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Committee & Speaker Biographies

Committee & Speaker Biographies

14th Annual PDA Global Conference on Pharmaceutical Microbiology

October 21-23, 2019, Rockville, MD

  • Amy McDaniel

    Amy L. McDaniel, PhD

    Bristol-Myers Squibb

    Amy McDaniel is the Microbiology Center of Excellence Leader at BMS, based in New Brunswick, NJ.  In this role she oversees microbiology methods globally, and is responsible for bringing new technologies into BMS.  Prior to Bristol Myers, Amy worked as a microbiology reviewer at the FDA in CDER, where she assessed applications for sterile pharmaceutical drug products.  She also has 18 years of experience in various roles in biotechnology at Pfizer, including QC Microbiology, Manufacturing, Technical Operations, and Quality Assurance.  Amy has written numerous articles and given many presentations on rapid microbiology methods and risk assessments in microbiology.

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    MaryEllen E. Usarzewicz, MS

    Bristol-Myers Squibb

    MaryEllen E. Usarzewicz received her B.S. in Microbiology from Wagner College in 2000. After several years working in CRO’s, she joined BMS in 2007, eventually ending up, through various roles as Associate Director, Microbiological Support Operations.  She oversees a group of 17 who are responsible for providing microbiological support of non-sterile and sterile clinical manufacturing operations including environmental monitoring, drug product testing and facility qualifications.  She is active in several teams in the Parenteral Drug Association.  In her spare time, she is busy raising 2 children.

  • Ebony Arrington

    Ebony S. Arrington, MS

    Pfizer, Inc.

    Ebony Arrington is a Manager within Production Operations at the Pfizer Sanford, North Carolina site. She works with the Central Support team responsible for cell banking, weigh and dispense operations, investigations, change controls, electronic batch record system, and document lifecycle management among other support functions for daily manufacturing operations at the Sanford facility. She also supports aseptic training to manufacturing colleagues, as well as microbial contaminations and environmental excursions. In her previous role, Ebony served as the site Cell Bank Lead managing production of starting material for vaccines such as Prevenar 13 and Trumenba. Prior to joining the Operations team, Ebony was a scientist within the QC Microbiology group responsible for the analytical development and implementation of new assays and technologies. Her past experience also includes environmental monitoring, product testing, as well as extensive knowledge and experience with fungal and microbial identification. She holds a Bachelor of Science in Biology with a concentration in Genetics from Duke University and a Master of Science degree in Clinical Research from Campbell University.

  • Renee Blosser

    Renée S. Blosser, MS

    FDA

    Renée Blosser joined the FDA in 2004 and is currently a Master Microbiology Reviewer in the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation at CVM. She has extensive experience in aseptic processing for finished drug products and review of media fill and sterility failure investigations. She also serves as a Quality Assessment Lead for review of pioneer and generic injectable drug products. Prior to joining the FDA, Renée worked in the field of antimicrobial drug development and surveillance of antimicrobial resistance.

    Renée received a Bachelor of Science in Biology from Florida State University and a Master of Science in Microbiology from the University of South Florida.

  • Bo Chi

    Bo Chi, PhD

    FDA

    Bo Chi is currently a reviewer in Branch IV in the Division of Microbiology Assessment, Office of Process and Facilities, Office of Product Quality in CDER/FDA. The branch is responsible for microbiology quality review and pre-license and pre-approval inspections of biotech products. Bo has been with the FDA for more than 15 years. She has a Ph.D. in Microbiology.

  • Irving Ford

    Irving Ford, MSc

    Celgene, Biotechnology Company

    Irving Ford is currently the Head of CAR T QC Laboratories at Celgene. Prior to joining Celgene, Irving was a significant contributor for activities supporting the commercial approval of Novartis’ CAR T product Kymriah®.

    Irving has over 28 years of QA/QC experience in the pharmaceutical/biotechnology and cell and gene therapies industries including, but not limited to, non-sterile, sterile, and low bioburden manufacturing production. Irving has designed, implemented and managed paperless laboratories.

    Irving has a successful track record working with laboratory, facilities, validation, manufacturing, regulatory, QA, R&D, and compliance personnel to manage and resolve complex quality and manufacturing issues.

    Irving has served as the subject matter expert during numerous contract service provider audits as well as for regulatory inspections/filings. Irving was also involved in a successful consent decree remediation.

    Irving is an active member of PDA and recently served on the planning committee for the 2018 PDA Global Conference on Pharmaceutical Microbiology. Irving is also a co-author/contributor for the PDA’s TR for EM of Low Bioburden Facilities.

    Currently, Irving is working on a task force for creating an ISO Standard for the apheresis collection. Irving is also co-authoring a White Paper for appropriate microbiological controls for ATMPs manufacturing.

  • Leslie Furr

    Leslie A. Furr, MS, SM (NRCM)

    US Pharmacopeia

    Leslie Furr is an Associate Scientific Liaison to the Compendial Sciences-General Chapters group at the United States Pharmacopeial Convention.  She has been with USP since 2018 where she is a liaison to the Packaging and Distribution and Microbiology Expert Committees.  Before becoming a liaison at USP she was an Expert Committee volunteer for the Chemical Medicines group with expertise in antibiotic testing.   She holds a certification from the American Society for Microbiology as a Specialist Microbiologist in Pharmaceutical and Medical Device since 2012.  Prior to working at USP, she was a Senior Microbiologist in the pharmaceutical industry where she spent 14 years in method development, R&D, and manufacturing support for non-sterile products.  She obtained her B.S. in Microbiology from the University of North Carolina at Charlotte and her M.S. in Pharmaceutical Sciences at the University of Florida.

