2018 Speakers

  • Kenneth D. Berthelette

    Scientist II, Consumables Separations Group Waters Corporation

    Kenneth has been with Waters Corporation since March 2012, and has worked on several product launches including CORTECS columns, UPC2 Torus columns, and Quality Control Reference Material development. As part of the Consumables Separation Group, Kenneth develops products with a focus on customer usage and application. Additionally, Kenneth helps educate customers on achieving success with new products, as well as generic chromatographic techniques. Kenneth has created two seminars highlighting method development techniques, and is working on a third seminar focused on LC troubleshooting.

    Kenneth received a Bachelor’s of Science from Bridgewater State College in Bridgewater MA in 2010. After college, he worked at Alpha Analytical (Westborough, MA) where he did environmental sample preparation implementing liquid-liquid extraction, solid-liquid extraction and sample clean-up techniques. 

  • 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.

  • Paul Cummings

    General Manager E&L Smithers Rapra

    As general manager, Paul is responsible for the Smithers Rapra Analytical Services lab located in Akron to support extractables and leachables studies for the medical device, pharmaceutical and food industries. The lab also provides chemistry support to Smithers Rapra’s existing analytical and physical testing laboratories.

    Paul’s specialty areas of expertise include mass spectrometry with a significant background in small molecule structure elucidation.  He also has extensive experience in extractables and leachables and other areas of packaging testing such as container closure integrity.

    Paul brings over 35 years of experience in chemistry and leadership in the pharmaceutical industry. Most recently he was a Research Fellow and Manager of Trace Organic Analysis for Intertek Pharmaceutical Services.  He has also worked at West Pharmaceutical Services, Drugscan, GlaxoSmithKline and Merck. 

    Paul holds a Bachelor of Science degree in Chemistry from Old Dominion University and a Master of Science Degree in Analytical Organic Chemistry from Villanova University.  He also served his country in the United States Army.

  • Charles Ducker, Ph.D.

    Principal Chemist/Group Leader Eurofins Medical Device Testing

    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.

  • James Hathcock

    Senior Director, Regulatory and Validation Consulting Pall Corporation

    Coming soon!

  • Theodore Heise, Ph.D., RAC

    Vice-President Regulatory and Clinical Services MED Institute

    Theodore (Ted) Heise has 25 years of experience in regulatory affairs, and currently serves as Vice President Regulatory and Clinical Services at MED Institute.  In this capacity, Dr. Heise leads the company in developing scientifically robust regulatory and clinical study strategies for its clients: entrepreneurs, consultants and developers bringing new medical products through the complex steps of the development process.

    Graduating Magna Cum Laude with a BS 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 10 years Dr. Heise has been a U.S. delegate to ISO TC 104, the technical committee for international consensus standards that govern biocompatibility testing and clinical investigations of medical devices.  He currently serves as convener of TC 194/WG 14—the TC’s working group on chemical characterization (ISO 10993-18). Dr. Heise is also active in developing processes to generate real world evidence for medical devices, representing Cook Medical on the corporate stakeholder board for the SVS/Vascular Quality Initiative and participating in projects within MDEpiNet (e.g., RAPID) and Harmonization by Doing.  

  • Jianfeng Hong

    Sr. Research Scientist, Chemistry Lab Manager Fresenius Kabi USA LLC

    Mr. Jianfeng Hong has over twenty years of experience in the pharmaceutical and medical device industry as an analytical chemist and laboratory manager. He is currently a Sr. Research Scientist and the manager of the Chemistry Laboratory of Fresenius Kabi USA LLC at Lake Zurich, Illinois.

    He is leading a group of analytical chemists to perform extractable/leachable for medical grade material used for medical device and liquid pharmaceutical containers, as well as material used in the manufacture processes.  These materials include polymeric sheeting, port tubes, filters, stoppers, glass vials etc. He is a frequent speaker / presenter at national and international conferences in the topics of extractable and leachable testings. 

  • John Iannone

    Director of Extractables/Leachables & Impurities AMRI

    John Iannone has a background in Biomedical Engineering from Boston University, where he later became a research faculty member. Since joining the Biotech/Medtech Industry 14 years ago, John has assisted multiple pharmaceutical & medical device companies with the development of their product safety evaluation strategies. Previously a Technical Specialist and Program Manager at Toxikon, he now is the Global Director of Extractables/Leachables and Impurities at Albany Molecular Research, Inc (AMRI). His areas of expertise include Material Qualification & Biocompatibility, Extractables & Leachables, Chemical Characterization, and attainment of Biological or Toxicological risk assessments for medical devices, pharmaceutical container systems, bioprocessing systems, and combination products. John has given numerous technical presentations and has led many workshops on Extractable & Leachable Considerations, Biocompatibility, Microbiology, and Regulatory Testing Requirements.  He also participates in the development of both industry groups’ recommendations and regulatory guidelines through Expert Panel membership, global Technical Committees, and industry collaborations. He has lead regulatory focused webinars, seminars, discussions and committees aimed at providing expert insights on the utility, limitations, and considerations of chemical characterization to support material safety evaluations. In addition to leading the AMRI E&L lab operations, his responsibilities also include providing technical consultation to clients regarding unique testing requirements in an effort for them to meet global regulatory expectations.

