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Committee & Speaker Biographies

Committee & Speaker Biographies

2021 PDA Endotoxins Workshop

07 October 2021

  • Jay Bolden

    Jay S. Bolden

    Eli Lilly
    Mr. Jay Bolden is an Associate Quality Advisor-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 21 years of industry experience in development, process and laboratory microbiology, and microbiology laboratory leadership.
  • Jessica Hankins

    Jessica V. Hankins, PhD

    Bristol Meyers Squibb

    Jessica Hankins, Ph.D. is a Associate Scientific Director in the Microbiology Center of Excellence/Analytical Strategy and Operations for Bristol Meyers Squibb. 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.

  • Ingo Spreitzer PhD

    Ingo Spreitzer, PhD

    Paul-Ehrlich-Institut

    Dr. Ingo Spreitzer is working for the Paul-Ehrlich-Institut as the deputy head of Section 1/3 Microbiological Safety. He is specialized in Pyrogen- and Endotoxin-Testing, and works as the current Chair of the Endotoxin Working Party together with the European Pharmacopeia. During his PhD-research on immune-activating components of bacteria (Prof. Thomas Hartung) Dr. Spreitzer was introduced to the world of Pyrogen testing. He started at the PEI in 2001, his duties are drug QC by BET (all methods), Pyrogen testing (rabbit pyrogen test until 2014, now replaced by MAT), assessment and the exploration of new methods. He was a member of the EDQM MAT-Working Party since 2001. In 2010 the MAT was introduced into the Ph.Eur. Since 2013 he is the Chair of the BET-Working Party, which now covers MAT, BET and rFC. Finally in 2020 rFC was introduced into the Ph.Eur. In June 2021 the Ph. Eur. announced to completely replace the RPT by MAT or BET within the next 5 years.

  • Anders Thorn

    Anders Thorn, MSc

    Novo Nordisk A/S

    Anders Thorn has been with Novo Nordisk since 2005 in the Quality Control Microbiology department, responsible for the Test for Bacterial Endotoxins. He has managed harmonisation and optimisation projects within the BET at Novo Nordisk. Through his years in the pharmaceutical industry he has gained an in-depth understanding of testing methodology, pharmacopoeial requirements and current Good Manufacturing Practices in the field of pharmaceutical microbiology.

  • Reyes Candau-Chacon

    Reyes Candau-Chacon, PhD

    U.S. FDA
    Reyes Candau-Chacon, PhD is a microbiologist in Branch 2 of the Division of Biotechnology Manufactruing (DBM), Office of Pharmaceutical Quality, CDER). DBM evaluates the microbial quality and sterility assurance as well as the facility compliance status of biological license applications. This is conducted in a comprehensive manner and includes reviewing the microbiology aspects of the BLA as well as inspecting the manufacturing facilities. In addition, the division participates in writing guidelines, policies, and procedures.

    Prior to her current position, Reyes worked in the Diagnostic industry developing methods to detect genetic biomarkers in blood circulating DNA and before that, she worked in the Biotech industry developing Molecular Biology tools. Reyes holds a PhD in Biology from the University of Sevilla, Spain and conducted post-doctoral research in Marburg, Germany and at the University of Pennsylvania on transcriptional regulation in yeast and mammalian cells.
  • Emmanuelle Charton PhD

    Emmanuelle Charton, PhD

    EDQM

    Emmanuelle Charton holds a PhD in biochemistry from the Institut National Agronomique de Paris-Grignon. Since 2006 she is Head of Division B in the European Pharmacopoeia department at the European Directorate for the Quality of Medicines and HealthCare (EDQM). The Scientific Secretariat for the elaboration of European Pharmacopoeia texts related to microbiology fall under the responsibility of her division. Her work experience includes QA/QC in a facility for the production of parenteral products and preparation to GMP inspections in a global pharmaceutical company, research and development in biochemistry in a global company selling food and chemicals. She has over 25 years’ experience at the EDQM, including as scientific administrator to the groups of experts in the fields of biology and microbiology and as a supervisor to the corresponding work in the EDQM laboratory.

  • Benjamin Claywell

    Benjamin Claywell

    Eli Lilly and Company

    Ben Claywell is a Sr. Scientist in the Eli Lilly and Company Global Quality Laboratories. He is part of a team with global QC oversight for developing, validating, transferring and troubleshooting endotoxin, microbiology, QPCR and ELISA methodologies. Ben holds a B.S. in Chemistry-Biochemistry from Purdue University.

