Integrated Clinical Development & Supply: Breaking Down the Early Development Journey of a Small Molecule
Summary: In the era of seamless drug development, reducing time to the clinic and getting rapid regulatory approval has become the goal of nearly every early drug development sponsor. Handling drug development, manufacturing, and clinical supply efficiently can help sponsors save costs and provide maximum benefit for patients. In order to improve the efficiency of the drug development continuum, integrated solutions have become an effective option for sponsor companies to streamline the transition from early development to the clinic, in addition to providing timely clinical supplies to help keep study timelines and budgets on track. Along with a discussion, examples of real-life tactical and operational decisions involved in the integrated approach to drug development will be presented.