October 19-21, 2020, Online
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.
Dr. Lynne Ensor is a Vice President, Technical, for Parexel International since August 2019. She is a 21-year veteran of the Food and Drug Administration (FDA). Her areas of expertise include biopharmaceutical sterile product manufacturing and testing (including the incorporation of novel manufacturing processes and emerging technologies), CGMP, risk mitigation strategies, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. Dr. Ensor has vast experience in remediation strategies for product issues at pharmaceutical manufacturing facilities, including resolving consent decrees, warning letters, and drug shortages. She served as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/OPQ/CDER, responsible for new, generic and biologic drug product quality review and facility assessment. Dr. Ensor has authored regulatory articles, peer-reviewed scientific publications, and was involved in the harmonization of global regulatory expectations. Her previous FDA management positions include serving as the Director of the OPF’s Division of Microbiology Assessment, Director of the OPS’s New and Generic Drug Product Quality Microbiology staff, and Director of OGD’s Division of Microbiology. Lynne was previously employed at Roche Biomedical Laboratories, the University of Maryland at Baltimore’s School of Medicine, and earned her B.S. in Biology and Ph.D. in Microbiology from the University of Maryland, College Park.
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, Dosage Forms, 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 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 35 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), Biophorum Operations Group (BPOG) 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.
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.
Vineeta Pradhan joined the Food and Drug Administration (FDA) in 2016 and is currently working as a Microbiologist in the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation at the Center for Veterinary Medicine (CVM). She reviews the pre- and post-approval CMC information of generic sterile injectable drugs for the entirety of the drug application lifecycle. She has experience in moist steam sterilization, aseptic processing, media fills and microbiological testing.
Prior to joining the FDA, Vineeta worked as an Assistant Professor at the Northern Virginia Community College, Loudoun Campus in Sterling, Virginia.
Vineeta received her Ph.D. in Microbiology from The Ohio State University.
Christine Sherman is a member of the Takeda Global Microbiology Management team and is based in Cambridge, Massachusetts. Within Takeda, her role is supporting Sterilization and Aseptic Processing. 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 a Sterility Assurance roles for the vaccine 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 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).
Friedrich is QC Lead of iNeST (individual Neoepitope Specific Therapy) project located in South San Francisco, CA.
After studying biology with focus on Microbiology at the Technical University of Braunschweig, Germany he earned his PhD at the Institute of Microbiology and Hygiene, Charité, Berlin, Germany.
He joined Roche in 2001 working as Micro lab Manager and Senior Manager on various topics (environmental monitoring, biochemical cleaning analytics, microbiological IPC and analytics for release, endotoxin testing, LER). Friedrich led several Roche-Genentech Micro expert teams (e.g. identification, microbiological testing) and co-chaired the PDA LER Task Force. He chaired and co-chaired several Endotoxins and Pyrogen Sessions at Pharmalab and PDA. Before starting his current position he was Senior Manager at Roche-Genentech Global QC and Head of Roche-Genentech global Endotoxin Expert Group and Roche-Genentech global SME on microbial impurity contaminations and LER.
Keira Anderson-King is the Sterility Assurance Specialist for Australia and New Zealand Compounding at Baxter.
Prior to this role, Keira held the position of Microbiology Quality Manager at ANSTO (Australia's only nuclear reactor) where she was responsible for all Microbiology and Sterility Assurance activities across the radiopharmaceutical sections.
Keira has over 7 years experience in developing, validating and performing a range of microbiology test methods (including sterility testing, endotoxin LAL testing, particle counting, bioburden testing and water monitoring). This is in addition to developing and maintaining Sterility Assurance programs (including environmental monitoring, depyrogenation, cleaning and disinfection, media fills, operator qualification, clean room qualification and sterilisation).
Keira has extensive knowledge on the application of Microbiology and Sterility Assurance in the radiopharmaceutical space. Keira has applied this knowledge as part of the Australian Therapeutic Goods Association (TGA) radiopharmaceuticals technical working group, which developed the guidance document 'Manufacture of sterile radiopharmaceuticals labelled with fluorine-18' published in February 2019.
