In this webinar, Dr. Santosh Shah discusses the general industry standards for utilizing critical reagents in bioanalytical labs, importance of bridging various lots of critical reagents and maintaining stocks, and reviews proper storage, management, and documentation of critical reagents.
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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 Q&A, Nan Zhang MD PhD, Vice President of Global Central Lab and Biomarker Services at Frontage, speaks on the role of analytical and central laboratories in providing accurate laboratory data and seamless logistics services.
In this poster, we validate ultra-high sensitive SIMOA assays for the successful quantitation of neurofilament light chain (NF-L) and glial fibrillary acidic protein (GFAP).