Guo Sun

Since 2010 to be Study Physician for Fulvestrant China Registration Study from the initial stage until Imported Drug License (IDL) approval by CFDA, and publication. Co-author for abstract of International Prestigious San Antonio Breast Cancer Symposium 2014. Lead Physician for targeted therapy in Thyroid Cancer and achieved response for HA queries timely and in quality. Global Study Team Physician for one Global Phase 3 Registration Study for US, EU, Japan, China, ect, Targetet therapy in Thyroid Cancer. Analysis and Report: one phase 3 registration study; Reply to China CDE query for four studies based comprehensive safety analysis. CSP: one phase 3 registration study , one phase 1 PK study, One NIS, One Post approval Commitment NIS, one ISS (phase 2, RCT). IDL submission: two submissions; CTP submission: three submissions; CDE Supplementary Submission: one compresensive response within tight timeline and with high quality.

Lead Physician for Targeted therapy in Thyroid Cancer for registration related activities. Lead Physician for PARP inhibitor China development in Ovarian Cancer, Breast Cancer and Gastric Cancer; also for MEK inhibitor China development in Non Small Cell Lung Cancer (NSCLC). NPTL (New Product Team Leader) for 2 important China alone LCM, leading the cross-functional new product development team, including RA, Clinical Operation, Medical, Statistical, etc.

Medical-Mkt related activities: Company TA Summit Meeting, Medical lead Scientiric Meeting, etc. Study Physician for Fulvestrant China Registration Study in BCa since 2010. Lead Phase IV Post Marketing Studies, including ISS and NIS. Medical lead on launch of new products, Faslodex 250mg New Product (1st indication in China) launch at 2011 and Zoladex 10.8mg new dosage launch at 2012.