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.
Linda Boele joined Kite Pharma EU in the role of Sr. Manager QC Microbiology in September 2018. Linda is very experienced and had several roles in the pharmaceutical/biotech/food industry in the microbiology area. She started in research at LUMC and TNO. After that she had several roles with increasing responsibilities at Eurofins-MicroSafe laboratories. She also worked in Quality Control management positions in both Eurofins and Nutricia medical nutrition in The Netherlands. Linda helped setting up the microbiolgy team for QC, took care of the Microbiology labs but also played a key role in setting up the Sterility Assurance concept in Kite Pharma EU- TCF04.
Richard L. Friedman is Deputy Director, Office of Manufacturing 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 decisions relating to 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.
Helen Gates is a Microbiologist with more than fifteen years’ experience within the Pharmaceutical Industry, holding roles within Microbiology, Quality and Production, supporting the manufacture of sterile and non-sterile active pharmaceutical ingredients. Helen acted as the subject matter expert for topics including contamination control, environmental monitoring, aseptic process and equipment validation and water systems.
Helen joined Ecolab in 2019 as a Global Technical Consultant for Ecolab Life Sciences, advising on application and use of specialist cleanroom biocides in line with current regulatory guidance and industry best practice.
Karen Ginsbury is a pharmaceutical consultant with 30 years experience working in and with the pharmaceutical industry. A UK trained pharmacist with a second degree in Microbiology, from Birkbeck College, University of London, she has a passion for quality and a deep respect for microbes. She is a frequent presenter at events around the world, performs many audits each year and works with companies to set up, maintain and improve their quality systems. Karen is a founder member and past president of the Israel Chapter of PDA, a past member of RAQAB and was co-chair at the founding of the outsourced operations and pharmacopeial interest groups. She is also a past member of the editorial committee of the PDA letter.
Stephen Langille is a Senior Microbiology Consultant at ValSource Inc. who specialized in microbiological and particulate matter contamination control of drug, device, and biological products. He holds a B.S. degree in Biology from the University of Massachusetts and a Ph.D. in Microbiology from the University of Maryland. He spent 19 years with the FDA as a Microbiology Reviewer, Branch Chief, and Director of the Division of Microbiology assessment in the Center for Drug Evaluation and Research and joined ValSource, Inc. in February of 2019. He currently serves as a member of the Unite States Pharmacopoeia Compounding Expert Committee and on several Parenteral Drug Association technical committees.
Joe McCall, SM (NRCM) is the Associate Director of Quality Assurance Technical Services at ADMA Biologics in Boca Raton, FL. He has over 25 years of experience as a professional microbiologist at such companies as Bausch & Lomb, Genzyme, DSM Pharmaceuticals, STERIS Life Sciences, and Mass Biologics. Joe has been an active industry member throughout his career, teaching courses at PDA TRI, the University of Tennessee HSC, and providing training at FDA CBER Division of Product Quality and Manufacturing. Joe has developed and delivered numerous training seminars on pharmaceutical microbiology at companies and conferences across Europe, Asia, South America, and the US. He has been a proud member of PDA for over 15 years and is one of the few ASM Certified Specialists in Pharmaceutical and Medical Device Microbiology on the National Registry of Certified Microbiologists.
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.
Paula Peacos, M.S. has over 30 years of industry experience as a Microbiologist. She has worked in contract manufacturing organizations as well as small, mid-size and large pharmaceutical organizations. Ms. Peacos has extensive experience in aseptic processing, API/drug substance, ATMP and nonsterile production, both clinical and commercial, as well as microbiological laboratory management Ms. Peacos also has extensive experience performing compliance audits internationally as a microbiological subject matter expert. She is an experienced trainer and has developed and implemented customized developmental and remedial programs. In recent years, Ms. Peacos has published several articles and delivered presentations at major industry meetings on topics such as data integrity, root cause analysis and using microbial recovery rates for trending analysis outside of the aseptic environment. Ms. Peacos also currently serves on two PDA Technical Report (TR) Teams. She is a contributing member of the Microbial Data Deviations Team, and Chair of the Environmental Monitoring for Low Bioburden Facilities Team. Ms. Peacos is currently employed as a Senior Consultant ValSource, Inc.
Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty 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 as co-chair 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 teaches industry regulators as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course and at the University of Tennessee 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. His main hobby is storm chasing and is very active in tornado research and tornado safety.
Morgan Polen is a subject matter expert on contamination control, airflow visualization and particle monitoring in cleanrooms with over 30 Years of industry experience. 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 international cleanroom standards and best practices. He has extensive experience in working on cleanroom projects in the United States, Canada, Mexico, Germany, Malaysia, Taiwan, South Korea, Singapore, Thailand, China, Philippines, India and Turkey and is a valuable resource in addressing contamination control in critical environments for the electronics, aerospace and healthcare industries.
As a key member of Microrite’s Expert Contamination Control team, Morgan is instrumental in development of proactive contamination control strategies through pragmatic risk assessment, troubleshooting contamination issues and helping with FDA 483/warning letter remediation activities.
Dr Johannes Reich is Managing Director at Microcoat Biotechnologie GmbH in Germany where he is responsible for Endotoxin and Pyrogen test services. Johannes actively engages with the regulatory and scientific community through participation in dedicated working groups, presentations and publications in peer-reviewed journals. He has published in respected journals on endotoxin assays and Low Endotoxin Recovery (masking), and is internationally known for his expertise concerning the phenomenon of low endotoxin recovery in biopharmaceuticals. Johannes received his PhD in Chemistry from the University Regensburg in Germany.
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.
Joanny Salvas has a bachelor’s degree in biotechnological engineering and a Master in Applied Sciences (Chemical engineering). She has been developing and implementing Process Analytical Technologies for more than 10 years at Pfizer, both in Solids and Sterile Injectable processes. Her background in process control, statistical analysis, multivariate data analysis and spectroscopy enabled her to support many successful implementations of advanced control strategies in the Pfizer network. She leads the Pfizer RMM steering team responsible for establishing the strategy, the evaluation and implementation of technologies as well as the development of future microbiology analytics.
Don Singer is Senior Microbiology Technical Consultant, N.A. for Ecolab, and a Fellow in the American Society for Quality. Don has been a member of the USP Microbiology Committee of Experts since 2000. He is currently chair of the PDA Task Force for the Technical Report titled, "Industry Challenges and Current Technologies for Sterile Pharmaceutical Package Integrity Testing“, and was co-author of the TR “Exclusion of Objectionable Microorganisms”. Don is also member of the European Pharmacopeia Group 1 Microbiology Committee. He is a Certified Specialist Microbiologist (NRCM) and Certified Pharmaceutical GMP Professional (ASQ), and is a former Malcolm Baldrige National Quality Award Examiner. Don’s career spans over 35 years as an author, instructor, and manager of microbiology research, quality control and quality assurance in the biopharmaceutical, pharmaceutical, cell therapy, cosmetic, and food industries. Currently Don is an adjunct instructor in the Biopharmaceutical Quality graduate program at University of Maryland Baltimore County.
Niels Visschers started to work directly at MSD Oss after his graduation in 2005. He joined the local Quality Control Microbiology department. During his 15 years of service at QC-M department he performed multiple conventional tests, lead the Implementation of a sterility test Isolator project and eventually became Assistent Manager. At the start of this year Niels Joined the global Center of Expertise Microbiology where he is mainly responsible for site support in the Merck network regarding: Water testing, Bioburden Testing, Sterility testing and EM. Besides the site support Niels is responsible for design and execute development studies in Rapid Microbiological Methods for EM. Niels holds a bachelor’s degree in applied science from Hogeschool Arnhem en Nijmegen, The Netherlands.