Speakers

View the leading 2017 experts who presented their latest research in Lyon

  • Dan Carrier

    Applications Laboratory Manager Anatune

    I joined Anatune in July 2011 as an Applications Chemist becoming the Applications Laboratory Manager in September 2013. I hold a BSc Applied Chemistry and an MSc in Analytical Chemistry, Birkbeck, London. I started my career at GSK in Harlow and have many years’ experience  in LC/MS and GC/MS within Pharma.

  • 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.  

  • 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

    Global Extractables & Leachables Senior 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.

  • Edwin Jao

    Branch Chief FDA

    Edwin Jao joined FDA in 2003. He is currently an acting branch chief in division III, branch VII of Office of Process and Facility (OPF), Office of Pharmaceutical Quality (OPQ), CDER. In his capacity he provides oversights for reviews of manufacturing process for NDA and ANDA. Prior to OPF, he was a CMC reviewer with Office of New Drug Quality Assessment (ONDQA), now renamed Office of New Drug Product (ONDP) for 12 years, covering various phases of new drug product approval process.

  • Matthew Jorgensen

    Chemistry and Materials Scientist Nelson Laboratories

    I am a seasoned scientist with a diverse background in chemistry and material sciences. Currently I focus my efforts on using chemistry in the evaluation of medical device biocompatibility. My academic work has focused on synthesis and characterization of biomimetic materials, fabrication of microscale devices, and photonics. I have a professional interest in both technical and popular science writing, which has produced over 30 peer reviewed scientific articles and hundreds of blog articles.

    At Nelson Labs I draw on my chemistry and materials experience as well as my research acumen to create solutions for sponsors with interesting and challenging problems facing the assessment of their devices.

  • 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).

  • Ivan Kourtchev

    Scientist GlaxoSmithKline (GSK)

    Ivan Kourtchev is a Scientist in the Trace Analysis team at GlaxoSmithKline. Ivan has a strong interest in trace analysis method development for extractables and leachables.  Ivan obtained his PhD in Chemistry from University of Antwerp (Belgium) with an emphasis on organic trace analysis, molecular characterisation and speciation of environmental samples using mass spectrometry techniques. Prior joining GSK, Ivan worked first as a Marie Curie Fellow and then as a Senior Research Associate at University of Cambridge on the development of novel analytical approaches for analysis of complex environmental mixtures using ultra-high resolution mass spectrometry.  

  • Tiru Kumaravel

    Chairman GLR Laboratories

    Dr. Kumaravel is American Board certified and UK/Eurotox Registered Toxicologist with more than 25 years’ experience in industry as well as in academia. Dr. Kumaravel is an expert on biocompatibility testing of medical devices, development of testing strategy, biological safety assessment and has successfully defended biocompatibility reports with FDA and other global regulators. Dr. Kumaravel obtained his Bachelors degree in Medicine and Surgery from Stanley Medical College, Doctoral degree in Pharmacology/Toxicology from University of Madras and finally obtained PhD in Genetic Toxicology/Cancer Genetics from MGR Medical University, Chennai. He then carried out toxicology research at Hiroshima University, Japan; National Institutes of Health, USA and Princess Margaret Hospital, Canada. Subsequently, he has worked with world leading contract research companies such as Covance Laboratories and Huntingdon Life Sciences, where he worked with various international clients. He has extensive experience running and supervising toxicology studies, advising clients on their projects to comply with national and international guidelines. Additionally, he has experience of managing regulatory submissions. He has authored several confidential reports, 40 peer-reviewed publications and has 50 + conference papers to his name.

  • Melanie Pires

    Senior Pharmaceutical Assessor Medicines and Healthcare products Regulatory Agency (MHRA)

    Melanie Pires obtained her Pharmacy degree (B Pharm) and her PhD at King’s College London, United Kingdom. After a period of working in hospital pharmacy and as a postdoctoral researcher she joined the Medicines and Healthcare products Regulatory Agency (MHRA) based in London in 2003. She has also worked as a community pharmacist.

    Her current role at the MHRA is as a Senior Pharmaceutical Assessor within the Licensing Division’s Product Lifecycle Assessment Team where she is responsible for evaluating, assessing and providing scientific advice on both UK (national) and European Marketing Authorisation Applications (centralised, decentralised, mutual recognition) and post-approval variations for anti-infectives, products used in obstetrics and gynaecology and products for treatment of genitourinary conditions. In addition, she is responsible for assessment of applications for herbal products. She also has experience in assessing dermatology, drug-device combinations, CNS, musculoskeletal and over the counter products.

