Sheraton Arlington Hotel
1500 Convention Center Drive
Arlington, TX Reservations:800-325-3535
Guest room reservations may be made by calling 800-325-3535. Please mention "BES Conference" to receive the group rate of $129/night. This rate expires 1/16/17. There are a limited number of rooms available at this rate, so please make your reservation at your earliest convenience.
While “LER” has dominated the BET landscape for a few years, many of us are still concerned with day-to-day testing issues. While an update on LER activities is planned, the theme for this year's meeting is “Beyond and Before LER.” This year, we look to reinforce principles of BET that might be confusing, look to challenges with new products such as cellular and gene therapies and combination products, and discuss new paradigms on BET related topics such as validation of alternate tests such as Monocyte Activation Test (MAT). The speakers include a wide range of industry, vendor and regulatory participants.
Moderator/Speaker: Karen McCullough
Karen Zink McCullough is principal consultant at MMI Associates, a consulting firm specializing in Endotoxin and Microbiology Testing, GMP Auditing and Compliance, Laboratory Auditing and Compliance and Quality Assurance including nonconformance investigation and CAPA. Ms McCullough has over 35 years of experience in the Pharmaceutical Industry, and has worked in aseptic manufacturing, oral dosage, and diagnostics sectors. She is a highly respected speaker and trainer both nationally and globally. Karen's current interests are the use of microbiological assays as tools for process control.
Ms. McCullough is a charter member and current Chair of the LAL Users' Group. She is an elected member of the Microbiology General Chapters Expert Committee of the United States Pharmacopeia and serves as a member of the United States delegation to TC2-9, WG02, revision to ISO 14698 (Biocontamination standard). She recently edited the book, "The Bacterial Endotoxins Test: A Practical Guide", which provides background and advice on a range of topics related to the compliant performance of the Bacterial Endotoxins Test.
Title 1: USP Proposed Native Standard
Title 2: Hands On: Preventing Endotoxin Contamination (Non pyrogenation)
Speaker: Jay Bolden, Eli Lilly and Company
Mr. Jay Bolden is an Associate 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 16 years of industry experience in development, process and laboratory microbiology, and microbiology laboratory leadership.
Title 1: Results of a Harmonized Endotoxin Recovery Study Protocol Evaluation by 14 BioPhorum Operations Group (BPOG) Member Companies
Title 2: Recombinant Factor C: Alternate Test
Speaker: Allen Burgenson, LONZA
Allen L. Burgenson is the Regulatory Affairs Manager for Lonza Walkersville, Inc. and has over 30 years of experience in industries regulated by the FDA, including Foods, Drugs, Biologics, Medical Devices, and Cosmetics. He has worked in R&D, QC, QA and Regulatory Affairs.
Allen is the President of the Capital Area Chapter of the Parenteral Drug Association (PDA), and is involved in PDA activities on the local, national, and international level. He has been a Program Committee member for the annual PDA/FDA Joint Regulatory Conference in Washington, DC, and served as the Chair for this meeting in 2004. He is a member of the Horseshoe Crab Advisory Panel for the Atlantic States Marine Fisheries Commission (ASMFC).
Title: Challenges in Testing Cellular/Gene Therapy Products and Combination Products
Speaker: James F. Cooper, Pharm D., Endotoxin Consulting Services
James F Cooper, PharmD, was Professor of Pharmacy at the Medical University of South Carolina before founding Endosafe in 1987. Last year he received the James P. Agalloco Award for teaching excellence at PDA. His thesis work under Dr. Jack Levin at The Johns Hopkins University in 1971 led to application of the bacterial endotoxin test (BET) for parenteral products. His publications span the history of LAL technology. Since retirement in 2001, he continues his consultation, teaching, publishing related to endotoxin issues, BET root-cause investigations and CGMPs for positron-emission tomography drugs.
Title: Pyrogenic Outbreaks: 1970 to Present; OOS Investigations
Speaker: Ned Mozier, PhD., Pfizer
Ned Mozier is Senior Director of Analytical Research and Development in Pfizer’s Biotherapeutics Pharmaceutical Sciences division. He is responsible for the development, validation and testing of bioassays and host impurities for testing of biological and vaccine clinical trial material. Ned has worked for Pharmacia, Baxter and The Upjohn Company. He received his Ph.D. in Biochemistry from the University of Louisville (Ky, U.S.).
Title: Progress and Pitfalls of the Monocyte Activation Test as Relates to Product Quality Assessment
Speaker: Masakazu Tsuchiya, Ph. D, Charles River Laboratories
Dr. Masakazu Tsuchiya is a Senior Research Scientist in Endotoxin and Microbial Detection, Charles River, Charleston, SC, USA. He has more than 30 year experience in the detection of endotoxin and other microbial cell wall components. His notable achievement is the development of tools for microbial cell wall components, such as an endotoxin-specific Limulus Amebocyte Lysate (LAL) reagent, a beta-glucan-specific LAL reagent, and the Silkworm Larvae Plasma (SLP) reagent to detect peptidoglycan and beta-glucan.
Title: Case Studies: Invisible Interference in the Bacterial Endotoxins Test
Speaker: Veronika Wills, Associates of Cape Cod
Veronika Wills serves as the Associate Manager, Technical Services at Associates of Cape Cod, Inc. Her interests include biochemistry, microbiology and immunology, and she holds a Master’s Degree in Biochemical Engineering. Veronika has been with Technical Services at Associates of Cape Cod, Inc., for nearly 10 years and has been conducting BET training workshops, seminars and webinars in the U.S. and abroad.Title: The Importance of Using Qualified Disposables for the LAL Based Assays
Cancellation Policy: PMF and Microbiology Network reserve the right to modify or cancel any event. In the event of a cancellation, registrants will be notified as soon as possible and all registration fees will be reimbursed. PMF and Microbiology Network are not responsibile for lost airfare due to cancellations. Refund requests received at least 14 days prior to the date of the event will receive a full refund, less a $200 processing fee. After that, no refunds will be issued.You may enroll a substitute at any time before the conference begins.