Speakers

View the leading 2016 experts who presented their latest research in Dublin

  • Francois Bianchi

    Head of Global Packaging Migration B.Braun Medical

    Dr.  François Bianchi is Head of Global Packaging Migration for B.Braun Hospital Care. In this role, he is responsible to define the strategy and to establish the studies with staff from different departments covering the following responsabilities: analytical, packaging materials, toxicology, formulation, regulatory and quality. Ultimately, its responsability is to deliver risk assessments for L&E testing in development and life cycle management  projects.

  • Karin Bracht

    Senior Pharmaceutical Assessor MHRA

    Karin is a Senior Pharmaceutical Assessor in the Licensing Division of the MHRA which she joined in 2010. Her work focusses on assessment of applications for marketing authorisations of anti-invectives and fermentation products as well as contraceptives and uro-genital products. She has a special interest in paediatric medicines and is the current alternate UK delegate to the PDCO-Formulation Working Group.

    Prior to joining the MHRA, Karin has worked in academia for six years, doing research in the areas of drug resistance and drug-development of anti-cancer drugs. She qualified as a pharmacist and holds a PhD in Pharmaceutical and Medicinal Chemistry.

  • Jason Creasey

    Director GSK

    Jason Creasey is a graduate Analytical Chemist. He has worked for GSK since 1990, working full-time in the area of extractables and leachables since the mid 1990’s. Over that time period he has seen demand in this area grow exponentially. During that time Jason has held roles of increasing seniority relating to the support that GSK has given to extractables and leachables (E&L). He is currently the director of a team of analytical chemists who are responsible for GSK’s support for E&L activities across a wide range of product types including OINDP and parenterals. He has had the pleasure of commenting on PQRI guidelines on E&L for GSK and the E&L section in EMEA guidelines on inhalation and nasal products and co-author of a chapter within  book entitled “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”.

    Jason is 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, and Extractable and Leachable Safety Information Exchange otherwise known as ELSIE. Currently working on 2nd book chapter for the follow on to Leachable and Extractable Handbook on the subject of risk assessment. 

  • Kevin Day

    Associate Principal Scientist AstraZeneca

    I have worked for AstraZeneca for the 16 years.  During this time I have worked on drug development projects spanning all stages and aspects of development primarily as an analytical chemist.  Over the last 12 months I have become increasingly involved in the area of extractables and leachables and I am now the UK lead for AstraZeneca.

  • Noemi Dorival Garcia

    Postdoctoral Researcher National Institute for Bioprocessing Research and Training (NIBRT)

    I 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 my master degree in biology and chemistry in my home country, I worked in the Cayetano Heredia University (Peru) as assistant professor, and then I won a scholarship to the University of Granada (Spain) for my postgraduate studies, receiving my PhD in Analytical Chemistry in 2012. Following this, I continued undertaking postdoctoral research in the same group “Analytical chemistry and life sciences” for 2 years, where my 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, I moved to NIBRT in Dublin, working with Dr. Jonathan Bones in “Characterisation and Comparability Laboratory”, where I am responsible for the work package 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.

  • Luke Heaven

    Director of Marketing for Fluid Management Technologies Sartorius Stedim

    Luke Heaven holds the position of Director of Marketing for Fluid Management Technologies within Sartorius Stedim Biotech.  A graduate in Molecular and Cellular biology, Luke has over 18 years of experience with bio manufacturing including Production/Operations Management, Validation consultancy and Project Management in addition to his current commercial and technical based role.  Luke has been working solely with Single use disposables since 2004 giving personal experience of both supporting the implementation as well as driving the adoption during the period of the most dramatic expansion of the technologies. Luke’s current role includes both the marketing direction and the head of technical support for Europe, Asia, NEMEA and Cuba.  Luke is currently a board member of the UK Chapter of the PDA.

  • Christian Heiss

    Head of Analytical Chemistry Merck

    Born and educated in Heidelberg,

    1990-1995 Study of Chemistry in Darmstadt, finished with a degree as chemical engineer
    1996-1999 phD Studies in Heidelberg, Muenster and Bremen, finished 2001 with a phD in Chemistry
    1999 starting with Merck
    1999-2003 QA Computer validation
    2003-2006 QA for NCE (new active pharmaceutical ingredients)
    2006-2007 Plant manager assistant
    2007-2009 Plant manager inorganics
    2010-2016 Head of Analytical Chemistry within Central Analytics