  • Mitch Garber

    Mitch B. Garber, BS, RPh

    GlaxoSmithKline

    Mitch Garber is a Director of Sterile and BioPharm Product Quality with GlaxoSmithKline, where he provides technical and quality support for the manufacture of BioPharm bulk and sterile commercial and clinical products used worldwide.  He obtained his Bachelor of Science in Pharmacy from the University of Sciences in Philadelphia (formerly Philadelphia College of Pharmacy and Science) and is a registered pharmacist.  Mitch has over 34 years of professional experience in regulatory compliance, aseptic manufacturing, validation, GMP auditing, and sterile product/process development and quality.    

    He is active in the field of aseptic manufacturing and compliance and has served on committees within Parenteral Drug Association (PDA) and GSK including GSK’s Aseptic Manufacturing Taskforce Group.  Mitch has presented in several countries for PDA and GSK. He was also the Program Committee Chairman of the Delaware Valley Chapter of the PDA. 

  • Christine Sherman

    Christine Sherman, BA

    Takeda
    Christine Sherman is a member of the Takeda Global Microbiology Management team and is based in Cambridge, Massachusetts.  Her background in Microbiology consists of supporting facilities that manufacture pharmaceutical products (sterile and non-sterile), biologics, and vaccines.  Prior to joining Takeda in 2017, she worked for several microbiology laboratories in the pharmaceutical industry including Johnson & Johnson, Pfizer and later, Merck in Sterility Assurance roles in the vaccines facilities.  In these roles, she was responsible for ensuring product sterility by supporting environmental monitoring, process simulation, and smoke studies programs and well as facilitating internal Microbiology Communities of Practice focused on bioburden control.  Throughout her career, she has interacted with various regulatory agencies and supported internal audits as a Microbiology SME.
  • Kim R. Sobien, MBA

    PETNET Solutions | A Siemens Company

    Kim Sobien is currently the Principal Sterility Assurance Engineer for PETNET Solutions, a wholly owned subsidiary of Siemens Medical Solutions USA, Inc., which operates the largest network of PET radiopharmacies worldwide.

    Previously she has served as an Associate Director of Regulatory Compliance at Merck, Regulatory Compliance Lead at BD Rx, Inc., and Microbiology Laboratory Manager at Oso BioPharmaceuticals.  Her pharmaceutical industry career encompasses a breadth of experience with injectable pharmaceutical product Quality and Compliance, including pre-filled syringe generics, radiopharmaceuticals, and parenteral pharmaceutical contract manufacturing.

    Kim has a B.S. in Microbiology from the University of Wisconsin – La Crosse and a Master of Business (MBA) degree with an emphasis in Global Management from the University of Phoenix.  She is a member of the Parenteral Drug Association (PDA), past co-chair of the PDA Annual Global Conference on Pharmaceutical Microbiology, a member of the PDA Microbial Data Deviations (MDD) Technical Report writing team, and a Senior Member of the American Society for Quality (ASQ).

  • Ed C. Tidswell, PhD, BSc

    Merck

    Dr. Tidswell is Executive Director within the Sterile and Microbiology QA organization of Merck.  This role has ownership over microbiology issues across sterile and non-sterile sites within the Global Manufacturing Division.  His prior appointments include global R&D, and quality leadership roles supporting and innovating across large volume parenteral, small volume parenteral (small molecules, biologics, vaccines), medical device and bulk active pharmaceutical ingredient manufacturing and testing platforms for the likes of Baxter Healthcare, Eli Lilly and Evans Vaccines.  Dr Tidswell continues to actively publish and is a leading authority on pharmaceutical microbiology, risk, aseptic and sterile manufacture.  From 2013 he has served on the PDA’s Science Advisory Board and is currently a member of the PDA Journal’s Editorial Board.  In June 2010 Dr. Tidswell joined and continues to serve on the USP expert committee on Microbiology & Sterility Assurance.

  • John Arigo

    John T. Arigo, PhD

    FDA

    Dr. John Arigo is a Branch Chief in the Division of Microbiology Assessment in the Office of Process and Facilities in CDER/FDA.  His work relates to, among other things, the assessment of sterility assurance in INDs, NDAs, and ANDAs.  Prior to serving in this role he was a Master Microbiology Reviewer and Acting Team Leader in the Office of Generic Drugs Microbiology Division.

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    William E. Barry, PhD

    BioFire Defense, LLC

    William Barry is a Scientist at BioFire Defense, a bioMerieux company, which develops and manufactures nucleic acid tests for microbial detection in biodefense, clinical diagnostics, and industrial applications. William has worked as a Scientist in both Research and Development and Regulatory Affairs at BioFire, with a focus on biopharmaceutical applications. Before joining BioFire, he helped develop in vitro diagnostic tests for infectious diseases at Great Basin Scientific. He has a Ph.D. in Genetics and Molecular Biology from the University of Utah and a bachelor’s degree in Microbiology from the University of Iowa.  

  • 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.

