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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA Endotoxins Workshop

October 17-18, 2018, Bethesda, MD

Committee & Speaker Biographies

  • Ned Mozier

    Ned M. Mozier, PhD

    Pfizer Inc.

    Ned Mozier is Vice President of Portfolio and Project Management in Pfizer’s Research and Development organization within the division of Biotherapeutics Pharmaceutical Sciences. He chairs Pfizer’s Impurity Council. Pfizer has a diverse development portfolio including monoclonal antibodies, conjugates, therapeutic proteins, gene therapies and vaccines. Ned previously led the Bioassay and Impurity Testing group in Pfizer. He has also worked at Pharmacia, Baxter and The Upjohn Company. He received his Ph.D. in Biochemistry from the University of Louisville.

  • Jay Bolden

    Jay S. Bolden

    Eli Lilly and Company

    Mr. Jay Bolden is an Senior Consultant Biologist in the Eli Lilly and Company Global Quality Laboratories.  He is an internal endotoxin subject matter expert and leads a team with global QC oversight for developing, validating, transferring and troubleshooting endotoxin, microbiology, QPCR and ELISA methodologies.  Jay holds a B.S. in Biology and an Environmental Studies certificate from Indiana University, and has over 19 years of industry experience in development, process and laboratory microbiology, and microbiology laboratory leadership.

  • Jessica Hankins

    Jessica V. Hankins, PhD

    FDA

    Jessica Hankins, Ph.D. is a microbiology reviewer in the Division of Microbiology Assessment in FDA's Center for Drug Evaluation and Research. She has over 12 years research experience, which focused on the outer membrane of Gram-negative bacteria. Jessica's doctoral and post-doctoral work concentrated on understanding the biosynthetic pathway of LPS in Vibrio cholerae.

  • Johannes Reich

    Johannes Reich, PhD

    Microcoat Biotechnologie GmbH

    Johannes Reich holds a PhD from the University Regensburg. He focused his research on the aggregation and interaction behavior of lipopolysaccharides as well as the related activity in limulus based detection systems. In 2016, Johannes joined Microcoat Biotechnology GmbH and has recently been appointed General Manager. Johannes Reich also received a degree in Business administration from University of Applied Science in Regensburg, Germany. While pursuing his degree, he worked as Product Manager for the department “Drugs of Abuse” at Profos AG.

  • James Akers

    James E. Akers, PhD

    Akers Kennedy & Associates, Inc.

    After earning a Ph.D. in medical microbiology with a concentration n virology at the University of Kansas School of Medicine, Dr. Akers spend five years in academics teaching and doing research in virology   He left academics for the pharmaceutical industry in 1981 and has been working with Shibuya since 1991. Dr. Akers served as President of PDA from 1991-1993 and served for many years on that organizations Board of Directors.  He has been a member of the United States Pharmacopeia Expert Committee on Microbiology since 1995 and served as that Committee’s Chairman from 2005 to 2010.  Dr. Akers has chaired or served on many USP expert panels on a wide range of topics including analytical microbiology, translational medicine, sterile pharmacy compounding. Dr. Akers has authored over 100 publications and written 31 text book chapters as well as editing two books.  His principal areas of interest are aseptic processing technologies, sterilization, contamination control, and analytical microbiology.

  • Peter Bruegger

    Peter Bruegger

    Lonza AG Basel

    After study of Microbiology in Basel Peter Bruegger does additional studies in Environmental Hygiene and Biostatistics at the university Louis Pasteur in Strasbourg, France, and at the Endocrinological Institute of Heidelberg, Germany.

    In 1978, he became Head of Laboratory at Ciba Geigy, Stein, Switzerland. Since 1997 he has been Unit Head QA/QC at Novartis, Basel (CH). In 2008 he became QC Expert for Biological Analytics at Novartis, Technical Operations / Quality Assurance.

    Since 2008 delegate for Swissmedic as member of the Bacterial Endotoxins Test and Monocyte Activation Test Working Party (BET) at the EDQM in Strasbourg.

