October 19-21, 2020, Washington, DC
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.
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.