  • Crystal Booth

    Crystal M. Booth, MM

    PSC Biotech

    Crystal M. Booth, M.M., is a Regional Manager a PSC Biotech and has over 20 years of experience in pharmaceutical microbiology, environmental monitoring, and quality assurance.  She obtained her master’s degree in microbiology from North Carolina State University.  Crystal is a seasoned award winning technical writer and author of Method Development and Validation for the Pharmaceutical Microbiologist.  During her career, Crystal has worked in microbiology, consulting, quality assurance, CDMOs, R&D, and quality control laboratories.  Crystal has developed and validated numerous microbial methods and has worked with many different product types. 

  • Reyes Candau-Chacon

    Reyes Candau-Chacon, PhD

    FDA

    Reyes Candau-Chacon, PhD is currently Quality Assessment Lead in Branch IV of the Division of Microbiology Assessment (Office of Pharmaceutical Quality, CDER). Branch IV evaluates the microbial quality and sterility assurance 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 branch 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 hold 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.

  • Virginia Carroll

    Virginia A. Carroll, PhD

    FDA

    Dr. Virginia Carroll is a microbiology reviewer in the Division of Microbiology Assessment in FDA’s Center for Drug Evaluation and Research. As a reviewer of Biologics License Applications, she has expertise in aseptic processing and microbial control in drug product manufacturing and has participated on pre-approval inspections of drug manufacturing sites. Dr. Carroll has over 12 years biomedical research experience with a focus on autoimmune disease as well as lymphoma associated with HIV infection. She also has experience teaching college courses in basic microbiology and genetics.

  • Hilary Chan

    Hilary A. Chan, MS

    Takeda

    Hilary Chan is a Principal Quality Control Scientist in Global Microbiology at Takeda and is based out of Lexington, MA.  In her current role, Hilary is responsible for leading various technical improvement initiatives related to microbiological issues/contamination control for Takeda’s global manufacturing operations.  She is a business process owner for environmental monitoring and contamination control community of practice network lead for Takeda.  She is an invited speaker at industry conferences has authored various scientific publications. Hilary has 19 years of experience in the biotech industry and holds a Bachelor’s degree in Zoology from Colorado State University and a Master’s degree in Biomedical Science from Northeastern University.

  • Andrew Dick

    Andrew Dick, MS

    Johnson & Johnson

    Andrew Dick is a Senior Principal Microbiologist at J&J Consumer.  He has worked for Johnson and Johnson consumer for 14 years and has expertise in contamination prevention, troubleshooting contamination issues, involved in product recalls, conducting microbiological risk assessments at non-sterile and aseptic processing facilities, developing policies for cleaning and sanitization, microbiological test methods and validation protocols, suitability policy, and auditing of laboratories.

    Andrew has trained numerous personnel for both internal and external manufacturing networks.  He has also provided contamination control and investigation technique training for originations such as to the Parenteral Drug Association, Personal Care Products Counsel and Pharmaceutical Microbiology Forum. Recently (May 2019), he gave a half day seminar to the FDA CDER, Office of Compliance held at their headquarters.

    Andrew had also worked in the personal products industry, food industry and clinical microbiology. 

    In 2018, Andrew published a book with the PDA, “Contamination Prevention for Nonsterile Pharmaceutical Manufacturing”.   He also co-authored PDA Technical Report #67 “Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices and Cosmetics”.

    Andrew has a M.S. degree in Microbiology from Wagner College, Staten Island NY.  He’s earned an Alumni Fellow award at Wagner College in 2018.  He has a B.S. degree in Medical Technology.

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    Geneviève Dufour

    Health Canada

    Analyst in the Health Canada Microbiology Laboratory since 2011

    Bachelor degree at University of Montreal in Microbiology and Immunology

    Previous jobs were in research and development in molecular biology and genetics, Genome Quebec and CNRC

  • Rob Dunn

    Rob Dunn, PhD

    NC State University
    Biologist and Author, Never Home Alone: From Microbes to Millipedes, Came Crickets, and Honeybees, the Natural History of Where We Live
  • Irving Ford

    Irving Ford, MSc

    Celgene, Biotechnology Company

    Irving Ford is currently the Head of CAR T QC Laboratories at Celgene. Prior to joining Celgene, Irving was a significant contributor for activities supporting the commercial approval of Novartis’ CAR T product Kymriah®.

    Irving has over 28 years of QA/QC experience in the pharmaceutical/biotechnology and cell and gene therapies industries including, but not limited to, non-sterile, sterile, and low bioburden manufacturing production. Irving has designed, implemented and managed paperless laboratories.

    Irving has a successful track record working with laboratory, facilities, validation, manufacturing, regulatory, QA, R&D, and compliance personnel to manage and resolve complex quality and manufacturing issues.

    Irving has served as the subject matter expert during numerous contract service provider audits as well as for regulatory inspections/filings. Irving was also involved in a successful consent decree remediation.

    Irving is an active member of PDA and recently served on the planning committee for the 2018 PDA Global Conference on Pharmaceutical Microbiology. Irving is also a co-author/contributor for the PDA’s TR for EM of Low Bioburden Facilities.

    Currently, Irving is working on a task force for creating an ISO Standard for the apheresis collection. Irving is also co-authoring a White Paper for appropriate microbiological controls for ATMPs manufacturing.

