New Jersey-based Certara said changes in China's healthcare system mean the time is right for it to create a new consultancy based in Shanghai that will help Chinese drugmakers "make the drug development process safer and more efficient."Certara Strategic Consulting China CEO Christine Yuying Gao
The new company will be helmed by CEO Christine Yuying Gao, the former vice president of consulting services at Quantitative Solutions, the pharmacometrics consulting company that merged with Certara's Pharsight Consulting Services in 2015 to form Certara Strategic Consulting.
Certara CEO Edmundo Muniz said in a statement that recent moves by the China Food and Drug Administration to reform the drug registration and approval process demonstrate "China's commitment to increasing innovation in its healthcare system. Biosimulation is an innovation that will not only expedite bringing safer therapies to market, but also will support China's expansion of its fast-track drug approval process."
Certara Strategic Consulting will provide services to help drugmakers model and simulate molecules in the discovery process. It will also use "model-based meta-analysis to increase drug development productivity, quantitatively inform portfolio management, and improve clinical trial success," according to a release.
"We are just starting to see the profound impact that biosimulation, model-based meta-analysis, and comparative effectiveness analysis can have on a drug candidate's development, regulatory review, and clinical application. Certara can assist clients in maximizing their efforts at each of these stages," Gao said in the company's statement.
Certara Strategic Consulting works in a host of drug development sectors including treatments for oncology, cardiovascular problems, orphan drugs, central nervous system treatments, pediatrics, immunology, infectious disease, metabolic and others.
- here's the release