Things To Consider In Early Development For Late-Stage NCE Success – Part Two

By Richard Sidwell, Ph.D., Senior Vice President and Chief Scientific Officer, Societal CDMO

Navigating the complex process of New Chemical Entity (NCE) development can be daunting. While late-stage failures are more noticeable and impactful, the seeds of success are sown much earlier during the often-overlooked preclinical and early clinical phases. This three-part series, gleaned from expert insights at Societal™ CDMO, shines a light on crucial considerations for laying a solid foundation for late-stage success.

Sponsors can often face limited resources, tight timelines, and unforeseen scientific roadblocks during NCE development. The scarcity of pure API, analytical methods, and ever-present financial constraints can cause costly delays and prevent novel therapeutics from reaching patients in need.

However, within these challenges lie opportunities. Unveiling the secrets of formulation science, identifying reliable partners, and mastering the art of parallel development can transform these obstacles into stepping stones. Discover how strategic partnerships, robust process development, and a keen awareness of supply chain vulnerabilities can pave the way to a successful clinical trial.