  • Alan Hendricker

    Manager - Chemical Sciences Becton Dickinson

    Dr. Alan Hendricker has 15 years of experience in extractables and leachables analysis and 25 years of experience with mass spectrometry.  He received his undergraduate degree from Ohio University and Ph.D. from the Colorado School of Mines in 1999.  He was a co-author on the PQRI Working Group on Leachables and Extractables recommendation “Safety Thresholds and Best Practices for Leachables and Extractables in Orally Inhaled and Nasal Drug Products (OINDPs).” He has been an active member of the PQRI Leachables and Extractables Parenteral Ophthalmic Drug Product (PODP) working group. He has written and presented extensively on extractables and leachables issues.  Alan was a member of the Structural Chemistry Group at Magellan Laboratories through its acquisitions by Cardinal Health and subsequent purchase by the Blackstone Group as Catalent Pharma Solutions.  Since January of 2014, Alan works at Becton Dickinson (BD) as part of the corporate preclinical development group on extractables and leachables studies for BD devices and products.

  • Mike Hodgson

    Senior Research Manager Baxter International Inc

    An analytical scientist by training, Mike graduated from the University of Nottingham with a PhD in flavour and aroma science in 2004. The sample preparation and trace analysis experience gained during his time analysing and modelling the real time release and delivery of common flavour substances facilitated the transition into Pharma, and specifically the area of Extractables & Leachables. Over the past 12 years, Mike has held roles of increasing responsibility within GSK and Pfizer, where he has been accountable for defining and executing the regulatory strategy that mitigates the risk of patient exposure to leachables for a variety of product types including inhalation (DPIs and MDIs), parenteral (LVP, PFS and lyophilised formulations), biopharmaceutical (manufacturing processes, primary container closure and administration) and most recently cell & gene therapy products. In October 2016 Mike joined the Advanced Chemical and Investigations group within Baxter as a Senior Research Manager of the Extractables and Leachables Team. Areas of technical interest include coupling micro-extraction and enrichment techniques to high end chromatographic and mass spectrometry instrumentation in a highly automated fashion to enable the creation of large databases that support a scientifically led risk based approach through effective retrieval of knowledge and collaboration with the material supply chain.

  • 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. 

  • Malcolm Kimber

    Laboratory Operations Director Hall Analytical Laboratories

    Malcolm has spent over 30 years working with mass spectrometry (both GC and LC-MS), much of it concerned with the identification of unknowns encompassing the area of Extractables and Leachables across a wide range of devices/systems. He is the Laboratory Operations Director of Hall Analytical (a Division of Crawford Scientific Holdings) where he co-ordinates the E and L studies ensuring that the appropriate scientific work is undertaken and subsequently reported to allow toxicological assessment.  Hall Analytical has been doing Extractable/Leachable studies for over 15 years.

    Malcolm has a PhD in Mass Spectrometry (done in conjunction with the Metropolitan Police Forensic Laboratory).

  • Kristina Moller

    Scientist GE Healthcare

    At the Upsteam and Consumables department, BioProcess R&D GE Healthcare, Kristina holds a position as Scientist in a dedicated team focusing in the area of Extractables and Leachables. In the team Kristina is responsible for the analytical strategy, method development and method validation/verification. She also acts as the scientific/technical expert within analytical chemistry in the area of Extractables and Leachables in projects for new and existing products. The team is mainly working with single-use bioprocess equipment and material utilizing analytical techniques such as Q-TOF LC/MS and GC/MS.

    Prior to her position at GE Healthcare she has nine years of experience from the pharmaceutical industry working as an analytical expert as well as project manager in different departments such as QC, QA and R&D. She holds a Ph.D. in analytical chemistry, “Molecularly Imprinted Solid Phase Extraction and LC/MS for Biological Samples”, since 2006 from Stockholm University.

  • Nick Morley

    Investigator GlaxoSmithKline (GSK)

    Nick Morley is an Investigator in the Trace Analysis team at GlaxoSmithKline. Nick has spent over 8 years working in the E&L field and has a particular interest in sample enrichment and leachable risk assessment. Nick leads numerous E&L projects and uses his extensive E&L knowledge to perform risk assessments, define the projects technical activities and regulatory strategies. 

  • Wolfgang Muster

    Toxicology Project Leader Roche

    Dr Muster is a Senior Principal Scientist in the Pharmaceutical Sciences department at F. Hoffmann-La Roche in Basel, Switzerland. He received his diploma in Chemistry from the University of Würzburg (Germany) in 1989 and his Ph.D. in 1992 at the Institute of Toxicology. He joined Roche in 1992 and worked until 2003 as a study director for genotoxicology and project leader. Starting in 2003 he focussed his scientific interest on early safety screening heading a group called ‘In Silico and In Vitro Screens’. Since 2008 he holds the position as a toxicology project leader and is responsible for early safety profiling, specialized on the topic of data analysis and in silico safety prediction. In his role as toxicologist and in silico expert, he functions as a key contact for the toxicological assessment of impurities, degradants, E&Ls, intermediates and metabolites.

