to keep the program’s benefit–risk logic coherent from first-in-human through commercialization.

Odette is the Principal Consultant at Odette Alina, LLC, advising sponsors across autoimmune cell therapy, rare kidney disease/nephrology, neuroscience and oncology/immunology, consumer health, and multi-TA pipelines. She is frequently engaged for high-stakes agency interactions, complex dossier strategy (CMC + clinical), pediatric and risk planning, and AI/ML-enabled regulatory intelligence, especially in emerging therapeutic areas where the “therapy package” must remain coherent, inspection-ready, and ethically grounded.

Previously, she led global regulatory strategy and high-impact submissions at Vera Therapeutics and served as global regulatory lead for AtaiBeckley psychedelic programs (including DMT, R-MDMA, and ibogaine), supporting filings and agency engagement across the US, EU, UK, APAC, Latin America, and Canada. Earlier, at Memorial Sloan Kettering Cancer Center, she managed over 200 oncology IND submissions, experience that cemented her foundational view: regulation is a form of patient care, and every scientific choice must map to a real clinical consequence.

Based in Los Angeles and fluent in English and Polish, Odette speaks internationally on the frontier where AI, decentralized evidence, and controlled-substance development are reshaping the regulatory playbook.