Odette Hauke

Author disclosure. Odette Alina Hauke, M.S., is an epidemiologist and regulatory scientist in independent practice, advising sponsors developing oncology, rare disease and psychedelic drugs, including LSD, MDMA, DMT and ibogaine. She was previously Associate Director of Regulatory Affairs at AtaiBeckley and has served as a regulatory consultant to its ibogaine, R-MDMA and DMT programs. She is the regulatory lead for a team preparing a Solution Summary under ARPA-H Special Notice ARPA-H-SN-26-158 (ASCENT-IBO), the solicitation discussed in this article, for the October 15 deadline. With more than thirteen years of experience before FDA, DEA, EMA, MHRA and Health Canada, she has authored hundreds of IND applications in oncology and rare disease. She has no financial interest in, and no advisory relationship with, UTHealth Houston, UTMB, the IMPACT consortium, Stanford, Ambio Life Sciences, or any Texas state agency. She presented at FDA's September 14, 2026, public hearing on the potential future therapeutic use of psychedelic drugs, filed a comment in the associated docket, FDA-2026-N-7542, and intends to file a comment in FDA-2026-N-10429, the docket this article urges readers to address.