Scientific and Clinical Presentation on ...
Dr. Xiu-Min Li - Future of Health Technology Award Lecture at 20th FHTI produced by Renata Bushko
20th Anniversary Future of Health Technology Award Lecture: Can Chinese herb-based medicines heal the immune system and cure allergies? Xiu-Min Li M.D., M.S. , Honoree Future of Health Technology Award 2016 Professor of Pediatrics, Division of Allergy and Immunology Icahn School of Medicine at Mount Sinai Jaffe Food Allergy Institute Director, Center for Integrative Medicine for Allergies and Wellness Icahn School of Medicine at Mount Sinai Author of "Traditional Chinese Medicine, Western Science, and the Fight Against Allergic Disease" at Future of Health Technology Summit at MIT, Cambridge USA produced by Renata Bushko, Founder, Future of Health Technology Institute FHTI
001 Botanical Drug definition
FDA Botanical Drug Guidance for Industry training -01 1. definition of "botanicals" 2 botanical drug guidance waivers the requirement of describing mechanism of action, describing molecular structure, identification of active ingredients, and allow drug products to be plant mix 3. Challenges are: quality control & developing CMC contents
003 Botanical Drug Accelerated preclinical
Herbal medicines with prior human experience can shorten the preclinical development: 1) region of prior clinical studies 2) copies of study reports 3) review on prior data quality and relevance to the proposed use 4) botanical drug marketing history: annual sale, exposure population size, AE, compendia and publications 5) data only available in foreign countries: information reliability and relevance, English literature if any 6) bridge past experience with current proposed investigation: compare dosage, identity, and clinical settings
Drug Development and Approval in the U.S.
Presented At: Cannabis Sciences Virtual Event 2018 Presented By: Emily Leongini Attorney, Arent Fox LLP Speaker Biogrpahy: Emily is member of the FDA practice group in Arent Fox LLP's Washington D.C. office. Arent Fox is a D.C.-based internationally recognized law firm that provides strategic counsel to clients that range from Fortune 500 corporations and start-ups, to trade associations and foreign governments. Emily focuses her practice on a variety of highly-regulated products including prescription and over-the-counter drugs, dietary supplements, foods, and cannabis. She routinely counsels clients on issues that affect the cannabis industry, such as licensing and permitting requirements, labeling and promotional review, good manufacturing and distribution practices, and supply chain management. Before joining Arent Fox, Emily worked at the U.S. Food and Drug Administration for nearly six years. She has followed the legalized cannabis industry since 2004, while during graduate school, she worked with a major county health department to implement the requirements of California's Medical Marijuana Identification Card Program (SB 420). Emily also speaks and writes regularly on current regulatory issues facing the cannabis industry. She earned a JD from American University, Washington College of Law, a Master of Public Policy from the University of Southern California, and BA from the University of Texas at Austin. Webinar: Drug Development and Approval in the U.S. Webinar Abstract: Although more than half of U.S. states have legalized the use of medical marijuana, the U.S. Food and Drug Administration (FDA) has not yet recognized or approved the cannabis plant for therapeutic use. This presentation will provide an overview of FDA’s framework for regulating drugs and explain the process of FDA review and approval of new drugs. Special attention will be given to discussing the unique regulatory challenges and opportunities associated with developing cannabis therapies in the U.S., e.g., navigating the requirements of multiple federal regulatory agencies (FDA, NIDA, and DEA), developing botanical drug products, and FDA programs that grant expanded access to, and expedited review of, drugs intended to treat serious or rare diseases. Learning Objectives: Understand the requirements and process for obtaining FDA approval of new drugs, including phases of research and development, protocol development, approval of investigational new drug (IND) applications and new drug applications (NDAs) Understand unique regulatory challenges associated with developing cannabis therapeutics in the U.S. Earn PACE/CME Credits: 1. Make sure you’re a registered member of LabRoots (https://www.labroots.com/virtual-event/cannabis-sciences-2018) 2. Watch the webinar on YouTube above or on the LabRoots Website (https://www.labroots.com/virtual-event/cannabis-sciences-2018) 3. Click Here to get your PACE (Expiration date –March 14, 2020 06:00 AM)– http://www.labroots.com/credit/pace-credits/2769/third-party LabRoots on Social: Facebook: https://www.facebook.com/LabRootsInc Twitter: https://twitter.com/LabRoots LinkedIn: https://www.linkedin.com/company/labr... Instagram: https://www.instagram.com/labrootsinc Pinterest: https://www.pinterest.com/labroots/ SnapChat: labroots_inc
Developing Botanical New Drugs from Traditional Herbal Medicines Part 1 of 3
http://www.integrativeonc.org Dr. Jinhui Dou on Developing Botanical New Drugs from Traditional Herbal MedicinesâA Botanical Drug Reviewer's Perspective at Society of Integrative Oncology International conference in Shanghai in April of 2008