2019 Speakers

  • Kim Li

    Senior Manager Environment, Health, Safety and Sustainability Amgen Inc., USA

    Dr. Li is a Diplomate of the American Board of Toxicology (DABT) and has broad experience in safety assessments in both R&D and Operations. Her industry experience includes biopharmaceutical products, agrochemicals, consumer healthcare products and medical devices.  In her current role at Amgen, Dr. Li is the lead toxicologist on extractables and leachables (E&L) programs for container closure systems, drug delivery devices, single use technologies and drug-device combination products. She serves on the Extractables & Leachables Safety Information Exchange (ELSIE) consortium in various leadership roles including Chair of the ELSIE Board of Directors and prior to that, as co-lead for the Safety Information Working Group.  Dr. Li is also a US delegate to ISO TC 194 Biological Evaluation working groups to advance the knowledge base around material characterization and toxicology assessments for medical devices.

     

  • Nick Morley

    Principle Scientist Hall Analytical Laboratories, UK

    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, designing studies, 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. 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.

  • Petra Booij

    Investigator GlaxoSmithKline, UK

    Petra obtained a PhD in analytical chemistry from the VU University in Amsterdam, The Netherlands. She is currently working in GSKs E&L team based in Stevenage (UK). Her work focusses on trace level analysis, identification and confirmation of E&L using mass spectrometry, and risk assessments of E&L within biopharma and cell and gene therapy. She is a member of the ELSIE leachable team and involved in harmonising approaches for leachable testing.

  • Thomas Broschard

    Associate Director, Head of Chemical Toxicology Merck KGaA, Germany

    Thomas Broschard is a Senior Toxicologist (Eurotox registered) at Merck’s Chemical and Preclinical Safety Department in Darmstadt, Germany. He studied food chemistry and environmental toxicology at the University of Kaiserslautern from 1985 to 1990. He received his PhD in 1995 from the German Cancer Research Center (DKFZ), where he investigated mechanisms of chemical mutagenesis and carcinogenesis. From 1995 to 1997 he held a postdoctoral position at the Ecole Supérieure de Biotechnologie in Strasbourg, France. In 1998, he started his career as a regulatory toxicologist within the cosmetic and pharmaceutical industry. Since 2000, he held several positions at Merck’s Toxicology/Chemical and Preclinical Safety Department in Darmstadt. In his current position he is heading the Chemical Toxicology Group that is responsible for the global registration of industrial chemicals, the establishment of substance-specific threshold values (OEL, PDE) and the risk assessment of impurities in drug products with a focus on leachables and extractables.

  • Ronald Brown

    Toxicologist former U.S. FDA (retired)

    Ron Brown is a board-certified toxicologist who recently retired from the US FDA Center for Devices and Radiological Health.   At FDA, his research efforts focused on the developing new methods to assess the risk posed by patient exposure to extractable and leachable compounds released from medical device materials.   He is active in both domestic and international standards committees related to the biocompatibility of medical devices.  Until recently, he served as the co-chair of the US TAG for TC194 (Biological Evaluation of Medical Devices) and as convener of ISO/TC194/WG11 (Allowable Limits for Leachable Substances).  Ron is a founding member and former president of the Medical Device Specialty Section of the Society of Toxicology.  He previously held leadership roles in the Society for Risk Analysis and the Association of Government Toxicologists.  Prior to joining FDA, he was a Senior Associate at the ILSI Risk Science Institute in Washington, DC.

  • Michael Crease

    Manager of Project Management Smithers

    Biography to follow...

  • Jason Creasey

    Managing Director Maven E&L Ltd. UK (former GSK)

    Jason Creasey is a graduate Analytical Chemist. He has recently setup as an independent consultant providing advice in the area of extractables and leachables, after working for GSK in the area of extractables and leachables since the mid 1990’s.

    Over that time, he has seen demand in this area grow exponentially and Jason has held roles of increasing seniority relating to the support that GSK has given to extractables and leachables (E&L). Before setting up Maven E&L Ltd, he was the director of a team of analytical chemists who are responsible for GSK’s global R&D support for E&L activities across a wide range of product types and modalities. This included; biopharmaceutical and small molecules including Inhalation, Parenteral and Cell & Gene Therapy use.  He has had the pleasure of commenting on PQRI guidelines on E&L for GSK, the E&L section in EMEA guidelines on inhalation and nasal products and co-authoring a chapter within a book entitled “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”.