  • 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. 

  • Ben Jeyaretnam, Ph.D., MBA

    Deputy Director, Unit Leader, E&L Analytical Lead SANOFI

    Ben Jeyaretnam (Ph. D., MBA) leads E&L analytics and a group of scientists involved in qualifying Single Use System (SUS) at Sanofi, Swiftwater, PA for the last three years.  My group manages the studies internally and at external laboratories to generate analytical data needed to qualify the use of SUS in the production. 

    Ben Jeyaretnam has spent 15 years with Sanofi Pasteur in various roles:  Analytical team manager, Analytical lead on new vaccine projects, Assay transfer coordinator and developed and validated analytical methods.  He was also a reviewer and approver of CMC section of BLA and familiar with CTD format and is Knowledgeable in cGMP and GLP requirements.

  • GLAUCIA KARIME BRAGA, Ph.D.

    Quality Assurance Auditor of Public-Private Partnership at FURP Fundacao para o Remedio Popular

    I am Bachelor of Pharmacy (2002), Master in Pharmaceutical Sciences (2005 – Pharmaceutical Process Development) and Doctor in Pharmaceutical Sciences (2009 – Quality Risk Management), all awarded by University of Sao Paulo (Brazil). I am also Bachelor of Pedagogy/Education (2012) awarded by Federal University of Sao Carlos (Brazil).

    17 years of relevant experience in Quality Assurance, working for pharmaceutical companies, such as Janssen-Cilag (Johnson & Johnson Group); DLA Pharmaceutical (sterile pharma business of Dentsply Group), where I worked as Quality Manager (QA and QC), being in charge of Quality Budget, Key Performance Indicators,  auditing the Quality System (internal and suppliers),  contact person to Regulatory Bodies, harmonization of the internal documents with international guidelines such as ICH, PICS and Pharmacopeias, Regulatory Affairs, Training in Quality (Good Manufacturing Practices, Good Laboratory Practices, ISO 9001:2000 and ISO 13485:2003),and, for FURP, which is a Pharmaceutical Industry run by Sao Paulo State Government in Brazil, where my main tasks were related to cleaning validation, software validation, performance qualification and GMP training and audit support for supply chain. Nowadays, I still work at FURP, however I assumed a new task: I was nominated to be Auditor for the Public-Private Partnership Agreement. This Agreement is budgeted around R$ 2,6 billion and the scope of auditing is related to regulatory compliance, performance assessment, regulatory affairs/portfolio. In partnership area, in 2017 I was in charge of writing and presenting orally to the Health Ministry the executive projects of products that should be objective of a technology transfer to the company I work from a private company and sold to Health Ministry. 

    10 years of teaching experience, working as invited professor and/or coordinator of Postgraduate courses, being in charge of redesigning the curriculum and teaching classes on Quality Audit, Quality Management, Regulatory Affairs, Logistics and Health Care Management.
    3rd pillar: Since 2012, experience in a standard-setting organization (U.S. Pharmacopeia Headquarters, in Rockville, MD, USA), working as Visiting Scientist  for 6 months, in a hands-on, highly technical position, being in charge of writing the draft of 5 chapters on Good Distribution Practices, being in frequent contact with Scientific Liaisons and Expert Committee Members. After this work, I was nominated to participate as Expert in two other USP Panels related to Good Distribution Practices and Clinical Trials Materials and in 2015 I was nominated for 2015-2020 new cycle as USP General Chapters - Packaging and Distribution Expert Committee Member. I am a Subcommittee Co-Chair, that is in charge of reviewing the General Chapter <1079> that talks about Storage and Transportation of Drug Products. In 2013 and 2017 I was speaker in ANVISA in a workshop organized by USP Pharmacopeia Education on Packaging and Distribution.  Also in 2017 I was speaker of USP-APEC Center of Excelence in Supply Chain.  

  • Doug Kiehl

    Research Advisor, Team Leader Spectroscopy and E&L, Bio product Research & Development Eli Lilly Company

    Doug Kiehl is a Research Advisor at Eli Lilly, and currently leads the corporate Spectroscopy and Extractables & Leachables team.  His group's responsibilities include performing structural characterization of process impurities, related substances, degradation products and contaminants across small and large molecule portfolios as well as acquisition and qualification of raw materials for both small and large molecule process streams.  Additionally, his team is responsible for Lilly’s overall strategy and execution of Extractable and Leachable studies supporting the development and qualification of container/closure systems, manufacturing systems and drug delivery devices.  Mr. Kiehl has over 35 years' experience across 5 companies with the application of mass spectrometry in the structural characterization of highly diverse molecules, 23 years of which are in the Pharmaceutical Industry.  He represents Lilly on USP Expert Panels for Biocompatibility and Elastomeric Closure for Injections, he is on the Board of Directors for the Extractable/Leachable Safety Information Exchange consortium (ELSIE), is a member of the AAPS Impurities Steering Committee, a Chair for the International Society for Optics and Photonics (SPIE) Defense and Commercial Sensing conference and is a liaison for innovation-based collaborative relationships between the Pharma Industry and the US Department of Defense.

