2020 Recap by Yannis Jemiai, Chief Scientific Officer, Cytel

December 17, 2020

As Chief Scientific Officer, Dr. Yannis Jemiai plays a pivotal role in maintaining Cytel’s well-established reputation for statistical excellence and our track-record of bringing innovative analytic approaches to the development of medicines for human health. In this blog, we ask Yannis for his favorite Cytel events from 2020.

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One of my responsibilities at Cytel is to oversee the development of our software product lines, plan how our software should evolve and decide on what more can be done to maintain our industry leading software status. This year’s highlight was the reveal of our new SolaraTM software platform to optimize clinical trials. Solara revolutionizes the way product teams come together to design robust clinical studies that meet key business objectives. One way is by implementing our novel Advanced Design Framework , a method developed by Cytel’s thought-leaders after a decade of fine-tuning clinical development processes. This Framework demonstrates how to unify statistics and strategy in the era of cloud-computing, by making strategic use of well-resourced statisticians. It has been shown to improve development productivity by 10-20%.

In a recent Cytel Podcast, I talk about how to explore an expansive design space thoroughly without settling for suboptimal clinical trial designs; how to decide together on the benefits of these hundreds of thousands of designs using a quantitative evaluation framework; and how the complex tradeoffs across operational parameters can be easily communicated using visual tools and a collaborative decision platform.

Watch Podcast

You can also read the following blogs to learn more about Cytel's Advanced Design Framework:

  1. An Advanced Design Framework for Clinical Development in the Era of Cloud-Computing
  2. Cytel Introduces Advanced Design Framework: Part 1 - Methods for Thorough Exploration of Design Space
  3. Cytel Introduces Advanced Design Framework: Part 2- The Need for A Quantitative Evaluation Approach for Deciding Together
  4. Cytel Introduces Advanced Design Framework: Part 3 - Communication Techniques to Ensure Alignment on Data-Driven Clinical Trial Designs

Further strengthening our position in the industry was Cytel’s acquisition of Laiya Consulting, a drug development solutions company specializing in Bayesian adaptive trial designs and implementation. The acquisition adds to Cytel’s dedicated team of Bayesian experts to include several new and highly esteemed biostatisticians led by renowned Bayesian design specialist and Cytel network consultant Dr. Yuan Ji, who also jointly holds an appointment as Professor of Biostastistics at the University of Chicago.

As we look to make the benefits of sophisticated Bayesian methods ever more accessible to drug developers, we are taking strategic leaps to both bolster our core offerings and streamline their delivery to the market. The release of East Alloy was a tremendous milestone here — effectively removing the daunting computational barriers to more widespread, easy Bayesian method implementation. Partnering with Laiya allows us to smoothly feed into our broad Bayesian software capabilities with ever greater levels of statistical innovation and expertise. Throughout 2021, early phase capabilities like MUCE, i3+3, and other rule-based and model-based Bayesian methods, will be rolled into East Alloy. These new additions will also simplify the formidable process of reading literature, comparing existing methods via extensive simulation, calibrating modeling parameters for optimization, and generating final statistical report for submission and protocol writing.

Watch Yuan Ji’s Webinar to learn more about these new methods.

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As we turn to 2021, the future looks bright. We are excited to continue to build both statistical and collaborative functionality into the Solara platform to better address the pressing needs of the industry. I look forward to extending work we began in 2020 on projects related to Bayesian adaptive designs, master protocols, synthetic control arms and other advanced innovative methods.

I also look forward to continuing our successful webinar series on Bayesian methods, the C-Suite, New Horizons in Clinical Trial Design, and Introduction to Innovative Trial Design. Perhaps, I’ll see you there?