  • Richard Friedman

    Rick L. Friedman, MS

    FDA

    Richard L. Friedman is the Deputy Director, Science and Regulatory Policy, Office of Manufacturing and Product Quality, which is part of the compliance office in FDA's Center for Drug Evaluation and Research (CDER).  This position includes oversight of regulatory action recommendations relating to inspections and manufacturing site acceptability, and promoting sound regulatory policy development.  Mr. Friedman has authored several publications on topics including sterile drugs and quality systems.  Mr. Friedman has been a faculty member in Temple University School of Pharmacy’s  QA/RA graduate program since 2003. Prior to joining FDA in 1990, Mr. Friedman worked in the toxicology research division of Parke-Davis. Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989, and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.

  • James Gebo

    James ET Gebo, MPA

    National Institutes of Health, Department of Laboratory Medicine, Sterility Testing Service

    James Gebo has been the Quality Assurance Manager for the Sterility Testing Service in the Department of Laboratory Medicine at the NIH Clinical Center for the past two years. In this role, he has overseen the development and implementation of the QMS, assisted with the building of cGMP operational processes, and supported the designing of a new Sterility Testing Laboratory for the Service. Before working at the NIH, James spent over twelve years with Avista Pharma Solutions in Agawam, Massachusetts working in the cGMP CDMO and contract testing space. Over his tenure at Avista Pharma, James held various roles starting as a bench tech, moving into a team leader position over the Sterility and Virology testing groups, and finishing as the Manager of Technical Operations where he led the Agawam LIMS team during the development and implementation of a new multisite LIMS. During James' 15 years in the industry, he has worked in all areas of GMP and has extensive experience in microbiological testing for pharmaceuticals and medical devices, controlled environment validations, and electronic system validations.

  • Marc Glogovsky

    Marc Glogovsky, MS, SM(NRCM)

    Valsource LLC

    Marc Glogovsky, MS, S.M. (NRCM) has over 20 years’ experience in the pharmaceutical industry, specializing in Aseptic Operations, Contamination Control, and Risk-based Environmental Monitoring.  He has written a number of publications related to rapid microbiology, environmental monitoring, Mycoplasma and MALDI-TOF microbial identification.  Currently, he is a Senior Microbiology Consultant with ValSource. Prior to joining ValSource, he was responsible for managing the Environmental Monitoring Control division at Veltek Associates, Inc., and spent 10 years as a senior microbiology specialist at Merck KGaA.   Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology from Rutgers University.

  • Dennis Guilfoyle

    Dennis E. Guilfoyle, MS, PhD

    Johnson & Johnson

    For the last five years, Dr. Guilfoyle has been happily employed as the Senior Director, Microbiology & Analytical Regulatory Compliance with Johnson & Johnson, Corporate Compliance and Quality Control. He is responsible to provide scientific and compliance expertise to the corporate GXP audit teams, compliance remediation, and regulatory Intelligence and outreach functions. Dr. Guilfoyle serves as the expert on matters related to laboratory test standards, compendia requirements, cGMP and rapid microbiological methods. Collaterally he helps foster meaningful, credible and strong partnerships with health authorities ensuring that J&J is at the frontline in developing appropriate global microbiological laboratory requirements. Prior to working in industry, he had worked for over 40 years with the U.S. Food & Drug Administration (FDA) and was classified as an international expert in the field of pharmaceutical microbiology.  He is currently serving his 19th year as a member of the USP expert Microbiology committee and is a member of the PDA Science Advisory Board. Dr. Guilfoyle has been an Associate Professor for two Graduate courses entitled “cGMP” and “Process Validation”

  • Joyce Hansen

    Joyce M. Hansen, MBA

    Johnson & Johnson

    Joyce Hansen joined Johnson & Johnson as Vice President of J&J Sterility Assurance in 2012.  Joyce is responsible for providing strategic vision, leadership and governance for sterility assurance E2E lifecycle management for sterile products and the microbiological quality assurance for non-sterile products across Johnson & Johnson. Joyce has led several sterility assurance and sterilization organizations during her career and focuses on development and implementation of strategic plans.  She has over 40 years of experience in industrial microbiology and sterility assurance.  Prior to joining Johnson & Johnson, Joyce was the President and founder of J.M. Hansen & Associates, Inc., and previously held the position of Vice President of Sterility Assurance and Core Technical Competency Champion for Baxter Healthcare Corporation.  Joyce also held sterility assurance positions in Quality, R&D or Operations for Sherwood Davis & Geck, Baxter, Isomedix, and Becton Dickinson & Company. Joyce holds a B.S. in Microbiology, and a Masters in Management from Northwestern University.  Joyce has received two industry recognition awards, the 2001 International Meeting on Radiation Processing Award for Outstanding Contributions to Radiation Processing, and the 2008 AAMI Standards Developer Award.

