Several themes ran through the two days: global regulatory strategies, risk management, human factors engineering, system engineering, digital transformation, and the platform approach. A key message which emerged from multiple discussions was that platform-based development is rapidly becoming the industry standard. Looking ahead, the question will no longer be whether to use a platform but which one to use.
My presentation Strategies for Streamlining Clinical Development Programs for Drug-Device Combination Products explored how platform technologies, comprehensive services, and device manufacturer expertise can reduce complexity and shorten development timelines. A particular focus was the evolving relationship between pharma sponsors and device manufacturers, increasingly one of strategic partnership rather than component supply. Regulatory expertise, applied early, plays an important role here too, helping to align development decisions and improve interactions with health authorities.
Another key theme of the presentation was Ypsomed's Clear to Clinic approach, addressing one of the most persistent sources of delay in clinical development: trial readiness. By providing clinic-ready YpsoMate autoinjectors with an established technical baseline, rapid access to assembled devices across dose configurations, and support for submission documentation, it enables sponsors to introduce a device into early clinical trials without waiting for a fully customized commercial solution. At the same time, flexibility to adapt study design and support decentralized trials is also retained.
The presentation also touched on a significant regulatory advancement. The Molecule-Independent Device Bridging Approach (MIDBA), recently qualified by the European Medicine Agency (EMA), eliminates repetitive, molecule-specific pharmacokinetic studies when transitioning from manual subcutaneous injection to an autoinjector platform for monoclonal antibodies, offering sponsors a faster and less costly route to device bridging. The validity of the MIDBA approach was demonstrated using the YpsoMate 1 mL and 2.25 mL autoinjectors, which currently serve as the reference platform for the qualified methodology. The application of MIDBA to alternative autoinjector platforms requires additional evidence and scientific justification and will be assessed on a case-by-case basis.
Accelerating clinical development for drug-device combination products is not achieved through any single improvement. It requires a combination of platform technologies, expert services, and strong partnerships working together. Organizations that align these elements early will be best placed to achieve faster, more predictable paths from concept to clinic and ultimately to market.
Author
Karolina Snajdarova
Karolina Snajdarova is Regulatory Affairs Manager, Associate Director and Team Lead Autoinjectors at Ypsomed. She is responsible for regulatory affairs for the company’s autoinjector platforms and provides strategic regulatory support for customer-specific projects, including global registration activities in the EU, US, China, or Japan. In addition, she supports a variety of corporate strategic initiatives in her role at Ypsomed. Karolina holds a Master's degree in Chemistry for Medical Applications. She has a strong background in analytical chemistry and extensive regulatory expertise in various product categories, including cosmetics, personal protective equipment, medical devices, and drug-device combination products.
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