Knowde is excited to announce its partnership with Husch Blackwell to assist companies with psychedelic clinical trials & DEA licensing support in the United States.
Calgary, ALB, January 23, 2023. Today, psychedelic research is a rapidly growing area of innovation all over the world. Psychedelic R&D is a fast-paced and forward-thinking environment, and our team works with our clients to match this dynamic. We are working with companies focused on fast-tracking clinical trials through pathways such as the FDA's Breakthrough Therapy designation. In addition, funds allotted to these trials are critical to be used effectively. Mistakes can be costly to psychedelic companies, including the additional requirement to appease investors with clinical trial progress and viable go-to-market strategies.
We are excited to announce that we have partnered with Husch Blackwell to assist companies with site selection and DEA licensing support in the United States.
Husch Blackwell has a long track record in counselling those engaged in research and commercialization of novel—and controversial—therapies. As such, Husch Blackwell has established a multidisciplinary team to counsel 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, including the Controlled Substances Act (CSA), Money Laundering Control Act (MLCA), various criminal statutes covering the sale and consumption of psychedelics, and various state legal and regulatory regimes.
"The Psychedelics & Emerging Therapies team of Husch Blackwell is delighted to announce a collaboration with Knowde Group to counsel and assist clinicians and innovators seeking to enter clinical trials in the United States. Knowde Group offers crucial scientific expertise in psychedelic studies supporting study sponsors' goals of seeing these promising substances help patients. We are honoured to be working alongside such an experienced team of clinical trial professionals, led by Jaspreet Grewal and Sabrina Ramkellawan," said Kimberly Chew, Senior Counsel at Husch Blackwell.
Husch Blackwell's team comprises lawyers from its nationally recognized healthcare industry group who have deep experience with clinical trial frameworks, including third-party contracts with contract research organizations (CROs), principal investigators (PIs) and contract manufacturers of investigational drug substances and products, informed consent; and interactions with institutional review boards (IRBs) concerning protocols and study monitoring. This partnership will better enable us to get ahead and be ready to meet client needs and have sites that are preidentified and qualified to support psychedelic clinical trials.
"We are thrilled to be working alongside the incredibly accomplished and skilled team at Husch Blackwell. The Psychedelics & Emerging Therapies practice, led by Kimberly Chew, Natasha Sumner, and Karen Luong, is a perfect match for us at Knowde Group. Our mutual dedication to compliance, good clinical practices and deep understanding of this emerging sector will help us drive excellence for our clientele and inform best practices as clinical trials in this space continue to grow," adds Jaspreet Grewal, CEO of Knowde Group.
For additional information regarding this service, please contact Sabrina Ramkellawan, COO of Knowde Group at sabrina@knowdegroup.com.