Strategic CMC and Phase-Appropriate Drug Development

This presentation will explore the critical elements of a successful drug development strategy, focusing on key aspects such as an end-to-end CMC strategy, phase-appropriate drug development, and strategic partnerships with CROs and CDMOs, along with collaboration with consulting firms. A successful CMC strategy integrates pre-clinical studies, clinical development plans, regulatory frameworks, and the target product profile for commercialization. Phase-appropriate drug development emphasizes tailoring the process to each stage, optimizing resources, timelines, and costs. Partnering with CROs and CDMOs provides specialized resources for manufacturing, while collaborating with skilled consulting firms offers valuable insights to create a fully integrated, end-to-end drug product development strategy and execution. Together, these elements form a cohesive approach that accelerates drug development, mitigates risks, and enhances clinical outcomes. Additionally, considerations around tariff implications and the BioSecure Act will be discussed in relation to the design of an effective and resilient supply chain.