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    Fatima Hasanain

    Nordion, A Sotera Health Company

    Fatima Hasanain, MSc, is a Polymer Materials Specialist for Nordion (Canada) Inc., a leading supplier of gamma sterilization technology to the healthcare market. Fatima has a variety of expertise in radiation effects on polymer materials, pharmaceuticals and gamma sterilization. Fatima is the Technical Manager of the Dosimetry lab at Nordion and a member in the ASTM Radiation Processing: Dosimetry and Applications Subcommittee. She is also a member in the American Association of Medical Instrumentation (AAMI), International Organization for Standardization (ISO), and Parenteral Drug Association (PDA). Fatima is also a teaching faculty at PDA teaching about radiation sterilization. Fatima has publications in various peer reviewed journals including the Radiation Physics and Chemistry, PDA Journal of Pharmaceutical Science and Technology, Polymer, and Dyes and Pigments. Fatima holds a Masters degree in Organic and Polymer Chemistry and Bachelor of Science in Biochemistry and Biotechnology both from Carleton University.

  • Ayako Hasegawa

    Ayako Hasegawa, PhD

    Allergan

    Ayako Hasegawa, PhD, is currently leading R&D Pharmaceutical Microbiology department at Allergan as an associate director, focused on implementation of risk based holistic micro control strategy and evaluation of new technology providing best solution for micro challenges including micro QC tests.

    Ayako received both bachelor’s and doctorate degrees from University of California, Los Angeles. During her 11 years at Allergan, she was instrumental in strategic evaluation of alternative sterilization technologies, optimization of sterilization process and aseptic manufacturing process including process simulation, and spearheaded microbiological risk assessment of container closures for preserved and preservative-free, multi-dose products.

  • Rebecca Jordan

    Rebecca D. Jordan

    Celgene

    Rebecca Jordan is a Microbiology Specialist at Celgene's West Coast CAR-T manufacturing facility, where she focuses on the multifaceted discipline of contamination control. She has over 10 years’ experience in industry as a QC Microbiologist, where she has supported both large and small manufacturing firms, commercial facility start-up, development through licensure of parenteral drugs, facility and utilities monitoring, APS, CAPA, and quality risk management to name a few. She has also successfully navigated global regulatory audits, developed and implemented aseptic training programs, established EM trend and disinfectant efficacy programs, and consulted on new facility design projects for CAR-T therapy manufacturing. She is a keen investigator whose curiosity and dedication has led to a diverse and rewarding career. She holds a B.S. in Biology from Fitchburg State University.

  • Timothy Kedzior

    Timothy P. Kedzior, MED

    Novartis Pharmaceuticals Corporation

    Timothy Kedzior is Masters Degree educated in Instructional Technologies, with an emphasis on Interactive Technologies, from Wayne State University, Detroit, Michigan.  Thirty-plus years training development, delivery and analysis, in the pharmaceuticals, medical device, nuclear power, automotive, utility, and private sectors.  Certified as a Nuclear Instructor, Internal Auditor, Root Cause Analyst, with experience in Human Performance.

    Currently the Instructional Design Lead with Novartis Pharmaceusticals, working on the CAR-T019 product Kymriah.

  • Lily Koo

    Lily Y. Koo, PhD

    FDA

    Lily Koo is a Consumer Safety Officer in the Division of Manufacturing and Product Quality (DMPQ) in the Office of Compliance and Biologics Quality (OCBQ), at FDA’s Center for Biologics Evaluation and Research (CBER). Her primary responsibilities include review of facility and equipment information in license applications and supplements for cell and gene therapy products, blood fractionation products, viral vaccines, and in vitro diagnostic kits. Lily also conducts pre-license and pre-approval inspections of biological manufacturing facilities. Prior to joining CBER, she worked at the Center for Device and Radiological Health and the National Institutes of Health. Lily received her B.S. in bioengineering from University of Pennsylvania and her Ph.D. in chemical engineering from Massachusetts Institute of Technology.

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    Karine Lebel, MSc

    Health Canada

    Karine Lebel is a microbiologist in the Health Products, Food and Pesticide Laboratories at Health Canada. She has been working as microbiology analyst for the government of Canada for over 10 years. The main role of Karine is to verify the  compliance of diverse health products. She also has been an acting Specialist and Quality Coordinator.

    Karine holds a Bachelor’s degree in Microbiology and Immunology from McGill University and a Master’s degree in Molecular Biology from Laval University. Previously, she held positions as research assistant in molecular biology as well as yeasts and human genetics at both McGill and Laval University.

  • Lauren Levac

    Lauren E. Levac, MS

    PPD

    Lauren Levac is a senior scientist specializing in container closure integrity testing within microbiology testing services at the PPD® Laboratories GMP lab in Middleton, Wisconsin. Lauren and her team perform container closure integrity testing, which includes method development, validation and stability testing for a wide variety of container closure systems via headspace oxygen analysis and dye ingress.

  • Anthony Lorenzo

    Anthony F. Lorenzo

    FDA

    Mr. Lorenzo has been with the FDA since March 2010 in the Office of Compliance and Biologics Quality (OCBQ), Division of' Manufacturing and Product Quality (DMPQ), Manufacturing Branch 2 (MRB 2), Center for Biologics Evaluation and Research (CBER). Prior to joining the Agency, he had 20 years of experience in CGMP manufacturing; designing, building, commissioning, and validating biologic manufacturing facilities; and scaling up pilot scale to large scale manufacturing. Today, Mr. Lorenzo is the Team Lead responsible for planning, coordinating, and evaluating the overall review and approval process for BLAs and supplements in the branch.

