Certara, a provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, has 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 in research projects.
“As the benefits of using Simcyp and PBPK 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 Simcyp President and Managing Director Steve Toon, Ph.D. “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’s 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 PK outcomes in clinical populations. These include vulnerable populations such as pediatric patients, pregnant women, and patients with impaired organ function.
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 FDA, the EMA, 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 pre-competitive 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 powerful modeling and simulation platform.