Hyper-accelerated submission enables confident – and fast decisions for drug development teams and regulators

Viewing pharmacometrics as merely one of the final steps in a multi-year process can be a fatal mistake. It can cause pharmaceutical companies to spend years bringing a new drug candidate through development, only to stumble near the finish line: “Hyper-accelerated submission isn’t just about trimming a few weeks at the end – it’s about optimizing the entire drug development process from the very beginning,” explains Dr. Jakob Ribbing, Principal Director, MIDD Consultant & Senior Expert.

07.10.2026

Interview with Dr. Jakob Ribbing, Principal Director, MIDD Consultant & Senior Expert. The key to an accelerated submission is to plan ahead: “It’s about optimizing the entire drug development process from the very beginning.”

Jakob Ribbing has more than 25 years of experience in pharmacometrics, both as a specialist at a pharmaceutical company (Pfizer) and as a consultant at Pharmetheus. He’s been part of the process of bringing new drugs to market many times, and knows how it feels when a promising drug fails to deliver – as well as when it’s an even greater success than anyone could have anticipated.

No matter the outcome, the arrival of new data is always a highlight:

“Every read-out is exciting! Every new study result brings something to learn. You might think I’d grow tired of it, but that’s never happened - I still feel like a child opening a Christmas present,” Jakob says.

Saving time and patients’ lives

His experience shows that the fastest - and most cost-effective - drug submissions happen when pharmacometrics and Model-informed Drug Development (MIDD) are involved from the beginning. If model-informed approaches like MIDD aren’t built into early protocol design, key lab results and patient samples collected later can stall development. Instead of a smooth path to submission, companies can face avoidable delays - sometimes lasting weeks, months, or even years - losing valuable patent time and keeping critical treatments from patients.

“By leveraging MIDD, we can shorten or even skip entire studies, drastically reducing time to submission. Every month saved means longer patent lives for the sponsor and, most importantly, getting life-changing treatments to patients much faster,” Jakob explains.

Early unblinding incorporated into trial protocols

This process, called hyper-accelerated submission, requires a highly structured, proactive approach before the database lock. By engaging specialized consultants early on, companies can incorporate crucial elements, such as planned early unblinding, directly into their trial protocols. This head start lets pharmacometricians prepare models, run interim analyses, and refine report structures in parallel with ongoing trials.

“The earlier we’re involved, the smoother it all goes. Planning ahead, as early as Phase 2, and designing the Phase 3 protocol to support efficient data flows, like early unblinding, helps us avoid bottlenecks that could delay submission by weeks or months,” Jakob explains.

Regulatory expertise and standardized reporting: “Accelerating submission timelines is becoming the new standard”

To optimize this process, Pharmetheus uses standardized reporting frameworks to ensure seamless compliance and immediate execution as soon as final data is available. Because all consultants work in the exact same way, there are no discrepancies, enabling smooth collaboration across the entire company.

“Our strength is in how seamlessly we work together. By combining deep regulatory expertise, up-to-date reporting templates, and an embedded team approach, we make sure every analysis meets standards on time, without losing important context,” Jakob explains, adding:

“Pharmetheus has always had the foundation to do this exceptionally well through reproducible reporting.”

Through accelerated submission, pharmaceutical companies not only save time and lives; they also save internal resources, allowing greater focus on drug development itself. Faster use of MIDD will also make it possible to stop the development of ineffective drugs much earlier, saving time and effort and reducing unnecessary patient exposure. For Jakob, who has worked on the other side of drug development, these are equally important wins:

“This way of working will only grow, and everyone will move faster. Accelerating submission timelines is becoming the new standard.”

Links

Biography and publications: Jakob Ribbing

Read more about our Accelerated Submission services

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