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    Randa Melhem, PhD

    FDA

    Dr. Melhem is a Senior Chemistry, Manufacturing and Controls (CMC) Reviewer in the Division of Manufacturing and Product Quality, Office of Compliance and Biologics Quality at CBER/FDA. In this position Dr. Melhem performs CMC/Facility reviews of Biologics License Applications (BLA) and supplements, and she conducts pre-license and pre-approval inspections of manufacturing facilities for cell therapy products, viral vaccines, plasma derivatives and recombinant products, combination products, and in-vitro diagnostic products regulated by CBER. Additionally, Dr. Melhem reviews Investigative New Drugs (IND), Medical Devices, New Drug Applications (NDA) and supplements for CBER regulated products. Before joining FDA, Dr. Melhem worked in the Biotech industry and in Academia. Dr. Melhem received her PhD from Purdue University, and did her postdoctoral training at the University of Pittsburg, University of Michigan Medical School, and Georgetown University Lombardi Cancer Center.

  • John Metcalfe

    John W. Metcalfe, PhD

    FDA

    Dr. John Metcalfe holds a BA in biology from Merrimack College in Andover, MA, and a PhD in microbiology from the University of Rhode Island.  John spent 14 years teaching college microbiology courses prior to beginning a career in CDER in 2003.  At FDA, John works as a microbiologist where he performs a review of both sterile and non-sterile drug products providing an assessment of microbiological quality.  He is an FDA Liaison to the USP Expert Committee on Pharmacy Compounding, and is a published author in the area of drug product microbiological quality.

  • Michael J. Miller, PhD

    Microbiology Consultants, LLC

    Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology and the validation and implementation of rapid microbiological methods (RMM). He is currently the President of Microbiology Consultants, LLC (http://microbiologyconsultants.com) and owner of http://rapidmicromethods.com, a website dedicated to the advancement of rapid methods within healthcare related industries.

    For 30 years, he has held numerous R&D, manufacturing, quality, business development and executive leadership roles at multinational firms such as Johnson & Johnson, Eli Lilly and Company and Bausch & Lomb. In his current role, Dr. Miller provides technical, quality and regulatory solutions in support of RMMs, sterile and non-sterile pharmaceutical manufacturing, contamination control and GMPs.

    Dr. Miller has authored more than 100 technical publications and presentations and is the editor of PDA’s Encyclopedia of Rapid Microbiological Methods. He currently serves on the editorial and scientific review boards for American Pharmaceutical Review, European Pharmaceutical Review and the PDA Journal of Science and Technology. Dr. Miller was the chairperson for PDA's Technical Report #33 and currently serves as an advisor to the USP Microbiology Expert Committee in the area of rapid sterility testing.

    Dr. Miller holds a Ph.D. in Microbiology and Biochemistry from Georgia State University. 

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    Hien T. Nguyen, MS

    Biogen
    Hien Nguyen joined Biogen in 2016 in the Engineering and Technology organization. Before Biogen, she held various positions in R&D to develop chromatography capabilities. She has over 10 years of industry experience in downstream purification of proteins and antisense oligonucleotides.  She received her Bachelor of Science in Biology and Master of Science in Biotechnology from Northeastern University.
  • Manshi Patel

    Manshi V. Patel

    Merck & Co., Inc.

    Manshi Patel is the Associate Director of Global sterile and Validation-microbial control COE at Merck in West Point supporting all sterile microbial sites in managing microbial risks by providing expertise in new and existing microbial contamination control solutions aligning with regulatory expectations.  She is a Microbiologist graduated from India with extensive experience in microbiology, sterility assurance and contamination control. 

    She started her career at Quest Diagnostics as clinical microbiologist after which she moved to J&J into Quality where she led the startup of micro lab including implementation and validation of all microbial testing supporting the pilot plant (pre-commercial production system) and bulk products.

    With her expanding experience she took up an opportunity as a quality site microbiologist with oversight of sterility assurance of aseptic operations.  Her contribution included maintenance of the sites maturity level and drive continuous improvement representing Quality as part of manufacturing lean excellence to identify areas to standardize and develop ways to simplify in alignment with GMP regulations.  Additionally, her major contribution was the reduction of excursions (66%) sample site reduction that drove Operation Excellence improvements in compliance.

  • Janet Perez-Brown

    Janet Perez-Brown

    Bristol-Myers Squibb

    Janet Perez-Brown has been with Bristol-Myers Squibb since 2006.  Since joining the Analytical Strategy and Operations Microbiology group in 2008 Janet was one of the principle participants that developed methodology in response to questions from the FDA regarding microbial hold time and Container Closure Integrity studies for parenteral drug products. She has been responsible for numerous instrument qualifications and re-qualifications. In 2019, she became a member of the Microbiology Center of Excellence, and is working to identify new, automated microbiological test methods, assisting BMS sites with investigations, and providing feedback to health authority questions. She works closely with manufacturing, overseeing the bioburden testing of raw materials and in process materials for parenteral manufacturing.  Janet interacts with Analytical Project Team Leaders, formulators and manufacturing engineers to assure that appropriate samples are taken and dealt with, as well as overseeing the outsourcing of testing. Janet has been responsible for working with the stability groups to develop, validate and transfer microbial limits tests for a number of products. 

  • Jim Polarine

    Jim N. Polarine, MA

    STERIS Corporation

    Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for nineteen years.  His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient.  Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control.  He is active on the PDA’s microbial investigations task force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection.  Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA’s  Aseptic Processing Course and at the University of Tennessee’s Parenteral Medications Course.  Mr. Polarine is current President for the PDA Missouri Valley and Technical Coordinator for the IEST.  Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology.  He previously worked as a clinical research coordinator with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois.  His main hobby is storm chasing and is very active in tornado research and tornado safety.

