Evolution of Drug Development: Integrating the Patient Perspective Into Early Research

Abstract

Soaring drug development costs, increasingly stringent regulatory requirements, and demanding market access environments have necessitated that pharmaceutical companies examine their research processes in order to provide novel and meaningful solutions for patients. In this paper, we describe an initiative that aims to incorporate a better appreciation of the exam room experience of both patients and practitioners into the drug development pathway from the earliest point of research. Focusing on 4 core pillars-medical value, patient need, scientific rationale, and market environment-an integrated analytic process is undertaken so as to facilitate early identification of ideal target populations and criteria that will need to be met for successful entry into the treatment continuum. Collaborative interactions with other specialist roles within the organization are also described. It is argued that understanding the unmet medical need and the risks and opportunities inherent in different development scenarios can help direct early research so as to encourage truly transformative health care solutions.

Keywords: medical intelligence; medical value; patient perspective; risk/opportunity assessment; unmet need.