Mr. Jesse Lueth has 12 years of experience designing, coordinating, conducting procedures for, and monitoring in vivo toxicology studies in the pharmaceutical field. In addition, he is a co-author and reviewer of multiple SOPs for operational groups at a contract research organization (CRO) and was a subject-matter expert for an electronic data collection system.
Mr. Lueth has experience with a variety of therapeutic modalities, including small molecules, biologics, and gene therapies, for various indications (e.g., neurological, ocular, and infectious diseases). In addition, he has experience with advanced therapeutic dose administration routes (i.e., intrathecal, intraarticular, intraocular dosing).
Mr. Lueth is certified by the American Association for Laboratory Animal Science as a Laboratory Animal Technologist and Laboratory Animal Technician and is also certified by the Project Management Leadership Group, Inc., as a Project Manager. He has expertise in the generation and review of preclinical data, protocols, reports, and proposals.
As a member of ToxStrategies’ Biopharmaceuticals/Pharmaceuticals practice, he supports sponsors throughout the conduct of studies, including study monitoring. He ensures compliance with appropriate requirements outlined in SOPs, GLP regulations, stipulations required by Institutional Animal Care and Use Committees (IACUCs), the Guide for Care and Use of Laboratory Animals, and regulatory guidelines. As an experienced scientist in the pharmaceutical field, Mr. Leuth collaborates with study directors, technical staff, and subject-matter experts to provide scientific and technical guidance during study design and execution. In addition, he advises sponsors in decision-making steps by reviewing available scientific literature and data and offers input on modification options.