    Jason has been a member of several external groups concerned with the development of best practice guides for extractable and leachables issues these include; the IPAC-RS material working group, BPOG and continues as a scientific advisor to Extractable and Leachable Safety Information Exchange otherwise known as ELSIE. Currently he is working and commenting on risk- based approaches to E&L requirements, which he hopes will form part of an ICH guidance in the not too distant future.

     

  • Caitlyn Da Costa

    Senior Applications Scientist Waters Ltd, UK

    Caitlyn has worked for Waters as a Senior Applications Scientist for the past four years where her primary role is both pre and post sales applications support for both high resolution and tandem quadrupole mass spectrometers. Her focus for the 18 months has been around the chemicals and materials market and extractables and leachable applications. Prior to working at Waters, Caitlyn was studying for her PhD where she applied high resolution mass spectrometry and ion mobility separations to the analysis of lubricant oils and oil additives.

  • Sam Denby

    Facilitator BioPhorum, UK

    Sam holds an engineering doctorate in biochemical engineering from University College London. He has spent 20 years working in the bioprocessing industry holding upstream process development roles and carrying out technology transfer and CMC activities for Cambridge Antibody Technology, Medimmune and Oxford BioMedica. in 2010 Sam joined Becton Dickinson as application and scientific manager for their cell culture media and peptone products covering Europe, Middle East and Africa. in 2017 Sam joined BioPhorum as a facilitator and has been working with the extractables and leachables team since then to develop a sustainable approach to making extractables data readily available to the biomanufacturing industry. Supply partners have been part of this effort since 2018.

  • Dr. Michael Eakins

    Founder and Principal Consultant Eakins and Associates

    Dr. Michael Eakins is the Founder and Principal Consultant of Eakins & Associates with over 25 years experience in pharmaceutical research and development.  At Eakins and Associates, Michael provides experience and advice on parenteral primary packaging, especially on glass delamination and glass defects, the selection and product development in glass and plastic pre-filled syringes, and on extractables and leachables for parenteral packaging components. He regularly lectures on these topics worldwide for the USP.

    Michael was responsible for the pharmaceutical development of diagnostic radiology products at E. R. Squibb and Bristol-Myers Squibb and for global packaging initiatives for contrast media at Bracco SpA. 

    Michael was the Vice-Chair of the USP Packaging, Storage and Distribution Expert Committee in the 2005-2010 and 2010-2015 cycles and is currently a committee member for the 2015-2020 cycle. He is an active member of the Parenteral Drug Association, being the co-chair of the Glass Defects Task Force that revised Technical Report 43 and is a member of the Elastomers and Seals Defects Task Force. He obtained his Ph.D. from London University and has contributed to over 60 publications and 8 USA patents.

  • Thomas Egert

    Analytical Development Boehringer Ingelheim Pharmaceuticals, Germany

    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 Pall Biotech, USA

    James Hathcock, PhD is Senior Director of Regulatory and Validation at Pall BioTech, which includes responsibility for the extractables and leachables characterization strategy to support the safe and successful end-user implementation of technologies enabling pharmaceutical manufacturing.   He is an active member of ASTM, PDA, ISPE, and BPSA as well a USP <665> expert panel member. Since joining Pall in 2008, James has led chemical and performance characterization of Medical and BioTech components, as well as relevant technical packages supporting regulatory filings.  Prior to joining Pall, James was a professor of hematology at the Mt. Sinai School of Medicine in New York City, where he directed the protein purification core laboratory.

  • Ashley Hellenbrand

    Associate Group Leader PPD Ireland (Athlone GMP lab), Irland

    Ashley Hellenbrand is an associate group leader with the extractable and leachables group at PPD® Laboratories in Athlone, Ireland.  She received a bachelor’s degree in chemistry and environmental studies from the University of Wisconsin, Oshkosh (USA) and a Masters in analytical chemistry from the University of Maine (USA).

    Ashley has worked at PPD® Laboratories in Middleton, Wisconsin (USA) for 4 and a half years executing extractable and leachable studies including controlled extraction studies, method development and validation and leachable testing for stability samples.  She has successful executed many extractables and leachables programs with drug products approves by the FDA.  She has recently transitioned to the PPD® Laboratories in Athlone, Ireland to help lead the extractable and leachable team.  