  • Morgan Polen

    Morgan Polen

    Microrite, Inc.

    Morgan Polen is a subject matter expert on contamination control, airflow visualization and particle monitoring in cleanrooms with over 30 Years of experience in all industries utilizing cleanrooms. He is a member of the ISO Technical Committee 209 (Cleanrooms and Associated Controlled Environments) and a board member of IEST and has been instrumental in drafting and editing ISO 14644 and other cleanroom related standards. Well versed in the practical implementation of cleanroom standards, regulations and guidelines. A valuable resource in addressing contamination control in critical environments for the electronics, aerospace and healthcare industries. He possesses extensive experience in working on cleanroom projects across the globe and speaking on contamination control and pharmaceutical regulations for particle counting and environmental monitoring.

  • Stacey Ramsey

    Stacey N. Ramsey, MS, SM(NRCM)

    Alcami Corporation

    Stacey Ramsey is a career pharmaceutical microbiologist, specializing in sterile drug product development and testing. Originally from Wichita, Kansas, Stacey received her Bachelor of Science degree from Wichita State University in Biological Sciences, and a Master of Science degree from Friends University. Upon completing her education, she served in QC and development laboratories at Hospira in McPherson, KS, where she developed a broad understanding of manufacturing processes, environmental monitoring and controls, and drug product testing. After spending a decade in contract manufacturing, Stacey relocated to Wilmington, NC where she now serves as a Senior Scientist for contract laboratory, Alcami Corporation. In this role, Stacey specializes in streamlining and improving processes, with an emphasis on innovation and new ideas.

  • Dona Reber

    Dona B. Reber, MEd, SM(NCRM)

    Pfizer

    Dona Reber's 30+ years of experience started in clinical microbiology, moved to academic research and for the majority has focused on biopharmaceutical microbiology, contamination control strategies for aseptic/nonaseptic manufacturing, microbiology testing and development, managing and networking microbiologists for laboratory and manufacturing issues. Current activities include assessments, training for low bioburden and sterile injectables facilities, investigations, troubleshooting, and developing global policy documents. She is a longtime chair of the Pharmaceutical Micro Expert Discussion Group. Dona has trained new FDA inspectors on environmental monitoring and is a PDA inst! ructor for TR#13, Fundamentals of an Environmental Control Program. She is a contributing author to PDA Technical Report #70, Disinfection; TR# 67, Objectionable Organism; and TR#13. She is participating in revisions to TR#13, including for Low Bioburden Processes, and a new TR for Contamination Control. She is co-author of A Risk Assessment Approach to Microbiological Controls of Cellular Therapies (Journal of Science and Technology, expected in 2019); co-editor of two PDA Books, Microbial Identifications: The Keys to a Successful Program (2012) and Microbial Control and Identification: Strategies, Methods Applications (2018). She was awarded PDA Editor of the Year in 2018 for her latest book. Dona enjoys bicycling and supporting science career programs.

  • J. Kevin Rice

    J. Kevin Rice, PhD

    FDA

    J. Kevin Rice has worked within the Division of Manufacturing Technology (DMT)/Office of New Animal Drug Evaluation (ONADE) at the US FDA for 13 years. His focus areas are sterile injectable drug product review, in-use stabilty studies for multi-dose injetable animal drug products, and container-closure systems for injectable animal drug products.

  • Helen Saccone

    Helen Y. Saccone, PharmD, MSEL

    FDA

    CAPTAIN Helen Saccone serves as a Senior Advisor within CDER’s Office of Strategic Programs.   CAPT Saccone was part of the inaugural team that initiated the US-EU Mutual Reliance Initiative in 2014, that led the negotiations and implementation of the US-EU Mutual Recognition Agreement for the FDA.

    CAPT Saccone joined FDA in 2008 as a Program Management Officer within CDER’s Office of Compliance, then served as the Associate Director of Global Policy within FDA’s Office of Commissioner.  Prior to joining FDA, she worked as a pharmacy inspector for the DC Department of Health and a Senior Manager of Education at the American Pharmacists Association.

    CDR Saccone received her Doctorate of Pharmacy from Rutgers University and was commissioned into the US Public Health Service in 2009.

  • Anil Sawant

    Anil Sawant, MSc, PhD

    Merck & Co., Inc.

    Dr. Sawant has over 25 years of experience in Quality Operations, GXP Compliance Operations, Auditing, and Ethics & Research Integrity functions.  He has extensive experience working on small molecules, biologics, and vaccines, various dosage forms from injectable to topical, and medical devices and combination products. Prior to joining Merck, Dr. Sawant was Vice President, Enterprise Regulatory Compliance, Johnson & Johnson.  Prior to J&J, he served as the Vice President, Compliance & Research Integrity for Wyeth Pharmaceuticals (now Pfizer). Dr. Sawant holds a B.Sc. Honors and a M.Sc. Honors in Microbiology from Panjab University, India and a Ph.D. in Microbial and Biochemical Sciences from Georgia State University, Atlanta, GA. He has published numerous papers in peer reviewed microbiology and medical journals on glycoproteins, fermentation, medical device development, and GLP and GCP studies. Dr. Sawant has been the lead for four PDA Technical Report and Co-Chairs the PDA Task Force on Data Integrity. Dr. Sawant currently serves on the/PDA Board of Directors, Board of Directors Mind Your Brain Foundation and has served on Board of Directors of Georgia State University Alumni Association.  He is recipient of the Georgia State University Distinguished Alumni Achievement Award and the PDA Distinguished Service Award.

