This webinar discusses the strategic contributions of a contract research organization as a partner to support the clinical development process.
Between the concept of a novel chemical, biological, or advanced therapeutic medicinal product and the commercial debut of a therapeutic entity fall innumerable business decisions. Will a developer pursue an idea to fruition and seek intermittent funding for each aspect of discovery, development, manufacturing, and commercialization? Or will a sponsor opt to bring development to one of several inflection points, at which options for further development — including out-licensing, portfolio pruning, or modifications in program timelines — become viable as an alternative stratagem? Many factors play a role in the decisions, but an awareness of the strategic ramifications of clinical and regulatory insights designed to “de-risk” investment decisions is key to ensuring optimal engagement with investors, partners, and other entities interested in financially supporting, acquiring, or partnering. Indeed, lead identification and candidate optimization including choice of therapeutic target disproportionally influence the earliest stage development programs for small to midsize pharmaceutical companies, representing one of the more significant inflection points in the discovery to development transition.