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    Evelyn Der, RM, SM, CQA, CPGP

    Genentech

    Evelyn Der is a QC Senior Scientist at Roche Genentech Global Innovation and Implementation group based in South San Francisco, CA. In this role, she provides subject matter expertise as well as technical leadership on microbiology matters such as compliance, technology transfer, methods management, and contamination control. She is also Roche’s lead for the Analytical Technology Center, a QC network team focused on microbiological related analytical technology for all product modalities,. She has over 25 years of biopharmaceutical quality experience with a focus on microbiology. Evelyn received her Bachelor’s degree in bacteriology and immunology with a focus on clinical science from the University of California, Berkeley. She holds multiple certifications in Regulatory Affairs, Quality & Compliance from UC Berkeley, and Auditing and Pharmaceutical GMPs from the ASQ. She is also an ASM NRCM registered and specialist Microbiologist.

  • Phil Duncanson PhD

    Phil Duncanson, PhD

    AstraZeneca

    Phil Duncanson is the Chief Microbiologist for Global Quality at AstraZeneca.

  • Josiah Hosie

    Josiah B. Hosie

    Lonza

    Josiah Hosie is a Product Strategist for endotoxin software solutions for Lonza Biotech & Pharma. He has 15 years in product development experience in laborartory systems, automation, pyrogen detection and data visualization. In 2019 he co-authored a chapter on data integrity in the book Endotoxin Detection and Control in Pharma, Limulus and Mammalian Systems.

  • Karen McCullough

    Karen Z. McCullough, MS

    MMI Associates

    Karen Zink McCullough is the Principal Consultant at MMI Associates, LLC. She has a degree in Microbiology from Rutgers University and a Masters degree in Molecular Biology from the University of Oregon. Karen has been involved in endotoxin testing for 40+ years, and is an expert in the field, having published and spoken widely on the subject of bacterial endotoxins. She has held numerous leadership and executive level positions in pharmaceutical manufacturing, cell and gene therapy manufacturing and CDMOs and has been a key participant in a number of cell and gene start-ups, focusing on Quality Systems, Quality by Design, Facilities and Validation. She has been a member of the United States Pharmacopeia Expert Committee, Microbiology General Chapters since 2010.

  • Kevin Miller

    Kevin Miller, PhD

    Hamilton Company

    Kevin W.P. Miller, MS, PhD Senior Market Segment Leader, Government and Regulated Laboratories Kevin Miller is Sr. Scientific Leader for Government and Regulated Laboratories at Hamilton Robotics in Reno, NV, where he provides thought leadership towards automated solutions throughout all aspects of these focused markets. After earning a PhD in Molecular Biology from the University of Cambridge, Dr. Miller actively engaged in promoting, researching, and furthering forensic science advances, and remains committed to this endeavor today. In addition to academic and instructive teaching experience including developing and directing a Professional Science Master’s Degree Program at the California State University, Fresno, he led forensic scientists and crime scene investigators at federal, state and local levels of government while integrating new/emerging technologies such as the first local DNA database to use probabilistic genotyping for mixture resolution, and early adoption of digital and cloud-based documentation/reporting of laboratory results. He developed patented software to automate forensic facial reconstruction, and served as Program Manager for a mtDNA population database for the FBI, and ultimately migrated this into the CODIS database. Dr. Miller is actively involved in quality assessment, and publishes, and lectures on a wide breadth clinical and forensic issues across the globe.

  • Victoria Rensink

    Victoria Rensink, MLS(ASCP), CTBS

    Xtant Medical

    Victoria Rensink is a certified Medical Laboratory Scientist and Tissue Bank Specialist and is the Laboratory Manager at Xtant Medical. Xtant Medical designs and develops orthobiological tissue for transplant from cadaveric tissue. The laboratory at Xtant Medical evaluates infectious disease testing, performs pathogenic microbiology on all donor tissue and specimens, performs in-process testing on tissue samples, and performs final product testing on tissues and medical devices.

  • Douglas Roepke

    Douglas Roepke, MD

    Eli Lilly and Company

    At age five, Douglas Roepke told his mother he wanted to be a physician. 45 plus years later, he is an experienced clinical general pediatrician with 15 years of broad patient contact experience, including with the pediatric special needs population that extensively utilizes the products of the pharmaceutical industry. Since 2008, Doug has been at Eli Lilly and Company, focused on patient safety. He has both adverse event reporting and pharmacovigilance experience in safety. Doug has been in a product safety assessment physician role since 2015 focused on health hazard evaluations and other product safety assessments, drug adverse event /product complaint (AE/PC) surveillance, device safety activities, device AE/PC surveillance, corporate drug substance and drug product specifications, manufacturing change comparability, and anti-counterfeiting risk assessment and investigation support.

  • Kevin Williams

    Kevin L. Williams

    bioMerieux

    Kevin spent 30 years at Eli Lilly & Company developing endotoxin assays and detection technology in the QC lab. Since retiring from Lilly, he has worked at Hospira (now Pfizer), Lonza, GE Water and now bioMérieux. He has authored several books on endotoxin (Endotoxins 2nd and 3rd ed. – Informa) including most recently “Endotoxin Detection and Control in Pharma, Limulus, and Mammalian Systems” (2019, Springer Nature).