Odette Hauke

Odette Hauke is a regulatory scientist with thirteen years of experience across academia and industry, specializing in first-in-class psychedelic, neuroscience, and controlled-substance therapies. Her experience spans drugs, biologics, combination products, and medical devices, and through Regulatory Atelier (Odette Alina, LLC), she helps global sponsors move programs from first-in-human through commercialization by building regulatory and operational systems that hold under scrutiny, scale in the real world, and protect patients long after approval.

She is known for seeing regulatory risk early and translating complexity into executable strategy: IND, NDA, and BLA planning; REMS and supervised-dosing risk management; DEA compliance and controlled-substance logistics; site-of-care design, certification, and inspection readiness; and global strategy across the FDA, DEA, EMA, MHRA, and Health Canada. She is also valued for her strategic clarity about where psychedelic programs create durable value: the strongest path is not always the largest market, and orphan, neurodegenerative, and select pain indications can offer a cleaner clinical and regulatory path than crowded indications where every readout is contested.

At AtaiBeckley, she led regulatory strategy for first-in-class programs in R-MDMA, DMT, and ibogaine, translating Schedule I requirements into executable systems across multiple jurisdictions. She has also led global regulatory strategy for a BLA that received FDA Priority Review in January 2026. Earlier, at Memorial Sloan Kettering Cancer Center, she managed more than two hundred oncology IND submissions and supported FDA inspections across high-volume clinical programs. Her advisory work has included companies such as Regeneron, Travere Therapeutics, Vera, Johnson & Johnson, and Kenvue.

Her work has remained close to the patient from the beginning: as a pharmacy technician in assisted living, end-of-life care, and specialty pharmacies across New York City; through an internship with the NYU Langone PTSD Research Program; and as a clinical research coordinator in rare cancer at Memorial Sloan Kettering. That path still shapes how she builds: from the patient backward, never from the submission forward. A first-generation Polish American raised in New York City and based in Los Angeles, she holds an M.S. in Regulatory Affairs from Northeastern University, a B.S. in Epidemiology from Hunter College, and a certificate in Psychedelic Science and Medicine from Johns Hopkins University. She is a Women in Bio Impact Scholar, a speaker at leading psychedelic drug development forums, an exhibiting painter and photographer, and is fluent in English and Polish. Beneath all of her work is a single conviction: regulation is a form of patient care.

Selected Publications

Odette speaks and writes on regulatory strategy for high-scrutiny therapeutics, with a focus on psychedelic medicine, controlled substances, AI-enabled regulatory review, precision psychiatry, women’s mental health, and development strategy for complex CNS programs.

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.”