Certara: modeling and simulation to inform 'every phase of drug development'
Peking Union Medical College (PUMC) Hospital in Beijing, China, and Keio University in Tokyo, Japan, are the newest members of the drug development technology company’s global pharmacometrics network, as Phoenix Centers of Excellence.
Phoenix is the company’s software for pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) modeling and simulation. The Phoenix Centers of Excellence routinely publish their work to help benefit other researchers, in addition to acting as an informal scientific advisory group.
“Modeling and simulation (M&S) has already had a profound effect on drug development, but its impact is increasing every day as we learn more about biological science and advance our quantitative capabilities to understand those data,” Ellen Leinfuss, senior vice president at Certara, told Outsourcing-Pharma.com.
“M&S has the ability to inform every phase of the drug development process, from evaluating the viability of a compound emerging from the discovery phase, to informing certain label claims on more than 90% of all novel drug approvals,” she added.
However, she said that in order to “fully leverage” the value of M&S, there needs to be a support system in place with ongoing educational programs to “keep up with the rapid advances in this field.”
“To achieve its full potential, M&S needs to become an integral part of academia, industry and the regulatory process,” said Leinfuss.
'Changing the game'
Regulators use Phoenix software to review submittals, such as investigational new drug and new drug applications. Leinfuss said the United States Food and Drug Administration (FDA) specifically, is a proponent of M&S, calling it “among the enabling approaches to accomplish the envisioned efficiency and effectiveness in drug development.”
The administration has also incorporated M&S into the next PDUFA renewal and routinely asks sponsors to integrate it into their clinical pharmacology programs, Leinfuss explained.
“FDA has equipped its pharmacometrics teams across seven divisions with Certara’s Phoenix software, the same software used by our COE partners for teaching and research,” she added.
Ultimately, Leinfuss said the company is focused on changing the game in drug development “by leveraging the most advanced scientific and quantitative methods to bring new, safer therapies to patients.”
The company is also working on migrating toward precision medicine, focusing on the use of M&S at the point of care.
