2021 PMF Bacterial Endotoxin Summit:

Endotoxins from Autochthonous Microorganisms

Please join us for the highly anticipated 2021 PMF Bacterial Endotoxin Summit. This two-day conference will be held on September 13th and 14th and will focus on Endotoxins from Autochthonous Microorganisms.  

What are endotoxins from autochthonous microorganisms and why are they important to the manufacture and testing of parenteral drugs and medical devices?  This year’s Summit will focus on endotoxins as contaminants:  their structure and their detection. Several industry experts have gathered to share presentations and join in two expert panel discussions.

Presentation Topics Include:

• Phylogenetic, Biochemical, Clinical and immunological Characteristics of Bacterial Endotoxin
• Form vs. Function: The Impact of Membrane Components and Secreted Structures on Endotoxin Testing
• Endotoxin Diversity:  A Compendial Perspective
• Finding Bacterial Endotoxins on Medical Devices
  
• Endotoxins and Pharmaceutical Water Systems
  

Panel Discussions:

Day 1: Round Table; Endotoxins from Autochthonous Microorganisms

Day 2: Panel Discussion; The use of Autochthonous Endotoxins in Parenteral Drug Studies

 SCHEDULE

Day 1 - September 13, 2021

Day 2 - September 14, 2021

Speakers

Karen Zink McCullough, Moderator

Karen Zink McCullough is owner and principal consultant at MMI Associates.  She is acknowledged as an expert in the field of bacterial endotoxin testing, and has published widely on the subject. She is the editor and an author of the book, "The Bacterial Endotoxins Test:  A Practical Guide,"   Ms McCullough is Founder, Charter Member, and Steering Committee Member for the LAL Users' Group.  She is a  member of the USP Expert Microbiology Committee, General Chapters and is a US delegate to ISO TC 209, WG02.  Ms. McCullough received her BA in Bacteriology from Rutgers University and her MS in Molecular Biology from the University of Oregon. 

Presentation Title:  Endotoxin Diversity:  A Compendial Perspective

Dr. Terri Ellis 

Dr. Tim Sandle 

Dr. Sandle is the Head of Microbiology, Risk Management, and Sterility Assurance at Bio Products Laboratory Limited (a pharmaceutical organization). He has over twenty-five years experience of designing and operating a range of microbiological tests (including sterility testing, endotoxin LAL methodlogy, microbial enumeration, environmental monitoring, particle counting, bioburden, isolators and water testing). In addition, Dr. Sandle is experienced in microbiological and quality batch review, microbiological investigation and policy development.  Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He was chair of the Pharmig LAL action group and served on the Blood Service disinfection committee. He has written over five hundred book chapters, peer reviewed papers and technical articles relating to microbiology, healthcare and pharmaceutical science; and delivered papers to over one hundred conferences. He is also the editor of the Pharmaceutical Microbiology Interest Group Journal and runs an on-line microbiology website and forum (http://www.pharmamicroresources.com/). He is an experienced auditor and frequently acts as a consultant to the pharmaceutical and healthcare sectors. 

Presentation Title: Autochthonous endotoxins and water systems including failures of systems

Carolyn Brainwaithe 

Presentation Title: Finding Bacterial Endotoxins on Medical Devices

Dr. James Akers 

Presentation Title: Phylogenetic, Biochemical, Clinical and Immunological Characteristics of Bacterial Endotoxin

Panelists

Allen Burgenson  

Allen 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.  He is involved in PDA activities on the local, national, and international levels.  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 Crap Advisory Panel for the Atlantic States Marine Fisheries Commission (ASMFC).

Veronika Wills 

Veronika is the Head of Technical Support at Associates of Cape Cod. Veronika has a wealth of experience when it comes to endotoxin testing, currently she manages the global technical team at ACC and is based at ACC’s US office on Cape Cod. Veronika is a subject matter expert when it comes to endotoxin testing and often provides expert sessions at global events on endotoxin testing. 

John Dubczak 

John Dubczak is the Executive Director for Reagent Development for the Microbial Solutions division of Charles River Laboratories.  For the last 20 years, he was the General Manager and responsible for the production and technical operations for the Endosafe®brand in Charleston, SC. Prior to joining Charles River, John was a long-term employee of Baxter Healthcare Corp., where he developed Baxter’s proprietary LAL formulation and manufacturing process. As a member of the R&D team, he also developed methods for product testing and explored the clinical applications of LAL. With seven years of Large Volume Parenteral manufacturing experience, he brings an in-depth understanding of issues surrounding all aspects of endotoxin and microbiological testing.

Kevin Williams 

Kevin spent 30 years at Eli Lilly & Company developing endotoxin assays and detection technology in the QC lab.  He then worked at Hospira (now Pfizer), Lonza, and GE Water before moving to bioMerieux.  He has authored several books on endotoxin (Endotoxins second and third edition, Informa) including most recently Endotoxin Detection and Control in Pharma, Limulus and Mammalian Systems (2019, Springer Nature)