2017 Speakers

  • Jonathan Bones

    Principal Investigator National Institute for Bioprocessing Research and Training (NIBRT)

    Jonathan is the Principal Investigator of the NIBRT Characterisation and Comparability Laboratory. Jonathan received a PhD in Analytical Chemistry in 2007. Following this he undertook postdoctoral research with Prof. Pauline Rudd at NIBRT. In 2010 Jonathan moved to Northeastern University in Boston, working with Prof. Barry L. Karger at the Barnett Institute of Chemical and Biological Analysis. Jonathan returned to NIBRT in 2012 following receipt of funding from Science Foundation Ireland to form his own independent research group. His research is focused on the development and application of advanced LC-MS and CE-MS solutions to solve challenges associated with the characterisation and comparability assessment of therapeutic proteins and manufacturing processes as well as understanding complex biological systems.

  • Raymond Colton

    Founder and President VR Analytical

    Raymond Colton is the founder and president of VR Analytical, a CRO that specializes in extractables and leachables testing (E/L).  He has been working in the E/L field for over 17 years.  He is the author of a book chapter, numerous presentations, and published papers. He was also the lead author of the first two papers about extractables and leachables published by the Bio-Process Systems Alliance in Bio-Process International. Colton earned his Bachelor of Science degree in Chemical Engineering from Clarkson University in New York, and a Master of Science in Chemical Engineering from the University of Washington. He also obtained a Masters of Business Administration from New York University. He is a member of the Parenteral Drug Association, the BioProcess Systems Alliance and the Oregon Bioscience Association.

  • Kate Comstock

    Senior Marketing Specialist Thermo Fisher Scientific

    Kate is a Senior Marketing Specialist in Pharma and Biopharma Marketing at Thermo Fisher Scientific, Mass Spectrometry Division.  Kate joined Thermo in 2010 to support new product development and small molecule applications in pharmaceutical industry using high resolution mass spectrometry.   Prior to Thermo, Kate was a research scientist at the core mass spectrometry lab of Roche Pharmaceutical , CA.

  • Peter Cornelis

    R&D Scientist and Business Development Toxikon

    Peter got his Degree of Master in Applied Biological sciences with a Major in Biotechnology at the Catholic University of Leuven in 2000.

    In 2003 he started working at Toxikon Europe as a Study Director for Microbiology and In-vitro Toxicology. From 2007 until 2016, Peter acted as Department Supervisor of the Microbiology and In-vitro Toxicology lab, where he was in charge of coordination and organization of the GMP and GLP lab.

    Since September 2016 Peter acts Business Development and R&D Scientist. He is responsible for research, implementation and marketing new business opportunities.

  • Charles Ducker

    Principal Chemist/Group Leader Eurofins Medical Device Testing

    Dr. Charles Ducker is a Principal Chemist/Group Leader for Eurofins Lancaster Laboratories / Eurofins Medical Device Testing Extractables and Leachables group where he performs extractables and leachables testing using LC/MS-TOF, LC/MS/MS, GC/MS, and ICP-OES technology.  Specializing in LC/MS analysis, Dr. Ducker has 13 years of experience in the biotech industry and has served as the lead scientist for two significant drug discovery and development programs during his career.  Dr. Ducker has 10 peer reviewed publications and earned a Ph.D. in Biochemistry/Molecular Biology from The Pennsylvania State University, as well as a B.S. in Biology from Millersville University.  

  • Thomas Egert

    Analytical Development Boehringer Ingelheim Pharmaceuticals

    Thomas Egert is a research scientist at Boehringer Ingelheim, Germany. Dedicated to analytical chemistry for 20+ years, his current role includes responsibility for materials selection and E&L qualification as well as analytical troubleshooting during packaging development.

    Thomas is an active member of the Extractables and Leachables Safety Information Exchange Consortium (ELSIE) and the PQRI Parenteral and Ophthalmic Drug Product (PODP) – E&L Working Group. While contributing to several industry seminars in the field of pharmaceutical packaging, his special interest is devoted to predictive physico-chemical models for mass transfer from primary contact materials into pharmaceuticals.

