Certara launches Simcyp Access

PRINCETON, N.J.—Early in March, Certara, a provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, announced the launch of Simcyp Access. This new cloud-based licensing approach provides trained individuals at smaller pharmaceutical companies (less than 500 employees) with a method for using Certara’s Simcyp population-based simulator (Simcyp Simulator) in research projects.

“As the benefits of using Simcyp and PBPK [physiologically-based pharmacokinetic modeling] have moved from being an ‘academic nicety to a regulatory necessity,’ we recognized that we needed to expand the ways in which scientists can avail themselves of this technology,” said Certara’s Simcyp president and managing director Dr. Steve Toon. “We launched Simcyp Access in response to that need, and to support the growing interest in using PBPK for testing ideas and hypotheses without necessarily specifying a consulting project. There is an increasing number of experienced PBPK modelers within smaller pharmaceutical companies that would like to do their own modeling—Simcyp Access is for them.”

Certara says the Simcyp Simulator is the pharmaceutical industry’s most sophisticated platform for determining first-in-human dose selection, designing more efficient and effective clinical studies, evaluating new drug formulations and predicting drug-drug interactions (DDIs) and pharmacokinetic outcomes in clinical populations. These include vulnerable populations such as pediatric patients, pregnant women and patients with impaired organ function.

Toon tells DDNews, “The simulator offered under Simcyp Access is the Simcyp Simulator; it’s only the method of being able to use the simulator that differs. Heretofore, a sponsor could only gain access to the simulator by joining the Simcyp Consortium and purchasing multiyear licenses. We also provide consulting services where Simcyp scientists use the simulator on behalf of specific drugs for sponsors. Simcyp Access is specifically for smaller organizations that only need to use the simulator on a specific project for a limited time period.”

Employees are considered trained on the Simcyp Simulator if they have attended a Simcyp Workshop within the past three years. This in-depth training helps to ensure that pharmaceutical researchers gain maximum benefit from their modeling and simulation investment and do not generate any spurious results. Simcyp scientists are also available to offer technical support and guidance if required.

The Simcyp Simulator has been widely adopted by pharmaceutical companies and regulatory agencies worldwide. It is employed by the U.S. Food and Drug Administration (FDA), the European Medicines Agency, the Japanese Pharmaceuticals and Medical Devices Agency and China’s Food and Drug Administration. For example, the Simcyp Simulator has been leveraged to inform more than 100 label claims for new drug approvals from FDA in the past few years. These label additions include potential DDIs, dosing regimens and data about new populations.

Most of the top 40 pharmaceutical companies (including all of the top 10) are members of the Simcyp Consortium, meeting in a precompetitive environment to participate in the product’s ongoing development. An additional 70 companies use the simulator for consulting. Simcyp Access provides clients with a third option for using this platform.

“A smaller company is typically working on one or a few drugs in total, and would only need to use the simulator for a short period of time,” Toon tells DDNews. “This is a great return on investment, in terms of time and budget against the huge benefits in knowledge gained via the technology.”

Simcyp Workshops are already scheduled in San Francisco; Krakow, Poland; Princeton, N.J.; and Tokyo in 2017. “The workshops are five days and cover both theory, practice and hands-on technology transfer. They are delivered by a team of Simcyp scientists, led by one of our world-renown PBPK leaders,” notes Toon.

Asked if there will be workshops located in other locales, Toon says, “Should the need for more workshops in 2017 arise, we will evaluate. We also can offer bespoke training.”