2019 Speaker Lineup

Meet the experts who spoke at last year's E&L US Conference

The 2020 speakers will be released mid-January, 2020.

  • Benton Cartledge, Ph.D.

    Senior Scientist PPD Laboratories

    Benton Cartledge is a senior scientist with the extractable and leachables group at PPD® Laboratories.  He received a bachelor’s degree in chemistry from the University of Indianapolis (Indiana, USA) and Ph.D. in analytical chemistry from the University of Denver (Denver, CO).

  • Piet Christiaens

    Dr. Piet Christiaens

    Scientific Director Nelson Labs NV

    Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two Analytical Contract Laboratories.

    From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, TX (US) where he conducted research on a new hydrogenation catalyst system for Hydrogenated Triblock Co-polymers (Kraton Polymers).

    From 2001 onwards, Mr. Christiaens held the position of Scientific Director at Toxikon Europe where he developed analytical methods and protocols for both extractables and leachables studies for the Medical and Pharmaceutical Industries.

    Currently Mr. Christiaens oversees all laboratory operations at Nelson Labs NV and is also giving support to the European business development. 

  • Greg Erexson, PhD

    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.  

  • Barbara A Falco

    Consultant/Owner Barbara Falco Pharma Consult LLC

    Barbara is an accomplished Senior Executive, Board Member and Consultant with more than 25 years of success across the pharmaceutical, biotech and medical device industries. Leveraging extensive experience in pharmaceutical quality assurance her broad areas of expertise include leadership, risk assessment, project management and brand security.

    Throughout her executive career, Barbara has held leadership positions at Barbara Falco Pharma Consult, LLC; Abbott Laboratories (formerly Kos Pharmaceuticals), and Johnson Matthey Pharmaceutical Materials. In her current role as a President and Owner of Barbara Falco Pharma Consult, she has been responsible for business development, creating quality management systems, strategic planning, regulatory strategy and remediation, and managing supplier company relationships. In her role as Executive Director of Quality Assurance at Kos Pharmaceuticals, she was responsible for developing company quality management systems, managing the supplier quality program and interfacing with global regulators to maintain regulatory compliance. At Abbott laboratories she was a key member of the transition team to transfer Kos products to Abbott facilities globally.

    Barbara also has extensive experience managing and auditing suppliers as well as a background working in quality assurance and control in the API industry.

    She spent over 10 years on the board of directors of the International Pharmaceutical Aerosol Consortium (IPAC-RS) where she served as the chair of the supplier quality working group which developed and published (2006 & 2011) guidelines for orally inhaled and nasal drug product component supplier quality.

    Barbara continues to serve as a science advisor for IPAC-RS.

  • Katiria Flores, Ph.D.

    Development Scientist I, Pharmaceutical Development Alexion Pharmaceuticals, Inc.

    With experience in development, design and execution of extractables and leachables studies for commercial and clinical biopharmaceuticals products, Katiria leads toxicological evaluation and risk assessment of identified extractables and leachables to support product development programs.

    Katiria receieved her Ph.D. in Physiology and Neurobiology with practical knowledge in toxicology, drug transporters and drug metabolism and has extensive experience with in-vitro toxicity studies and in-vivo pharmacology studies involving drug transporters to investigate cellular responses to hepatotoxicants in mouse liver, kidney and brain. Hands-on experience with IV, SC, IP and PO dosing, blood and tissue collection.

  • Jennifer L. Goode

    Biocompatibility Program Advisor, Office of Device Evaluation FDA, Center for Devices and Radiologic Health (CDRH)

    Jennifer L. Goode, BS, Biomedical Engineer has served as the Biocompatibility Program Advisor for the Office of Device Evaluation since 2015.  Ms. Goode began her career at CDRH in 1994, as a premarket reviewer responsible for the review of medical devices and combination products for surgical and interventional treatment of the peripheral vasculature, as well as cardiac monitoring, pacing, neurology and obstetrics and gynecology devices.  Beginning in 2007, Ms. Goode has served as an FDA liaison to and International Expert for several ISO Working Groups responsible for the development of international standards for the biocompatibility evaluation of medical devices, including ISO 10993-1, ISO 10993-4, and ISO 10993-18.   Since 2017, Ms. Goode has represented CDRH on the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). This committee is responsible for coordination of review and acceptance of fit for purpose new or revised toxicology test methods that reduce, refine, or replace the use of animals.  In 2018, Ms. Goode was selected as FDA’s Alternate Agency Representative to ICCVAM.  Since 2018, Ms. Goode has also served as the CDRH regulatory expert for the USP Biocompatibility Expert Panel which is tasked with revision of General Chapters <87>, <88>, and <1031>. In 2018, Ms. Goode was also selected to serve as the regulatory co-chair for the US AAMI Biological Evaluation (BE) mirror committee to ISO/TC 194. The AAMI/BE committee is responsible for coordinating US positions on all ISO standards related to biocompatibility evaluation of medical devices.   Since 2008, Ms. Goode has also served as one of two Office of Device Evaluation representatives to the Biocompatibility Standards Task Group (STG) at CDRH.  This Biocompatibility STG is responsible for coordinating FDA input to, and scientific review and recognition of all biocompatibility standards used by CDRH.

