Anticipating the Hurdles in Drug Development
SCx CMC Solutions was founded by two former pharmaceutical scientists and engineers—Ray and Kevin. Independently and together, they have successfully navigated the unpredictable nature of drug development from early funding stresses to late-stage pivots, and overextended drug formulations that just wouldn’t cooperate.
Select the drug development stage to explore common experiences, see how your experience compares, and get a clearer sense of what might come next for you and your pharmaceutical drug product.
Where is your pharmaceutical company in the business cycle of drug development?
At This Drug Development Stage
Early-stage pharma companies face limited funding, porous timelines, and pivotal choices. Kevin recalls launching oral formulations at a startup with little runway, no manufacturing team, and one investor milestone ahead. Figuring out which CMC tasks truly mattered was daunting—and just as often, deciding what could wait felt overwhelming.
At This Drug Development Stage
This stage is fueled by early promise but weighed down by pressure. You’re shaping regulatory strategy, building your first FDA submission, and managing scarce resources. Kevin recalls guiding a small team through its IND preparation—where careful planning and strategic support helped them avoid costly missteps and maintain momentum.
At This Drug Development Stage
Phase 2 proves promise but quickly raises the stakes. One team assumed supply chain logistics would be their biggest hurdle—until unstable degradation profiles in tox studies upended the timeline. For Ray, few thought experiments become real exercises quite like shoehorning impurity data revisions, sourcing comparators, and rethinking vendor choices for a “finished” program.
At This Stage
Late-stage pharmaceutical development is a major milestone, where scaling up and meeting regulatory demands reveal whether everything is truly in sync—or not. Ray swears his white hair traces back to a particular Phase 3, where he somehow overcame ERP headaches, shipping snags, and last-minute label drama that nearly derailed registration.
At This Stage
Even the strongest internal teams hit limits. During a complex pharmaceutical spray drying scale-up, Kevin’s team faced inconsistent yields and looming deadlines. It took a seasoned expert with niche formulation experience to troubleshoot the issue and restore forward motion.
At This Stage
In an ideal world, science would speak for itself. But credibility and strategy often dictate financial viability. When Kevin added a respected scientific advisor to an early program’s board, it proved more than reputational. Their decades of perspective became a masterclass in big-picture thinking, shaping both decisions and direction.
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