WALTHAM, MASS - After months of successfully deploying its new strategic decision-support software Solara, Cytel Inc., a leader in the field of clinical trial design and statistical software solutions is opening patent-pending Solara for general release.
Cytel is also simultaneously launching a new program designed specifically for biotech CMOs who lack an in-house statistical design team, or who only run a small number of trials each year. This will include access to Cytel biostatisticians who are equipped with, and trained to use the Solara platform.
Solara enables medical, operational, commercial, and statistical leaders to leverage massive computational power to simulate thousands of possible clinical trial designs in under an hour to identify the most promising options.
Using current technology, exploring each design typically takes several hours. With Solara, biostatisticians can accomplish the same amount of work in a few minutes. This powerful technology enables cross-functional teams to explore an exponentially larger design space to identify alternatives that optimize speed, savings, and probability of success.
Study designs that have been optimized using Solara generate, on average, 10-20% savings in speed, cost, or probability of success. These improvements are driven by the identification of improved combinations of design variables that would rarely have been found through manual exploration.
According to Cytel CEO Joshua Schultz, Solara is a tool for empowering pharma executives during one of the most critical parts of the drug development process: clinical trial design.
“A Phase III clinical trial can easily cost $100 million,” said Schultz, “Choosing the wrong design not only wastes time and money, but it can also easily prevent safe and effective drugs from reaching the patients who need them.
“Current state of the art technology only allows product development teams to explore perhaps a few dozen options out of millions of possibilities. There simply isn’t time to explore every possibility, and this means the best design option is routinely missed.”
Sponsors of new medicines have to make tradeoffs between the speed and cost of a clinical trial. Solara enables biopharma leadership to understand these tradeoffs in a clear, quantitative manner and make decisions that are aligned with business and clinical strategy. During the limited release, drug companies which used Solara reduced the length of clinical trials and their costs by 10-20%.
French biotech company Da Volterra, for example, had a new medicine proven safe and effective in Phase I and II trials, but needed Phase III approval to get to market. Aspiring to a small clinical trial to operate within its budget, the biotech considered a sample size re-estimation design, a sophisticated approach that is more efficient than traditional methods.
After working with a Cytel statistician equipped with Solara, Da Volterra identified a different design that would improve speed, savings and probability of success of the trial even more. This design, which had not yet been identified after several months of exploration, was discovered by Solara within two hours.
“Clinical trial design selection is currently too much like an art and not enough like a science,” said Professor Cyrus Mehta, the acclaimed biostatistician who co-founded Cytel. “Solara, for the first time, will allow pharmaceutical companies to explore millions of options, and make strategic, data-empowered choices. This will allow more safe and effective drugs to get approval and get into the hands of the patients who need them.”
The idea for Solara came from a discussion about building on the success of Cytel’s flagship software product, East, between CEO Joshua Schultz and Chief Scientific Officer Dr. Yannis Jemiai. East is the current industry standard for clinical trial design and is used by the Federal Drug Administration and biostatisticians worldwide, but Schultz and Jemiai felt that non-statisticians within the industry could benefit from more robust collaboration with the statisticians through a data driven approach.
“Many are concerned with the statistical uncertainties of the competitive landscape, the regulatory hurdles, the optimal way to enter the market, not just statisticians,” says Dr. Yannis Jemiai.
Explaining the role that Solara can play, Jemiai adds, “Josh and I realized that if a tool like this could be developed, business and clinical executives can meaningfully channel their strategic insights towards clinical trial design itself, the blueprint on which the rest of the trial will be executed. East has provided our clients with statistical rigor, now Solara will add the strategic rigor.”
After six months of limited release, Solara is now available to the entire pharmaceutical industry in two formats: as a standalone SaaS product, and as part of a consultancy program for smaller companies which lack an in-house biostatistician to lead the clinical trial design process.
About Cytel: Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty years, Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to navigate uncertainty, prove value and make confident, evidence-based decisions. Our experts deliver industry-leading software, data-driven analytics, real-world evidence and strategic consulting. Headquartered in Waltham, Massachusetts, Cytel has more than 1,400 employees across North America, Europe and Asia. For more information about Cytel, please visit us at www.cytel.com. You also can follow us on LinkedIn and Twitter and like us on Facebook.