Sabune Joane Winkler
J.D.
Sabune Winkler is a U.S.-trained life sciences attorney, entrepreneur, global clinical operations strategist, and trial-negotiation expert with three decades of experience navigating the complex legal and regulatory landscape of research, therapeutic development, and emerging psychedelic medicine. A Harvard Medical School Bioethics Fellow and former Harvard Medical School attorney, she also served as counsel, advisor, and negotiator for leading Harvard-affiliated institutions including Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Brigham and Women's Hospital, and Dana-Farber Cancer Institute.
As Senior Counsel with Outside GC and through a strategic alliance with Liance Legal (Netherlands), Sabune offers clients seamless, world-class legal support across the U.S. and EU. This partnership provides continuous "follow-the-sun" coverage with attorneys spanning both continents, enabling accelerated global study start-up, EU Clinical Trials Regulation implementation, GDPR/HIPAA harmonization, and multilingual contract negotiation. She was also a participant in the competitive, invitation-only Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics Psychedelics Bootcamp at Harvard Law School, furthering her commitment to shaping the novel legal and policy issues in the emerging psychedelics sector. Clients seeking comprehensive support for clinical trial budgeting can access Saphan Pont's affiliated clinical trial billing services.
Sabune has negotiated thousands of agreements across more than 40 countries, structuring and negotiating the full spectrum of Phase I–IV site-specific and global clinical trial agreements, CRO master service agreements, lab agreements, vendor and consulting agreements, investigator grants, data-sharing arrangements, informed consent forms, and international research collaborations. With the U.S. National Institutes of Health, Sabune architected and co-led the national SMART IRB initiative—now adopted by more than 1,400 institutions and the backbone of compliance with the NIH's 2020 single IRB mandate. Her work established the infrastructure that will enable sponsors to meet the FDA's proposed single IRB requirement for industry-sponsored research. She has also been a principal investigator, and her scholarship has appeared in several journals including the American Journal of Bioethics, Clinical & Translational Science, IRB: Ethics & Human Research, and Nursing Ethics. She is the senior author of two widely used learning modules for the CITI Program on community-engaged and social behavioral research, and she co-developed a library of research participant resources, including a suite of informational brochures, available in 16 languages, downloaded more than 100,000 times, which continue to be used and adapted regionally and nationally.
Committed to expanding access to ethical innovation globally, Sabune extends her expertise beyond U.S. borders through her leadership in the Democratic Republic of the Congo. As Chief Legal Operations Officer and Co-Founder of Musau Enterprises, SARL, based in Kinshasa, she oversees a diversified Congolese conglomerate active in IT, infrastructure, agriculture, health, and finance—aligning local opportunities with international capital, technology, and compliance standards. She also advises the DRC government on health initiatives. Her cross-border experience reflects a rare ability to translate complex legal and regulatory frameworks into executable legal strategies across global markets.
A sought-after thought leader and keynote speaker, Sabune has delivered hundreds of presentations at national and international conferences, webinars, and symposia. Her keynote addresses include appearances before the National Institutes of Health, the Secretary's Advisory Committee on Human Research Protections (SACHRP), the OHRP National Research Community Forum, PRIM&R Advancing Ethical Research, the American Biological Safety Association, and the Massachusetts Society for Medical Research. She has also served as faculty for clinical research training programs at Harvard Catalyst, Massachusetts General Hospital, and Emmanuel College.
Sabune is deeply committed to service beyond her client practice. She serves on a pro bono basis as an Advisor to Liberia's National Research Ethics Board, promoting the highest ethical standards in research throughout Africa. She also provides pro bono legal support in complex asylum and immigration matters, including legal research on country conditions and human rights issues, preparation of briefs and declarations, and case file management. A founding member of the Psychedelic Bar Association, Sabune is an active participant in its Psilocybin Education Initiative Subcommittee.
Sabune's practice spans the full therapeutic development lifecycle—from drug discovery and pre-clinical research through Phase I–IV clinical trials and commercialization. She partners with emerging biotechs, global pharmaceutical companies, contract research organizations, psychedelic medicine companies, medical device manufacturers, and leading academic medical centers and research hospitals, delivering the seasoned perspective of in-house counsel without big-firm overhead. Her practical, business-oriented advice compresses timelines, controls costs, and mitigates regulatory risk.
Contact Sabune at sabune@saphanpont.com.