  • Anita Sawyer

    Biocompatability and Standards Manager Becton Dickinson

    Anita York Sawyer is an experienced biomaterial/ biocompatibility scientist with over 30 years of experience. She holds a MS degree in Biology with post graduate studies in Toxicology and Pathology. As Manager, Biological Sciences in Becton Dickinson’s Corporate Toxicology Department for fifteen years, she led study directors in the performance of in-vitro and in-vivo biocompatibility studies for BD’s devices.  Her initial research focus was the development of in-vitro test methods to-evaluate the thrombogenicity of cardiovascular materials, which led to a successful hemocompatibility material screening program. Additional R&D projects included the development of antithrombotic, anti-adhesive, anti-infective and anti-restenotic coatings for intravascular catheters and stents. Anita has managed the biocompatibility/ pre-clinical testing programs for three medical device companies, including Cordis, a J&J Company. She is an expert on the pre-clinical safety evaluation of medical devices including standards development and has been an active member of ISO TC 194, Biological Evaluation of Medical Devices since 1990, and is presently Convenor of ISO Working Group 12 (Sample Preparation and Reference Materials) and US Co-Chair for Working Groups 1 (Evaluation and Testing) and 9 (Effects on Blood); and a Technical Expert for seven other Working Groups, including Working 14 (Material Characterization). She is also Chair of the Biocompatibility Committee of ASTM, author of two ASTM test methods, and a member of the USP Expert Panel for Biocompatibility Tests. She is currently leading an ISO Task Force investigating the suitability of ISO 10993 Extraction Conditions for hazard identification.

  • Beate Treffler

    Regional Head Europe, Segment Healthcare Polymer Solutions Clariant

    Beate Treffler has over 20 years of experience in additives for plastic applications and plastic processing. In March 2015 she joined the Business Unit Masterbatches of Clariant as Regional Head Europe Segment Healthcare Polymer Solutions. Within Clariant Plastics & Coatings BU Masterbatches provides colour - and functional additive - masterbatches as well as – compounds for the Medical & Pharmaceutical industry.

    Before taking over  this new task she was heading the global technical marketing team for waxes in the Business Unit Additives of Clariant and was involved in project management for new developments and for the Clariant Commercial Excellence programme (Lean Sigma; certified Green Belt).

    After studying chemistry and accomplishing a degree in Chemical Engineering, Beate joined the former company Hoechst in Gersthofen (South Germany). This speciality chemicals part of Hoechst was acquired in 1997 by Clariant (former speciality chemicals part of Sandoz/CH).

    She worked in the R&D department covering additives including flame retardants, waxes and polymer additives for plastic applications.

    After return from maternity leave in 2000 she reinforced the technical marketing department concentrating on project management and new developments comprising metallocene polyolefin waxes, new esters waxes and renewable lubricants for the plastics industry. In July 2011 Beate was appointed Head of Technical Marketing Waxes for Plastics.

  • Gilbert Tumambac

    Senior Principal Scientist Pall Life Sciences

    Gilbert Tumambac, Ph.D. is a Sr. Principal Scientist in the Regulatory and Validation Consulting group at Pall. He has over 12 years of industry experience which includes 5 years with Merck & Co., Inc. working on analytical method development, validation and impurity identification, and over 7 years with Pall where he currently serves as one of the E&L SMEs supporting single-use and continuous  processing technology. He has a PhD in Organic Chemistry from Georgetown University in Washington, DC.

  • Lise Vanderkelen

    Department Head Pharma Services Toxikon Europe

    Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2012.  She started at Toxikon Europe in 2013 as study director at the Extractables & Leachables Department, focusing on Injectables and Parenterals and in 2014 she became responsible for the chemical characterization testing for the medical device industry. Today, she is Department Head Pharma Services at Toxikon Europe. The main focus of this department is identifying organic impurities in drug products. 

  • Shivkumar Vishwanathan

    Director and VP Marketing GVS Cibatech

    Shivkumar Vishwanathan is a Chemical Engineer and a Packaging Technologist by training. He has close to 2 decades of experience in the Manufacturing, R&D, Audit and Laboratory testing and consulting. He has worked in Multinationals like Clariant, Bureau Veritas, Ciba, BASF and Intertek. For the last 8 years along with process risk assessment he has been involved in creating awareness in the Pharmaceutical Industry on Extractable & Leachables through several training programmes and lectures. He has been involved in more than 100 EL studies on various dosage forms including Injectibles, Ophthalmics, Transdermal patches, nasal sprays, Liquid Orals etc. He started his own testing and consulting facility – GVS Cibatech in 2015 and continues to provide his expertise in both testing and consulting on pharmaceutical packaging. 

  • 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.

  • Xiaochun Yu

    Principal Scientist PPD

    Xiaochun Yu is a Principal Scientist at PPD; he has a Ph.D. in polymer chemistry and has worked in the extractables/leachables area for 14 years.  As a technical expert and team leader, he has helped establishing the extractables/leachables study capability in PPD, advised numerous clients and colleagues on the overall strategy design of extractables and leachables programs and led the successful completion of hundreds of extractables and leachables programs for many pharmaceutical and biopharm