  • Tim Hulme

    Principal Consultant Smithers

    Tim has over 30 years’ experience in chemical analysis, both with classical techniques  and a wide variety of instrumental techniques. Before working at Smithers Rapra, Tim worked for ConvaTec (wound care/medical devices company) as an analytical scientist and before that at Glaxo Group Research (pharmaceutical company), also as an analytical scientist

    Tim’s principal responsibility is for the project management of Extractables and Leachables projects but he also runs many customised analytical chemistry projects, both large and small.

    Tim has a BSc (Hons) in Applied Chemistry from the University of Hertfordshire and then studied an MSc in Pharmaceutical Analysis at Liverpool John Moores University. He is a Chartered Chemist (CChem), Chartered Scientist (CSci), a Member of the Royal Society of Chemistry and a Fellow of the Royal Microscopical Society. 

  • Dr. Nina Macho

    Scientist Pharmacology and Toxicology Octapharma, Austria

    Nina Macho graduated in nutritional sciences at the University of Vienna, and in toxicology at
    the Medical University of Vienna. After investigating dietary factors which protect against
    DNA damage at the Cancer Research Institute of Vienna, she worked in the field of
    ecotoxicology at the Austrian Institute of Technology. In 2013 she joined the Department of
    Pharmacology and Toxicology at Octapharma. In her current position, Nina is responsible for
    toxicological risk assessment of impurities in biopharmaceutical products.

  • Asger Wisti Nørgaard

    Senior Research Scientist Novo Nordisk, Denmark

    Asger W. Nørgaard has a long background in experimental analytical chemistry with mass spectrometry (MS) as speciality. Upon completion of his master’s degree, Asger worked in public research for 10 years. His research was focused on MS characterisation of occupational exposures, including fragrances, cleaning and coating products, biocides, engine exhaust and nano materials. At Novo Nordisk, Asger has worked with Extractables and Leachables (E&L) and general analytical support since 2016. Main work areas are E&L with focus of production utensils, ad hoc identification of unknowns by MS in addition to analytical method development.

     

  • Raphael Nudelman

    Ph.D., ERT, Dir., Chemical & Computational Toxicology Teva Pharmaceuticals

    Raphael completed his Ph.D. in organic chemistry from the Weizmann Institute of Science in Israel, followed by postdoctoral positions in the US Air Force Research Lab in Aberdeen Proving Ground, Maryland USA and in Duke University Medical Center, North Carolina USA. He joined Teva Pharmaceutical Industries' Medicinal Chemistry department in 2003 and in 2010 he established the Chemical & Computational Toxicology group which he currently heads.

    Raphael is a member of the American Chemical Society (ACS), the American Association of Pharmaceutical Scientists (AAPS), and of the Israel Chemical Society (ICS). From 2011 to 2016, Raphael was the President of the Medicinal Chemistry Section of the Israel Chemical Society, and was as a Council member of the European Federation of Medicinal Chemistry (EFMC). He is a member of the Advisory Council of High School Chemistry Education in the Israel Ministry of Education and a member of the Advisory Editorial Boards of Elsevier’s journal Drug Discovery Today: Technologies, and of Trends in Medicine and Health (TMH).

  • Berk Oktem

    Chemist U.S. FDA, USA

    Biography to follow...

  • Patricia Parris

    Project Toxicologist AstraZeneca, UK

    Trish is a Project Toxicologist in Drug Safety & Metabolism within AstraZeneca and has a background in Genetic Toxicology. She joined AstraZeneca in 2015 and in addition to managing the non-clinical safety strategy for respiratory and inflammatory disease pharmaceuticals she has a global role providing guidance on all aspects of drug impurity issues. In recent years, Trish has worked with the ICH M7 sub-group to develop the Addendum table co-authoring the hydrogen peroxide monograph; and 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 Sub-team.

     

     

  • David Saylor

    Research Materials Engineer Food and Drug Administration, USA

    Dr. Saylor has been a staff member at the US Food and Drug Administration for the past 14 years in the Division of Biology, Chemistry and Materials Science (DBCMS) within the Office of Science and Engineering Laboratories (OSEL) in the Center for Devices and Radiological Health (CDRH) where he currently serves as the Materials Performance Laboratory Leader.  At the USFDA, he has pursued research in the area of theoretical and computational materials science applied to medical device applications.  These efforts have focused on the dynamics of medical device material systems and tissue interactions at multiple length scales: atomistic/molecular, microstructural, and device scales.  This research has addressed a variety of premarket and postmarket issues for medical devices, including the impact of manufacturing changes and tissue composition on the performance of controlled drug release systems, the release and retention of nickel in patients implanted with nickel-containing alloy devices, and patient exposure to potentially toxic additives in biomedical plastics.