    Prior to joining Boehringer Ingelheim, Thomas held various positions in the field of organic trace analysis at an analytical service provider. Thomas holds a diploma in chemical engineering and a master’s degree in bio- and pharmaceutical analysis.

  • Greg Erexson

    Senior Principal Research Scientist AbbVie

     Greg Erexson, PhD, DABT, ATS, FRSB, ERT is a Senior Principal Research Scientist at AbbVie, Inc. in North Chicago, IL (2013-present) in Occupational and Environmental Toxicology, Preclinical Safety.  He was at Abbott Laboratories, North Chicago, IL in 2012 prior to the split of Abbott into two separate companies, Abbott and AbbVie on January 2, 2013.  Greg was at Baxter Healthcare in Round Lake, IL from 2006 to 2012 as a Regulatory Toxicologist primarily working in the areas of risk assessment of E&L and extraneous matter.  He received both his PhD and Master’s degrees from North Carolina State University, Raleigh, NC in Toxicology and Comparative Biomedical Sciences.  Greg received his Bachelor’s degree in Biology from the University of North Carolina, Chapel Hill, NC.  From 2000 to 2006, Greg was a Manager-Study Direction at Covance Laboratories, Inc. in Vienna, VA.  He was board-certified in general toxicology by the American Board of Toxicology (DABT) in 1999 and recertified in 2004, 2009 and 2014.  He was inducted as a Fellow in the Academy of Toxicological Sciences (ATS) in 2014 and as a Fellow in the Royal Society of Biology (FRSB)-UK in 2015.  Greg became a European Registered Toxicologist (ERT) in 2015.  He has been involved with the Extractables and Leachables Information Safety Exchange (ELSIE) consortium essentially since its inception in 2007.  He is currently the chair of the ELSIE Board of Directors.  Greg was also a member of the USP Toxicology Expert Committee from 2010 to 2015, former president of the Midwest Regional Society of Toxicology and the Medical Device and Combination Product Specialty Section.  Greg has authored over 90 peer-reviewed scientific publications.  

  • 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.

  • Desmond Hunt

    Principal Scientific Liason U.S. Pharmacopeial Convention (USP)

    Dr. Desmond G. Hunt is a Principle Scientific Liaison in the Science−General Chapters at the United States Pharmacopoeia.  For the 2015-2020 revision cycle, he is responsible for assisting USP Expert Committees, Packaging and Distribution and Dosage Forms, in the development and revision of USP Standards. Dr. Hunt has over 15 years of research experience and prior to joining USP, in 2005, was a Research Fellow at the National Institutes of Health, Bethesda, MD, USA. Dr. Hunt has conducted a number of studies relating to the development and establishment of public standards for materials used for pharmaceutical packaging and has developed Pharmacopeial Education Courses on pharmaceutical packaging, the determination of particulate matter in parenterals and ophthalmic products and good storage and shipping practices. He is a member the Product Quality Research Institute Container-Closure and Extractable and Leachable Working Groups.

    He obtained his Master of Science and Doctoral Degree from the University of Texas at Austin, USA.

  • Michael Jahn

    Head Forensic Chemistry, Drug Product Services Lonza

    Dr. Michael Jahn is leading the group Forensic Chemistry at Lonza’s Drug Product Services in Basel, Switzerland. During his previous 11 years in industry (Ciba Expert Services, Novartis) Michael was setting up and leading analytical laboratories specialized in trace analysis and structure elucidation with a strong focus on E&L testing. For Novartis Biologics Michael was implementing the strategy for E&L assessment of all manufacturing, storage and administration materials, with this contributing to numerous INDs/IMPDs and BLAs. In his current position Michael is using his extensive analytical and regulatory knowledge on the topic E&L to support Lonza’s customers from the (Bio‑)Pharmaceutical Industry.

  • 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. 

