The Early-Development Journey of a Small Molecule: An Integrated Perspective

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.

In this session, learn about the benefits and challenges of integrated approaches, as well as insights on whether integrated solutions can be the key to achieving today’s more aggressive development milestones. Examples of real-life tactical and operational decisions involved in the integrated approach to drug development will also be presented.

Beth Negash, Scientist III in the Solid Oral Formulation Development, Catalent Pharma Solutions