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

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.

In Part One, we delve into the bedrock of any successful NCE: robust raw materials. Identifying reliable sources for GMP-compliant Active Pharmaceutical Ingredients (APIs) and excipients is paramount. We also exlpore the intricate process of preformulation and formulation development, the stage where the NCE's therapeutic potential is sculpted. Here, meticulous data gathering on factors like solubility and stability is essential, laying the groundwork for scientifically driven, targeted formulations. By embracing a data-driven approach and employing statistical design of experiments, researchers can efficiently navigate the vast design space and identify promising lead candidates.

But a formulation's potential must be translated into a scalable, manufacturable product. Therefore, early processability and scalability considerations are woven into the development fabric. This involves employing quality-by-design principles, defining critical process parameters, and fostering close collaboration with quality assurance and regulatory teams. Understanding the regulatory landscape and tailoring the Chemistry, Manufacturing, and Controls (CMC) strategy accordingly reduces the risk of late-stage roadblocks.

Learn about the importance of assessing and mitigating risk at every stage of development and ensure that your NCE has the maximum potential for commercial success.