  • Nick Morley

    Principal Scientist Hall Analytical

    Nick is a Principal Scientist at Hall Analytical Laboratories responsible for providing technical support to new and existing customers in the field of E&L, helping to define the most appropriate testing protocols to meet their needs. Hall Analytical is a contract analysis laboratory which focusses on problem solving.  We have an extensive range of chromatographic and mass spectrometric instrumentation, combined with highly experienced and skilled scientists, and have been developing methods for the analysis of extractables and leachables across a broad range of devices/systems for over 15 years.

    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. Nick had a particular focus on biopharmaceutical and cell and gene therapy products, with responsibility for defining E&L strategies, authoring E&L regulatory sections and  interacting with regulatory agencies. Nick developed a leachable risk assessment process, aligned to ICH Q9 and Quality by Design (QbD) principles, and a sample enrichment technique which are widely used across GSK.

  • Rasmus Worm Mortensen

    Senior R&D Scientist Analytical Support Leo Pharma

    I got my PhD in Analytical Chemistry in year 2000. I work with UHPLC-MS on compounds and products from the discovery phase through development, registration and post-marketing.

    My main responsibilities are UHPLC method development and impurity identification and -tracking on both pure substances as well as drug products using high resolution MS equipment.

    I have been a main driver in E&L work at LEO for more than 10 years.

    The E&L work I have been involved in includes designing studies, writing protocols, evaluating data, and doing analytical method development including hands-on lab work.

  • Lee M. Nagao, Ph.D.

    Senior Director, Science, Regulation & Policy Drinker Biddle & Reath LLP

    Lee M. Nagao, Ph.D., is a Senior Director of Science, Regulation and Policy at the law firm of Drinker Biddle and Reath, LLP, and is a member of the Firm’s Life Sciences Consortium Management and Regulatory Affairs Practice Group. The Group works extensively with pharmaceutical, biopharmaceutical and medical device companies on a range of scientific and regulatory collaborations and provides strategic and regulatory guidance to individual life sciences companies. Lee plays a lead role serving scientific and regulatory consortia including the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), the Extractables and Leachables Safety Information Exchange (ELSIE), and the Product Quality Research Institute (PQRI). Lee has extensively published and presented on extractables and leachables, materials quality topics, and other aspects of pharmaceutical development.  She has represented various industry groups before regulatory and scientific agencies and organizations in the US, Europe and Asia, including the FDA, EMA, CFDA, Taiwan CDE, and USP.

  • Andreas Nixdorf, Ph.D.

    Business Development Manager SGS Institut Fresenius GmbH

    Since the date of his PhD/doctorate in 1997, he worked in different managerial positions in Life Science industry prior he proceeds with his carrier at SGS in 2007. From 2007 to 2010 he was responsible for project management and regulatory consultancy at the customer service Pharma at SGS Institute Fresenius GmbH. Andreas introduced Extractables & Leachables testing services at SGS in 2008 and got his current position in 2010.
     

  • Dr. Daniel Norwood

    Executive Partner SCIO Analytical & Senior Consultant at Smithers Rapra

    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.

  • Dr. 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.

  • 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.

  • 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.

  • Erica J. Tullo, Ph.D.

    Technology Manager, E&L WestPharma

    Ms. Tullo has over nine years of experience in extractable and leachable analysis of container closure and delivery systems and devices. She currently serves as Technology Manager for Extractables and Leachables (E&L) at West Pharmaceutical Services, Inc., where the focus of her role is to collaborate across industry to further scientific knowledge and determine the most current testing technology in E&L. Prior to this role, she was a group leader in E&L at Eurofins Lancaster Laboratories.

    Ms. Tullo received a Ph.D. in Applied Science and a M.S. in Chemistry from the College of William and Mary.  While at William and Mary, she focused on determining various gas-phase thermochemical properties of a variety of organic and biological molecules, including constrained diamines and amino acids, using mass spectrometry. She performed high-level ab initio and density functional theory calculations in support of the experimental studies. Ms. Tullo is also the author/co-author of several articles on this topic and has presented the work at various conferences. She is an active participant in the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) working group. 

  • 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.

  • 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.

  • Doris Zane, PhD, DABT

    Sr. Director, Preclinical Development Intarcia Therapeutics, Inc.

    Doris Zane, PhD, DABT, is the Senior Director of Preclinical Development at Intarcia Therapeutics where her current roles incudes leading the nonclinical safety program and nonclinical/clinical bioassays.

    Doris is an active member of the Society of Toxicology where she currently serves as President of the Northern California Regional Chapter.

    Doris has over 13 years of experience in the biotech industry. Prior to joining Intarcia Therapeutics, Doris held positions at Genentech/Roche, Trinity Biosystems and Berlex Biosciences.

    Doris received her PhD in Molecular and Cellular Physiology from University of California at Davis, MS in Biological Sciences from Stanford University and BA in Molecular and Cellular Physiology from University of California at Berkeley. She is a Diplomate of the American Board of Toxicology. She is the first author of multiple patents, peer-reviewed publications, invited chapters/reviews and abstract/scientific presentations.