Thought Leadership

Avoiding Potential Pitfalls: Phase Appropriate CMC Development and Regulatory Considerations

Incorporation of phase appropriate development strategies is becoming increasingly essential to manage the balance between speed, cost, and completeness during development. The possibilities for both Chemistry, Manufacturing, and Controls (CMC) development and filing approaches range from the minimalist style to a continuously supported style. The minimalist style is preparing only the things necessary for the next filing to save money and time. The continuously supported style is keeping a development program up-to-date and fully current so filings are ready to go. There are pros and cons to both styles, and while there is no right answer, there probably is a “best answer” to suit each company’s culture, funding runway, and the ultimate goal for the project.

In this webinar, development and regulatory experts will discuss the phases of oral solid dosage form development from a CMC perspective. At each phase, they will identify the minimal expectations for CMC development and filing, as well as other considerations to address, thereby setting the stage for later success. In addition, they will present key learnings and past experiences of issues that came up, how they were resolved, and how they could have been avoided or mitigated by taking certain strategic actions earlier in development.

This webinar will touch on several case studies that will alert drug developers to (and help them avoid) potential pitfalls and late-stage gaps in their CMC development.

What You Will Learn

Participants will be able to:

• Identify key phase appropriate development decisions in CMC
• Understand the benefits of incorporating phase appropriate development principles in CMC development
• Develop strategies to apply phase appropriate development strategy at each stage of development
• Explain the role of phase appropriate development in improving regulatory review outcomes