Cannabis and cannabis-derived substances have been used to treat a wide range of ailments throughout human history. Medical texts from Ancient China to the Roman Empire show that cannabis was relied upon throughout the ancient world. Cannabis-derived products were marketed as medicine in the US as recently as the 1930s. However, since its inclusion in Schedule I of the 1970 Controlled Substances Act, research into cannabis’ therapeutic potential has been greatly restricted in the US.
Recent changes in federal and state regulation of cannabis and cannabis-derived substances have renewed interest and scrutiny into its potential as a medicine. As states continue to allow for use of cannabis and cannabis products, preliminary studies and anecdotal evidence suggest that patients are turning to these products to treat a variety of disorders, including pain, post-traumatic stress disorder (PTSD), epilepsy and depression. Despite this growing adoption, the vast majority of these products have not been thoroughly evaluated. There is still much that is unknown about the safety and efficacy of these products, including effects of long-term use, potential drug-drug interactions, effects on fetal development and more.
US Food and Drug Administration (FDA) approval for these products will require that these questions be answered, though conducting this research can appear to be an overwhelming barrier for sponsors, particularly as cannabis remains a Schedule I substance on the federal level. This webinar will outline a path for the development of cannabis-based medicine, including barriers to research and how to navigate them, necessary studies required for FDA approval and how results from these studies can impact drug scheduling and risk management and surveillance requirements post-approval.
Sidney Schnoll, MD, PhD, Vice President, Pharmaceutical Risk Management Services, PinneyAssociates
Dr. Sidney (Sid) Schnoll is an internationally recognized expert in addiction and pain management who applies his experience of over 30 years in academic medicine to the issues of risk management. Dr. Schnoll counsels pharmaceutical clients on regulatory/scientific strategy and development as well as implementation and assessment of risk management activities, including engagement with the FDA. He has served on the FDA’s Drug Abuse Advisory Committee (DAAC), NIH study sections, National Board of Medical Examiners test development committees and the board of the College on Problems of Drug Dependence (CPDD). Dr. Schnoll has been listed in The Best Doctors in America and is a Fellow of CPDD and the American Society of Addiction Medicine. His areas of research include both addiction and pain management with special emphasis on prescription drug abuse and perinatal addiction.
Jack Henningfield, PhD, Vice President, Research, Health Policy, and Abuse Liability, PinneyAssociates
Dr. Jack E. Henningfield is one of the world’s leading experts on addiction and the behavioral, cognitive and central nervous system (CNS) effects of drugs. He headed clinical pharmacology and abuse potential assessment at the National Institute on Drug Abuse (NIDA) where his responsibilities included Controlled Substances Act (CSA) abuse potential and drug scheduling recommendations.
Dr. Henningfield counsels pharmaceutical clients on the assessment of the abuse liability of new CNS-acting drugs and formulations, evaluation of the potential application of the CSA to new products, assessment of the tamper resistance of novel formulations and development of risk management approaches. He frequently liaises with the FDA on issues concerning drug scheduling and addiction and has presented frequently to FDA Advisory Committees. He has contributed to numerous comments to FDA on topics including prescribing of opioids for chronic pain, development and regulation of abuse-deterrent opioid formulations and abuse potential assessment.
Dr. Henningfield is also an Adjunct Professor of Behavioral Biology at The Johns Hopkins University School of Medicine. His NIDA Clinical Pharmacology laboratories conducted pioneering assessments of cannabis abuse potential and effects.
Marilyn A. Huestis, PhD, President, Huestis & Smith Toxicology, LLC
Professor Dr. Dr. (h.c.) Marilyn A. Huestis brings an extraordinary breadth and depth in clinical and forensic toxicology, anti-doping, diagnostic screening and confirmation drug testing, and cannabinoid agonists and antagonists. Through her research, she focused on improving people’s lives by reducing deaths from drugged driving, finding novel medications to treat drug dependence and using drug testing as a tool for drug dependence treatment. Her research encompassed the mechanisms of action of cannabinoid agonists and antagonists, effects of in utero drug exposure, and the neurobiology and pharmacokinetics of novel psychoactive substances.
Currently, Dr. Huestis is a Senior Fellow at the Institute on Emerging Health Professions, Thomas Jefferson University on the Steering Committee of The Lambert Center for the Study of Medicinal Cannabis and Hemp, Thomas Jefferson Medical School, both in Philadelphia, on the Smart Approaches to Marijuana (SAM) Science Advisory Board, a Senior Scientific Advisor of NMS Labs, Consultant to the US Department of Transportation, Science and Policy Advisor of PinneyAssociates, and President of Huestis & Smith Toxicology, LLC.
In 2016, Dr. Huestis retired as a tenured senior investigator and Chief, Chemistry and Drug Metabolism Section, Intramural Research Program, National Institute on Drug Abuse, National Institutes of Health, after 23 years of conducting controlled drug administration studies. Her research program focused on discovering mechanisms of action of cannabinoid agonists and antagonists, effects of in utero drug exposure, alternative matrices drug testing, driving under the influence of drugs, and the neurobiology and pharmacokinetics of novel psychoactive substances. She also was an Adjunct Professor at the University of Maryland School of Medicine until 2017.
Who Should Attend?
Mid and senior-level professionals responsible for clinical and regulatory affairs and the clinical development of cannabinoid drug products.
Relevant areas of expertise include:
- Regulatory affairs
- Drug safety/pharmacovigilance
- Risk management
- Project management
- Clinical research
What You Will Learn
The focus of this webinar is to provide a roadmap for developing cannabinoids into medicines, including:
- Historical overview of role of cannabis and cannabinoids in medicine
- The most promising indications for cannabinoid medicines
- Recent advances in medicinal cannabis science
- Most pressing research priorities in cannabis medicine development
- The barriers to conducting cannabinoid research and how to navigate the regulatory and legal requirements
- Interpreting study results and how they influence development strategy and potential postmarketing requirements
PinneyAssociates helps our pharmaceutical and consumer healthcare clients to reduce their regulatory risk and enhance the commercial and public health value of their life sciences products. During the past 40 years, PinneyAssociates experts have advised and served with pharmaceutical companies, the National Institute on Drug Abuse, College on Problems of Drug Dependence, the FDA, and others in the development of comprehensive abuse potential assessment, tamper testing of abuse-deterrent formulations, and risk management for CNS drugs.