Odette Hauke is a regulatory scientist and exhibiting artist who designs global development pathways for first-in-class therapies in rare disease, immunology, psychedelic medicine, neuroplastogens, and AI-enabled therapeutics. A first-generation Polish New Yorker now based in Los Angeles, she works at the thresholds of science and policy, where data are incomplete, guidance lags behind the mechanism, and decisions still have to be made, and turns those spaces into clear, defensible regulatory architectures.

With twelve years in biopharmaceutical development, Odette builds end-to-end regulatory and commercialization strategies that withstand scientific and statistical scrutiny, align with global health-authority expectations, and carry programs from first-in-human through approval, labeling, and inspection readiness. She has contributed to dozens of IND/CTA submissions and multiple late-stage and global filings across the US, UK, EU, APAC, and Latin America. Her work is anchored in three non-negotiables: ethical integrity, rigorous quality, and a clear, defensible line of beneficence to patients.

Odette’s regulatory philosophy is rooted in ground-level exposure to healthcare systems. She began in healthcare as a pharmacy technician in New York City, where she saw how pricing, access models, insurance, and socioeconomic status quietly determine what patients actually receive at the counter. Early experiences in both religious and clinical settings exposed her to the rituals, hierarchies, and infrastructures that govern access to care. That lens, where structure, ethics, quality, and patient welfare are inseparable, still guides how she designs frameworks for emerging therapies.

She began her scientific career at NYU Langone’s PTSD Research Program and then spent seven years at Memorial Sloan Kettering Cancer Center managing oncology clinical trials and IND submissions across pediatric, immunology, and early-phase translational programs. Working alongside investigators treating patients with life-threatening disease cemented the principle that anchors her work: regulation is a form of patient care, and every scientific decision must map to a concrete clinical consequence and a defensible benefit–risk balance.

Today, Odette serves as Director of Regulatory Affairs at Vera Therapeutics, where she leads global regulatory strategy and high-impact submissions for first-in-class rare-disease programs across the US, UK, EU, APAC, and Latin America. Previously, she oversaw global regulatory strategy and submissions for psychedelic modalities at AtaiBeckley, including DMT (VLS-01), ibogaine (IBX-210), and MDMA-derived neuroplastogens (EMP-01). She has also advised organizations such as Kyverna Therapeutics, Johnson & Johnson, Kenvue, Travere Therapeutics, and Regeneron on complex regulatory intelligence, integrated submissions, labeling, and launch preparedness.

Parallel to her regulatory work, Odette maintains an active visual art practice. Her drawings and photography have been featured in galleries and philanthropic auctions, and she treats form, detail, and composition as instruments of precision and care, whether she is arranging evidence in a briefing book or framing a subject on film. A lifelong student of nature, symbolism, and uncertainty at the limits of current evidence, she is drawn to “threshold spaces” where structure meets the unknown, and her task is to turn those moments into something traceable, auditable, and justifiable.

Sponsors engage Odette when they need more than a compliant filing: they need a regulatory architecture that can withstand scientific challenge, anticipate agency risk, and carry a first-in-class therapy from first-in-human through launch, and a guide who can reconcile quantitative evidence with irreducible uncertainty, then still point to a path that feels ethically, scientifically, and humanly sound.