Patient-Centric Product Development: A Summary of Select Regulatory CMC and Device Considerations

Patient-centric drug development describes the systematic approach to incorporating the patient's perspectives and preferences into the design, assessment, and production of a therapeutic product. While a patient centric approach can be applied at any stage of the drug development lifecycle, an integrated end-to-end strategy is often most effective to create an optimized product for the patient at the earliest possible timepoint. The impor-tance of patient centricity is well recognized by health authorities and biopharmaceutical organizations which have established toolsets, guidances, and methodologies for incorporating patient input during the clinical stage of development. However, in addition to clinical research, there are other significant aspects of product develop-ment that profoundly impact the patient experience. Specifically, chemistry, manufacturing, and control (CMC) and device aspects must also be acknowledged and addressed as part of a cohesive patient-centric development strategy. This review explores current applications and regulatory considerations for patient-centric approaches across the product lifecycle, including R&D, early product development, clinical development, device and combi-nation product development, and post-approval change management. Specific topics of discussion include the contributions of product modality, formulation, and devices to the patient experience; usage of the Quality Tar-get Product Profile (QTPP) as a patient-centered design tool; and post-approval product optimization. Future advancements in regulatory data management and information exchange are also explored as potential ena-blers of patient engagement which support enhanced communication and interconnectivity between stakehold-ers. Multidisciplinary collaboration between patients, health authorities, health care providers, and the biopharmaceutical industry is ultimately necessary for ensuring that medicinal products, and their correspond-ing regulatory processes, take on a patient-first mindset that prioritizes patient needs, values, and preferences.(c) 2023 The Authors. Published by Elsevier Inc. on behalf of American Pharmacists Association. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)