Deborah Minor

In drug development, the next milestone often reveals how strong the current plan really is. A program may appear to be moving forward. Vendors are active, studies are underway, analytical work is progressing, and timelines are being tracked. But as the program gets closer to IND-enabling studies, clinical supply, tech transfer, or later-stage manufacturing, gaps can become more visible. A process that worked at small scale may not be ready for larger batches. An analytical method may need...

Securing a funding round is a major step for any emerging pharmaceutical or biotech company. It validates the science, builds momentum, and gives the team the resources to move the program forward. But funding also brings pressure. Investors want to see progress. Timelines become more visible. Key development decisions need to happen quickly. For many companies, this is the point where the work becomes less about the promise of the program and more about execution. Start With a Clear...

Early development is centered on the science: proving the concept, advancing preclinical work, preparing for funding milestones, and moving toward clinical development. While these priorities are critical, Chemistry, Manufacturing, and Controls can quickly become one of the most important factors influencing whether a program advances smoothly or encounters costly delays. At Drug Discovery Alliances, we see that CMC decisions made early in development can have long-term implications for...