Moving a molecule from discovery through early clinical development is rarely a straight path. Development teams must navigate technical and operational hurdles, including scale-up challenges, evolving impurity profiles, formulation issues, unexpected toxicology findings and the constant pressure to meet critical development milestones and clinical timelines. As programs progress, even small setbacks can create significant delays and strain limited budgets, making it essential to have the experience and tools to troubleshoot issues quickly and practically.
Join Cambrex experts Cy Credille and T.J. Harper as they discuss the most common – and some uncommon – challenges encountered during early pharmaceutical development and share creative yet practical strategies for overcoming them. They will share real-world examples of how the team at Cambrex’s facility in Longmont, Colorado, has accelerated development for clients through collaboration to solve manufacturing, analytical and formulation challenges.
Key Learning Objectives:
- How to handle the unexpected in early drug development with minimal impact to timelines, and how to move forward when complexity arises
- Case studies from Longmont, Colorado, where the Cambrex team specializes in providing drug substance and drug product development services to support IND submissions
Who Should Attend:
- R&D
- CMC (Chemistry, Manufacturing, and Controls)
- Process Development
- Pharmaceutical Manufacturing