Patient-centric drug development focuses on the patient’s experience and needs to better ensure adherence and enhance treatment. This approach collects and uses patient and caregiver input to inform both drug development and regulatory decision making (1). In 2025, FDA published a series of guidance documents that allows for the patient’s voice to be incorporated into the development process (2) and for a better patient experience.
Medicines, such as those used to treat cancer or rare diseases, developed and formulated using this tailored approach often require pharmaceutical companies to enlist the services of contract development…