October 26-28, 2020
Bethesda, Maryland
Extractables & Leachables USA offers a unique opportunity for leading E&L experts and decision makers to discuss the latest updates on regulations, best practices, compliance, case studies, biocompatibility, BPOG, USP, advances in the sector, working group updates, and much more. Attendees network, build beneficial relationships, and hear panels featuring diverse industry perspectives on issues facing the E&L industry in both the US and globally.
The 2020 agenda is here!
Speakers include representatives from expert companies such as The FDA, Baxter International Inc., PPD, West Pharmaceutical Sciences, AstraZeneca, Becton Dickinson, Thermo Fisher Scientific, and many more.
Session topics include:
The pre-conference Masterclass, guided by industry experts Dr. Daniel L. Norwood and Mr. Paul Cummings, will explore E&L concepts and outline best practices.
The Poster Session provides the opportunity for industry and academic experts to share their technical research, testing results, and latest case studies with an audience of E&L professionals from across the supply chain.
Dr. Dennis Jenke is a Baxter Distinguished Scientist in the Technology Resources Division of the Baxter Healthcare Corporation. In this role, he works with a team of analytical chemistry professionals whose primary responsibility includes the development, validation and application of diverse analytical strategies and methods for the discovery, identification and quantification of trace constituents in pharmaceutically relevant solutions and samples.
Dr. Dujuan Lu has been leading the extractables and leachables (E&L) team at SGS Fairfield New Jersey site since 2015. She has extensive pharmaceutical industry experience with more than 200 E&L studies on a broad range of container closure systems, including pharmaceutical finished packaging, process equipment (SUS, MUS, etc) and medical devices. Before joining SGS, she was working at Fresenius Kabi, leading E&L projects to support transfusion and infusion medical device and parenteral products. She has more than 10 years of experience on trace analysis by LC/MS and GC/MS.
Dr. Dujuan Lu obtained her PhD in analytical chemistry from the University of Pittsburgh. She has authored more than 10 peer-reviewed journal publications with more than 300 citations. She has more than 20 international conference presentations as invited speakers and technical session chairs. She is serving as an expert reviewer for more than 10 prestigious journals in the field of analytical chemistry and pharmaceutical science.
Doug obtained his BS and MS in Biology from St. John’s University, Jamaica, NY in 1977 and 1980, respectively and became board certified in general toxicology (DABT) in 2003. Doug is a full member of the American College of Toxicology (ACT), Society of Toxicology (SOT) and has served as President, VP and Secretary/Treasurer for the Northeast Chapter of SOT (NESOT). Doug was employed as a toxicologist at Sandoz (now Novartis) and Boehringer Ingelheim. Doug has assumed various project and regulatory strategy roles and is currently a Research Fellow in Regulatory Strategy and Compliance at Pfizer. Doug has been the Nonclinical Drug Safety Team Lead for 5 drug product approvals, the most recent being Xeljanz (tofacitinib citrate) for the treatment of rheumatoid arthritis.
A recognized expert in the evaluation and qualification of E&L in drug products. He co-chaired a PQRI L&E work group and co-authored the PQRI Best Practices Recommendations for Evaluation of L&E in Orally Inhaled and Nasal Drug Products (OINDP, 2006). Doug serves as a co-chair for the PQRI work team for L&E evaluation in parenteral and ophthalmic drug products (PODP), the Co-Topic Lead for the International Conference on Harmonisation (ICH) Expert Working Group (EWG) and Implementation. Working Group (IWG) for Elemental Impurities (Q3D), an Expert Panel member for USP <381> Elastomeric Closures for Injection and Biocompatibility <87> and <88>, and is past Chair and current Board member of ELSIE.
Benton Cartledge is a senior scientist with the extractable and leachables group at PPD® Laboratories. He received a bachelor’s degree in chemistry from the University of Indianapolis (Indiana, USA) and Ph.D. in analytical chemistry from the University of Denver (Denver, CO).
Pharmacist and doctor in toxicology with emphasis on degradation products. 10 years of experience in degradation chemistry, including stress testing, development of stability-indicating methods, identification and qualification of degradation products. She worked at Aché Laboratórios Farmacêuticos as senior researcher and, nowadays, is a consultant in the area impurities assessment that includes degradation products, mutagenic impurities, elemental impurities and extractable and leachable, offering both analytical and toxicological support at Spektra Consultoria, at which is founder.
Dr. Sahotra got his BSc in Chemistry from the University of Central Lancashire, followed by MSc in Drug Chemistry from Newcastle University. In 2018 he completed his PhD in organic chemistry. Since then he has been working for Markes International, specialist in thermal desorption technology. His current job involves the sampling and analysis of air borne chemical from products and materials.
Aspen Research Corporation is a premier contract research organization that provides analytical services and materials R&D. Our ISO 17025 accreditation and GLP program enable the company to be at the forefront of extractable and leachable studies, food contact notification studies, method development and pre-clinical support studies. Aspen partners with biotech, pharmaceutical and medical device industries to deliver the support that is needed for product development and regulatory submission.
The U.S. Food and Drug Administration and European Medicines Evaluation Agency (EMEA) have expressed concerns over potential toxicity and efficacy effects of chemicals released into drug products through exposure to components used in manufacturing and packaging. These chemicals are referred to as Extractables and Leachables (E&L). Accurate and definitive E&L studies should be performed in compliance with USP, ICH, PQRI, and ISO 10993. All E&L studies by Daicel Pharma Services are conducted in their US-FDA audited analytical facility and fully support regulatory compliance. Daicel Pharma Services offers GMP Analytical Services with comprehensive Extractable and Leachables Studies and GMP Stability Studies. Daicel’s Extractable and Leachables studies test a large number of packing materials, manufacturing systems, and drug products, as well as offer Glass Delamination studies to meet the demanding testing specifications of regulatory authorities. Learn more at www.daicelpharmaservices.com