  • 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.

  • Theodore Heise, PhD, 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 12 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. As convenor, Dr. Heise is leading the process of re-writing ISO 10993-18 to reflect current best practices in chemical characterization, including evaluation of extractables and leachables.

  • Dr. Dennis Jenke

    Chief Executive Scientist Triad Scientific Solutions, UK

    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. 

  • Dr. Matthew Jorgensen

    Senior Extractables and Leachables Expert 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.

  • Jing Kong, PhD

    Senior Scientist, Analytical Characterization R&D Ethicon (Johnson & Johnson Medical Devices)

    Jing Kong is a senior scientist at Ethicon, Johnson & Johnson. She earned her PhD in Chemistry from Carnegie Mellon University, where she studied various synthetic peptide nucleic acids by MALDI-ToF. She lectured Physical Chemistry and Organic Chemistry at Carnegie Mellon University and Duquesne University after graduation.

    Her industrial experience first started in the E&L field at SGS, focusing on the identification and quantitative analysis of Extractables and Leachables from medical devices and pharmaceutical packaging materials. Jing continued her career in E&L field with Ethicon, analytical characterization team. In her current role, she provides analytical support for R&D and manufacturing with the emphasis on Extractables and Leachables analysis on various samples from raw materials, packaging components, to finished products such as sutures, hemostasis pads, wound closure systems, breast implants, and other medical devices.

  • Kady Krivos, Ph.D.

    Senior Scientist, Corporate Functions-Trace Analytical Capability Procter & Gamble

    Kady Krivos received a B.A. in Chemistry from The College of Wooster (Wooster, OH) in 2005. After working for several years at a contract research lab doing bioanalytical method development on LC-MS and GS-MS instrumentation, she returned to graduate school an obtained her Ph.D. in Analytical Chemistry from The University of Cincinnati (Cincinnati, OH), studying with Professor Patrick Limbach.

    Kady is currently a Senior Scientist in Procter & Gamble’s Corporate Functions-Trace Analytical Capability.  She joined P&G’s R&D as a Scientist in 2010.  At P&G, she is responsible for strategies to implement an array of complex mass spectral quantification and identification problems, across all of P&G’s consumer product programs, from upstream innovation projects through marketed-product and manufacturing needs.  Her research interests include instrumentation and methodologies for mass spectral analysis, including non-regulated assessments of products for extractable & leachables. Kady is the author of 9 publications and patents.

  • Markus Obkircher, PhD

    Head of Reference Materials Research & Development Millipore Sigma

    Markus Obkircher is the head of Merck’s Reference Materials Research & Development division with teams in the US and Switzerland. He is responsible for the in-house development of new analytical standards and certified reference materials. Prior to this position he was R&D Manager in Buchs, Switzerland, with a strong focus on synthesis, characterization and certification of reference materials. He joined Merck / Sigma-Aldrich five years ago after heading the development unit for a custom API manufacturer. Before that he completed his post-doctoral studies at Harvard in Boston and his PhD thesis in Basel, Switzerland.

  • R. Daniel Mellon, PhD

    Pharmacology Toxicology Supervisor FDA, Center for Drug Evaluation and Research (CDER)

    Dr. Mellon obtained his BS in biology from Allegheny College in Meadville, PA, his PhD in Pharmacology from Georgetown University, and completed post-doctoral research at the National Cancer Institute prior to joining the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND).  He began his career at FDA as a Pharmacology Toxicology Reviewer in the Division of Anesthetics, Critical Care, and Addiction Drug Products in the fall of 2001.  In August of 2003, Dr. Mellon was appointed the Pharmacology Toxicology Supervisor in that division, which has subsequently been renamed the Division of Anesthesia, Analgesia, and Addiction Products (DAAAP).  He is currently a member of the Pharmacology Toxicology Coordinating Committee (PTCC) within the Office of New Drugs, CDER, FDA as well as the supervisory co-chair for both the Immunotoxicology and Neurotoxicology Assessment Subcommittees of PTCC.

  • Nick Morley

    Principal Scientist Hall Analytical Laboratories

    Nick is a Principal Scientist at Hall Analytical Laboratories responsible for providing technical support to new and existing pharma, med device and ENDs customers in the field of extractables and leachables. Nick’s area of expertise includes E&L study design, 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. Where he had responsibility for the E&L assessment of devices, closure systems and manufacturing processes to ensure patient safety, product quality and regulatory approval. 

  • Dr. Nikhil Sahotra

    Materials Emission Market Specialist Markes International, UK

    Dr. Sahotra got his BSc in Chemistry from the University of Central Lancashire, followed by MSc in Drug Chemistry from Newcastle University. In 2018 he completed his PhD in organic chemistry. Since then he has been working for Markes International, specialist in thermal desorption technology. His current job involves the sampling and analysis of air borne chemical from products and materials.

