Husch Blackwell is pleased to announce the launch of its Psychedelics and Emerging Therapies team, an interdisciplinary, cross-office group of lawyers capable of addressing the challenges faced by innovators that seek to research, develop and commercialize novel therapies based on psychedelic drugs. Many of these drugs are regulated by a patchwork of state and federal laws regulating Schedule I controlled substances.
The establishment of the firm’s Psychedelics and Emerging Therapies team makes Husch Blackwell the first Am Law 100 firm to create a practice devoted to serving the psychedelics industry.
Similar to the early days of the medical cannabis movement, psychedelic drugs such as MDMA, psilocybin, LSD, ketamine and DMT are being developed for therapeutic use in a complex and difficult legal and regulatory environment. Although the current legal and regulatory environment can frustrate efforts to research these drugs for use in new therapies, Husch Blackwell attorneys are guiding researchers, manufacturers, investors, clinicians, and other participants around and through these various state legal and regulatory regimes. The firm’s multidisciplinary team covers commercial, regulatory and legal requirements spanning U.S. Food and Drug Administration (FDA) guidance on clinical trials, Drug Enforcement Agency (DEA) licensing, material transfer agreements and cooperative research and development agreements (CRDA).
“Recently concluded and ongoing research demonstrates that certain Schedule I substances could be medically useful in treating various mental health disorders, including anxiety, depression and PTSD,” said Curt Chase, leader of Husch Blackwell’s Healthcare, Life Sciences and Education industry team. “We feel the time is right, particularly given the scale of emerging mental health challenges, to assist innovators who seek to bring new therapies to market in a safe and responsible manner.”
Led by Natasha Sumner, Kimberly Chew and Karen Luong, the Psychedelics and Emerging Therapies practice provides clients a full suite of legal services—including healthcare regulatory, corporate law, corporate governance, banking and finance, and intellectual property, among others—that bear upon the development of new products and therapies.
Sumner, Chew and Luong will be joined by Seth Mailhot, leader of Husch Blackwell’s FDA regulatory practice, to headline the 2022 Psychedelic Therapeutics & Drug Development Conference on May 23-24, 2022, in Washington, D.C. Their session will delve into the FDA and DEA considerations of psychedelics research.