    Today,  Head of Bioassay & Microbiology at Lonza AG Switzerland. One major topic is the introduction of a robust methodology for MAT with the goal to replace the rabbit pyrogen test.

  • Lynne Ding

    Lynne JL Ding, PhD

    National University of Singapore

    Jeak Ling DING is a Professor at the Department of Biological Sciences, National University of Singapore (NUS). Her research focusses on understanding the basic biology of ‘Host-Pathogen interaction and innate immunity”. Her findings have been published in Nature Immunology, EMBO J, Proc Natl Acad Sci (USA), PLoS Pathogens, Cell Death & Differentiation, Science Signaling, J Immunology. She keeps a keen eye on potential biomedical applications of her discoveries.

    For her research achievements, Prof Ding has received various awards e.g. National Science & Technology Award for 'outstanding contributions to genetic engineering' (1995); Far Eastern Economic Review Award for Scientific Innovations (2000); NUS Outstanding Researcher Award (2000); Faculty of Science, NUS Outstanding Researcher Award (2008); Provost Chair Professorship, NUS (2009); Outstanding Innovation and Enterprise Award, NUS (2012); Fellow, Singapore National Academy of Science (2016).

  • James Henderson

    James Henderson

    Eli Lilly and Company

    Jim Henderson has 27+ years of experience around QC Laboratories in multiple roles: analytical equipment qualification and validation, global consultant for data integrity and lab analytical equipment qualification and validation, and Business QA / Computer System QA.  Jim has been deeply involved in data integrity improvement efforts for the past 7 years.  He co-authored and delivered a global project to train QC Lab personnel in data process mapping, identifying and remediating data integrity risks.  Jim co-authored the internal global standard on Laboratory Analytical Equipment Qualification and Software Validation.  Jim co-authored the new Rx-360 GMP Audit Manual Data Governance and Data Integrity. 

  • Antje Hermelink

    Antje Hermelink

    West Pharmaceutical Services

    Dr. Antje Hermelink received her PhD in medical biophysics from the Humboldt University, Berlin and worked subsequently for more than 8 years at the Robert-Koch Institute, a German federal governmental agency and research institute responsible for disease control and prevention.

    She is a global subject matter expert and Senior Laboratory Manager at West Pharmaceutical Services, with over 10 years of experience in medical Microbiology.

    As part of her role, she is leading developmental projects with a strong focus on global harmonization of final release test methods on medical devices.

    Prior to her current position, Antje was part of the Global outbreak alert and response network of the WHO and employed as laboratory administrator of the Ebola response team in 2015 in Freetown, Sierra Leone.

  • Mark Kapeckas

    Mark J. Kapeckas

    Sanofi Biologics

    Collaboration and passionate sharing of solutions are woven into Mark Kapeckas’ fabric.  There are too many patients to serve, and unmet medical needs to work in a less efficient way.  Mark Kapeckas’ career spans the fields of traditional pharmaceuticals, electronic materials, contract manufacturing, and biologics.  Roles have included positions in R&D for test methods and new products, Project and Program Management, Quality Control, Quality Assurance, Quality Engineering.  Mark has focused this unique experiential perspective on Biologics Quality for the past 10 years.  Mark currently leads several global initiatives within the Sanofi Biologics Quality organization.  Relevant micro-focused leadership roles include the Sanofi Global Working Group and Quality Commission responsible for all aspects of Low Endotoxin Recovery (LER).  Also head of the Micro Test Method Lifecycle Management Group globally, Mark drives continuous improvement of micro testing and compliance globally.  Externally, Mark is an active member of the BioPhorum Operations Group (BPOG) Rapid and Reliable Micro Methods sub-team.

  • Scott Kaszuba

    Scott Kaszuba

    Pfizer Inc.

    Scott Kaszuba studied Biology at the University of Massachusetts at Lowell. He has been working for the QC Microbiology group at Wyeth/Pfizer’s Andover MA facility for fifteen years. In his current position, Scott, is one of the managers overseeing all testing and non-testing activities performed within the QC Microbiology group.

