Increasing the effectiveness of pharma endotoxin testing

Meg Provenzano, Global Product Manager for Endotoxin at Veolia.

Meg has over 15 years of experience in bacterial endotoxin testing and has held several positions in Quality Control, Technical Support, and Product Management. In her current role, she develops contamination control strategies, helps customers troubleshoot BET assays, and defines the BET product strategy and roadmap for the Sievers Analytical Instruments product line. Meg is a member of Modern Micro Methods (M cubed) and the Parenteral Drug Association (PDA). She is passionate about advocating for patient safety within the pharmaceutical industry. Previously a Product Manager at Charles River Laboratories, Meg holds a B.S. in Marine Science and Biology from Coastal Carolina University (South Carolina) where she focused on Bottlenose Dolphin population research.

Wiet Cuenen of MSD Animal Health in the Netherlands.

With over 39 years of experience at MSD Animal Health, Wiet has held a variety of roles across different functions, developing a wealth of microbiology expertise along the way. He began his career at MSD Animal Health in 1986 at the Virological- Bacteriological and Antibiotic R&D departments in different roles. Over the years, he advanced through several positions of increasing responsibility within the Quality Control and Science and Technology organizations. In the Quality organization, he was Manager of Microbiology for 10 years and supported MSD AH The Netherlands and in the Science and Technology  organization he set up a Center of Excellence Microbiology and progressively taking on more complex responsibilities in different roles within Global MMD AH sterile network for 11 years. Currently, he serves as the Microbiology Project Lead, where he is responsible for introducing, harmonization and centralization of new microbiological technology and processes within MMD AH.

Trusha Desai – Senior Scientist at the National Institute for Biological Standards and Control within the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA)

Trusha Desai is a Senior Scientist at the Standards Lifecycle function of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. She first joined the Pyrogens Section of the institute before moving to the National Institute for Biological Standards and Control (NIBSC) in 2008 as a Scientist to perform ISO17025 compliant Bacterial Endotoxin Testing (BET). Her knowledge and understanding of BET methods was applied to the establishment of the 3rd WHO International Standard for endotoxin testing, a process that saw her collaborate with the European, US and Japanese Pharmacopoeias (Ph. Eur., USP and JP). She currently leads the project for the replacement of the 3rd WHO IS for endotoxin testing and the development of WHO Reference Reagents for non-endotoxin pyrogens to be used in Monocyte Activation Testing (MAT) as positive control.

Veronika Wills – Associate Director Global Technical Service groups at Associates of Cape Cod

Veronika Wills directs Global Technical Service groups at Associates of Cape Cod, Inc. She joined the team in 2007 and has since become a globally recognized subject matter expert and public speaker on endotoxin and glucan testing. She brings an in-depth expertise that is vital to ACC customers when it comes to technical support of testing complex sample matrixes, troubleshooting, method validations, investigations and regulatory aspects of BET. Most recently, Veronika has been heavily involved in the assessment and implementation of recombinant technologies and their automation. Veronika holds a Master’s Degree in Biochemical Engineering from the Institute of Chemical Technology in Prague, Czech Republic.