  • Anita Y. Sawyer

    Independent Biocompatability Expert ISO/TC I94 Extraction Task Force Leader

    Anita York Sawyer is an experienced biomaterial/ biocompatibility scientist with nearly 30 years of experience in R&D and the management of biocompatibility testing and relevant standards. She holds a BS in Microbiology and MS in Biology with post-graduate studies in Toxicology and Pathology.  Her initial research focus was the development of in-vitro test methods to-evaluate the thrombogenicity of cardiovascular materials, which led to a successful in-vitro 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 BD and Cordis, a J&J Company. She is an expert on the pre-clinical safety evaluation of medical devices and has been an active member of ISO TC 194, Biological Evaluation of Medical Devices since 1990. She is presently Convenor of ISO TC/ 194 Working Group 12 (Sample Preparation and Reference Materials), US Co-Chair for Working Groups 1 (Evaluation and Testing) and WG 9 (Effects on Blood); and a Technical Expert for seven other ISO TC/194 Working Groups, including WG 14, Material Characterization. She is author of two ASTM in-vitro hemocompatibility/ thrombogenicity test methods and Sub-Committee Chair for ASTM F04.16, Biocompatibility of Materials. Anita is also a member of the USP Biocompatibility of Materials Expert Panel. In the last two years she has led the ISO 10993 Extraction Condition Task Force and served as the interlaboratory Round Robin project leader.

  • Sandi Schaible

    Senior Director, Analytical Chemistry and Regulatory Toxicology WuXi AppTec, USA

    With over 25 years’ experience, Ms. Schaible is responsible for oversight and direction of WuXi AppTec’s Analytical Chemistry department in St Paul, Minnesota. The analytical staff she manages is responsible for providing custom chemistry testing services including extractables/leachables, materials characterization and target analysis testing, method development, method validation as well as standardized testing including compendial testing.

  • Dr. Cheryl Stults

    Principal C&M Technical Consulting

    Dr. Stults is Principal at C & M Technical Consulting, LLC, working with various local and global companies to advance the development of parenteral and inhalation products. Her primary area of focus is on device and packaging materials analysis and characterization for purposes of selection, qualification and control. She holds a Ph.D. in Analytical Chemistry from Michigan State University and a Masters in Management from Aquinas College. Prior positions include: Senior Fellow at Novartis Pharmaceuticals Corporation, Assistant Research Professor at San Francisco State University and Quality Associate at a Johnson & Johnson owned company. She was co-editor of the Leachables and Extractables Handbook (Wiley 2012) and has been a member of the Board of Directors for two consortia: Extractables and Leachables Safety Information Exchange (ELSIE) and International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). She has been actively involved in the ELSIE Pilot Protocol Study and database development. She previously led IPAC-RS working groups to develop Materials Baseline Requirements for OINDP, a Leachables and Extractables Development Paradigm and a Chemical Risk Evaluation tool and has continued involvement as an IPAC-RS Science Advisor participating in global outreach and materials related initiatives. Dr. Stults is currently a USP Packaging and Distribution Expert Committee member contributing to development and revision of materials-related chapters.

  • Gyorgy Vas, Ph.D.

    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.

  • Stephen Warren

    Scientist AstraZeneca

    Stephen manages the internal and external E&L activities within AstraZeneca’s Inhaled Product Development unit.  After graduating the University of North Carolina at Chapel Hill he began his career in pharmaceutical development and has over 16 years of industry experience with a focus on inhalation technology and testing.  In his current role at IPD-US, he runs the global leachables stability programs, conducts extractables characterizations, authors Reg-CMC submission documents, provides on market support for product changes, handles investigations into unknown E&L related compounds, and manages leachables method development/validation activities.  As an E&L subject matter expert in OINDPs, he is part of AZ’s E&L Global Network and represents AZ as a member of ELSIE and the IPAC-RS Materials Working Group where he works to advance understanding of the impact of E&L on product quality and process performance.

  • Dr. 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.  

  • Xiaochun Yu, Ph.D.

    Senior Principal Scientist & E&L Subject Expert PPD Laboratories

    Xiaochun Yu is a senior principal scientist and extractables and leachables subject expert at PPD® Laboratories.  He received a bachelor’s degree in chemistry from Zhejiang University, China, and a Ph.D. in polymer chemistry from the Institute of Chemistry, Chinese Academy of Sciences, China. 

    Dr. Yu has led a team working in extractables and leachables for more than 15 years and has provided advice and consulting to numerous pharmaceutical companies for their extractables and leachables programs. He has led the successful design and execution of many extractables and leachables programs with drug products approved by FDA. In 2018 alone, at least 10 drug products, with extractables and leachables studies completed by Dr. Yu’s team, were approved by FDA.

  • Doris Zane, PhD, DABT

    Executive Director of Nonclinical Development Intarcia Therapeutics, Inc.

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

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

    Doris has over 15 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.