Making Fit-for-Purpose Decisions in Pharma Development

Managing Timelines and Deliverables in Pre-Clinical and Early Clinical Development

Once a compound has been chosen as a clinical candidate, several key questions need to be answered to meet preclinical and early clinical needs. With aggressive timelines, budget constraints, and the evolving needs of a program, trying to develop the best process from the outset can delay drug substance supply and become a bottleneck for the program. The focus should instead be on developing a process that is suitable for the current stage, a process that is “fit-for-purpose.” In other words, a process doesn’t need to be fully optimized right from the start.

For example, perhaps your current process gives you API in acceptable purity, but there is room to improve the conditions, yields, and purities of several steps. You can spend the time now further optimizing the process, or you can establish that the process is sufficiently robust and suitable for this stage and the desired improvements can be looked at in a future round of development. The decision comes down to several factors:

• Deliverables: What needs to be demonstrated/supplied?

• Timeline: When is it needed?

• Risk: What are the risks of moving forward with the current process? What can be done to mitigate that risk?

• Future work: What can be deferred to a later time?

Understanding what is needed at each milestone and making sure that the right work has been completed at the right time is critical to ensuring the success of the program. With experience across all phases of the drug development lifecycle, our team can help you identify what is critical at the current stage and assess potential risks. This expertise in developing fit-for-purpose processes can help you meet deliverables within the necessary timelines and minimize the chances for future delays in your program.

Author: Jill Caputo, Drug Discovery Alliances