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.

Critical reagents – the key components used in LBA – are central to ensuring the consistency and reliability of the assay and can often slow the progress of LBA due to limited availability. In this panel discussion, we examine the current scope of LBAs, the advantages and limitations including matrix interference, as well as the solutions for overcoming these. Additionally, we explore the platforms currently used and the key factors to consider when choosing a platform. Finally, we will highlight key areas for progression.

This study is aimed at developing a Nanoemulsion formulation of a poorly water-soluble and thermally, oxidatively, and photolytically unstable active pharmaceutical ingredient (API) for ophthalmic application, specifically for the reduction of intraocular pressure (IOP) and to provide neuroprotection.