Toxicology studies in drug development help identify potential safety issues and target organs in humans to identify translational markers of potential toxicity in later human trials and they can provide high-quality and reliable data on which to base the safe starting dose in humans. The data from these studies, and particularly the no-observed-adverse-effect level (NOAEL) information is essential for the safe and effective development of new drugs. In this podcast, we discuss the importance of NOAEL information in safety and toxicology studies.
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N-(n-butyl) thiophosphoric triamide (NBPT) (Figure 1) is an active ingredient in nitrogen stabilizer (urease inhibitor), which temporarily inhibits the action of the urease enzyme to improve the efficiency of urea-containing fertilizers. Given the potential for NBPT residues to be present in milk and tissues of dairy cattle, due diligence is needed to demonstrate the safety of NBPT in urea-based fertilizers used on forages and crops intended for consumption by Holstein dairy cows.
As biotech and pharma companies have become more streamlined and “virtual”, the use of CROs to conduct and/or manage portions of, or all of, a complete IND-enabling program has become common practice. However, the complexity of such programs, involving expertise in drug synthesis, regulatory, CMC, bioanalysis, toxicology, chemistry, pathology, and related disciplines makes management of these many inputs very challenging and subject to risks of poor execution or delayed submissions. This webinar, presented by a CRO-industry veteran, will provide insights on best practices, highlight common pitfalls, and identify “trade secrets” that can benefit industry newcomers, as well as more seasoned professionals. Topics addressed in this webinar include CRO qualification/selection, contracts, scheduling, protocol/program design, study conduct and monitoring, data and report review, and more. The session is intended to help participants interact more effectively and constructively with their CRO partners and ultimately save time, money & headaches in their development programs.
Speaker: Glenn Washer, President, Frontage Laboratories North America and Executive Vice President for Global Safety and Toxicology, Frontage Laboratories, Inc.
Glenn is a board-certified toxicologist, with >35 years in the industry. Prior to Frontage, he headed Charles River’s North America preclinical businesses and earlier served in executive roles in international CROs & Biotechs. He served as Faculty for the Pharmaceutical Education & Research Institute, as an Editorial-board-member of the International Journal of Toxicology, and lecturer for the Society of Toxicology, Drug Information Association, Society of Quality Assurance, McGill University and Universite de Montreal. He has also served on multiple corporate and industry boards.
In this podcast, we discuss 5 common errors in designing and managing IND-enabling toxicology programs with a special guest: Glenn Washer, EVP of Global Safety and Toxicology at Frontage Laboratories, Inc.