Highlights from ASTM International & USP Global Workshop on Cannabis Quality, Part 1
December 7 - 8, 2022
Day 1: Regulators Panel
Session 1: An overview of quality requirements for cannabis products in Canada
Speaker: Andrew Waye, Ph.D., Health Canada
Andrew has been a cannabis scientist since 2014, after completing his doctorate studying the effects of phytochemicals on neuroendocrine function. He joined Health Canada's Office of Cannabis Science and Surveillance in early 2018 and provides key scientific support to Health Canada's cannabis program. He is also an important contributor to both the USP and European Pharmacopoeia's cannabis efforts. Prior to joining Health Canada, Andrew helped set up and lead one of Canada's top cannabis quality control testing labs.
Session 2: Overview of CANNRA and Regulatory Work Related to Product Safety
Speaker: Gillian Schauer, Ph.D., MPH, Cannabis Regulators Association
Dr. Schauer is the Executive Director of the Cannabis Regulators Association (CANNRA), a nonpartisan, nonprofit organization that convenes, educates, and supports government agencies involved in cannabis regulation and policy implementation across more than 40 states and U.S. territories. Dr. Schauer has more than two decades of experience working on drug policy, including work with U.S. federal agencies and states on both cannabis policy and tobacco control policy. She has a PhD in public health and behavioral science from Emory University, and a Master in Public Health from the University of Washington, and has more than 70 peer-reviewed publications.
Session 3: ANVISA - Legislation related to controled substances
Speaker: Joao Perfeito, MSc, ANVISA Clinical and Industrial Pharmacist; Master’s degree in Health Sciences.
Expert in Health Regulation of General Office of Drugs at the Brazilian Health Regulatory Agency (Anvisa) for 15 years, where currently works as Manager of Herbal and Complementary Medicines.
Day 1: Standards Panel
Session 4: ASTM–USP Global Workshop on Cannabis Quality
Speaker: Robin J. Marles, Ph.D., Health Canada
Robin is a volunteer with the United States Pharmacopeia, chairing the Botanical Dietary Supplements and Herbal Medicines Expert Committee, and is a member of the USP Cannabis Expert Panel. He is employed as the Senior Scientific Advisor, Bureau of Nutritional Sciences, Food Directorate, Health Canada, where he advises on safety, quality and health claims for botanical, nutrient, and novel food ingredients, and clinical trials on foods for a special dietary purpose.
Session 5: USP Perspectives on Cannabis Quality
Speaker: Nandu Sarma, Pharm.D., US Pharmacopeia
Dr. Nandakumara (Nandu) Sarma is Director, Dietary Supplements and Herbal Medicines at US Pharmacopeia (USP) responsible for strategy and external stakeholder engagement for new and innovative projects, working with global stakeholders and expert volunteers in the development of quality standards (monographs and general chapters) for dietary supplements and herbal medicines that are published in the USP Dietary Supplements Compendium and the Herbal Medicine Compendium. Before joining USP 2006, he was a post-doctoral fellow at National Cancer Institute, Bethesda, and Thomas Jefferson University, Philadelphia and was a Senior Scientific Officer at The Himalaya Drug Company, India. His research experience includes isolation and analysis of active components of botanicals and their biologic activity. He published more than 25 scientific articles in peer-reviewed journals. Dr. Sarma holds a Pharmacist degree and a Ph.D. in pharmaceutical sciences (pharmacognosy) from Banaras Hindu University, India.
Session 6: ASTM International and Cannabis Industry Standards Development through Committee D37
Speaker: David Vaillencourt, MSc, Vice Chair, ASTM Committee D37 on Cannabis
David Vaillencourt is the Founder and President of The GMP Collective assisting clients globally to implement best practices that ensure the quality, safety, and compliance of cannabis and cannabinoid products. He is a respected speaker on cannabis business strategy and compliance having spoken at dozens of events nationally and internationally. David serves as the Vice Chair of ASTM International’s Committee D37 on Cannabis standards supporting over 1,2000 volunteer members, is the current Chair of NCIA’s Facility Design Committee, in addition to serving on several non-profit boards. Prior to founding the Collective, David’s experience included the Director of Quality for a large multi-state cannabis operator and supervisory roles in Quality Control and project management for multi-million-dollar life-science projects for the federal government. He holds a Master of Science and has also developed curriculum and taught courses at the college and secondary levels.
Session 7: Quality issues and Medicinal Cannabis in The Netherlands
Speaker: M.J. van de (Marco) Velde, Ph.D., Dutch OMC
In 1995 Marco van de Velde graduated for his PhD about the modulatory role of fatty-acid metabolites in the signal transduction cascade in inflammatory processes. Thereafter he continued his career as senior policy advisor at the Ministry of Health in the Netherlands. In 2003-2005 he did his Master of Modern Business Administration (MBA). As manager he is in charge of a business unit executing different kind of legislation on pharmaceutical products and medical devices as well as the Office of Medicinal Cannabis (OMC). His knowledge and experience cover price regulation and reimbursement of pharmaceutical products, registration as well as licensing of pharmaceutical companies and issuing of (export)certificates. As head of the OMC he and his co-workers are responsible for the availability of standardized medicinal cannabis in the pharmacy, for scientific research and product development. With that the OMC looks over the export (and import) of medicinal-- cannabis as raw material to other European countries as well as Canada, Israel and Australia.
