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September 29, 2017

Title: Natural Product-Drug Interactions: Case Studies from the NaPDI Center

Speaker: Mary F. Paine, RPh, PhD, Associate Professor, Department of Pharmaceutical Sciences, College of Pharmacy, Washington State University, Spokane, WA

Date: 25 October, Wednesday

  7:00 AM (PDT)
  4:00 PM (CET)
  3:00 PM (GMT)
  11:00 PM (Tokyo,Seoul)
  10:00 PM (Beijing)
   5:00 PM (IST, Israel)


Summary of the presentation:

Many patient groups, including those afflicted with cancer, cardiovascular disease, hepatitis C, and HIV/AIDS, often supplement their prescribed pharmacotherapeutic regimens with herbal and other natural products (NPs), raising concern for adverse interactions. As with drug-drug interactions, the most common pharmacokinetic mechanisms underlying NP-drug interactions include induction and inhibition of drug metabolizing enzymes and transporters. However, unlike for drug-drug interactions, harmonized guidelines for assessing the risk of NP-drug interactions do not exist. Because NPs are inherently complex mixtures that vary substantively in bioactive constituent composition, both between brands and between batches of the same brand, a multidisciplinary effort involving clinical pharmacologists, natural products chemists, and health informaticists is needed for rigorous assessment of the drug interaction liability of NPs. The NIH-funded Center of Excellence for Natural Product-Drug Interaction (NaPDI) Research was created in September, 2015. The mission of the NaPDI Center is to provide leadership in the identification, evaluation, and dissemination of potential clinically significant pharmacokinetic NP-drug interactions. One over-arching goal of the Center is to develop a set of Recommended Approaches to guide researchers in the proper conduct of NP-drug interaction studies; they are anticipated to evolve over time as new technologies and research data emerge. These Recommended Approaches will be based on results generated from a series of Interaction Projects that will examine four carefully selected NPs as precipitants of metabolism- and/or transporter-mediated interactions with clinically relevant object drugs. Three of these NPs – green tea, goldenseal, and cannabinoids – have been advanced to Interaction Projects that include human mechanistic in vitro studies, physiologically-based pharmacokinetic modeling and simulation, and clinical studies. The green tea project is near completion, and the goldenseal and cannabinoids projects are in progress. Key data generated from the Interaction Projects will continue to be entered into a data repository, which will be disseminated to researchers via a public access portal. Collectively, the efforts of the NaPDI Center are expected to lead to improved design of future NP-drug interaction research and ultimately, improved decisions regarding the optimal management of clinically relevant interactions.

Speaker's biogpraphy:

Mary F. Paine, RPh, PhD is an Associate Professor in the Department of Pharmaceutical Sciences in the College of Pharmacy at Washington State University (WSU) and an Affiliate Associate Professor in the Department of Pharmaceutics at the University of Washington (UW). Prior to joining WSU in 2013, she was an Assistant Professor in the Eshelman School of Pharmacy at the University of North Carolina at Chapel Hill. She received her BS in pharmacy at Oregon State University, her PhD in pharmaceutics at the UW, and completed an NIH-funded post-doctoral fellowship in clinical pharmacology at the University of Michigan. She has extensive experience in the use of human-derived in vitro systems, pharmacokinetic modeling and simulation, and the conduct of clinical studies to address xenobiotic-drug interactions, particularly those involving inhibition of drug metabolizing enzymes and transporters in the intestine. Her longstanding NIH-funded research program focuses on the elucidation of causative ingredients and mechanisms underlying interactions between prescription and non-prescription medications and natural products, which include botanical dietary supplements and fruit juices. She has coauthored more than 80 publications as original research articles, invited reviews, and book chapters. She is an Associate Editor for Clinical Pharmacology and Therapeutics and Drug Metabolism and Disposition. She served on the Executive Committee of the Research Triangle Park Drug Metabolism Discussion Group and the Drug Metabolism Division of the American Society for Pharmacology and Experimental Therapeutics (ASPET). She is currently a delegate of the US Pharmacopeial Convention, representing ASPET, and is a member the Expert Panel on green tea hepatotoxicity for the US Pharmacopeia.