Rapid Delivery of API Enables Accelerated IND Application– Challenges and Solutions

Process development runs through the entire life cycle of new drug development and plays important roles in each stage. However, as the purpose of each development stage changes, the priority of the process development also changes accordingly. For the IND stage, the main purpose of process development is to scout the most efficient way within a limited timeline to produce the API, ensuring timely toxicology study and subsequent clinical trials. Therefore, rapid delivery of API is crucial for a timely IND submission.

In this webinar, we will discuss the importance of phase-appropriate process development and various frequent-encountered challenges in process development during the IND filing stage. These risks include scalability difficulties resulting from an inappropriate medicinal chemistry process; process safety issues; unanticipated risks of residual PGI/elemental impurities; API delivery delays caused by inappropriate specification settings; and scheduling challenges in delivering tox batches within restricted timeframes. With case studies, we will dive into these challenges in detail and share our experience in resolving them.

Key Learning Objectives:

• The importance of phase-appropriate process development for IND filing
• Common obstacles and difficulties in process development

Who Should Attend:

• Early-Stage Drug Developers
• R&D Scientists