Early autoinjector integration can reduce downstream complexity and accelerate clinical development. See how Immunovant integrated its device in Phase IIb and progressed around five times faster than average.
In many clinical development programs, uncertainty around drug product characteristics or study design leads teams to delay autoinjector integration. This can appear to preserve flexibility by avoiding early commitment. In practice, however, it often shifts constraints downstream. Late integration of autoinjectors in Phase III studies or beyond can also increase costs due to additional studies, such as pharmacokinetic (PK) bridging studies. As a result, additional development steps, increased regulatory complexity, and slower progression through clinical phases and into the commercial phase can follow.
Experience shows that bringing the autoinjector into the program earlier can change this dynamic. When device integration is aligned early with clinical and regulatory planning, teams gain speed, reduce risks involved with failing PK bridging studies, and build submission readiness sooner rather than later.
A real-world example: Immunovant
Immunovant, a clinical-stage immunology company developing targeted therapies for autoimmune diseases, selected Ypsomed as its autoinjector partner to support their program from clinical development through to commercialization. Rather than deferring the device decision, Immunovant chose to integrate a customized autoinjector already at the Phase IIb stage.
This early adoption reflected a clear development strategy: preparing for later phases and real-world implementation by addressing device considerations upfront. By aligning the autoinjector with the clinical program early on, Immunovant was able to move forward with greater confidence and fewer uncertainties, and the project could progress extremely quickly, some five times faster than average (see graph). This unpreceded speed was achieved by making available both the active device and the matching placebo device. Despite differing physical characteristics, equal injection times and masking of differences could be achieved with two different devices that appear identical from the patient perspective, avoiding additional complexity.
No bridges downstream: Early integration removes need for clinical bridging work later
Early device integration was enforced by the submission support. For the Immunovant program, Ypsomed provided standardized documentation that could support Investigational New Drug (IND) submission. Ypsomed supported Immunovant throughout Phase IIb program planning, helping to align device-related considerations with clinical and regulatory requirements as well as chemistry, manufacturing, and controls (CMC) requirements. This created a more predictable submission pathway and reduced uncertainty during preparation as the commercial presentation could be used in the pivotal trials. As a result, the need for clinical bridging work was removed.
Ready for home: The move towards decentralized trials
The Phase IIb trial was set up globally with a strong focus on home use by patients. Early device readiness supported this decentralized approach and enabled patient-friendly administration without reliance on healthcare professionals for every injection. This approach can also lead to easier patient recruitment, as patients can self-administer at home, and thereby also potentially reduce trial costs by accelerating recruitment and limiting patient travel needed for in-office visits. The additional benefits of implementing autoinjectors in such trials are numerous. For the participants, autoinjectors can reduce the feelings of pain and anxiety, and provide a user-friendly experience. They also ensure precise and consistent dosing and minimized human errors. Beyond this, they reflect market use, and open up the possibility of connected, data-capturing add-on devices. As trials continue to evolve, early consideration of the delivery device will become increasingly important.
Set out your stall early for faster time to market
The Immunovant project demonstrates how a proactive decision for early autoinjector integration may positively influence clinical development and time to market. Through early alignment, structured support, and standardized documentation, the collaboration achieved speed, submission confidence, and reduced downstream complexity, including avoidance of lengthy bridging studies and additional clinical trials.
For teams looking to realize these benefits more systematically, we have recently launched the Clear to Clinic program, providing a standardized, repeatable framework to accelerate, simplify, and de-risk clinical programs. Clear to Clinic enables the use of autoinjectors in clinical trials with clinic-ready devices and a coordinated supply path.
Rapid clinical supply
quick access to assembled clinic-ready devices with various dose configurations and placebo options
Gain flexibility in study design and adaptations
Design and adapt your study protocol with flexibility and confidence
Enable decentralized trials
Use proven self-injection devices backed by robust documentation
Author
Roger Lüscher
Roger Lüscher is Project Manager for Autoinjectors at Ypsomed. With more than 14 years of experience in MedTech product development, he specializes in managing mechanical and mechatronic product platform projects, and has been with the company since 2017. In his current role, he supports the strategic positioning of the YpsoMate autoinjector by aligning business processes with pharmaceutical customer needs, advancing innovation in clinical and commercial settings, and fostering strategic partnerships. Mr. Lüscher holds an MSc in Industrial Management and Manufacturing from ETH Zurich.
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