  • Naren Meruva

    Principal Scientist Waters Corporation

    Naren is a Principal Scientist in Waters Global Marketing Operations based in Boston, USA. He specializes in analysis of harmful constituents in tobacco products using chromatography and mass spectrometry technologies. He has more than 15 years of experience in developing, validating and harmonizing analytical methods for regulatory compliance and has led and participated in CORESTA and ISO technical groups and collaborative studies. 

    In his current role, he is responsible for developing strategic collaborations with key opinion leaders on food safety, dietary supplements, tobacco, cannabis and environmental issues. His current research initiatives include developing targeted and non-targeted methodologies for multi-residue screening, impurity characterization, leachables and extractables and omics applications.         

    Prior to joining Waters, Naren was an analytical lab manager with Altria Companies for 13 years responsible for establishing analytical methods for accurate measurement of FDA harmful constituents in tobacco products to facilitate regulatory reporting, product assessments, substantial equivalence fillings and new product applications.

    Naren holds a PhD in analytical chemistry from University of South Carolina and an MBA degree from Virginia Tech University.

  • James Mullis

    Laboratory Manager, Extractables/Leachables and Trace Organic Analysis PPD

    James has spent over 25 years in the pharma business and is currently Laboratory Manager for PPD in L/E .  He started his career at GSK and performed some of the first studies on PNAs and nitrosamines in metered dose inhalers.  He moved to Magellan Labs in 1995 with Dan Norwood to establish Magellan’s (now Catalent Pharma Solutions) trace organic analysis laboratory.  At Magellan he performed L&E work, including controlled extraction studies, method development and validation and later became head of the of the Method Dev/Validation and routine analysis section.  Later he moved to Boehringer Ingelheim and worked in the organic trace analysis group working on a variety of projects including L&E, forced degradation impurity analysis and genotoxic impurity assays.  Prior to coming to PPD he worked for a SiO2 Medical Products, a medical device manufacturer of vials and syringes, as the R&D Analytical Lab Manager.  He has served on the IPAC-RS Materials Working Group and served on the USP Expert Panel for leachables chapter <1664>.  He enjoys the field of trace organic analysis regardless of the problem to be solved and has a natural curiosity for all things science and nature.

  • Dr. Daniel Norwood

    Executive Partner SCIO Analytical

    Dr. Norwood is a Distinguished Research Fellow in Analytical Development for Boehringer Ingelheim Pharmaceuticals, Inc., and has held senior industry positions at Magellan Laboratories and the Glaxo Research Institute. He chaired the PQRI working group on Leachables and Extractables in Orally Inhaled and Nasal Drug Products, and is currently a member of the PQRI working group for Parenteral and Ophthalmic Drug Products. He has served on the Board of the Extractables Leachables Safety Information Exchange, and is a member of the USP Packaging, Storage and Distribution Expert Committee where he chairs the subcommittee on extractables and leachables.

  • Motoshi Onoda

    Research Chemist Toray Research Center

    Motoshi  has  more  than  15 years of experience in the analysis of organic chemistry, especially, in the organic trace analysis.

    Through his business career in Toray Research Center, Inc. in Japan, he has been serving the clients in the various kinds of fields; bio-materials,  pharmaceuticals, foods, industrial materials and electronic devices, etc.

    His  expertise is mainly in the analysis of HPLC and LC/MS and he is now in charge of the trace analysis group.

    In the past few years, he has been applied the cutting edge high resolution LC/FTMS to get the qualitative and quantitative information of industrial materials including medical and food packages.

  • Ina Pahl

    Senior Scientist of R&D Sartorius Stedim

    Ina Pahl is chemist and started with Sartorius Stedim Biotech in 1997. She is senior scientist at 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. The data are used to provide customer information on extractables data for the qualification of single-use components. She has published in the field of analytical chemistry, extractables data of single use components, sensors, and fundamentals of membranes. Ina is active member of DECHEMA.

  • Roger Pearson

    President of Analytical Services Aspen Research Corporation

    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.

