by Karen Z. McCullough
What’s new at this year’s BES? EVERYTHING!
Last year our BES highlighted test interference, but our topic for this year is LER, a very specific form of interference, which is a significantly more focused topic than in years past. We’re fortunate that each of our speakers is a published expert on the topic. This is the ONLY conference to be held this year that focuses on this very timely and important topic.
Have you wondered if your products could exhibit LER? Have you wondered how to resolve LER in your product? Have you wondered if LER is a public health problem? THIS IS THE CONFERENCE for your questions to be answered!
The conference will be held in Iselin, NJ on September 14-15, 2015.
Our FDA speaker for this year is Dr. Marla Stevens-Riley, Senior Microbiologist Division of Regulations, Guidance, and Standards FDA/OMPT/CDER/OPQ/OPPQ. Her presentation is entitled, “Ten things that the FDA wants you to know about Low Endotoxin Recovery (LER).”
We’re fortunate to have a number of industry analysts and managers will recount their own experiences with LER:
- Low LPS and Endotoxin Recovery: Keeping an Eye on the Big Picture – Jay Bolden, Eli Lilly
- Holistic Approach to Control: Impacts of Low Endotoxin Recovery – Joseph Chen, PhD and Friedrich von Wintzingerode, PhD, Genentech/Roche
- LER…Just when you Thought You were Safe – Jeanne Mateffy, Matthew Nelson, Jack Negron-Nieves, Amgen
- Biological Product Matrices and LLR vs LER: What is Clinically Relevant? Cheryl Platco, Merck
We have a number of experts who will give us some background and technical information on how to identify and deal with the issue:
- Low Endotoxin Recovery and How to Address It – Michael Dawson, PhD, Associates of Cape Cod
- Understanding the Principles of Endotoxin Masking and Demasking – Johannes Reich, PhD and Holger Grallert, Hyglos
- Visualized LPS Morphology Changes Using High Speed Atomic Force Microscopy – Masakazu Tsuchiya, PhD, Charles River Laboratories
- LPS and LER in the Context of Preventing Microbial Contamination Events in Drug Manufacturing – Kevin Williams, LONZA
Expert Panels to Answer Your Questions
We’re also pleased to have experts who will be participating with our speakers in round tables
- Dennis Guilfoyle, PhD, Johnson and Johnson (former FDA)
- James F. Cooper, PharmD, Endotoxin consultant (founder of Endosafe)
- All speakers