2023 Pre-Conference Workshop II
Sunday, May 14, 2023
4:15 pm PDT
(tentative time)
(tentative time)
Psychedelics & Clinical Trials: Site Feasibility and Audit Preparedness
FDA-approved clinical trials are critically important for psychedelics to becoming accepted and recognized as substances with approved medical use. Psychedelics such as MDMA and psilocybin are approaching federal regulatory approval for use to treat depression, anxiety, and a variety of substance use disorders. Many innovators and scientists are interested in running clinical trials in order to prove safety and efficacy and as a necessary step to eventual commercialization. The speakers will provide an overview of current psychedelic clinical trials for certain mental health and behavioral health treatments, outline some of the requirements for clinical site feasibility, licensing requirements that sponsors will need to bear in mind when choosing a clinical trial site, the challenges of running and operating clinical trials for Schedule I drugs, and areas of concern in order to be prepared for a clinical site audit.
Learning Objectives:
⇒ Learn about licensing requirements for clinical sites.
⇒ Learn about agreements with Contract Research Organizations, who will be running your clinical trial.
⇒ Be introduced to an analysis framework to help trial sponsors consider various clinical trial sites and determine which sites are feasible.
⇒ Identify issues that may come up in an audit and could shut down your clinical trial.
⇒ Identify potential fraud and abuse risks around clinical trials reimbursement.
Learning Objectives:
⇒ Learn about licensing requirements for clinical sites.
⇒ Learn about agreements with Contract Research Organizations, who will be running your clinical trial.
⇒ Be introduced to an analysis framework to help trial sponsors consider various clinical trial sites and determine which sites are feasible.
⇒ Identify issues that may come up in an audit and could shut down your clinical trial.
⇒ Identify potential fraud and abuse risks around clinical trials reimbursement.
Workshop Leaders
Sabrina Ramkellawan, CCRP, CCRAChief Operatiing Officer & Co-Founder
Axial Bridge (formerly known as Knowde Group)
Karen Luong, JDSenior Counsel
Husch & Blackwell
Kimberly Chew, JDSenior Counsel
Husch & Blackwell
Natasha Sumner, JDSenior Counsel
Husch & Blackwell
Axial Bridge, Inc is a female-minority founded company providing phase I to III clinical trial management services globally with offices in Canada, the US and the United Kingdom. Our organization is dedicated to the advancement of emerging Biotech and Life Science companies by providing a more customised approach to consulting services including strategic support from preclinical advisory up to commercialization, including reimbursement strategies.
Axial Bridge understands the importance of funding to drive clinical trials and innovation; as such Knowde Group provides a unique offering of connecting investors to viable biotech and life science companies that have a strong and viable go-to-market strategy.
Our team has deep industry expertise in a broad range of therapeutic areas and indications including Mental Health, CNS/Neurology, Ophthalmology, Sleep Medicine, Gastroenterology, Dermatology, Oncology, Rare Diseases, and Chronic and Neuropathic Pain conditions and more. In addition, we can support decentralized trials, digital health products and advise on the use of AI in drug discovery.
At Axial Bridge we understand the business of research and combining innovation and extensive experience, we take a progressive approach to consulting services, clinical research, commercial outsourcing, and data intelligence. We help clients connect the dots between their needs and our offering that uses a strong collaborative approach and vast connected network of global expert advisors, preidentified research sites, vendors and partners.
Axial Bridge understands the importance of funding to drive clinical trials and innovation; as such Knowde Group provides a unique offering of connecting investors to viable biotech and life science companies that have a strong and viable go-to-market strategy.
Our team has deep industry expertise in a broad range of therapeutic areas and indications including Mental Health, CNS/Neurology, Ophthalmology, Sleep Medicine, Gastroenterology, Dermatology, Oncology, Rare Diseases, and Chronic and Neuropathic Pain conditions and more. In addition, we can support decentralized trials, digital health products and advise on the use of AI in drug discovery.
At Axial Bridge we understand the business of research and combining innovation and extensive experience, we take a progressive approach to consulting services, clinical research, commercial outsourcing, and data intelligence. We help clients connect the dots between their needs and our offering that uses a strong collaborative approach and vast connected network of global expert advisors, preidentified research sites, vendors and partners.
Husch Blackwell has a long track record in counseling those engaged in research and commercialization of novel—and controversial—therapies. We were one of the first large national law firms to establish a practice group devoted to cannabis, and as the utility and acceptance of psychedelic therapies have gained a foothold across the medical community, our firm is once again at the forefront in developing a multidisciplinary team to represent clients in this growing area of treatment.
Similar to the early days of the medical cannabis movement, psychedelic drugs such as MDMA, psilocybin, LSD, ketamine and DMT are emerging in a complex and difficult legal and regulatory environment that can frustrate efforts to develop new therapies. Our team 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, including the Controlled Substances Act (CSA), Money Laundering Control Act (MLCA), various criminal statutes that cover the sale and consumption of psychedelics, and various state legal and regulatory regimes.
Our team is multidisciplinary by nature and integrates subject-matter authorities who can drill down into relevant issues at every phase of research, development, commercialization and medical practice. We assist entrepreneurs and investors in forming ventures and developing governance structures best suited for operation in the psychedelic industry. Once established, clients turn to our regulatory and finance lawyers to assist with operationalizing and funding the enterprise.
Similar to the early days of the medical cannabis movement, psychedelic drugs such as MDMA, psilocybin, LSD, ketamine and DMT are emerging in a complex and difficult legal and regulatory environment that can frustrate efforts to develop new therapies. Our team 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, including the Controlled Substances Act (CSA), Money Laundering Control Act (MLCA), various criminal statutes that cover the sale and consumption of psychedelics, and various state legal and regulatory regimes.
Our team is multidisciplinary by nature and integrates subject-matter authorities who can drill down into relevant issues at every phase of research, development, commercialization and medical practice. We assist entrepreneurs and investors in forming ventures and developing governance structures best suited for operation in the psychedelic industry. Once established, clients turn to our regulatory and finance lawyers to assist with operationalizing and funding the enterprise.
