WEBINAR RECORDING: A CRO Perspective and Insights into Biological Product Registration and Testing with an Emphasis on Aquatic Toxicity Testing

Presented: October 11, 2023

Presenters: Hank Krueger, Vice President of Regulatory & Scientific Affairs and Sarah McCoy, Biologics Team Lead, both of Eurofins Agroscience Services.

Moderator: Solito Sumulong, Regulatory and Product Development Services, AgriThority

Description: Through experience with conventional chemicals, Contract Research Organizations (CROs) have developed a keen understanding of how to conduct toxicity tests with conventional chemicals and how to maintain test concentrations for the duration of the test. Microbial pesticides provide additional inherent challenges associated with conducting ecotoxicological tests, specifically around delivery and maintenance of the test article. This webinar will analyze the unique issues surrounding toxicity testing of microbial pesticides, as illustrated within aquatic testing, and discuss what inputs are needed to develop better guidance for testing in relation to biological product registration and analysis.

Presenter Bios:

Dr. Hank Krueger has been working in regulatory ecotoxicology for 35 years.  He has been working with microbial products and conventional chemicals throughout his career. He was the director and manager of Aquatic, Plant and Insect Toxicology in Easton, Maryland for 25 years and managed business and financial affairs, as well as providing technical direction in program coordination and development. His background is in both aquatic and terrestrial ecotoxicology and early in his career at Wildlife International served as Director of Field Programs for 10 years, where he had overall responsibilities for directing activities of mesocosms, terrestrial and aquatic field studies, as well as plant studies conducted in greenhouses. He obtained his M.S. Degree from Central Michigan University and his Ph.D. from the University of Wyoming where he worked at the US Fish and Wildlife Cooperative Research Unit. His expertise is in plant and animal regulatory ecotoxicology that includes greenhouse, pollinator, and aquatic studies.  His particular interests are in algae, honey bee and bumblebee lab testing, fish bio-concentration, fish and frog endocrine disruption, invertebrate sediment testing, plant injury scoring, and the development of new testing methods.  Most recently, he delivered a talk to OECD in Paris on the challenges of standard aquatic toxicity studies with microbial products moderated a BPIA panel discussion on “Anything New with Global Regulation of Biological Products”.

Sarah is a Study Director and the Team Lead of the Biologics Department at Eurofins Agroscience Services in Easton, MD.  She has a Master’s degree in Molecular Biology and Genetics from the University of Delaware as well as research background in biomarker discovery with extensive experience in molecular biology assays including RNA sequencing, qPCR and protein quantification methods.  Sarah has worked at Eurofins for five years; developing experience in aquatic toxicology.  She and her team are working to expand GLP testing capabilities on biological pesticide products for support of ecotoxicology studies and microbial product characterization.

For past webinar recordings, please visit the Lunch and Learn Webinar Archive.