Session 8: The European Directorate for the Quality of Medicines & Healthcare (Edqm)
Speaker: Jaume Sanz-Biset, Ph.D., Ph. Eur., EDQM Pharm.D., Ph.D. in Pharmacognosy.
Scientific administrator of Ph. Eur. Expert Groups 13B (herbal drugs and herbal drug preparations), 10A (synthetic APIs and excipients), and the PA (Pyrrolizidine alkaloids) Working Party.
Day 2: Industry Panel
Session 9: Control and Characterisation of Botanically Derived Cannabis Drugs
Speaker: Alan Sutton, Jazz Pharma
Alan joined GW Pharmaceuticals in 2001, initially leading analytical chemistry developing methodologies for characterization of complex botanical materials, which included identifying novel cannabinoid degradation pathways. Out of the characterization work, Alan also initiated the crystallization of CBD in the laboratory, which was subsequently refined and scaled up for Epidiolex manufacture. As well as writing CMC regulatory documentation for product submissions and developing the majority of GW’s original product and material specifications, he has engaged with a variety of regulators in Europe and the US. Subsequently in 2019, he joined the Growing Ops team and lead a group specializing in understanding of the effects of environment and growing changes on plant profiles, as well as supporting molecular plant breeding and speeding up the characterization of new genotypes for inclusion into the company project pipeline.
Session 10: Good Medicinal Cannabis Cultivation Practice
Speaker: Tjalling Erkelens, Bedrocan
Tjalling Erkelens (1956) is the founder of Bedrocan and currently holds the position of Chairman of the Board. He has developed and standardised unique methods of producing cannabis to pharmaceutical standards achieved by no other company until today. His strong commitment to product quality resulted in the Dutch Bedrocan production facilities being approved for GMP/API (Good Manufacturing Practice/Active Pharmaceutical Ingredients) by the Dutch Health Authorities in 2017.
Session 11: Quality Control of Cannabis-Derived Prescription Drugs
Speaker: Prof. Giovanni Appendino, Indena
Giovanni Appendino retired the past February after being for over two decades Full Professor of Organic Chemistry at the University of Eastern Piedmont in Novara, Italy. His research activity has taken inspiration from natural products to address problems in various realms of organic chemistry (phytochemistry, reaction mechanisms, new synthetic methods), interfacing them with biomedical research.
Day 2: Laboratory Panel & Discussion on Key Issues
Session 12: Harmonisation of cannabis quality standards for medical and scientific use
Speaker: Martin Woodbridge, PGC.PHC, DPH, MPHC, Woodbridge Research
Martin Woodbridge's consultancy services chiefly comprise regulatory policy and clinical services development. He has advised the United Nations INCB and several Governments on good regulatory practice for the medical and scientific use of cannabis. He is the author of 'A primer to medicinal cannabis' and co-author of 'The clinical use of cannabis-based medicines'. For the past 8 years has provided general advisory services in the Asia-Pacific for Bedrocan Int. And, as a member of ASTM D37, he is currently the technical lead for a novel indoor cultivation practice, GMCCP.
Session 13: Analytical Testing for the Cannabis Industry: Consumer Safety vs Regulatory Requirements
Speaker: Chris Hudalla, Ph.D., ProVerde Labs
Dr. Hudalla is a Ph.D. analytical chemist with more than 35 years of research experience in analytical chemistry. He is the Founder and Chief Scientific Officer of ProVerde Laboratories, Inc., a premier analytical research and testing facility for the regulated cannabis and hemp industries. He is active in numerous scientific organizations, contributing to efforts for the development and standardization of cannabis testing methodologies aimed at ensuring consumer safety.
Session 14: Development, Analyses & Production of APIs
Speaker: Remco Vree Egberts, Ph.D., Ofichem
Remco Vree Egberts BASC is working for 10+ years at Laboratorium Ofichem B.V., GMP API manufacturer located in the Netherlands. During his first 7 years at the company, he was as R&D project manager responsible for process and analytical development of APIs, a.o. pharmaceutical products containing cannabis as active ingredient. In his current position as QC Manager responsible for two QC laboratories where analytical tests, according GMP, are performed by a professional team. From his broad experience in the cannabis field, Remco was involved in the implementation and verification of the OMC monograph at Laboratorium Ofichem B.V.
Session 15: Insights Into Cannabis Products Quality
Speaker: Mahmoud ElSohly, Ph.D., University of Mississippi
Mahmoud A. ElSohly is a Research Professor at The National Center for Natural Products Research, and Professor of Pharmaceutics and Drug Delivery, School of Pharmacy, University of Mississippi (UM) and is the Director of the National Institute on Drug Abuse (NIDA) Marijuana Project at UM. He is also the President and Laboratory Director of ElSohly Laboratories Incorporated, an analytical forensic drug testing and product development laboratory. He received his undergraduate and Masters from Cairo University, Cairo, Egypt and his Ph.D. in 1975 from the University of Pittsburgh, School of Pharmacy, Pittsburgh, PA. He has been with the University of Mississippi since 1975 and has been Director of the NIDA Marijuana Project since 1981. He has over 40 years’ experience working with the isolation of natural products (notably cannabis secondary metabolites), synthetic, analytical and forensic chemistry. He has more than 40 patents and over 400 publications in these areas of science. Dr. ElSohly is also a member of many professional organizations such as American Society of Pharmacognosy, American Chemical Society, American Academy of Forensic Sciences, Society of Forensic Toxicologist, International Cannabinoids Research Society, International Association of Cannabinoid Medicines to name a few and received numerous awards.