This webinar explores the critical path from small molecule candidate selection to First‑in‑Human (FIH) clinical studies, showing how strategic API development can accelerate overall program timelines. As emerging drug candidates become increasingly complex and pressure for rapid clinical entry intensifies, early planning of quantity, quality, and supply of API is more important than ever. The webinar will outline best practices for establishing a robust supply route, optimizing synthetic processes, and selecting appropriate regulatory starting materials to enable efficient GMP production. The session will also delve into solid‑form and material‑science considerations – including polymorph and salt screening, solid form selection, and stability assessment – that directly influence downstream formulation and manufacturability. Finally, attendees will gain insight into phase‑appropriate analytical strategy, specification setting, and regulatory considerations, all of which are essential to delivering high‑quality API for FIH studies.

By attending this webinar, you will learn about:

• API material supply can be rate-limiting to downstream activities and the sourcing strategy in development campaigns should take that into account.
• Early consideration of regulatory starting materials and the GMP production pocket helps define CMC investment, batch strategy, and logistics.
• API solid form screening and selection and understanding of critical physical attributes links to manufacture and testing of drug substance and crucial downstream drug product considerations.
• Planning for impurity coverage, ensuring analytical methods are appropriate, and setting phase-appropriate specifications reduces risk and supports drug substance testing and release.
• A clear understanding of the evolving regulatory landscape, including expectations for non‑mutagenic impurities, PMIs, and nitrosamines, ensures a strong, compliant data package for clinical progression.