2018 Speakers

The following experts are confirmed to share their experience:

  • Baiba Cabovska

    Senior Manager Waters Technologies

    Baiba Cabovska currently is a Senior Manager in Chemical Materials Business Operations for Waters Technologies based in Milford, MA. She is responsible for customer collaborations and addressing customer needs in materials characterization with a special focus on extractables and migration testing.

    Prior to joining Waters, Baiba worked at Mannkind Corporation doing analytical development for insulin based products as well as extractables testing for a dry powder inhalation device. 

  • Noemi Dorival Garcia

    Research Fellow National Institute for Bioprocessing Research and Training (NIBRT)

    Noemi Dorival joined NIBRT as postdoctoral researcher to be part of the project “Facility of the future – the plastic factory, enabling single use technologies” funded by Science Foundation Ireland. After the completion of her Masters degree in biology and chemistry in her home country, Noemi worked in the Cayetano Heredia University (Peru) as assistant professor, and then won a scholarship to the University of Granada (Spain) for her postgraduate studies, receiving her PhD in Analytical Chemistry in 2012. Following this, Noemi continued undertaking postdoctoral research in the same group “Analytical chemistry and life sciences” for 2 years, where her research activities were focused on the analysis of emerging contaminants, mainly pharmaceuticals and endocrine disrupting chemicals in environmental matrices and their removal using membrane bioreactor technology. In 2015, Noemi moved to NIBRT in Dublin, working with Dr. Jonathan Bones in “Characterisation and Comparability Laboratory”, where she is responsible for the area related to characterisation of E&L compounds from single-use technology solutions, using different analytical techniques, as LC-MS, GC-MS, ICP-MS and HS-GC-MS, and new sample preparation techniques for the extraction and clean-up of matrices related to biomanufacturing processes solutions.

  • Dr. Zhenxia Du

    Professor, Center of Analytical Chemistry and Testing Beijing University of Chemical Technology

    1997.8-Current: Center of Analytical Chemistry and Testing, Beijing University of Chemical Technology.

    Dr. Du’s strength is in the development of methods for GC/MS, SFC-MS and LC-MS applied to food safety, environment safety, medicines and polymer materials.  She also is extremely experienced in spectral analysis using IR, NMR and MS approaches for structural deduction. Through solving many difficult problem for many enterprises, she has established good cooperation with many companies, such as the Chinese academy of inspection and quarantine, State Grid Company of China, Tongfang NUCTECH Co. Ltd, Beijing Tong Ren Tang Chinese Medicine Co. Ltd. and many universities. 

    As visiting scholar, Dr. DU has studied at Purdue University in the United States in 2012. At the same time, Dr. Du began a cooperation with Waters Corporation and established the polymer additives library (more than 300 kinds of material) which commonly used in plastic packaging materials. Based on the additive polymer library, the method to identify main leachables-polymer additives in medical products was developed by ultra-performance liquid chromatography-quadrupole time-of-flight-mass spectrometry (UPLC-QTOF MS) and realized the rapid screening extractables and leachables. As a director  or  participants of the National Science-technology Support Plan Projects, National nature Science Foundation, philanthropic projects supported by the General Administration of Quality Supervision, Inspection and Quarantine(GAQSIQ) and other projects from the enterprises. Dr. Du has public more than 80 papers in Analytical Chemistry, Journal of Chromatography A, Journal of Hazardous Materials, Food Chemistry, so on. About packaging materials compatibility research, Dr. DU published 8 relating dissertations.

  • Dr. Andrew Feilden

    Chemistry Operations Director Smithers Rapra

    Andrew Feilden joined Smithers Rapra as a Principal Consultant in June 2011 and was appointed Chemistry Operations Director in October 2012. He specializes in extractable and leachable testing and the selection and assessment of materials for medical and pharmaceutical applications. Andrew previously worked at AstraZeneca for 12 years, leading their extractable and leachable testing. He has been working in the field of trace analysis using hyphenated techniques such as GC-MS and LC-MS for over 12 years. Whilst at AstraZeneca he was an active member of industry working groups, the IPAC-RS container closure group and he was the co-chair of ELSIE material group. Andrew gained a degree and D.Phil from York University.

  • Queenie Gai

    Extractable Lab Supervisor – BioReliance Validation Services, China Merck Chemicals (Shanghai) Co., Ltd.

    Queenie Gai received her M.S. in Analytical Chemistry from East China University of Science and Technology. She joined Merck in 2013 and now serves as E&L Lab Supervisor in Merck BioReliance Validation Lab.  BioReliance Validation lab is responsible for Merck’s overall strategy and execution of E&L studies supporting the development and application of SUS. Queenie is responsible for leading local team to provide extractables validation services on single use system to global customers.  She also coordinates global E&L projects and E&L test method development and validation.  

