About Odette
Odette Alina Hauke is a regulatory scientist with thirteen years of experience across academia and industry, specializing in first-in-class psychedelic, neuroscience, and rare disease therapies. Through Odette Alina, LLC, she helps global sponsors carry programs from first-in-human through commercialization, building regulatory and operational systems that hold up under scrutiny, scale in practice, and protect patients long after approval.
She is known for seeing regulatory risk early and turning 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 equally clear 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 course than crowded fields where every readout is contested.
At atai Beckley, she served as regulatory consultant for MDMA, DMT, and ibogaine programs, translating Schedule I requirements into systems that held across the U.S., EU, UK, and Canada. At Vera Therapeutics, she directed global regulatory strategy and lifecycle submissions for atacicept, supporting the BLA filed under the Accelerated Approval Program that received FDA Priority Review in January 2026 and accelerated approval in July 2026. Earlier roles at Regeneron, Travere Therapeutics, and Memorial Sloan Kettering Cancer Center spanned regulatory intelligence and quality systems, rare-disease development, and IND submissions with FDA inspection support. Her advisory clients through the firm have ranged from Johnson & Johnson and Kenvue to early-stage psychedelic and biopharma sponsors.
Her work has stayed 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 rather than from the submission forward. A first-generation Polish American raised in New York 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, and an exhibiting painter and photographer, fluent in English and Polish. Beneath the work runs 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 the development of complex CNS programs.
"Designing Defensible Protocols: Documentation, Training, and Informed Consent for High-Risk Psychedelics,"** ABA Health eSource (American Bar Association, Health Law Section) (July 28, 2026). With Kimberly Chew and Odette Hauke. Part of the ibogaine series.
"Building Litigation-Ready Safety Narratives," ABA Health eSource (American Bar Association, Health Law Section) (2026). With Odette Hauke and Kimberly Chew. First in a four-part series on ibogaine.
"Beyond The IND Clock: What Operation TrialBlazer Gets Right - And Where It Stalls (Part 1)," Clinical Leader (July 10, 2026). With Kimberly Chew and Odette Hauke. Two-part series.
"Beyond The IND Clock: The Legal Architecture Of QRIs And What Industry Must Say Before July 22 (Part 2)," Clinical Leader (July 10, 2026). With Kimberly Chew and Odette Hauke. Two-part series.
"FDA's HALO Platform And Elsa 4.0: Five Critical Risks For Sponsors," Clinical Leader (May 26, 2026). With Kimberly Chew and Odette Hauke.
"Trump's Psychedelics EO Creates A Regulatory Collision," Law360 / Law360 Healthcare Authority (May 19, 2026). With Kimberly Chew and Odette Hauke.
https://www.law360.com/health/articles/2478897
"5 Critical Risks With The FDA's Real-Time Trial Monitoring," Clinical Leader (also syndicated on Life Science Leader) (May 8, 2026). With Kimberly Chew and Odette Hauke.
https://www.clinicalleader.com/doc/critical-risks-with-the-fda-s-real-time-trial-monitoring-0001
"Previewing FDA National Priority Vouchers In Psychedelics EO," Law360 / Law360 Healthcare Authority (April 30, 2026). With Kimberly Chew and Odette Hauke.
https://www.law360.com/cannabis/articles/2470425
"AI At The FDA: Legal Implications And Strategic Considerations For Drug Developers," Clinical Leader (January 19, 2026). With Kimberly Chew, Odette Hauke, and Kathleen Snyder. Part 1 of two.
"Navigating FDA's New AI Systems: Practical Tips For Regulatory Success," Clinical Leader (January 19, 2026). With Kimberly Chew, Odette Hauke, and Kathleen Snyder. Part 2 of two.
"2025 Legal Milestones That Will Shape Psychedelics Sector," Law360 / Law360 Healthcare Authority (December 18, 2025). With Odette Hauke and Kimberly Chew.
Selected speaking engagements
What Pharma Wants: Positioning Psychedelic Assets for Partnership & Acquisition — San Diego, CA, April 8, 2026.
The 6th Annual Psychedelic Therapeutics and Drug Development Conference — New Orleans, LA, February 26–27, 2026. "Psychedelics, Protocols, and Prompts: Navigating Regulatory Rigor and AI-Enabled Review in the Next Wave of Psychedelic Therapeutics."
International Society for Research on Psychedelics (ISRP) — New Orleans, LA, February 26–27, 2026. "Ibogaine as a Regulatory Stress Test: Translating EMA's Psychedelic Framework into US FDA Guidance for a High-Risk Molecule."
Global Innovation in Women's Health Pitch Showcase 2026 — San Francisco, CA, January 12, 2026. "Women's Mental Well-Being in 2026: Indications, Evidence, and a Clear Regulatory Path."
8th Neuropsychiatric Drug Development Summit — Boston, MA, 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."