In this webinar, speaker Christopher Gilmer introduces microbiological testing for raw materials, APIs, and finished products, discusses the validation of methods and product testing requirements, and clarifies general procedures to investigate unexpected results.

The emergence of global pandemics has led to an expansion of studies focused on vaccine development for infectious agents. Moreover, breakthroughs in understanding the immune system in recent years have brought a new wave of treatments using immune system modulators and immunotherapies. The ELISpot assay is a powerful tool in addressing the bioanalytical needs of vaccine development, immunotherapies, and gene therapies. Tremendous global harmonization efforts have been carried out to create optimized protocols and guidelines for ELISpot assays. Successes in these efforts are now being transferred to other areas in which there is an urgent need for compliant, high-throughput image acquisition and analysis systems.

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. Here we discuss how to more effectively and constructively interact with CRO partners and ultimately save time, money & headaches in your development programs.