Challenges and opportunities to include patient‐centric product design in industrial medicines development to improve therapeutic goals

Abstract

In the past, drug developers in industry chose approaches mainly focusing on the drug product's efficacy, safety and quality according to the level required by regulatory expectations stipulated in guidelines, pharmacopoeia and other regulatory provisions. By putting more focus on the patient perspective, regulatory authorities are currently raising their requirements regarding successful product submissions. The increasing involvement of patients in the product development process (e.g. conduction of human factor use tests, integration of feedback from patient and patient advisory groups into clinical programmes) requires adaptations to the existing and established industrial drug development processes without compromising fast patient access to innovative therapies. This review provides an expert opinion on the emerging challenges and opportunities to implement a patient‐centric approach into new drug development programmes. The aim is to better understand the challenge of finding the right balance between bringing innovative drugs fast to the patients and to develop these in parallel in a patient‐centric product form as well as why this is an opportunity and how stakeholder parties (e.g. patients, clinicians, pharmacists, caregivers, regulators) can provide support to achieve desired outcomes.

A composite endpoint for acceptability evaluation of oral drug formulations in the pediatric population

“…Due to the lack of a validated approach, assessing and comparing acceptability of pediatric solid oral dosage forms is currently not possible [11]. This gap is intended to be closed with the proposed composite endpoint based on deglutition and palatability.…”

“…It is intended to broadly discuss the results with academic and industry experts, clinicians, regulators and patients to provide an internationally accepted method for acceptability assessment. In addition, the suggested acceptability assessment procedure may in future serve as a test system to enable patient centric drug development [11].…”

Commentary on the EMA reflection paper on the pharmaceutical development of medicines for use in the older population

“…For new medicines, the product life‐cycle management should start during early drug development, when clinical evidence is generated on the targeted disease(s) and hence patient populations. By identifying the unmet needs of the target populations such as children, older people and pregnant woman and defining the associated objectives to be reached, a patient centric approach to medicines development will help to balance the advantages and disadvantages of the available options in product design and realise an optimum medication portfolio upon first and continued entry to the market 14 …”

Better Medicines for Older Patients: Considerations between Patient Characteristics and Solid Oral Dosage Form Designs to Improve Swallowing Experience

“…As it is well understood that older patients struggle to swallow large SODF, a simple patient-centric approach could focus on the manufacturing of reduced dosage form sizes in order to enhance swallowing experience and patient compliance [ 26 , 128 , 129 , 130 , 131 , 132 , 133 ]. Following this concept, and for a given pharmaceutical drug product, a wide range of SODF presentations should be available on the market to meet the heterogeneous needs of the older patient population [ 134 , 135 , 136 , 137 ].…”