Certara, a global biosimulation technology-enabled drug development company, has launched Certara Strategic Consulting China in Shanghai. This new company is being led by President and CEO Christine Yuying Gao, M.D., Ph.D., former vice president of consulting services at Quantitative Solutions, a global pharmacometrics consulting company. Quantitative Solutions merged with Certara’s Pharsight Consulting Services in July 2015 to form Certara Strategic Consulting.
“The recent announcement that the China Food and Drug Administration has introduced new procedures for drug registration and approval demonstrates 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. We are delighted to be able to provide biosimulation consulting support for our clients in China,” said Certara Chief Executive Officer Edmundo Muniz, M.D., Ph.D.
Certara Strategic Consulting provides outsourced drug discovery and development modeling and simulation, and strategic pharmacometric services to more than 100 biopharm companies, non-profit foundations, and regulatory agencies worldwide. It also uses model-based meta-analysis to increase drug development productivity, quantitatively inform portfolio management, and improve clinical trial success. In addition, the organization’s unique clinical outcomes databases enable it to analyze the comparative effectiveness of a new drug within its competitive landscape.
“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,” said Dr. Yuying Gao.
Certara Strategic Consulting’s therapeutic areas of expertise include oncology, cardiovascular, orphan/rare diseases, central nervous system, pediatrics, immunology, infectious disease, metabolic and endocrine disease, women’s health, pain, respiratory and ophthalmology.
Dr. Yuying Gao has more than 20 years’ experience in clinical pharmacology research and drug development. She has partnered with more than 50 pharmaceutical companies and modeled more than 100 compounds in clinical development.