The story behind MIDBA: An exclusive interview

The EMA qualification of the molecule-independent device bridging approach (MIDBA) marks a major step forward for clinical device bridging. By providing a qualified framework under defined conditions, MIDBA has the potential to reduce development burden, shorten timelines, and accelerate patient access.

If you're new to MIDBA, start with our blog, "MIDBA: A new regulatory approach to clinical device bridging," which explains the methodology, its scientific basis, and where it can be applied.

In this interview, we look beyond the qualification itself to explore what it means for pharmaceutical companies and the future of drug-device combination development.

Inside the discussion

Conventional pharmacokinetic (PK) bridging studies have long been accepted as part of introducing an autoinjector into clinical development. They are repetitive, resource-intensive, and a significant source of time, cost, and complexity. MIDBA challenges that model by enabling existing PK comparability data to be leveraged under defined conditions, reducing the need to generate new evidence for every program. The qualification was demonstrated using the YpsoMate 1 mL and YpsoMate 2.25 mL autoinjector platforms.

The conversation also looks at what this means in practice. For pharmaceutical companies using the qualified YpsoMate platforms, MIDBA has the potential to reduce regulatory uncertainty, simplify development, and accelerate time to market. More broadly, it reflects a shift toward evidence-based regulatory approaches that make better use of existing scientific data while maintaining regulatory rigor. If that direction continues, its influence could extend well beyond this single qualification.

Watch the interview to hear how MIDBA came about, why it matters, and what it could mean for the future of clinical device bridging.