Odette Hauke is a global regulatory scientist, clinical development strategist, and exhibiting artist working at the threshold where emerging science meets regulatory consequence. She specializes in translating scientific possibility into approval-ready reality, particularly in first-in-class and high-complexity programs where evidence is still maturing and policy has not yet caught up.

Over more than 13 years, she has led global IND, CTA, NDA, BLA, and MAA strategies across the U.S. Food and Drug Administration, European Medicines Agency, Medicines and Healthcare Products Regulatory Agency, Health Canada, as well as Latin America and APAC. Her work spans rare and ultra-rare disease, neuroscience, oncology, autoimmune disease, nephrology, cell and gene therapy, and psychedelic therapeutics, with a consistent focus on programs that challenge conventional regulatory frameworks.

She is the founder of Odette Alina, LLC, where she advises sponsors on regulatory architecture that can withstand scrutiny, from first-in-human studies through commercialization. Her work integrates strategy with execution: cross-functional dossier leadership, CRO and vendor oversight, inspection readiness, pediatric planning, REMS and EU Risk Management Plans, and global labeling strategy, including promotional review. The objective is continuity, ensuring that a program’s benefit–risk narrative remains intact as it scales.

Her advisory work has supported programs across ataiBeckley, Kyverna Therapeutics, Travere Therapeutics, Vera Therapeutics, Johnson & Johnson, Kenvue, and Regeneron Pharmaceuticals. Earlier, she led global regulatory strategy for atacicept at Vera Therapeutics, served as regulatory lead for first-in-class psychedelic programs (DMT, R-MDMA, ibogaine) at ataiBeckley, contributed to regulatory intelligence, labeling, and promotional review at Regeneron Pharmaceuticals, and managed more than 200 oncology IND submissions at Memorial Sloan Kettering Cancer Center.

She is known for disciplined judgment under uncertainty, anticipating regulatory risk early, constructing resilient development pathways, and maintaining inspection readiness as programs scale, particularly in areas where traditional frameworks are strained, including controlled substances and complex CNS therapies.

Born and raised in New York and now based in Los Angeles, she holds a Master of Science in Regulatory Affairs from Northeastern University and a Bachelor of Science in Epidemiology from Hunter College. She is a Women in Bio Impact Scholar and an invited speaker at international conferences, including the Psychedelic Therapeutics and Drug Development Conference 2026 and the International Society for Research on Psychedelics Conference 2026, and has published on AI-enabled regulatory systems and psychedelic development in Clinical Leader and Law360.

Her work is grounded in a simple conviction: regulation is a form of patient care.

Selected Publications

Selected Speaking Engagements

  • Invited Speaker, What Pharma Wants: Positioning Psychedelic Assets for Partnership & Acquisition — San Diego, April 8, 2026.

  • Invited Speaker, The 6th Annual Psychedelic Therapeutics and Drug Development Conference — New Orleans, February 26–27, 2026. “Psychedelics, Protocols, and Prompts: Navigating Regulatory Rigor and AI-Enabled Review in the Next Wave of Psychedelic Therapeutics.”

  • Invited Speaker, International Society for Research on Psychedelics (ISRP) — New Orleans, February 26–27, 2026. “Ibogaine as a Regulatory Stress Test: Translating EMA’s Psychedelic Framework into US FDA Guidance for a High-Risk Molecule.”

  • Invited Speaker, Global Innovation in Women’s Health Pitch Showcase 2026 — San Francisco, January 12, 2026. “Women’s Mental Well-Being in 2026: Indications, Evidence, and a Clear Regulatory Path.”

  • Invited Speaker, 8th Neuropsychiatric Drug Development Summit — Boston, September 11, 2025. “Navigating the Evolving FDA & EMA Guidance to Accelerate Approval of MDMA, Psilocybin & DMT-Derived Therapies”; “Securing Regulatory Buy-In for Precision Psychiatry: Regulatory Perspectives on Targeting Precise Patient Subtypes and Implications for Drug Labeling.”