June 28 - July 1, 2021
Arlington, VA
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.
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. Stults is Principal at C & M Technical Consulting, LLC, working with various local and global companies to advance the development of parenteral and inhalation products. Her primary area of focus is on device and packaging materials analysis and characterization for purposes of selection, qualification and control. She holds a Ph.D. in Analytical Chemistry from Michigan State University and a Masters in Management from Aquinas College. Prior positions include: Senior Fellow at Novartis Pharmaceuticals Corporation, Assistant Research Professor at San Francisco State University and Quality Associate at a Johnson & Johnson owned company. She was co-editor of the Leachables and Extractables Handbook (Wiley 2012) and has been a member of the Board of Directors for two consortia: Extractables and Leachables Safety Information Exchange (ELSIE) and International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). She has been actively involved in the ELSIE Pilot Protocol Study and database development. She previously led IPAC-RS working groups to develop Materials Baseline Requirements for OINDP, a Leachables and Extractables Development Paradigm and a Chemical Risk Evaluation tool and has continued involvement as an IPAC-RS Science Advisor participating in global outreach and materials related initiatives. Dr. Stults is currently a USP Packaging and Distribution Expert Committee member contributing to development and revision of materials-related chapters.
Carsten Worsøe is a research scientist in an analytical development department at Novo Nordisk. In over 18 years at Novo Nordisk, his main responsibility has been to develop analytical methods for L&E test procedures of new packaging/container closure systems under development. Within Novo Nordisk Carsten has been one of the main actors to bring relevant people in packaging materials, toxicology, formulation, regulatory and analytical together to perform risk assessments and strategies for L&E testing in development projects.
Nick is a Principal Scientist at Hall Analytical Laboratories responsible for providing technical support to new and existing pharma, med device and ENDs customers in the field of extractables and leachables. Nick’s area of expertise includes E&L study design, defining E&L strategies, performing leachable risk assessments and authoring E&L regulatory sections.
Prior to joining Hall, Nick spent over 10 years at GSK in the field of extractables and leachables. During this time, he worked on a range of therapeutic areas including inhalation, topical and parenteral. Where he had responsibility for the E&L assessment of devices, closure systems and manufacturing processes to ensure patient safety, product quality and regulatory approval.
Dr. Pearson received his B.S. in Chemistry from Montana State University and his M.S. and Ph.D. in Environmental Chemistry from the University of Minnesota’s School of Public Health. Dr. Pearson joined Aspen Research in 1997 from a post-doctoral position at the University of Minnesota. His prior professional experience includes positions as a Research Chemist and Production Superintendent for Celanese Chemical Corporation. Dr. Pearson has extensive experience in gas chromatographic analysis of volatile and semi-volatile compounds, has coordinated many studies of off gassing phenomena at elevated process temperatures, and is an expert at coupling analytical results back to their process chemistry. He is an industry recognized expert in Extractables and Leachables techniques whose studies have been instrumental in assisting risk professionals in providing guidance for companies navigating in various regulatory arenas.
Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis.
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.
