The biopharma industry addresses the global unmet medical needs of patients through the discovery, development and access to medicines. To appropriately serve all populations, the consideration of variability to research model design, clinical study participants that represent the patient populations and their perspectives in medical research, varied perspectives and experiences, and engagement with educational ecosystems are pivotal. Literature reviews have addressed individual stages of the drug product lifecycle through these principles separately. This review aims at providing a holistic view of the specific application of inclusion and engagement principles in all stages of the lifecycle, catalyzing biopharma leaders into action, and educational activities in the context of guidelines, regulations, and case studies. Genetic heterogeneity, representative pre-clinical animal models, and data and algorithms to mitigate pre-clinical research bias are reviewed. Participation of all populations that reflect the clinical indication and the engagement of patient perspectives in clinical development is described. Principles for broad access, affordability, and healthcare system strengthening for inclusive access to medicines are explored post-regulatory approval. Finally, inclusive perspectives in product decision making and educational collaborations are described for upskilling the globally distributed biopharma workforce. A comprehensive understanding of these principles enables leaders to spark the development of safe and effective medicines that serve all patient groups by improving patient outcomes and health-related quality of life.
Keywords: Clinical development; Education; Engagement; Patient access; Preclinical research.
Copyright © 2025 The Authors. Published by Elsevier B.V. All rights reserved.