What are the current trends in patient-centric drug delivery in the pharmaceutical industry, and how are these trends reshaping clinical trial design, formulation strategies, and patient adherence?
Bill Welch, Executive Director of Market Development for PCI Pharma Services: Across modalities and markets, patient-centric drug delivery is converging on three themes: self-administration at home, integration of drug delivery device platforms earlier in clinical trials, and alignment of formulations with device and human factors requirements. A variety of issues are driving these trends, including the rise of chronic ailments, the expansion of rare disease treatments, healthcare systems shifting care away from clinical settings for economic reasons, and patients requesting less stressful administration strategies. The number of biologic drug products requiring subcutaneous administration is another element at play. For injectables, that translates into a preference for prefilled syringes, autoinjectors, pens and on-body delivery systems designed for easy administration, with intuitive interfaces and built-in safeguards to reduce user error and anxiety.
These trends are already reshaping clinical trial design. Protocols increasingly incorporate self-administration, decentralized and hybrid visit schedules, as well as patient-centric sampling strategies that enable data collection in the home. Among other benefits, these conveniences help improve recruitment, retention and data richness.
Evolving early-stage organization strategies suggest that brand owners are already seeing the value of this patient-friendly approach. Early device selection and human factors work are now being considered as part of early Quality Target Product Profiles (QTPP) within the pharmaceutical development strategy upstream, so that investigators can evaluate usability, adherence and real-world handling alongside traditional safety and efficacy endpoints. This may make the front end of the clinical process more complicated, but pharma companies increasingly feel that the ends justify the means.
To accommodate this shift, formulation strategies must now support higher concentrations, longer acting profiles and subcutaneous delivery within device and volume constraints, while controlling pain during injection and injection site tolerability. When executed in clinical trials, this integrated approach that aligns formulation, device, and human factors can significantly improve adherence and persistence, translating into better long-term outcomes and more robust real world evidence packages for regulators and payers.
Which emerging technologies (e.g., wearable injectors, smart packaging, digital companion apps, or connected devices) are most influential in advancing patient centric drug delivery, and what are the key technical and implementation challenges life science companies face in adopting them?
Welch: Wearable injectors, smart packaging and connected autoinjectors are currently among the most influential technologies in advancing patient-centric drug delivery, because they enable safe, reliable self-administration and real-time insight into how therapies are used in the home. For complex biologics, on-body large-volume injectors allow subcutaneous delivery of doses that would previously have required infusions. However, some issues remain unsettled – including matters concerning autoinjector volume limits, as well as the specific dynamics most suitable for on-body injector (OBI) utilization. For now, OBI utilization for large-volume at home administration remains a frontier, with only a few reported applications; however, the substantial value of benefits like connected sensors that provide objective adherence and dosing data to sponsors and clinicians is becoming more widely recognized.
In parallel, smart kit and packaging elements such as clear structural design, intuitive component layout, color-coding and stepwise carton or tray organization can aid usage, minimize handling errors, and make complex regimens feel more manageable for patients and caregivers.
However, there are several technical and implementation challenges that must be considered. On the drug product side, sponsors must ensure compatibility of high value, sensitive formulations with new materials and device geometries – all while controlling extractables, leachables, container closing integrity (CCI), dose accuracy and robustness under real world handling conditions. Packaging design must balance drug–material compatibility, barrier performance, CCI and cold chain robustness with child resistance, senior usability and clear instructions for use (IFU). Adding smart or sustainable features may trigger extra stability, validation and regulatory work, and can increase line complexity, cost, and data management demands across the supply chain.
What are the main regulatory considerations and hurdles when designing patient centric drug delivery systems, and how can sponsors engage effectively with agencies to align on patient centricity driven endpoints and device drug combinations?
Christopher Hamlin, Director of Regulatory Affairs for PCI Pharma Services: Designing patient-centered drug delivery systems means navigating a complex regulatory landscape that spans drugs, devices, and combination products, all while keeping real patients at the heart of the approach. The key win is agreeing on endpoints that truly matter to people—adherence, usability, and patient-reported outcomes—supported by validated processes and equipment, solid data on device–drug compatibility, and a transparent link to labeling. Early decisions about how the product will be classified shape the submission path and evidence needed, from design controls and risk management to lifecycle planning that includes post-market surveillance for device performance and patient experience across regions.
When engaging regulators, sponsors should aim for clear, concise conversations that align on patient-centric endpoints, device–drug interaction data, and lifecycle management from inception. In doing so, they are well-advised to share a practical usability plan with human factors milestones, a realistic data-readout map linked to regulatory claims, and a governance model that clearly maps chemistry, manufacturing and controls (CMC), quality, user experience, and pharmacovigilance. And they should be prepared to discuss labeling, training materials, and post-approval commitments, as well as provide a real-world evidence plan to demonstrate ongoing post-launch patient value.
Looking ahead, what are the future opportunities and major blockers - such as cost, reimbursement, health equity gaps, or interoperability with digital health ecosystems - that could accelerate or limit the adoption of patient centric drug delivery in the next 5–10 years?
Welch: Over the next 5–10 years, patient-centric drug delivery will be shaped by a combination of technological innovation, healthcare system evolution, and economic pressures. Among the most promising opportunities involve the introduction of drug-device combination products in early clinical trials, which not only provides real-world data but also improves adherence and supports value-based care models by demonstrating outcomes outside of traditional clinical settings. Personalized therapies, including biologics and advanced therapies, will also drive demand for more patient-centric delivery systems such as autoinjectors, pens and on-body delivery devices.
However, several hurdles could slow adoption. Cost remains a major barrier, particularly in instances where combination products and connected devices are more expensive than traditional delivery methods. Reimbursement frameworks often lag behind innovation, making it difficult for healthcare systems to justify higher upfront costs even when adherence and long-term outcomes may improve. Finally, health equity is another concern, as digital and connected delivery solutions may not be accessible to all patient populations due to cost, digital literacy, or infrastructure limitations.
PCI is a CDMO providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the healthcare services business. The company currently has 38 sites across seven countries (United States, Canada, United Kingdom, Ireland, Germany, Spain and Australia), and over 8,000 employees working to bring life-changing therapies to patients.