Navigating The Small Molecule CMC Pathway: Strategies For Avoiding Regulatory Hurdles And Early Drug Development Pitfalls

Advancing a small molecule candidate from discovery to clinic is a complicated journey fraught with formulation challenges and regulatory hurdles. Bridging from discovery and clinical development can present many questions and unknown challenges for drug developers, and having trusted and experienced guidance at this stage can help streamline the pathway from discovery towards IND, reduce risk, and improve the likelihood of clinical success.

Hear from NGT BioPharm Consultants and Quotient Sciences and gain insight into the timeline for each stage of the development process, the benefits of employing an integrated drug substance and drug development approach for a clinical program, and how to navigate regulatory complications. Learn more as this panel of experts discuss the factors that can accelerate development timelines and help improve downstream clinical outcomes.