Overview
From allusions in Alice in Wonderland to subject matter in Ted Talks, psychedelics are moving from pop culture parody toward mainstream medicine. What challenges does this evolution pose for the pharmaceutical community? Panelists will explore regulatory uncertainty, including psychedelics as a Schedule I drug and efficacy; patient safety data gaps; potential benefits of use; and cultural significance of psychedelics to many Indigenous people and the importance of those roots as psychedelics are developed for pharmaceutical purposes.
Get Access
- +$100 for nonmembers
Speakers
Commander Gene Gunn, Bioresearch Monitoring Specialist, FDA and US Public Health Service
Robert Haferd, Restorative Justice Coordinator, Office of the Attorney General of the District of Columbia
Karen Luong, Litigation Attorney, Husch Blackwell LLP
Moderated by Deborah Miran, DMiran Consulting
INVESTIGATOR GENE GUNN is a FDA Specialist in the Bioresearch Monitoring program and a Commissioned Officer in the United States Public Health Service. He has been with the FDA and USPHS for over 13 years and currently serves as a member of the BIMO Foreign Cadre where he conducts inspections of drug, biologic, and device trials conducted at locations outside the US at the trial site and sponsor level.
ROMAN (ROBERT) HAFERD (he/him) has been working on the front lines of restorative justice and drug policy reform for nearly a decade. He serves as the first Restorative Justice Coordinator at the Attorney General’s Office for Washington DC, where he has helped build the nation’s largest restorative justice program inside the prosecutor’s office. Roman was a Steering Committee Member of the successful campaign to pass the Entheogenic Plant and Fungus Policy Act, which made certain medicines among the lowest law enforcement priorities in Washington DC. Roman is a founding board member of the Psychedelic Bar Association, serving as the board steward of its Ethics Committee. He also serves as board member and Director of Community Engagement for the Psychedelic Medicine Coalition, a non-profit hub and advocacy organization that promotes safe, equitable access to psychedelic and plant medicines. Roman is a founding partner of Roots to Sky Sanctuary, a BIPOC-owned community farm located at the headwaters of the Potomac River. Roman has also represented civil rights plaintiffs in cases around the country involving deprivations of Constitutional rights and law enforcement misconduct. Roman is Black American with mixed ancestry, African American and European American lineages. Roman holds a JD from Harvard Law School and a BA from Bucknell University.
KAREN LUONG guides clients through high-stakes litigation, focusing on product liability and mass tort matters. Manufacturers, construction companies, automotive manufacturers and retailers, insurers, contractors, suppliers and business owners are a few of the clients relying on Karen’s experience, counsel and defense. She is well versed in complex litigation involving toxic products, materials and chemicals. Karen regularly represents clients in state and federal court in matters of product liability, premises liability, personal injury and other complex allegations. She is known for her ability to defend client reputation along with the legal claims at hand. Karen is the co-founder and co-lead of the firm’s Psychedelic and Emerging Therapies practice group. This groundbreaking group guides researchers, manufacturers, investors, clinicians and other participants around and through the myriad obstacles that result from the patchwork of state and federal laws regulating Schedule I controlled substances. In addition to Karen’s focus on psychedelic law and complex products liability, she also has experience representing clients in general commercial litigation, business litigation and the cannabis industry.
DEBORAH MIRAN, former commissioner, was a member of the Natalie M. LaPrade Maryland Medical Cannabis Commission from 2013- 2016. While serving on the commission, she was also a member of the executive committee, policy, and research subcommittees, and was chair of the education subcommittee. She was responsible for developing education programs for doctors and patients, and was also an integral part of crafting the current regulations. Prior to the commission she was president and founder of Miran Consulting, Inc. There she advised both brand and generic drug makers on the FDA approval process. Ms. Miran was senior director of regulatory affairs for Alpharma, a generic drug manufacturer, where she directed the submission activities for new and abbreviated new drug applications to the FDA. She has spent over 30 years in the U.S. pharmaceutical industry. Ms. Miran received her bachelor of science in chemistry from Iowa State University.Virtual Learning FAQ
Related Content