  • Andrew Teasdale

    Senior Principal Scientist Impurity Management and External Advocacy AstraZeneca, UK

    Andrew Teasdale PhD is a Senior Principal Scientist - Impurity management and External Advocacy at AstraZeneca. Andrew has over 20 years’ experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. In his current role he chairs AstraZeneca’s Impurity Advisory Group. Dr Teasdale has published a number of papers relating to genotoxic and elemental impurities and other impurity related matters and has been a speaker at many international conferences. Dr Teasdale has also led a number of industry expert groups; these include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI) and the Extractables and Leachables safety Information exchange (ELSIE).  He led the recent development of the ICH M7 addendum table and was the inventor of the purge tool concept, Mirabilis.™  He also published 2 books the first (published 2010) addressing Genotoxic Impurities – Genotoxic Impurities Strategies for Identification and Control (Wiley and Son) more recently (Nov 2017) a book focused on practical implementation of ICH Quality Guidelines.   

     

  • Jeremy Tinkler

    Director of Regulatory Consultancy and Quality Assurance MedPass International, France

    Jeremy Tinkler joined MedPass in 2007 after 10 years as a toxicologist in labs and the UK Health and Safety Executive, followed by 20 years at MHRA, as Principal Specialist in Biosciences and Implants.  He has taken a leading role in standards development in risk management, biological safety, clinical evaluation and implants, as well as MEDDEV 2.7/1 on clinical evaluation.  He is now Chairman of ISO/TC 194 (biological and clinical evaluation).

  • Sara Ullsten

    R&D Section Manager GE Healthcare, Sweden

    Sara Ullsten is R&D Section Manager at GE Healthcare LifeSciences. She manages the extractables and leachables lab, focused on testing polymeric materials and components used in the manufacturing of biopharmaceutical drug substances and products. She has 15 years of experience in the Life Sciences’ field and has held several positions in R&D as senior scientist, project manager, lab manager and people leader. Sara has a Doctors’ degree in chemistry from Uppsala University.

  • Tom Van Wick

    Principal Scientist Abbott

    All-round scientist with recognized expertise in HPLC and capillary electrophoresis hyphenated with mass spectrometry in the field of impurity profiling and structure elucidation. 
    Experience in management functions as well as project responsible scientist representing analytical development in working in multi-disciplinary project teams. 
    Strong affinity with efficiency improvements. Recognized for drive, enthusiasm, innovation, high quality performance and a pragmatic approach.

    Area: Chemical and pharmaceutical development (R&D, manufacturing)
    Key interests: Mass spectrometry, HPLC method development, Electrophoresis, Genotox impurities, Heavy metal analysis, Extractables and leachables

  • Ping Wang

    Scientific Director Janssen R&D, USA

    Dr. Ping Wang is a Scientific Director with Janssen R&D. He has been leading Janssen’s effort in the evaluation, selection and risk assessment related to polymeric materials used in the manufacturing, packaging and delivery of biologics, small molecules and transdermal drug products for the past decade. His main interests and expertise are risk-based material evaluation, E&L strategies and methodologies, single use systems, biocompatibility, biologics drug development, analytical technologies, regulatory implications and toxicological assessment of impurities. He is a board member of Extractables and Leachables Safety Information Exchange (ELSIE) Consortium. As an active member of Biophorum Operations Group (BPOG), he was a key contributor to the BPOG’s standardized extractable protocol, and the best practice guide for leachable risk assessment. He is a holder of Regulatory Affairs Certificate (RAC).

  • Ken Wong

    Deputy Director Sanofi Pasteur, USA

    Specialties: * Qualification of process stream contact materials including single-use technologies and packaging materials.

    * Extractables & Leachables compliance remediation strategy development, execution, implementation and realization.

    * Container closure intergrity test, Extractable and Leachable (E&L) test methods development and validation.

    * Strategy development for process contact and packaging material changes and specification changes.

    * Analytical laboratories (CRO) managements and technical assessments.

    * Risk ranking / assessment model design.

    * Shipping cold chain and container qualification.

  • 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.