    During the last twenty-five years he published in the area of early safety profiling and computational toxicology and was an often sought speaker for congresses and workshops. He represented Roche in a number of expert panels and consortia dealing with safety databases, toxicological assessment of impurities as well as development of new technologies for the prediction of toxicological effects.

  • Glenn Myatt

    Chief Scientific Officer Leadscope

    Dr. Myatt is one of the founders and is currently the Chief Scientific Officer of Leadscope, Inc. He has over 25 years of experience researching and developing in silico solutions. He is currently the principal investigator on two US National Institutes of Health research grants and has co-authored 21 publications (including a number of papers related to ICH M7), three books as well as five book chapters.

  • Selma Riasat

    E&L Project Manager Smithers Rapra

    Expertise: Polymer processing, Antioxidants, Extractables and Leachables analysis

    Polymer expert in polymer stability, synthesis of novel phenolic antioxidants for reactive processing (e.g. PEX), synthesis of novel steroid derivatives incorporated into polymers and novel method development of grafting antioxidants (hindered amines). Analytical expertise using a wide variety of analytical techniques including LC-MS/UV, GC-MS, FT-IR, and NMR, in the characterisation of polymeric materials, antioxidants and degradation analysis and GC-MS structural elucidation.

    Expertise in polymer and antioxidant science to supports a wide verity of pharmaceutical and material produce clients.

  • Gordon Ross

    Team Leader/Senior Applications Scientist Agilent Technologies

    Gordon Ross is a Senior Applications Scientist with Agilent Technologies based near Manchester, UK. He leads a team of applications scientists and is responsible for the Agilent Centre of Excellence Demonstration Facility in Cheadle, UK.

    After obtaining a BSc from University of Glasgow, Gordon went on to work in St Bartholomew’s Hospital and Medical College, University of London, as a Research Assistant and later as a Senior Biochemist,

    There, he worked on the development of various bioanalytical techniques, including HPLC, for use in the investigation of endocrine function and the diagnosis of endocrine disease. During this time he gained a MSc in Analytical Chemistry from Birkbeck College, University of London. In 1989, together with Prof. David Perrett, of the Medical Professorial Unit at Bart’s, Gordon began studies on the use of the then novel technique of Capillary Electrophoresis (CE) in the analysis and characterisation of haemoglobin in normal and diseased states, and the analysis of drugs and endogenous compounds in biofluids; these studies formed the basis of his doctoral thesis.

    Having successfully obtained his doctorate, Gordon went on to work for Hewlett-Packard (now Agilent Technologies) based in Germany and worked in the development, marketing and support of Capillary Electrophoresis applications. He has has lectured on CE, CEC, CE/MS, LC and LC/MS throughout the world and has published, over 40 peer reviewed papers, invited and other publications, including two book chapters. In 1998 Gordon was invited by the United States Pharmacopoeia Committee of Revision, as an expert on CE, to become a member of the Expert Working Group for preparing the general chapter on CE for the US Pharmacopoeia.

    Since 2001 Gordon has been based in UK working on demonstration, development and support of CE/MS and LC/MS applications using Single Quadrupole, Ion Trap, Triple Quad, TOF and QTOF instruments. He maintains his clinical interests working with external collaborations in the growing field of Clinical Metabolomics and is an industrial supervisor for 3 PhD students at different Universities in UK. More recently he has promoted the definition and implementation of screening workflows using TOF technology in various fields from environmental to food to forensic analysis. It is this effort which has led him into an interest in the screening and analysis of extractable and leachable compounds in the environmental, food, manufacturing and bio/pharmaceutical arenas.  

  • Sigrid Saaler-Reinhardt

    Director Corporate Project Management Midas Pharma

    Prof. Dr. Sigrid Saaler-Reinhardt holds the position as Director Corporate Project Management at Midas Pharma in Ingelheim, Germany. After her study in Biochemistry at the Free University of Berlin she graduated for her PhD in cell biology. Her research focus was on cellular ectopic receptor expression systems, the generation of monoclonal antibodies and their analytical and functional characterisation. After her Habilitation at the Johannes Gutenberg-University of Mainz in 1997 she became a Professor for Genetics. From 2004 to 2006 Prof. Saaler-Reinhardt moved into the field of IP management to coordinate tech transfer projects in the life sciences at the University of Mainz. In 2006 she joined Midas Pharma started with being Head of R&D and IP Management and later working as Director Custom Synthesis and Biotechnology. Since 2014 she is Director Corporate Project Management coordinating complex drug product development projects with partners in different territories.

