Regulatory Considerations For First-Time Drug Developers

Developing innovative therapeutics for patients lies at the heart of translational science. This “bench-to-bedside” approach centers on translating foundational research into therapeutic applications. Early-stage drug developers face the challenge of balancing rigorous science with business imperatives to advance new treatments, often constrained by tight budgets and deadlines. The journey to commercial success is steep; fewer than 0.1% of preclinical programs ultimately gain market approval.

The initial transition from basic research to approximately Phase 2 is especially fraught, often referred to as the “valley of death.” Here, therapeutic candidates face numerous potential setbacks—including issues with efficacy, safety, funding, and reproducibility. Many programs also encounter regulatory delays, often compounded by complex CMC (Chemistry, Manufacturing, and Controls) hurdles before clinical trials can begin. However, this high rate of failure in early stages can be mitigated through careful planning, patience, and the right expertise. Moving a new biologic from bench to bedside is inherently challenging, but for drug developers, partnering with an experienced CDMO can significantly improve the chances of advancing through the valley of death and into subsequent phases toward regulatory approval.