  • Ven Raman

    Principal Scientist/Manager MilliporeSigma (Merck)

    Dr, Ven Raman is a Principal Scientist/Manager, Small Molecules Characterization for Analytical Technologies Group at MilliporeSigma. Ven Raman joined MilliporeSigma in 1984 and served in the areas of analytical chemistry, R&D and support to microelectronics and biopharmaceuticals applications. Currently Ven Raman is involved in extractables/leachables characterization of MilliporeSigma products and single use systems providing information to customers for risk assessment. Also engaged in membrane characterization, material change control, secondary sourcing and customer support.   Ven Raman received his M.S. from Indian Institute of Technology, Madras, India in Analytical Chemistry and Ph.D. from University of Toledo, Ohio in Physical Chemistry. 

  • Dr. Timothy Robison

    Pharmacology and Toxicology Team Leader, CDER FDA

    Timothy W. Robison, Ph.D., D.A.B.T. is a Pharmacology and Toxicology Team Leader in the Division of Pulmonary, Allergy Products, and Rheumatology Products in the Center for Drug Evaluation and Research at the Food and Drug Administration in Silver Spring, MD.  Prior to becoming a Team Leader, he was a Pharmacology and Toxicology Reviewer in the Division of Pulmonary, Allergy Products, and Rheumatology Products and Division of Gastrointestinal and Coagulation Drug Products. Tim earned a B.S. degree in Biochemistry and a Ph.D. degree in Pharmacology and Toxicology from the University of California at Davis. He became a Diplomat of the American Board of Toxicology in 2004. Tim is a member of numerous professional and honorary societies both at the local and national level. He serves on the FDA/CDER Genetic Toxicology, Computational Toxicology, Pharmacokinetic/Toxicokinetic, and Biologics Subcommittees. He serves on a working group for extractables and leachables in parenteral drug products. Dr. Robison has been the recipient of several research awards including the National Institutes of Health. He has authored numerous publications and been an invited speaker at various societies and institutes specific to his field throughout the United States.

  • Kevin Rowland

    Laboratory Manager Jordi Labs

    Kevin Rowland, M.S. received his bachelor’s degree in ceramic engineering in 2001 followed by a master’s degree in 2003  in materials science and engineering both from Alfred University.  He then received a master’s degree in chemistry from Brown University under Dr. Brian Moulton in 2008 with research focusing on molecular self-assembly.  Kevin has been at Jordi Labs for 6 years and has served as team leader for the GCMS and LCMS groups.  His work has focused on interpretation of high-resolution MS data for identification of non-target, unknown compounds.  He is currently serving as Laboratory Manager.  Jordi Labs provides analytical solutions to its customers in the polymer, pharmaceutical, nanotechnology, and biotechnology industries.

  • 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

    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.
  • David Weil

    Senior Application Scientist Agilent Technologies

    Dr. David A Weil, is a senior application scientist working for Agilent technologies since 2004.  His major research focus has been on the application of high resolution mass spectrometry coupled with multidimensional separations techniques (GC, LC, and 2DLC, SFC, Ion Mobility) to characterize complex pharmaceutical products (extractable/leachable, impurity profiling, polymer analysis).  He is active in many collaborations with experts in the E/L field (e.g. Eli Lilly, BD, Abbott, 3M, Jordi Labs, WuAppTech, Euorfins) investigating how new technologies, software and workflows can advance the E/L.  Prior to joining Agilent, Dr. Weil was the leader of the 3M’s Corporate Research Analytical mass spectrometry group (1990-2004) responsible for characterization of extractable/leachable impurities present from a wide variety of drug delivery products including Meter Dose Inhalers, Transdermal Patches, Injectable products and Nasal/oral Sprays packaging.  The group also focused on the safety risk fluorochemical additives such as perfluorooctasulfonate (PFOS) and perfluorooctacarbonate (PFOA) leading to removal of these compounds from most pharmaceutical constructs.   David’s polymer and polymer additive background comes from working at The Goodyear Tire and Rubber Company and from working as an Application Scientist for Nicolet/Extrel FTMS for four years in FTMS research.  

  • Carsten Worsøe

    Carsten Worsøe

    Principal Scientist Extractables and Leachables Novo Nordisk

    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.