  • Jack Levin

    Jack Levin, MD

    University of California School of Medicine, San Francisco

    Dr. Levin has been a member of the faculty of the University of California School of Medicine in San Francisco since 1982. Previously, he was Professor of Medicine at The Johns Hopkins Univ. School of Medicine, Baltimore, MD. Dr. Levin is the author or co-author of over 250 original research publications, reviews, and book chapters. He was Editor-in-Chief of the Journal of Endotoxin Research from 1998 to 2004. His studies of blood coagulation in Limulus, the horseshoe crab, performed at the Marine Biological Laboratory (Woods Hole, MA), identified the key role of amebocytes, the only type of circulating blood cell in the horseshoe crab, in blood coagulation. His recognition of the sensitivity of amebocytes and subsequently of lysates prepared from washed amebocytes to bacterial endotoxins led to his original description of the Limulus Amebocyte Lysate Test for the detection of bacterial endotoxins in 1964.  His studies of the biological effects of bacterial endotoxins and utilization of the Limulus Test for detection of endotoxin in the blood of patients with various clinical disorders led to his receiving the Bang Award for research in bacterial endotoxins and to election as an honorary life member of the International Endotoxin and Innate Immunity Society. In 2014, Dr. Levin received a special award from the Parenteral Drug Association in recognition of the 50th anniversary of his initial description of the Limulus Amebocyte Lysate (LAL) Test.

  • Karen McCullough

    Karen Z. McCullough, MS

    MMI Associates

    Karen Zink McCullough is owner and principal consultant at MMI Associates.  She is acknowledged as an expert in the field of bacterial endotoxin testing, and has published widely on the subject. She is the editor and an author of the book, "The Bacterial Endotoxins Test:  A Practical Guide,"   Ms McCullough is Founder, Charter Member, and Steering Committee Member for the LAL Users' Group.  She is a  member of the USP Expert Microbiology Committee, General Chapters and is a US delegate to ISO TC 209, WG02, revision to ISO 14698, "Biocontamination."  Ms. McCullough received her BA in Bacteriology from Rutgers University and her MS in Molecular Biology from the University of Oregon.  

  • Youwen Pan

    Youwen Pan, PhD

    Genentech

    Youwen Pan, Ph.D., a Senior QC Scientist at Global QC, Roche/Genentech, has more than 15 years of working experience in QC microbiology. His expertise majors in QC microbiological test methods, alternative microbiological methods, sterility assurance of both aseptic processing and terminal sterilization.

  • Kevin Williams

    Kevin L. Williams

    bioMerieux
    Kevin Williams worked for Eli Lilly for 30 years, developing QC tests for endotoxin detection, process control and control strategies of raw materials/excipients and container/closures. He wrote and edited the 2nd and 3rd editions of the book Endotoxins. He currently works for bioMerieux. 
  • Veronika Wills

    Veronika Wills, MSc

    Associates of Cape Cod, Inc.

    Veronika Wills manages the Technical Services group at Associates of Cape Cod, Inc. She joined the team in 2007 and thanks to her strong knowledge of biochemistry, microbiology and immunology, brings an expertise that is vital to ACC customers when it comes to technical support of testing complex samples, Low endotoxin recovery matrixes and troubleshooting of the Bacterial Endotoxins Test at all levels. Veronika speaks frequently at scientific conferences and seminars globally and is an established expert on endotoxin testing. Veronika holds a Master’s Degree in Biochemical Engineering from the Institute of Chemical Technology in Prague, Czech Republic.

  • Qing (Joe) Zhou

    Qing (Joe) Zhou, PhD

    Allergan

    Qing Zhou, PhD, received his Ph.D. in physiology from University of Illinois at Urbana-Champaign and did his postdoc training in molecular biology at Washington State University. He currently is associate director in Non-Clinical and Translational Sciences at Allergan where he assumes responsibilities of large molecule immunogenicity evaluation, assay development and biomarker development. He also serves as bioanalytical lead and clinical biomarker team lead supporting clinical studies. He has special interest in IIRMI risk assessment for biotherapeutic products and precision medicine.