Name: New Era of Biomarker-driven Clinical Trials & Regulatory Approvals in US & China
Start: 2019-06-01T18:00:00-05:00
End: 2019-06-01T20:00:00-05:00
Location: Hyatt Regency McCormick Place

New Era of Biomarker-driven Clinical Trials & Regulatory Approvals in US & China

Predicine is a molecular insights company that is committed to biomarker-driven precision medicine. Predicine has developed a breakthrough cfRNA and cfDNA liquid biopsy technology for non-invasive cancer profiling, disease monitoring and assessing minimal residual disease. Through its CLIA and/or CAP facilities in US and China, Predicine partners with leading biopharma companies and hospitals to support global clinical trials and personalized cancer therapy.

Predicine

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New Era of Biomarker-driven Clinical Trials and Regulatory Approvals in US and China
This educational symposium will provide a forward-looking perspective of how biopharma companies could leverage innovations in biomarkers and regulatory initiatives to enable precision clinical trials and concurrent NDA submissions in US and China. 
Recently, both FDA and NMPA encouraged biomarker-driven precision clinical trials and cross-border NDAs, even with clinical data generated solely in one region such as China, US, or EU. This has sparked strong interests for Chinese oncology pharmaceuticals to enter the Western market. Meanwhile, China is becoming the first country to get new drugs approved, ahead of US and EU, further driving the need for global clinical trials.  
A panel of industry leaders and regulatory experts will discuss how technology and regulatory innovation will reshape the global drug development landscape.
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Agenda: 
6:00pm - 6:30pm                                Reception (food and drinks will be served)
6:30pm - 7:30pm                                Welcome and Presentations
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<LI>Liquid biopsy and comprehensive biomarker solutions for global clinical trials - Shidong Jia, CEO, Predicine</LI>
<LI>Cross-border clinical trials and New Drug Applications in U.S and China - Dan Zhang, Executive Chairman, Fountain Medical Development</LI>
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7:30pm - 8:00pm                                Networking
 
How to get to Grand Park A meeting room from McCormick Place:
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New Era of Biomarker-driven Clinical Trials & Regulatory Approvals in US & China

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