Overview
Almost daily, we hear about the purported benefits, as well as risks, associated with the use of cannabis and cannabis-derived compounds such as CBD. What does the research actually show? This webinar will provide an overview of research outcomes regarding both therapeutic and other benefits of cannabis/CBD, including toxicity concerns, in both healthy and patient populations. The panel will also discuss CBD safety questions FDA is currently considering, new technologies to deliver cannabis to the body more efficiently for therapeutic and adult-use purposes, and an update on federal efforts to expand cannabis research.
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Speakers
Claire Beggs, Senior Director, Regulatory Affairs, GW Pharmaceuticals
Ziva Cooper, Research Director, UCLA Cannabis Research Initiative
Aidan Hampson, Special Content Expert-Cannabis, National Institute on Drug Abuse
Moderated by Christina Markus, Partner, King & Spalding LLP
CLAIRE BEGGS is Senior Director Regulatory Policy & Compliance at GW Pharmaceuticals. After studying Biology in Oxford she worked initially for Oxford University, then an Oxford academic led consultancy before working at Pfizer Pharmaceuticals for 16+ years in several roles across Europe and International regulatory affairs over numerous therapy areas. This was followed by 8 years at AbbVie Pharmaceuticals as Immunology Therapy Area Head and Head of Eastern Europe, Middle East and Africa.
ZIVA COOPER is the Research Director of the UCLA Cannabis Research Initiative in the Jane and Terry Semel Institute for Neuroscience and Human Behavior and Associate Professor-in-Residence in the Department of Psychiatry and Biobehavioral Sciences at David Geffen School of Medicine. Her current research involves understanding variables that influence both the therapeutic potential and adverse effects of cannabis and cannabinoids through double-blind, placebo-controlled studies. Current funded projects include 1) understanding differences between men and women in their response to the abuse-related and pain-relieving effects, and the role that circulating hormones and endocannabinoids contribute to these differences, 2) the potential for THC and CBD to reduce reliance on opioids, 3) impact of cannabis use on HIV-associated inflammation, and 4) the effectiveness of cannabidiol to address symptoms associated with rheumatoid arthritis. Dr. Cooper strives to incorporate a translational approach to understating both the potential therapeutic and adverse effects associated with cannabis and cannabinoids.
AIDAN HAMPSON is an internationally recognized Cannabis Pharmacologist, who has studied cannabinoids and cannabinoid drug development since 1994. Under the tutelage of Nobel Laureate, Dr Julius Axelrod at the National Institute of Mental Health he discovered the neuroprotective and anti-inflammatory antioxidant potential of cannabidiol (US Patent: #6630507). He also demonstrated that CBD can prevent alcohol-induced brain damage in rodent models. Other researchers have since taken these findings in multiple directions and demonstrated antioxidant benefits of CBD in multiple disease state models. Other areas of his expertise include pharmacokinetics (PK) and formulations. Dr Hampson conducted two Postdoctoral fellowships in PK at UCSF and SUNY and oversaw PK studies of new drugs at Cortex Pharmaceuticals. He has recently published three clinical PK papers examining novel markers that confirm clinical trial participants are taking their medications. Dr. Hampson is a Special Expert on Cannabis at the National Institute on Drug Abuse (NIDA). In 2018, he wrote about how drugs progress from lab findings to clinical trials in a book on entitled “Cannabis Use Disorder”. In 2017, he co-wrote a review with the NIDA Director, Nora Volkow, on “Endocannabinoids and Cannabis at the Intersection of Stress and Reward.” Aidan regularly advises and present at Not For Profit and Regulatory Cannabis related organizations, such as the US State Hemp Regulators organization, US State Cannabis Commissioners Conference, the American Lung Association and the Institute on Food Policy.
CHRISTINA M. MARKUS is a partner and Deputy Team Leader in the Washington, DC office of King & Spalding for the FDA & Life Sciences Group. Her practice focuses on the regulation of drugs, biologics, and other products by FDA, DEA, and related state agencies (e.g., boards of pharmacy). Ms. Markus represents companies in a range of regulatory compliance, enforcement, and business transactions (e.g., due diligence assessments) involving product development and approval, safety, labeling, marketing and advertising, and supply chain. Ms. Markus was selected as a “Life Sciences Star” in the 2012, 2013, and 2014 LMG Life Sciences publications, and as one of the Best Lawyers in America (2015 edition) for FDA Law. She recently completed an appointment by the Institute of Medicine (IOM)/National Academy of Sciences as the legal member of the IOM Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). In response to a Congressional request, and with funding from FDA, IOM evaluated studies of drugs and biologics that have been performed under two statutory regimes that incentivize and, in some instances, mandate pediatric research through the drug approval process. The Committee assessed historical execution under these laws and offered recommendations and briefings to FDA and the US Congress, which were considered during the reauthorization of BPCA and PREA (signed into law in July 2012).Virtual Learning FAQ
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