  • Steffanie Strathdee

    Steffanie Strathdee, PhD

    UC San Diego
    Dr. Strathdee is an infectious disease epidemiologist, Associate Dean of Global Health Sciences and Harold Simon Professor of Medicine at the University of California San Diego where she co-directs the Center for Innovative Phage Applications and Therapeutics.  Strathdee recently co-authored a memoir entitled The Perfect Predator: A Scientist’s Race to Save Her Husband from a Deadly Superbug.  In 2018, she was named by TIME magazine as one of the 50 Most Influential People in Health Care for her work that revitalized phage therapy in the West.
  • Kenneth Tai

    Kenneth P. Tai, PhD

    Genentech

    My name is Kenneth Tai and I am currently a quality control scientist at Genentech.  I received my Ph.D. in 2012 studying the structure and function of antimicrobial peptides in innate immunity.  During that time I solved the 3D structure of an antimicrobial peptide using NMR, elucidated multiple conserved regions necessary for its functional activity, and published 9 journal articles.   After graduating, I took a position as a technical applications scientist at ThermoFisher, supporting PCR, real-time PCR, SNP genotyping, relative quantification, gene expression, siRNA, microRNAs, and all Applied Biosystems themocyclers (including real-time).  I led cross-functional projects and troubleshooting between, sales, manufacturing, regulatory, and quality.  I became the global single point of contact (SPOC) for all real-time PCR reagents.  I started my career in quality control at Genentech and served several roles: Senior QC Associate, QC Associate Scientist, and currently, a QC Scientist. I have worked on method development, transfer, and validation for real-time PCR assays for adventitious agents testing. I am currently working to bring Next Generation Sequencing (NGS) as a method to replace multiple adventitious agents testing and to work towards a real-time release of product to provide medicines as quickly as possible to our patients. 

  • Sarah Wallace

    Sarah L. Wallace, PhD

    NASA Johnson Space Center
    Sarah Wallace received her B.S. in Biology from Wichita State University and her doctorate in Biomedical Science from the Microbiology and Immunology Department at the University of Texas Medical Branch (UTMB). While attending graduate school at UTMB, she was awarded both a Texas Space Grant Consortium Fellowship and a NASA Space Life Science Fellowship, which afforded her the opportunity to conduct much of her doctoral research in collaboration with the Microbiology Laboratory at the Johnson Space Center. In her current position with NASA Johnson Space Center, Dr. Wallace serves as a technical lead in the Microbiology Laboratory, which is responsible for mitigating infectious disease risk during human spaceflight. Her responsibilities include the assessment of microbial risk based on vehicle and mission architecture as well as crewmember, food, and environmental monitoring. These assessments are used to develop requirements for NASA and commercial spaceflight vehicles, including the International Space Station. In addition to her operational support of human spaceflight, Dr. Wallace leads new technology initiatives for her discipline with the goal of reducing Earth-dependence for complex sample analysis. She has served as PI for numerous spaceflight investigations, including those to increase off-planet molecular biology capabilities. Specifically, she has led multiple investigations to apply sequencing to microbial monitoring, which resulted in the first identification of microbes collected and cultured entirely off Earth. She is continuing to advance modern microbiome analysis off the planet with her current flight study, the Biomolecule Extraction and Sequencing Technology (BEST) payload, by implementing a culture-independent, direct swab-to-sequencer process that can be conducted completely on the ISS. Dr. Wallace’s work is also aimed at understating how the spaceflight environment impacts cellular behavior.
  • Will Waterfield, PhD

    Independent Consultant

    Will Waterfield, PhD, began his professional career at Lederle Laboratories (Pearl River, NY) in the Recombinant Oral Polio Vaccine Group he later led the Vero Cell based Inactivated Polio Vaccine (IPV) Commercial Manufacturing. Tetanus, Diphtheria, PNU-IMUNE, Tuberculosis Tines, Pneumo-Conjugate and Glassware/Media Operations GMP operations were added to his responsibilities. After the IPV project was cancelled, Dr. Waterfield was named as project lead of the partial demolition of the IPV facility, design, construction, start-up, commissioning and licensure of the pneumococcal conjugate vaccine (Prevenar) facility occupying IPV facility footprint. He stayed on to direct Prevenar Polysaccharide Commercial Operations until 2003. He departed commercial vaccine operations and created the Manufacturing Science and Technology (MSAT). MSAT are wet lab/pilot plant development laboratories dedicated to support commercial operations. From 2012 until his departure in 2018, he focused on evaluating and implementing new pharmaceutical technology and created a business process to identify and implement best in class and next in class technology. NextGeneration Manufacturing Technologies (NextGen) reaches across all of Pfizer. NextGen conducts interviews of process owners and searches the technical solutions landscape addressing the needs of Commercial Operations as well as monitors project progress against milestones, advances timelines and cancels project not meeting endpoints.