  • Jessica Shea

    E&L Global Technical Services Manager MilliporeSigma (Merck)

    Jessica Shea is responsible for Extractables and Leachables Global Technical support.  Previously, she was the manager of the Extractables and Leachables (E&) Laboratory for the Provantage® Lab Service group at MilliporeSigma (Merck). She has more than 8 years of E&L experience including method validation, designing of custom testing and interpreting industry and regulatory Guidance. 

    Jessica has a Bachelor of Science, Biochemistry from Saint Michael's College and has worked at MilliporeSigma (Merck) Since 2007.

  • Alicja Sobantka

    Expert for Material Qualification Octapharma

    Alicja is currently employed at the Octapharma Pharmazeutika Produktionsges.m.b.H. where she is responsible for material qualification at corporate level. She performs extractables and leachables assessments including the planning and supervision of extractables and leachables studies.

    Prior to joining Octapharma, Alicja had a tenured position as a researcher at the French National Institute for Agricultural Research (INRA) where she investigated various possibilities to increase sustainability in the food processing industry. In 2015 she won the award “Allocation d´installation scientifique pour jeunes chercheurs”, which is offered on an annual basis by Rennes Métropole. Alicja has compelled broad experience in material and polymer science and technology at the Institute for Composite Materials (IVW) in Kaiserslautern as well as at the Centre for Neutron Science (JCNS) and at the Institute for Nuclear Waste Disposal and Nuclear Safety (IEK-6) at the Research Centre in Jülich.

    After completion of undergraduate studies in food chemistry and toxicology at the Technical University in Kaiserslautern Alicja graduated in chemical engineering with the focus on process engineering and polymer technology at the University of Applied Sciences in Kaiserslautern. She holds a PhD in environmental engineering from the Vienna University of Technology in Austria.

    Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood. Octapharma employs more than 6,200 people worldwide to support the treatment of patients in 105 countries with products across three therapeutic areas: critical care, haematology (coagulation disorders), immunotherapy (immune disorders). Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Mexico and Sweden. For more information visit www.octapharma.com.  

  • Jerome Vachon

    Lead Scientist in the Materials Science SABIC

    Jérôme Vachon joined SABIC in 2010, working currently as Lead Scientist in the Materials Science group within the Technology department (Geleen, The Netherlands). His main research activities include developing new polyolefin type of materials with a particular focus on purity, for both healthcare and food contact applications.  Dr. Vachon contributed in setting up and generating Extractables data for several of SABIC polyolefin healthcare grades. He holds a Chemical Engineering degree from CPE Lyon and obtained a PhD in Organic Chemistry from the University of Geneva. 

  • Chris Waine

    Toxicologist bibra toxicology advice and consulting

    Chris Waine, Bibra toxicology advice & consulting Ltd, Wallington, Surrey. Chris has been involved in preparing health hazard and risk assessments for clients from a range of industrial sectors including food, household products and medical devices, and is taking a particular interest in Extractables and Leachables studies. He is also skilled at running (Q)SAR predictions of toxicology and is taking a leading role developing bibra’s capabilities to computationally estimate occupational and consumer exposures.

  • Pete Watts

    Director of Toxicology bibra toxicology advice and consulting

    Pete is a European and RSB/BTS registered toxicologist with 39 years’ experience in reviewing and critically evaluating toxicological data and other scientific information.  He has a keen interest in the e-cigarette sector, focusing on the safety of ingredients, emissions and extractables and leachables. Pete also works closely with a wide portfolio of companies in the pharma, medical devices and packaging sectors. Responsibilities include health risk assessment of pharmaceutical impurities, contaminants and excipients, PDE setting, and biocompatibility assessment of medical devices in line with the EU Directive, ISO 10993 and FDA guidance.

  • Steven Watts

    Business Development Manager A&M STABTEST

    After studying molecular biology at the Bielefeld University and graduating with a PhD in genetics and molecular biology in 2005, Dr. Steven Watt was granted a position as assistant professor at the department of proteome and metabolome research. There he was in charge of a mass spectrometry service unit, dealing with proteome and metabolome projects. In 2009 he joined Thermo Fisher Scientific as an instructor for scientific and pharmaceutical mass spectrometry applications. In his current position as a business development manager at A&M STABTEST he is involved in customer relations, marketing and the development of new analytical services in the field of pharmaceutical analysis.

  • 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.