  • Dr. Dennis Jenke

    Chief Executive Scientist Triad Scientific Solutions

    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. Daniel Norwood

    Executive Partner SCIO Analytical & Senior Consultant at Smithers Rapra

    Dr. Daniel Norwood joined SCIO Analytical as Executive Partner in June 2015. Prior to SCIO Analytical, Dr. Norwood was a key technical employee at Boehringer Ingelheim Pharmaceuticals where he was successful in various pharmaceutical development roles, including Director Physical and Chemical Analysis.  In June 2015, Dr. Norwood retired with the title of Distinguished Research Fellow in Analytical Development.  Prior to joining Boehringer Ingelheim, Dr. Norwood, with Dr. Feinberg, founded the Structural Chemistry Group at Magellan Laboratories, later Catalent Pharma Solutions, which became widely recognized for its work in pharmaceutical impurity structure elucidation, and in leachables and extractables characterization. Prior to Magellan, he was a pharmaceutical development scientist at the Glaxo Research Institute.  

    Dr. Norwood is an internationally recognized expert in the field of leachables and extractables assessment in pharmaceutical development and manufacturing.  He served as chair of the widely-quoted Product Quality Research Institute (PQRI) Working Group on leachables and extractables in inhalation drug products. He is also a member of the PQRI Working Group on leachables and extractables in parenteral and ophthalmic drug products (PODP), and has served on various technical teams of the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS). Since 2010, he has served as a member of the USP Expert Committee on Packaging, Storage and Distribution where he chairs the subcommittee on extractables and leachables. Dr. Norwood has received several industry awards, including the CEO’s Award from Glaxo (1994), the President’s Award from Boehringer Ingelheim (2007), the Excellence in Research Award from PQRI (2009), and the Award for an Innovative Response to Public Health Challenges from USP (2013). Dr. Norwood completed his bachelor’s degree in Biochemistry at Virginia Tech and his doctorate degree in Environmental Chemistry at the University of North Carolina at Chapel Hill, School of Public Health.

  • Ina Pahl

    Senior Scientist Device Technologies, Research & Development Sartorius Stedim Biotech GmbH

    Ina Pahl is a chemist and started with Sartorius Stedim Biotech in 1997. She is senior scientist in R&D in the department of Device Technology where she works in a team whose tasks are to develop and perform extractables studies, and evaluate the results thereof. She has published in the field of analytical chemistry, extractables data of single use components, sensors, and fundamentals of membranes. Ina is an active member of DECHEMA and ELSIE.

  • Dr. Albrecht Poth

    Senior Toxicologist Dr. Knoell Consult GmbH

    Albrecht Poth is Senior Toxicologist and head of business development for medical devices. He is responsible for customer collaborations focusing on the global registration and certification of medical devices.

    He has over 25 years’ experience in the field of medical devices. He served for over 10 years as chairman of the ISO technical committee 194 (Pre-clinical and clinical evaluation of medical devices) and he is currently chairman of the national mirror committee to ISO TC 194 and acting chairman of an expert working group within ISO TC 194. His functional experience includes technical, scientific and general management at several different contract research organizations active in the field of medical device testing and consulting.

  • Dr. Cheryl Stults

    Principal C&M Technical Consulting

    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.

  • Gyorgy Vas, Ph.D.

    Business Technical Scientific Liaison Intertek

    Gyorgy Vas has over 20 years of experience in scientific research, product development, and laboratory management. Much of that time has been spent in a cGMP environment, where he has provided his expertise to solve problems related to finished pharmaceutical products and medical devices.

    In his current position, he advises on regulatory filing strategies for multiple clients, and his group provides solutions for mitigating deficiency letters. Gyorgy led the implementation of state-of-the-art solventless sample preparation techniques into the cGMP laboratory processes, and is one of the few in this field with expertise in method development and validation for ultratrace (parts-per-trillion) level impurities in finished pharmaceutical products and medical devices.

  • Weichun (Wes) Yang

    Senior Scientist II Baxter

    Wes joined Baxter in December 2015 as Sr. Scientist II and manager of Suzhou extractable and leachable team at Baxter Suzhou R&D center. Wes’s major responsibilities include leading the Suzhou E&L team to support new product development and launch; maintenance of current products; collaborating with key internal and external partners to achieve operational excellence; future technical direction and capability of the team.

    Prior to Baxter, Wes was the analytical lab manager at Kemin Industries in Des Moines, IA. Before that, Wes worked few years as research associate at University of California, Riverside.

    Wes received his B.S. in Chemistry from Zhejiang University and Ph. D. in Analytical Chemistry from Brigham Young University. Wes published over 30 papers in peer-reviewed journals including Analytical Chemistry and Lab on a Chip.

  • Lynn Yao

    Scientific Affairs Manager, China West Pharmaceutical Packaging (China) Co., Ltd.

    Lynn currently serves as Scientific Affairs Manager (China) in West Pharmaceutical Packaging (China) Co., Ltd., in her role, Lynn helps to review and analyze the industry development as well as the regulatory changes in China for injectable, and offer scientific advice.

    Lynn joined West as a Technical Support Engineer, providing technical support in mainland China.

    Before joining West, Lynn worked in a technical support role with a company dealing with biochemical and microbiological reagents after she graduated from University with a Master degree in Biochemical Engineering.