New Medicines, Novel Insights - Patient Guided Drug Development

By Stacy Hurt, M.H.A., M.B.A., Chief Patient Officer

In drug development, there has traditionally been a focus on the scientific aspects of treatment rather than on patient access and engagement. However, recognizing that patients are the ultimate consumers, Parexel advocates reversing this approach. Addressing patient concerns is crucial for commercial success in a competitive market, a shift underscored by the FDA's emphasis on patient-guided drug development through recent guidance documents. Despite the idealistic nature of a patient-guided approach, achieving it requires listening, learning, and integrating patient perspectives across diverse stakeholder interactions.

This report outlines best practices to embed patient centricity throughout drug development processes. By systematically involving patients from early asset planning stages onward, sponsors can significantly enhance the effectiveness and relevance of their drug development efforts across various therapeutic areas. This proactive engagement not only optimizes individual assets but also strengthens a company's entire portfolio within specific therapeutic domains.