Pfizer, AstraZeneca, BD, Eli Lilly, ELSIE, and many more experts featured as presenters in the 2021 agenda.
View The Agenda
June 29 - July 1, 2021
Arlington, VA
The 2021 Event Includes:
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.
Extractables and Leachables Studies at Daicel Pharma Services
Understanding complex chemical interactions is critical to designing a proper extractables and leachables program. Examples include migration from container closure systems, manufacturing components or delivery devices into pharmaceuticals and biologics.
Daicel Pharma Services has over ten years of experience in designing and managing large customized E&L studies with the goal of submitting data for FDA review and approval. Daicel is familiar with guidelines from organizations such as the FDA, ISO, ICH, BPOG, and USP. Our capabilities include:
Daicel Pharma Services offers innovative analytical solutions to support timely and safe drug development with improved cost efficiency. Our GMP facilities are FDA compliant and offer a full suite of solutions including stability studies, microbiology, peptide and biologics.
Whether your project requires full or supplemental support, we have the experience and flexible service options to meet your needs, on time and within budget.
Jordi Labs specializes in the analysis of medical devices, pharmaceutical packaging and food contact applications. We have the experience and knowledge to make your E&L study a success. Jordi partners with our customers to develop and execute E&L studies empowered by more than 4 decades of analytical experience and state of the art instrumentation. Our lab is ISO 17025:2017 accredited and we offer cGMP compliant services when required.
Bryan Katzenmeyer has over 10+ years of experience specializing in mass spectrometry and separation techniques for the characterization of materials, polymers, monomers, and small molecules as well as increasing leadership roles within technical organizations. He currently oversees the Americas Materials Science business marketing segment for Waters Corporation. The Materials Science business market focuses on polymers, fine and specialty chemicals, extractables/leachables, medical device testing, cosmetics and personal care products, fuel/energy, and agrochemicals. Prior to joining Waters, Bryan was an Analytical Group Leader and Senior Scientist at Valspar (now part of Sherwin-Williams). While here he managed the liquid chromatography and mass spectrometry team focused on developing and validating analytical methodologies to characterize extractables and leachables, resins, oligomers, monomers, and other small molecules in packaging coatings for the food and beverage industries. Bryan received his Ph.D. in Polymer/Analytical Chemistry at The University of Akron working under Distinguished Professor Chrys Wesdemiotis. Here, he researched interfacing liquid chromatography and ion mobility separation with multi-dimensional mass spectrometry for the structural characterization of polymeric materials. He also obtained a M.S. in Chemistry from the University of Wisconsin-Madison and a B.S. in Chemistry from Penn State University.
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.
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.
Bio Coming Soon
Theodore (Ted) Heise has three decades of experience in regulatory and clinical affairs, and currently serves as Vice President Regulatory and Clinical Services at MED Institute. In this capacity, Dr. Heise leads efforts to develop scientifically robust regulatory and clinical study strategies for the company’s clients: entrepreneurs, consultants and developers bringing new medical products through the complex steps of the development process.
Graduating Magna Cum Laude with a B.S. in chemistry from the University of Nebraska at Omaha, Dr. Heise went on to earn a Ph.D. in analytical chemistry from Iowa State University. He has been a member of the Regulatory Affairs Professionals Society since 1993, and the American Chemical Society since 1988.
For the past 12 years Dr. Heise has been a U.S. delegate to ISO TC 194, the technical committee for international consensus standards that govern biocompatibility testing and clinical investigations of medical devices. He currently serves as convenor of TC 194/WG 14. As convenor, Dr. Heise led the process of re-writing ISO 10993-18 to reflect current best practices in chemical characterization, including evaluation of extractables and leachables.
Bio Coming Soon
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.
Trish joined Pfizer in February 2020 as a Global Risk Assessment Services Toxicologist in Drug Safety R&D. Trish has a background in Genetic Toxicology and over the last 12 years has built expertise in mutagenic impurity, extractable and leachable, and contamination risk assessments. In recent years, Trish participated in ICH M7 working group to develop Appendix 3 and co-authored hydrogen peroxide monograph. In addition, she authored the vinyl acetate monograph in the subsequent publication Bercu et al., (2018). Trish is also the co-chair of the Extractables and Leachables Safety Information Exchange (ELSIE) PDE and Sensitisation Sub-teams and is an active member of the EFPIA working group to support ICHQ3E.
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.
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